fluconazole and vandazole together
 

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Iluca


Iluca may be available in the countries listed below.

Ingredient matches for Iluca Fluconazole

Fluconazole is reported as an ingredient of Iluca in the following countries:

Bangladesh

International Drug Name Search


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Vaginal anti-infectives


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Vaginal anti-infectives are available as creams, pessaries (tablets), gels or solutions to treat either bacterial or fungal vaginal infections. Vaginal antifungal products are used to treat vaginal thrush. Antibacterial vaginal products are used for bacterial infections such as bacterial vaginosis. Other products are used to manage irritation or minor soreness.

See also

Medical conditions associated with vaginal anti-infectives:

AcneBacterial VaginitisCutaneous CandidiasisFungal Infection ProphylaxisOral ThrushPerioral DermatitisRosaceaTinea CorporisTinea CrurisTinea PedisTinea VersicolorVaginal Yeast Infection Drug List:/tags/gyne-lotrimin-cream/
/tags/vandazole/
/tags/monistat-7-cream/
/tags/gynazole-1-cream/
/tags/metrogel-vaginal-gel/
/tags/clindamax-cream/
/tags/derma-gran-af-topical/
/tags/aloe-vesta/
/tags/avc/
/tags/betadine-cream/
/tags/canesten-topical/
/tags/clindacin-p/
/tags/clotrimazole-7/
/tags/desenex-spray/
/tags/fungicure-pump-spray/
/tags/fungoid-kit/
/tags/gyne-sulf/
/tags/micatin-cream/
/tags/micatin-foot-powder/
/tags/micatin-jock-itch/
/tags/micon-7/
/tags/minidyne-solution/
/tags/mitrazol/
/tags/monistat-1-combo-pack-cream/
/tags/mycelex-cream/
/tags/ony-clear/
/tags/polydine-solution/
/tags/secura-antifungal-topical/
/tags/terazol-3-suppositories/
/tags/tetterine-cream/
/tags/trysul/
/tags/v-v-s/

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Vandazole


Generic Name: metronidazole (Vaginal route)

met-roe-NYE-da-zole

Commonly used brand name(s)

In the U.S.

Metrogel-Vaginal Vandazole

In Canada

Flagyl Neo-Metric Nidagel

Available Dosage Forms:

Suppository Gel/Jelly Cream

Therapeutic Class: Antibacterial

Chemical Class: Nitroimidazole

Uses For Vandazole

Metronidazole vaginal is used to treat women with vaginal infections (e.g., bacterial vaginosis).

Metronidazole belongs to the class of medicines known as antibiotics. It works by killing the bacteria or preventing their growth. However, this medicine will not work for vaginal fungus or yeast infections.

This medicine is available only with your doctor's prescription.

Before Using Vandazole

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

In deciding whether to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For vaginal metronidazole, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies on the relationship of age to the effects of metronidazole vaginal gel have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for bacterial vaginosis in teenage females but should not be used before the start of menstruation.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of metronidazole vaginal gel in the elderly.

Pregnancy Pregnancy Category Explanation All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Amprenavir Disulfiram

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Amiodarone Busulfan Fluorouracil Mycophenolate Mofetil Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Carbamazepine Cholestyramine Cyclosporine Lithium Milk Thistle Tacrolimus Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Aseptic meningitis, history of or Encephalopathy (brain disorder), history of or Leukopenia (low white blood cells), history of or Optic neuropathy (eye disease with vision changes), history of or Peripheral neuropathy (nerve disease with pain, numbness, or tingling), history of or Seizures or epilepsy, history of—Use with caution. May make these conditions worse. Liver disease, severe—Patients with severe liver disease may have an increase in side effects. Proper Use of metronidazole

This section provides information on the proper use of a number of products that contain metronidazole. It may not be specific to Vandazole. Please read with care.

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine is to be used only in the vagina. Use it at bedtime, unless your doctor tells you otherwise.

Do not get it in your eyes, nose, mouth, or skin. If this medicine does get into your eyes, wash them out right away with large amounts of cool tap water. If your eyes still burn or are painful, check with your doctor.

This medicine usually come with patient directions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Wash your hands with soap and water before and after using this medicine.

Metronidazole vaginal gel is in a tube. You will use an applicator to put the gel into your vagina. The applicator has a plastic tube called a barrel that is open at one end and has a plunger (another piece of plastic that can move inside the barrel) at the other end.

To fill the applicator: For cream or gel dosage forms: Break the metal seal at the opening of the tube by using the point on the top of the cap. Screw the applicator onto the tube. Squeeze the medicine into the applicator slowly until it is full. Remove the applicator from the tube. Replace the cap on the tube. For vaginal tablet dosage form: Place the vaginal tablet into the applicator. Wet the vaginal tablet with water for a few seconds. To insert vaginal metronidazole using the applicator For all dosage forms: Relax while lying on your back with your knees bent (or in any position that you feel comfortable). Hold the full applicator in one hand. Insert it slowly into the vagina. Stop before it becomes uncomfortable. Slowly press the plunger until it stops. Withdraw the applicator. The medicine will be left behind in the vagina. Remove the applicator from your vagina. Use each applicator only once, and then throw it away.

To help clear up your infection completely, it is very important that you keep using this medicine for the full time of treatment, even if your symptoms begin to clear up after a few days. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses. Also, continue using this medicine even if your menstrual period starts during the time of treatment.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For bacterial vaginal infections: For vaginal dosage form (cream): Adults and teenagers—One applicatorful (500 milligrams [mg]), inserted into the vagina. Use the medicine one or two times a day for 10 or 20 days. Children—Use and dose must be determined by your doctor. For vaginal dosage form (gel): Adults and teenagers—One applicatorful (5000 milligrams [mg]) inserted into the vagina once a day (at bedtime) for 5 days. Each applicatorful contains 37.5 mg of metronidazole. Children—Use and dose must be determined by your doctor. For vaginal dosage form (tablets): Adults and teenagers—One 500 milligram (mg) tablet, inserted high into the vagina. Use the medicine once a day in the evening for 10 or 20 days. Children—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Vandazole

It is important that your doctor check your progress after you finish using this medicine. This is to make sure that the infection is cleared up.

If your symptoms do not improve within a few days after you start this medicine or if they become worse, check with your doctor.

You should not use this medicine if you have taken disulfiram (Antabuse®) within the last 2 weeks. Disulfiram is used to help people who have a drinking problem. If these 2 medicines are taken close together, serious unwanted effects may occur.

Drinking alcoholic beverages while using this medicine may cause stomach pain, nausea, vomiting, headache, or flushing or redness of the face. Alcohol-containing medicines (e.g., elixirs, cough syrups, tonics) may also cause problems. The chance of these problems occurring may continue for at least a day after you stop using metronidazole. You should not drink alcoholic beverages or take other alcohol-containing medicines while you are using this medicine and for at least 3 days after stopping it.

Stop using this medicine and check with your doctor right away if you have dizziness, problems with muscle control or coordination, shakiness or an unsteady walk, slurred speech, or trouble with speaking. These may be symptoms of a serious brain condition called encephalopathy.

Stop using this medicine and call your doctor right away if you have confusion, drowsiness, fever, a general feeling of illness, a headache, loss of appetite, nausea, a stiff neck or back, or vomiting. These could be symptoms of a serious condition called aseptic meningitis.

Stop using this medicine and check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

This medicine may cause some people to become dizzy or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert. If these reactions are especially bothersome, check with your doctor.

Vaginal medicines usually leak out of the vagina during treatment. To keep the medicine from getting on your clothing, wear a mini-pad or sanitary napkin. Do not use tampons (like those used for menstrual periods) since they may soak up the medicine.

To help clear up your infection completely and to help make sure it does not return, good health habits are also required.

Wear cotton panties (or panties or pantyhose with cotton crotches) instead of synthetic (e.g., nylon or rayon) panties. Wear only freshly washed panties daily.

Do not have sexual intercourse while you are using this medicine. Having sexual intercourse may reduce the strength of the medicine. This may keep the medicine from working properly. Also, oils in the cream and vaginal tablets (but not the vaginal gel) may damage latex (rubber) contraceptive devices (e.g., cervical caps, condoms, or diaphragms), causing them to leak, wear out sooner, or not work properly.

Avoid using douches or other vaginal products unless your doctor tells you to.

Many vaginal infections (e.g., trichomoniasis) are spread by having sexual intercourse. You can give the infection to your sexual partner, and the infection could be given back to you. Your partner may also need to be treated for some infections. Until you are sure that the infection is completely cleared up after your treatment with this medicine, your partner should wear a condom during sexual intercourse . If you have any questions about this, check with your doctor.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Vandazole Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Itching in the vagina pain during sexual intercourse thick, white vaginal discharge with no odor or with a mild odor Less common Abdominal or stomach cramping or pain burning on urination or need to urinate more often burning or irritation of penis of sexual partner itching, stinging, or redness of the genital area

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common Diarrhea dizziness or lightheadedness dryness of the mouth feeling of a furry tongue headache loss of appetite metallic taste or other change in taste sensation nausea vomiting

Metronidazole may cause your urine to become dark. This is harmless and will go away when you stop using this medicine.

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Any vaginal or genital irritation or itching pain during sexual intercourse thick, white vaginal discharge not present before treatment, with no odor or with a mild odor

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Vandazole side effects (in more detail)

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More Vandazole resources Vandazole Side Effects (in more detail) Vandazole Use in Pregnancy & Breastfeeding Vandazole Drug Interactions Vandazole Support Group 2 Reviews for Vandazole - Add your own review/rating Vandazole Prescribing Information (FDA) Vandazole Concise Consumer Information (Cerner Multum) MetroCream Cream MedFacts Consumer Leaflet (Wolters Kluwer) MetroCream Concise Consumer Information (Cerner Multum) MetroCream Prescribing Information (FDA) MetroGel Prescribing Information (FDA) Metrocream Metrolotion Noritate Prescribing Information (FDA) Rozex Emulsion MedFacts Consumer Leaflet (Wolters Kluwer) Vitazol Prescribing Information (FDA) Compare Vandazole with other medications Bacterial Vaginitis
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MetroGel-Vaginal


Generic Name: metronidazole vaginal (MET roe NYE da zole)
Brand Names: MetroGel-Vaginal, Vandazole

What is MetroGel-Vaginal (metronidazole vaginal)?

Metronidazole is an antibiotic that fights bacteria in the body.

Metronidazole vaginal is used to treat vaginal infections caused by bacteria.

Metronidazole vaginal may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about MetroGel-Vaginal (metronidazole vaginal)?

Do not use metronidazole vaginal if you have ever had an allergic reaction to it.

Before using metronidazole vaginal, tell your doctor if you have liver disease, a seizure disorder, problems with circulation (such as Raynaud's syndrome), or if you have taken disulfiram (Antabuse) within the past 14 days.

Avoid having sex until your vaginal infection has been completely treated and you have finished using the medication.

Avoid using other vaginal creams or douches at the same time as metronidazole vaginal unless your doctor approves.

Use metronidazole vaginal for the entire length of time prescribed by your doctor, even during your menstrual period. Your symptoms may get better before the infection is completely treated. If the infection does not clear up after you have finished one course of therapy, or if your symptoms get worse, see your doctor. You may have another type of infection that metronidazole will not treat. What should I discuss with my doctor before using MetroGel-Vaginal (metronidazole vaginal)?

Do not use metronidazole vaginal if you have ever had an allergic reaction to it.

Before using metronidazole vaginal, tell your doctor if you are allergic to any drugs, or if you have:

liver disease;

a seizure disorder; or

problems with circulation (such as Raynaud's syndrome).

If you have any of these conditions, you may need a dose adjustment or special tests to safely use metronidazole vaginal.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Metronidazole vaginal may pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use MetroGel-Vaginal (metronidazole vaginal)?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor.

Wash your hands before and after using this medication.

Insert the cream into your vagina using the applicator as directed.

Your medication may come with disposable applicators. Use each applicator for only 1 day and then throw it away. If you use the medication twice daily, wash and rinse the applicator after your morning dose and use it again for your evening dose. Then throw it away and use a new applicator the next day.

Use metronidazole vaginal for the entire length of time prescribed by your doctor, even during your menstrual period. Your symptoms may get better before the infection is completely treated.

If the infection does not clear up after you have finished one course of therapy, or if your symptoms get worse, see your doctor. You may have another type of infection that metronidazole will not treat.

You may need to use a sanitary napkin during treatment, but do not use a tampon.

Metronidazole vaginal can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using this medication.

Store metronidazole vaginal at room temperature away from moisture or heat. Do not allow it to freeze. What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of metronidazole applied in the vagina is not expected to produce life-threatening symptoms.

What should I avoid while using MetroGel-Vaginal (metronidazole vaginal)? Avoid getting this medication in your eyes, nose, or mouth. If it does get into any of these areas, rinse with plenty of cool water.

Avoid wearing tight-fitting, synthetic clothing such as nylon underwear or panty hose that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until your infection is healed.

Avoid having sex until your vaginal infection has been completely treated and you have finished using the medication.

Avoid using other vaginal creams or douches at the same time as metronidazole vaginal unless your doctor approves.

Avoid drinking alcohol while you are using metronidazole vaginal. MetroGel-Vaginal (metronidazole vaginal) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Rare but serious side effects may include:

seizure (convulsions); or

numbness, burning, pain, or tingly feeling in your hands or feet.

Less serious side effects may include:

mild burning or stinging when the medication is applied;

pelvic pain or cramps;

loss of appetite, constipation, upset stomach, vomiting;

dizziness, sleep problems (insomnia);

runny nose;

urinating more than usual;

acne, increased sweating; or

breast discharge or enlargement.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect MetroGel-Vaginal (metronidazole vaginal)?

Tell your doctor if you have taken disulfiram (Antabuse) within the past 14 days. Also tell your doctor if you are using:

cimetidine (Tagamet);

lithium (Eskalith, Lithobid, Lithonate); or

a blood thinner such as warfarin (Coumadin).

There may be other drugs that can interact with metronidazole vaginal. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More MetroGel-Vaginal resources MetroGel-Vaginal Side Effects (in more detail) MetroGel-Vaginal Use in Pregnancy & Breastfeeding MetroGel-Vaginal Drug Interactions MetroGel-Vaginal Support Group 3 Reviews for MetroGel-Vaginal - Add your own review/rating MetroCream Cream MedFacts Consumer Leaflet (Wolters Kluwer) MetroCream Prescribing Information (FDA) MetroGel Prescribing Information (FDA) Metrocream Metrocream Topical Advanced Consumer (Micromedex) - Includes Dosage Information Metrogel-Vaginal Advanced Consumer (Micromedex) - Includes Dosage Information Metrolotion Noritate Prescribing Information (FDA) Rozex Emulsion MedFacts Consumer Leaflet (Wolters Kluwer) Vandazole Prescribing Information (FDA) Vitazol Prescribing Information (FDA) Compare MetroGel-Vaginal with other medications Bacterial Vaginitis Where can I get more information? Your pharmacist can provide more information about metronidazole vaginal.

See also: MetroGel-Vaginal side effects (in more detail)


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Fluconazole 50 mg capsules


1. Name Of The Medicinal Product

Fluconazole 50 mg capsules, hard

2. Qualitative And Quantitative Composition

Each capsule, hard contains 50 mg fluconazole.

Excipient: 50.56 mg lactose/hard capsule

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Capsules, hard

Size '4' hard gelatin capsule filled with white to off-white powder and imprinted with 'E' on white to off-white opaque cap and '95' on white to off-white opaque body with yellow ink.

4. Clinical Particulars 4.1 Therapeutic Indications

Acute or recurrent vaginal candidiasis when systemic therapy is considered appropriate.

Mucosal candidal infection. These include oropharyngeal, oesophageal, mucocutaneous and non-invasive bronchopulmonary candidiasis and candiduria, in patients with compromised immune function.

Systemic candidiasis in non-neutropenic patients.

Acute cryptococcal meningitis in adults. Fluconazole can be used as maintenance therapy to prevent relapse of cryptococcal disease in patients with AIDS.

Prophylaxis of deep-seated candida infections (particularly Candida albicans) in patients with neutropenia due to bone marrow transplantation.

Consideration should be given to official guidance on the appropriate use of antifungal agents.

Paediatric use

Not all indications are applicable for paediatric patients; see details in section 4.2.

Fluconazole should not be used for tinea captis.

4.2 Posology And Method Of Administration

Oral use, capsules should be swallowed whole, independent of food intake.

The dose is depending on the type and severity of the fungal infection. The treatment of infections requiring multiple dosing must be continued until clinical parameters or laboratory results show that the active fungal infection has declined. An insufficient treatment period may lead to recurrence of the active infection.

Depending on the severity of the disease and the clinical state of the patients intravenous administration may be required. It is not necessary to change the daily dose of fluconazole when changing the route of administration from intravenous to oral.

Adults:

Vaginal candidiasis: 150 mg as a single dose.

Mucous membrane candidiasis:

Oropharyngeal candidiasis: Normal daily dose: 50-100 mg for 7-14 days. Duration of treatment depends on clinical response.

Oesophageal mucocutaneous, non-invasive bronchopulmonary candidiasis and candiduria: Normal dose is 50 mg daily for 14-30 days. In severe and particular recurrent cases the dose can be increased to 100 mg.

Systemic candidiasis:

The dose in candidaemia and other invasive Candida infections is 400-800 mg on the first day and 200-400 mg daily thereafter. The dose depends on the type and severity of the infection. In most cases a loading dose of 800 mg on the first day followed by 400 mg daily thereafter may be preferable. The duration of treatment, often up to several weeks, is determined by the clinical response.

Prevention of candida infections in neutropenic patients:

400 mg once daily. Prophylaxis with fluconazole should begin in time before the appearance of expected neutropenia. Treatment should be continued for 7 days after the neutrophil counts have increased to > 1x109/ l.

Cryptococcal meningitis in immunosuppressed patients: For infections with cryptococcal meningitis the usual dose is 400 mg on the first day followed by 200-400 mg once daily. Duration of treatment for cryptococcal infections depends on the clinical response, but is usually at least 6-8 weeks for cryptococcal meningitis.

For the prevention of relapse of cryptococcal meningitis in patients with AIDS, fluconazole may be administered at a daily dose of 200 mg.

Duration of maintenance treatment in AIDS patients should be carefully justified, because of the increased risk of resistance to fluconazole.

Paediatric use:

As with similar infections in adults, the duration of treatment is based on the clinical and mycological response. Fluconazole is administered as a single daily dose.

The capsules formulation may be unsuitable for children younger than 5-6 years.

For children with impaired renal function, see dosing in “Use in patients with impaired renal function”.

Children over four weeks of age:

The recommended dose of fluconazole for mucosal candidiasis is 3 mg/kg daily. A loading dose of 6 mg/kg may be used on the first day to achieve steady state levels more rapidly.

For the treatment of systemic candidiasis and cryptococcal infection, the recommended dosage is 6 - 12 mg/kg daily, depending on the severity of the disease.

For the prevention of fungal infections in immunocompromised patients considered at risk as a consequence of neutropenia following cytotoxic chemotherapy or radiotherapy, the dose should be 3 - 12 mg/kg daily, depending on the extent and duration of the induced neutropenia (see adult dosing).

A maximum dosage of 400 mg daily should not be exceeded in children.

Children four weeks of age and younger:

Neonates excrete fluconazole slowly. In the first two weeks of life the same mg/kg dosing as in older children should be used but administered every 72 hours. During weeks 3 - 4 of life the same dose should be given every 48 hours. There are few PK data to support this Posology in term newborn babies (see section 5.2).

A maximum dosage of 12 mg/kg every 72 hours should not be exceeded in children below two weeks of life. For children between 3 - 4 weeks of life 12 mg/kg every 48 hours should not be exceeded.

The pharmacokinetics of fluconazole has not been studied in children with renal insufficiency.

Use in the elderly

The normal dose should be used if there is no evidence of renal impairment. In patients with renal impairment (creatinine clearance less than 50 ml/min) the dosage schedule should be adjusted as described below.

Use in patients (adults and paediatric) with impaired renal function

Fluconazole is excreted predominantly in the urine as unchanged drug. No adjustments in single dose therapy are required. In patients with impaired renal function who will receive multiple doses of fluconazole, the normal recommended dose (according to indication) should be given on day 1 and 2, followed by a daily dose based on the following table:

Creatinine clearance (ml/min.)

Percentage of recommended dose

>50

100%

50%

Regular dialysis

100% after each dialysis

The pharmacokinetics of fluconazole has not been studied in children with renal insufficiency.

4.3 Contraindications

• Hypersensitivity to fluconazole or to related azole compounds or to any of the excipients.

• Co-administration of terfenadine is contra-indicated in patients receiving fluconazole at multiple doses of 400 mg per day or higher based upon results of a multiple dose interaction study.

• Co-administration of other drugs known to prolong the QT interval and which are metabolised via the enzyme CYP3A4 such as cisapride, astemizole, pimozide and quinidine are contra-indicated in patients receiving fluconazole (see sections 4.4 and 4.5).

4.4 Special Warnings And Precautions For Use

Fluconazole should be administered with caution to patients with liver dysfunction (see also section 4.2).

Fluconazole has been associated with rare cases of serious hepatic toxicity including fatalities, primarily in patients with serious underlying medical conditions. In cases of fluconazole-associated hepatotoxicity, no obvious relationship to total daily dose, duration of therapy, sex or age of patient has been observed. Fluconazole hepatotoxicity has usually been reversible on discontinuation of therapy.

Patients who develop abnormal liver function tests during fluconazole therapy should be monitored for the development of more serious hepatic injury. Fluconazole should be discontinued if clinical signs or symptoms consistent with liver disease develop that may be attributable to fluconazole.

Patients have rarely developed exfoliative cutaneous reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, during treatment with fluconazole. AIDS patients are more prone to the development of severe cutaneous reactions to many drugs. If a rash, which is considered attributable to fluconazole, develops in a patient treated for a superficial fungal infection, further therapy with this agent should be discontinued. If patients with invasive/systemic fungal infections develop rashes, they should be monitored closely and fluconazole discontinued if bullous lesions or erythema multiforme develop.

The coadministration of fluconazole at doses lower than 400 mg per day with terfenadine should be carefully monitored (see sections 4.3 and 4.5).

In rare cases, as with other azoles, anaphylaxis has been reported.

Some azoles, including fluconazole, have been associated with prolongation of the QT interval on the electrocardiogram. During post-marketing surveillance, there have been very rare cases of QT prolongation and torsade de pointes in patients taking fluconazole. These reports included seriously ill patients with multiple confounding risk factors, such as structural heart disease, electrolyte abnormalities and concomitant medications that may have been contributory.

Fluconazole should be administered with caution to patients with these potentially proarryhthmic conditions.

Fluconazole should be administered with caution to patients with renal dysfunction (see also 4.2).

Fluconazole is a potent CYP2C9 inhibitor and a moderate CYP3A4 inhibitor. Fluconazole treated patients who are concomitantly treated with drugs with a narrow therapeutic window metabolised through CYP2C9 and CYP3A4, should be monitored (see section 4.5).

This medicinal product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concomitant use of the following other medicinal products is contraindicated:

Cisapride: There have been reports of cardiac events including Torsades de pointes in patients to whom fluconazole and cisapride were co-administered. A controlled study found that concomitant fluconazole 200 mg once daily and cisapride 20 mg four times a day yielded a significant increase in cisapride plasma levels and prolongation of QT interval. Concomitant treatment with fluconazole and Cisapride is contra-indicated (see section 4.3).

Terfenadine: Because of the occurrence of serious cardiac dysrhythmias secondary to prolongation of the QTc interval in patients receiving azole antifungals in conjunction with terfenadine, interaction studies have been performed. One study at a 200 mg daily dose of fluconazole failed to demonstrate a prolongation in QTc interval. Another study at a 400 mg and 800 mg daily dose of fluconazole demonstrated that fluconazole taken in doses of 400 mg per day or greater significantly increases plasma levels of terfenadine when taken concomitantly. The combined use of fluconazole at doses of 400 mg or greater with terfenadine is contraindicated (see section 4.3). The coadministration of fluconazole at doses lower than 400 mg per day with terfenadine should be carefully monitored.

Astemizole: Concomitant administration of fluconazole with astemizole may decrease the clearance of astemizole. Resulting increased plasma concentrations of astemizole can lead to QT prolongation and rare occurrences of torsade de pointes. Coadministration of fluconazole and astemizole is contraindicated.

Pimozide: Although not studied in vitro or in vivo, concomitant administration of fluconazole with pimozide may result in inhibition of pimozide metabolism. Increased pimozide plasma concentrations can lead to QT prolongation and rare occurrences of torsade de pointes. Coadministration of fluconazole and pimozide is contraindicated.

Concomitant use of the following other medicinal products cannot be recommended:

Erythromycin: Concomitant use of fluconazole and erythromycin has the potential to increase the risk of cardiotoxicity (prolonged QT interval, Torsades de Pointes) and consequently sudden heart death. This combination should be avoided.

Concomitant use of the following other medicinal products lead to precautions and dose adjustments:

The effect of other medicinal products on fluconazole

Hydrochlorothiazide: In a pharmacokinetic interaction study, coadministration of multiple-dose hydrochlorothiazide to healthy volunteers receiving fluconazole increased plasma concentrations of fluconazole by 40%. An effect of this magnitude should not necessitate a change in the fluconazole dose regimen in subjects receiving concomitant diuretics, although the prescriber should bear it in mind.

Rifampicin: Concomitant administration of fluconazole and rifampicin resulted in a 25% decrease in the AUC and a 20% shorter half-life of fluconazole. In patients receiving concomitant rifampicin, an increase of the fluconazole dose should be considered.

The effect of fluconazole on other medicinal products

Fluconazole is a potent inhibitor of cytochrome P450 (CYP) isoenzyme 2C9 and a moderate inhibitor of CYP3A4. In addition to the observed /documented interactions mentioned below, there is a risk of increased plasma concentration of other compounds metabolized by CYP2C9 and CYP3A4 co-administered with fluconazole. Therefore caution should be exercised when using these combinations and the patients should be carefully monitored. The enzyme inhibiting effect of fluconazole persists 4- 5 days after discontinuation of fluconazole treatment due to the long half-life of fluconazole (See section 4.3).

Alfentanil: A study observed a reduction in clearance and distribution volume as well as prolongation of T? of alfentanil following concomitant treatment with fluconazole. A possible mechanism of action is fluconazole's inhibition of CYP3A4. Dosage adjustment of alfentanil may be necessary.

Amitriptyline, nortriptyline: Fluconazole increases the effect of amitriptyline and nortriptyline. 5- nortriptyline and/or S-amitnptyline may be measured at initiation of the combination therapy and after one week. Dosage of amitriptyline/nortriptyline should be adjusted, if necessary

Amphotericine B: Concurrent administration of fluconazole and amphotericin B in infected normal and immunosuppressed mice showed the following results: a small additive antifungal effect in systemic infection with C. albicans, no interaction in intracranial infection with Cryptococcus neoformans, and antagonism of the two drugs in systemic infection with A. fumigatus. The clinical significance of results obtained in these studies is unknown.

Anticoagulants: In an interaction study, fluconazole increased the prothrombin time (12%) after warfarin administration in healthy males. In post-marketing experience, as with other azole antifungals, bleeding events (bruising, epistaxis, gastrointestinal bleeding, hematuria, and melena) have been reported, in association with increases in prothrombin time in patients receiving fluconazole concurrently with warfarin. Prothrombin time in patients receiving coumarin-type anticoagulants should be carefully monitored. Dose adjustment of warfarin may be necessary.

Azithromycin: An open-label, randomized, three-way crossover study in 18 healthy subjects assessed the effect of a single 1200 mg oral dose of azithromycin on the pharmacokinetics of a single 800 mg oral dose of fluconazole as well as the effects of fluconazole on the pharmacokinetics of azithromycin. There was no significant pharmacokinetic interaction between fluconazole and azithromycin.

Benzodiazepines (Short Acting): Following oral administration of midazolam, fluconazole resulted in substantial increases in midazolam concentrations and psychomotor effects. This effect on midazolam appears to be more pronounced following oral administration of fluconazole than with fluconazole administered intravenously. If concomitant benzodiazepine therapy is necessary in patients being treated with fluconazole, consideration should be given to decreasing the benzodiazepine dosage, and the patients should be appropriately monitored.

Fluconazole increases the AUC of triazolam (single dose) by approximately 50%, Cmax with 20-32% and increases t? by 25-50 % due to the inhibition of metabolism of triazolam. Dosage adjustments of triazolam may be necessary.

Carbamazepine: Fluconazole inhibits the metabolism of carbamazepine and an increase in serum carbamazepine of 30% has been observed. There is a risk of developing carbamazepine toxicity. Dosage adjustment of carbamazepine may be necessary depending on concentration measurements/effect.

Calcium Channel Blockers: Certain dihydropyridine calcium channel antagonists (nifedipine, isradipine, amlodipine and felodipine) are metabolized by CYP3A4. Fluconazole has the potential to increase the systemic exposure of the calcium channel antagonists. Frequent monitoring for adverse events is recommended.

Celecoxib: During concomitant treatment with fluconazole (200 mg daily) and celecoxib (200 mg) the celecoxib Cmax and AUC increased by 68% and 134%, respectively. Half of the celecoxib dose may be necessary when combined with fluconazole.

Ciclosporin: Fluconazole significantly increases the concentration and AUC of ciclosporin. This combination may be used by reducing the dosage of ciclosporin depending on ciclosporin concentration.

Cyclophosphamide: Combination therapy with cyclophosphamide and fluconazole results in an increase in serum bilirubin and serum creatinine. The combination may be used while taking increased consideration to the risk of increased serum bilirubin and serum creatinine.

Fentanyl: One fatal case of possible fentanyl fluconazole interaction was reported. The author judged that the patient died from fentanyl intoxication. Furthermore, in a randomized crossover study with twelve healthy volunteers it was shown that fluconazole delayed the elimination of fentanyl significantly. Elevated fentanyl concentration may lead to respiratory depression.

Halofantrine: Fluconazole can increase halofantrine plasma concentration due to an inhibitory effect on CYP3A4.

HMG-CoA reductase inhibitors: The risk of myopathy and rhabdomyolysis increases when fluconazole is coadministered with HMG-CoA reductase inhibitors metabolised through CYP3A4, such as atorvastatin and simvastatin, or through CYP2C9, such as fluvastatin. If concomitant therapy is necessary, the patient should be observed for symptoms of myopathy and rhabdomyolysis and creatinine kinase should be monitored. HMG-CoA reductase inhibitors should be discontinued if a marked increase in creatinine kinase is observed or myopathy/rhabdomyolysis is diagnosed or suspected.

Losartan: Fluconazole inhibits the metabolism of losartan to its active metabolite (E-31 74) which is responsible for most of the angiotensin Il-receptor antagonism which occurs during treatment with losartan. Patients should have their blood pressure monitored continuously.

Methadone: Fluconazole may enhance the serum concentration of methadone. Dosage adjustment of methadone may be necessary.

Non-steroidal anti-inflammatory drugs: The Cmax and AUC of flurbiprofen was increased by 23% and 81%, respectively, when coadministered with fluconazole compared to administration of flurbiprofen alone. Similarly, the Cmax and AUC of the pharmacologically active isomer [S-(+)-ibuprofen] was increased by 15% and 82%, respectively, when fluconazole was coadministered with racemic ibuprofen (400 mg) compared to administration of racemic ibuprofen alone.

Although not specifically studied, fluconazole has the potential to increase the systemic exposure of other NSAIDs that are metabolized by CYP2C9 (e.g. naproxen, lornoxicam, meloxicam, diclofenac). Frequent monitoring for adverse events and toxicity related to NSAIDs is recommended. Adjustment of dosage of NSAIDs may be needed.

Oral Contraceptives: Two pharmacokinetic studies with a combined oral contraceptive have been performed using multiple doses of fluconazole. There were no relevant effects on hormone level in the 50 mg fluconazole study, while at 200 mg daily, the AUCs of ethinyl estradiol and levonorgestrel were increased 40% and 24%, respectively. Thus, multiple dose use of fluconazole at these doses is unlikely to have an effect on the efficacy of the combined oral contraceptive.

Phenytoin: Fluconazole inhibits the hepatic metabolism of phenytoin. With coadministration, serum phenytoin concentration levels should be monitored in order to avoid phenytoin toxicity.

Prednisone: There was a case report that a liver-transplanted patient treated with prednisone developed acute adrenal cortex insufficiency when a three month therapy with fluconazole was discontinued. The discontinuation of fluconazole presumably caused an enhanced CYP3A4 activity which led to increased metabolism of prednisone. Patients on long-term treatment with fluconazole and prednisone should be carefully monitored for adrenal cortex insufficiency when fluconazole is discontinued.

Rifabutin: Fluconazole increases serum concentrations of rifabutin, leading to increase in the AUC of rifabutin up to 80%. There have been reports of uveitis in patients to whom fluconazole and rifabutin were coadministered. In combination therapy, symptoms of rifabutin toxicity should be taken into consideration.

Saquinavir: Fluconazole increases the AUC of saquinavir with approximately 50%, Cmax with approximately 55% and decreases clearance of saquinavir with approximately 50% due to inhibition of saquinavir's hepatic metabolism by CYP3A4 and inhibition of P-glycoprotein. Dosage adjustment of saquinavir may be necessary.

Sirolimus: Fluconazole increases plasma concentrations of sirolimus presumably by inhibiting the metabolism of sirolimus via CYP3A4 and P-glycoprotein. This combination may be used with a dosage adjustment of sirolimus depending on the effect/concentration measurements.

Sulfonylureas: Fluconazole has been shown to prolong the serum half-life of concomitantly administered oral sulfonylureas (e.g., chlorpropamide, glibenclamide, glipizide, tolbutamide) in healthy volunteers. Frequent monitoring of blood glucose and appropriate reduction of sulfonylurea dosage is recommended during coadministration.

Tacrolimus: Fluconazole may increase the serum concentrations of orally administered tacrolimus up to 5 times due to inhibition of tacrolimus metabolism through CYP3A4 in the intestines. No significant pharmacokinetic changes have been observed when tacrolimus is given intravenously. Increased tacrolimus levels have been associated with nephrotoxicity. Dosage of orally administered tacrolimus should be decreased depending on tacrolimus concentration.

Theophylline: In a placebo controlled interaction study, the administration of fluconazole 200 mg for 14 days resulted in an 18% decrease in the mean plasma clearance rate of theophylline. Patients who are receiving high dose theophylline or who are otherwise at increased risk for theophylline toxicity should be observed for signs of theophylline toxicity while receiving fluconazole. Therapy should be modified if signs of toxicity develop.

Vinca Alkaloids: Although not studied, fluconazole may increase the plasma levels of the vinca alkaloids (e.g. vincristine and vinblastine) and lead to neurotoxicity, which is possibly due to an inhibitory effect on CYP3A4.

Vitamin A: Based on a case-report in one patient receiving combination therapy with all-trans-retinoid acid (an acid form of vitamin A) and fluconazole, CNS related undesirable effects have developed in the form of pseudotumour cerebri, which disappeared after discontinuation of fluconazole treatment. This combination may be used but the incidence of CNS related undesirable effects should be borne in mind.

Zidovudine: Fluconazole increases Cmax and AUC of zidovudine by 85% and 75%, respectively, due to an approx. 45% decrease in oral zidovudine clearance. The half-life of zidovudine was likewise prolonged by approximately 128% following combination therapy with fluconazole. Patients receiving this combination should be monitored for the development of zidovudine-related adverse reactions. Dosage reduction of zidovudine may be considered.

Interaction studies have shown that when oral fluconazole is coadministered with food, cimetidine, antacids or following total body irradiation for bone marrow transplantation, no clinically significant impairment of fluconazole absorption occurs.

4.6 Pregnancy And Lactation

Pregnancy

Data from several hundred pregnant women treated with standard doses (<200 mg/day) of fluconazole, administered as a single or repeated dosage in the first trimester, show no undesired effects in the foetus.

There have been reports of multiple congenital abnormalities in infants whose mothers were treated for at least three or more months with high doses (400-800 mg daily) of fluconazole for coccidioidomycosis. The relationship between fluconazole use and these events is unclear.

Animal studies show teratogenic effects (see section 5.3).

Use in pregnancy should be avoided except in patients with severe or potentially life-threatening fungal infections in whom fluconazole may be used if the anticipated benefit outweighs the possible risk to the fetus.

Lactation

Fluconazole is found in human breast milk at concentrations similar to plasma, hence its use in nursing mothers is not recommended.

4.7 Effects On Ability To Drive And Use Machines

Fluconazole has no or negligible influence on the ability to drive and use machines.

However when driving vehicles or operating machines it should be taken into account that occasionally dizziness or seizures may occur.

4.8 Undesirable Effects

Fluconazole is generally well tolerated.

In some patients, particularly those with serious underlying diseases such as AIDS and cancer, changes in renal and hematological function test results and hepatic abnormalities (see section 4.4) have been observed during treatment with fluconazole and comparative agents, but the clinical significance and relationship to treatment is uncertain.

The following frequency data are used in the evaluation of undesirable effects:

Very common: (

Common: (

Uncommon: (

Rare (

Very rare (< 1/10,000, not known (cannot be estimated from the available data)

System Organ Class

Frequency

Undesirable effects

Blood and the lymphatic system disorders

Rare

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia

Immune system disorders

Rare

Anaphylaxis

Metabolism and nutrition disorders

Uncommon

Hypokalaemia

Rare

Hypertriglyceredaemia, hypercholesterolaemia

 

Psychiatric disorders

Uncommon

Insomnia, somnolence

Nervous system disorders

Common

Headache

Uncommon

Seizures, dizziness, paraesthesia, taste perversion

   

Rare

Tremor

Ear and labyrinth disorders

Uncommon

Vertigo

Cardiac disorders

Rare

Torsade de pointes, QT prolongation

Gastrointestinal disorders

Common

Abdominal pain, diarrhoea, nausea, vomiting

Uncommon

Dyspepsia, flatulence, dry mouth

 

Hepato-biliary disorders

Common

Alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased

Uncommon

Cholestasis, jaundice, bilirubin increased

 

Rare

Hepatic failure, hepatocellular necrosis, hepatitis, hepatocellular damage

 

Skin and subcutaneous tissue disorders

Common

Rash

Uncommon

Pruritus, urticaria, increased sweating, drug eruption

 

Rare

Toxic epidermal necrolysis , Stevens-Johnson syndrome, acute generalised exanthematous-pustulosis, dermatitis exfoliative, angioedema, face oedema, alopecia

 

Musculoskeletal, connective tissue and bone disorders

Uncommon

Myalgia

General disorders and administration site conditions

Uncommon

Fatigue, malaise, asthenia, fever

Pediatric population: The pattern and incidence of side effects and laboratory abnormalities recorded during paediatric use are comparable to those seen in adults.

4.9 Overdose

Symptoms:

There have been reports of overdose with fluconazole and hallucination and paranoid behaviour have been concomitantly reported.

Treatment:

In the event of overdose, symptomatic treatment (with supportive measures and gastric lavage if necessary) may be adequate.

Fluconazole is largely excreted in the urine; forced volume diuresis would probably increase the elimination rate. A three-hour hemodialysis session decreases plasma levels by approximately 50%.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic Group: Antimycotics for systemic use, Triazole derivatives;

ATC code: J02AC01.

Type of action

Fluconazole is a substance, which belongs to the triazole derivative class of drugs. The agent is particularly effective against Candida species and cryptococci.

Mechanism of action

Fluconazole has a highly specific effect on cytochrome-P450-dependent fungal enzymes and is a potent and specific inhibitor of fungal sterol synthesis.

Spectrum of activity

Fluconazole has a wide spectrum of antimycotic activity. In various in-vivo animal activity studies (p.o. and i.v.), fluconazole is active in superficial and systemic infections with Candida, Cryptococcus and various dermatophytes.

Candida krusei is resistant to fluconazole. The susceptibility of Candida glabrata is variable. Candida dubliniensis is not primarily resistant but shows a high tendency towards resistance, mainly during therapy. Fluconazole has little of no activity against Aspergillus, Mucor, Microsporum and Trichophyton species.

In animal experimental models of endemic mycosis, fluconazole was shown to be effective, including in infections with Blastomyces dermatitidis, Coccidioides immitis and Histoplasma capsulatum in normal and immunosuppressed animals. As with other azoles, due to the lack of a standardised procedure, the results of in-vitro tests are of lesser significance in terms of predicting clinical efficacy than the results of in-vivo studies.

In volunteers, 200-400 mg fluconazole daily have no clinically relevant effect on endogenous serum steroid concentrations or ACTH-stimulated cortisol release.

The efficacy of fluconazole in tinea captis has been studied in 2 randomised controlled trials in a total of 878 patients, comparing fluconazole with griseofulvin. Fluconazole at 6 mg/kg/day for 6 weeks was not superior to griseofulvin administered at 11 mg/kg/day for 6 weeks. The overall success rate at 6 weeks was low (fluconazole 6 weeks: 18.3%; fluconazole 3 weeks: 14.7%; griseofulvin: 17.7%) across all the treatment groups. These findings are not inconsistent with the natural history of tinea capitis without therapy.

5.2 Pharmacokinetic Properties

Absorption:

Fluconazole is well absorbed after oral intake. The absolute bioavailability is above 90%. The oral absorption is not affected by concomitant food intake. The maximum fasting plasma concentration is reached 0.5 - 1.5 hours after dose intake.. 90% of the steady-state level is reached 4-5 days after dosing once daily.

Plasma concentration is proportional to the dose. After administration of 200 mg fluconazole, Cmax is around 4.6 mg/l and plasma concentrations at steady-state after 15 days are around 10 mg/l. After administration of 400 mg of fluconazole, Cmax is around 9 mg/l and plasma concentrations at steady state after 15 days are around 18 mg/l.

Intake of a double dose on day 1 results in plasma concentrations of approximate 90% of steady-state on day 2.

Distribution:

The volume of distribution corresponds to the total body water. The protein binding in plasma is low (11-12%).

The concentration in saliva corresponds to the plasma concentration. In patients with fungal meningitis the concentration of fluconazole in the cerebrospinal fluid is approximately 80% of the corresponding plasma concentration.

In stratum corneum, epidermis-dermis and in exocrine sweat higher concentrations of fluconazole are reached compared to those in serum. Fluconazole is accumulated in the stratum corneum. At a dose of 150 mg once weekly the concentration of fluconazole in stratum corneum was after 2 doses 23.4 µg/g and seven days after the second dosing it was still 7.1 µg/g..

Elimination:

Fluconazole is mainly renally excreted. Approximately 80% of the administered dose is excreted in the urine in non-metabolized form. Fluconazole clearance is proportional to the creatinine clearance. Circulating metabolites have not been demonstrated.

The half-life in plasma is approximately 30 hours.

Pharmacokinetics in Children

Pharmacokinetic data were assessed for 113 paediatric patients from 5 studies; 2 single dose studies, 2 multiple dose studies and a study in premature neonates. Data from 1 study were not interpretable due to changes in formulation partway through the study. Additional data were available from a compassionate use study.

In children, the following pharmacokinetic data have been reported:

Age Studied

Dose (mg/kg)

Half-life (hours)

AUC (?g.h/ml)

11 days - 11 months

Single IV

3 mg/kg

23

110.1

9 months - 13 years

Single - oral

2 mg/kg

25.0

94.7

9 months - 13 years

Single - oral

8 mg/kg

19.5

362.5

5 years - 15 years

Multiple IV

2 mg/kg

17.4*

67.4

5 years - 15 years

Multiple IV

4 mg/kg

15.2*

139.1

5 years - 15 years

Multiple IV

8 mg/kg

17.6*

196.7

Mean age 7 years

Multiple oral

3 mg/kg

15.5

41.6

*Denotes final day

After administration of 2 - 8 mg/kg fluconazole to children between the ages of 9 months to 15 years, an AUC of about 38 pg.h/ml was found per 1 mg/kg dose units. The average fluconazole plasma elimination half-life varied between 15 and 18 hours and the distribution volume was approximately 880 ml/kg after multiple doses. A higher fluconazole plasma elimination half-life of approximately 24 hours was found after a single dose. This is comparable with the fluconazole plasma elimination half-life after a single administration of 3 mg/kg i.v. to children of 11 days-11 months old. The distribution volume in this age group was about 950 ml/kg.

Experience with fluconazole in neonates is limited to pharmacokinetic studies in premature newborns. The mean age at first dose was 24 hours (range 9-36 hours) and mean birth weight was 0.9 Kg (range 0.75-1.10 Kg) for 12 pre-term neonates of average gestation around 28 weeks. Seven patients completed


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Metronidazole topical


Class: Antibacterials
VA Class: DE101
Chemical Name: 2-Methyl-5-nitro-1H-imidazole-1-ethanol
Molecular Formula: C6H9N3O3
CAS Number: 443-48-1
Brands: MetroCream, MetroGel, MetroGel-Vaginal, MetroLotion, Noritate, Vandazole

Introduction

Antibacterial and antiprotozoal;1 2 27 29 47 183 also has anti-inflammatory and immunosuppressive effects;1 2 14 17 21 28 180 nitroimidazole derivative.3

Uses for Metronidazole Rosacea

Treatment of inflammatory lesions (papules and pustules) associated with rosacea (acne rosacea);1 2 8 9 10 16 17 18 19 20 21 47 180 184 207 topical gel designated an orphan drug by FDA for use in this condition.23

Has no beneficial effects on telangiectasia,2 9 10 17 19 21 47 rhinophyma,47 or ocular manifestations of rosacea.47 83

Optimal treatment not determined; inflammatory lesions may respond to long-term treatment with topical anti-infectives (e.g., metronidazole) or oral anti-infectives (e.g., doxycycline, tetracycline, erythromycin, ampicillin, metronidazole).10 11 12 13 15 16 17 20 21 47 80 82 2 8 9 10 16 17 18 19 20 21 47 80 81 82 Topical metronidazole may be preferred to oral metronidazole;17 147 has been effective in patients with inadequate response or relapse with other therapies (e.g., oral tetracycline).2 10 17 21 62

Effects appear palliative;17 18 19 47 81 61 99 manifestations recur commonly following discontinuance of therapy.17 18 19 47 61 99

Adjunctive measures recommended to decrease exposure to factors that exacerbate rosacea (e.g., excessive sunlight, wind, hot liquids, spicy food, alcohol, extremes of heat and cold).2 12 80

Bacterial Vaginosis

Treatment of bacterial vaginosis (formerly called Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, anaerobic vaginosis)109 111 112 114 115 119 120 122 123 139 153 183 214 in nonpregnant women.214

CDC recommends treatment of bacterial vaginosis in all symptomatic women (including pregnant women).109 In addition, asymptomatic pregnant women at high risk for complications of pregnancy should be screened (preferably at the first prenatal visit) and treatment initiated if needed.109

Treatment recommendations for bacterial vaginosis in HIV-infected women are the same as those for women without HIV infection.109

Regimens of choice in nonpregnant women are a 7-day regimen of oral metronidazole, a 5-day regimen of intravaginal metronidazole gel, or a 7-day regimen of intravaginal clindamycin cream;109 114 alternative regimens are a 7-day regimen of oral clindamycin or 3-day regimen of intravaginal clindamycin suppositories.109 114 The preferred regimens for pregnant women are a 7-day regimen of oral metronidazole or a 7-day regimen of oral clindamycin.109

Regardless of regimen used, relapse or recurrence is common;109 110 120 122 138 153 162 an alternative regimen (e.g., oral therapy when topical was used initially) may be used in such situations.109 122

Routine treatment of asymptomatic male sexual contacts of women who have relapsing or recurrent bacterial vaginosis not recommended.109 113 201 202 203

Decubitus and Other Ulcers

Treatment of infected decubitus ulcers†;27 39 40 41 42 212 topical metronidazole designated an orphan drug by FDA for use in treatment of grade III or IV, anaerobically infected, decubitus ulcers.23

Perioral Dermatitis

Treatment of perioral dermatitis†;210 211 topical gel designated an orphan drug by FDA for treatment of this condition.23

Trichomoniasis

Has been used intravaginally as an adjunct to oral metronidazole for treatment of trichomoniasis caused by Trichomonas vaginalis† in selected cases (e.g., refractory infections),156 205 but not included in CDC recommendations for treatment of trichomoniasis.109 Intravaginal metronidazole not effective used alone.114

Drug of choice for treatment of trichomoniasis is oral metronidazole or oral tinidazole.109 114 123 215 216

Metronidazole Dosage and Administration Administration

Administer topically to the skin2 180 184 207 or intravaginally183 214 in appropriate formulations.

Topical skin preparations (cream, gel, lotion) are for external use only and should not be used orally, intravaginally, or near or in eyes.1 177 180 184 207

Intravaginal preparations are for intravaginal administration only and should not be used orally, topically on the skin, or near or in eyes.183 214

Topical Administration

Apply topically to the skin as a 0.75 or 1% cream, 1% gel, or 0.75% lotion.1 19 180 184 207

Prior to topical application, wash affected area with mild, nonirritating cleanser.1 2 180 184 207 To minimize risk of local irritation, some clinicians suggest application be delayed until about 15–20 minutes after skin cleansing.99

Rub cream, gel, or lotion into affected area.1 19 180 184 207 Avoid contact with eyes.1 19 180 184 207

If irritation occurs at application site, reduce application frequency or discontinue.1 19 180 184 207

Cosmetics may be applied to skin after application of cream, gel, or lotion;1 47 180 184 207 allow lotion to dry ?5 minutes before applying cosmetics.207

Intravaginal Topical Administration

Administer intravaginally as a 0.75% gel using vaginal applicators provided by the manufacturers.183 214

If once-daily regimen used, administer dose at bedtime.183 214

If once-daily regimen used, use new vaginal applicator for each dose.214 If twice-daily regimen used, use new applicator each day; wash, rinse, and dry applicator after morning dose and discard after evening dose.214

Dosage Pediatric Patients Bacterial Vaginosis Treatment in Nonpregnant Postmenarchal Females Intravaginal

0.75% gel: One applicatorful (approximately 37.5 g of metronidazole) once daily (at bedtime) or twice daily (in morning and evening) given for 5 consecutive days.214

Adults Rosacea Topical

0.75% cream or lotion: Apply thin film to cleansed, affected area twice daily (morning and evening)180 207 or as directed by clinician.207

1% cream or gel: Apply thin film to cleansed, affected area once daily.1 184

Optimum treatment duration not established;10 17 18 19 21 47 81 has been continued for ?21 weeks in clinical studies.2 9 10 16 17 18 19 20 21 29

Chronic therapy (usually intermittent) may be necessary, particularly for moderate to severe disease.61 99

Clinical improvement usually occurs within 3 weeks.17 21 Once adequate response occurs, adjust frequency and duration of treatment according to disease course.47

Although disease may remit during treatment,17 18 19 relapse occurs commonly following discontinuance.17 18 19 47 61 99

Bacterial Vaginosis Treatment in Nonpregnant Women Intravaginal

0.75% gel: One applicatorful (approximately 37.5 g of metronidazole) once daily (at bedtime) or twice daily (in morning and evening) given for 5 consecutive days.109 111 112 114 115 183 214

Cautions for Metronidazole Contraindications

Known hypersensitivity to metronidazole, other nitroimidazole derivatives, or any ingredient in the formulation.1 180 183 184 207 214

Warnings/Precautions Warnings Seizures and Peripheral Neuropathy

Convulsive seizures and peripheral neuropathy (characterized by numbness or paresthesia of an extremity) reported with oral or IV nitroimidazoles (e.g., metronidazole, tinidazole).183 217 214

If abnormal neurologic signs develop with vaginal gel, promptly discontinue drug.183 214

Use vaginal gel with caution in patients with history of CNS disease.183 214

Interactions

Psychotic reactions reported in alcoholic patients receiving oral metronidazole and disulfiram concurrently;183 214 disulfiram-like reactions to alcohol reported in patients receiving oral metronidazole.106 183 214 Similar reactions could occur with intravaginal metronidazole.183 214

Avoid intravaginal metronidazole in patients who have received disulfiram within the last 2 weeks.183 214 Caution patients to avoid drinking alcohol while being treated with intravaginal metronidazole.183 214 (See Specific Drugs under Interactions.)

General Precautions Administration Precautions

Avoid contact with the eyes.1 180 183 184 207 214

Topical cream, gel, or lotion may cause tearing.1 180 184 207

Vaginal gel may cause ocular burning and irritation.183 214

Iirrigate eyes with copious amounts of cool water if contact occurs.183 214

Local Irritation

If reaction suggesting local irritation occurs, advise patient to use the topical preparation less frequently or discontinue use.1 180 184 207

History of Blood Dyscrasia

Use with caution in patients with evidence or history of blood dyscrasia.1 180 184 207

Transient leukopenia and neutropenia reported with systemic metronidazole;30 adverse hematologic abnormalities not reported to date with topical metronidazole.2 21 47

Vaginal Intercourse and Use of Vaginal Products

Patients treated with vaginal gel should not engage in vaginal intercourse111 112 113 183 214 and should not use other vaginal products (tampons, douches) during entire treatment course.111 112 113 214

Vaginal intercourse or other vaginal products could reduce efficacy of intravaginal metronidazole (e.g., by dislodgment and/or dilution, by increased vaginal pH secondary to deposition of semen).111 112 113 214

Superinfection

Symptoms of known or previously unrecognized vaginal candidiasis may become more prominent during intravaginal metronidazole therapy.183 214 Symptomatic Candida vaginitis reported during or immediately after therapy.183 214

Systemic Adverse Effects

Although topical application to skin results in lower systemic absorption than oral or IV administration, adverse systemic effects (e.g., metallic taste,1 180 207 nausea,1 180 207 paresthesia,184 tingling or numbness of extremities1 180 207 ) have been reported with topical metronidazole.1 180

Although intravaginal administration results in lower systemic absorption than oral or IV administration, consider possibility that adverse effects reported with systemic metronidazole could occur when drug is given intravaginally.115 119 183 214

Specific Populations Pregnancy

Category B.1 180 183 184 207 214

Safety and efficacy of intravaginal metronidazole for treatment of bacterial vaginosis in pregnant women not established.109 119 183 214 Existing data do not support use of intravaginal agents during pregnancy and intravaginal metronidazole not included in current CDC recommendations for treatment of bacterial vaginosis in pregnant women.109

Lactation

Distributed into milk following oral or IV administration;1 30 45 131 180 183 184 207 214 not known whether distributed into milk following topical or intravaginal administration.183 f 214

Discontinue nursing or the drug.1 180 183 184 207 214

Pediatric Use

Safety and efficacy of topical1 180 184 207 or intravaginal183 metronidazole not established in pediatric patients.

One manufacturer states safety and efficacy of vaginal gel established in postmenarchal females based on extrapolation of data from adult women; safety and efficacy of vaginal gel not established in premenarchal females.214

Geriatric Use

Safety and efficacy of topical gel in geriatric patients ?65 years of age appear similar to those in younger adults.1

Insufficient experience with vaginal gel in patients ?65 years of age to determine whether geriatric patients respond differently than younger adults.214

Hepatic Impairment

Use vaginal gel with caution in severe hepatic impairment.183 214

Reduced elimination and increased plasma concentrations may occur in severe hepatic dysfunction.183 214

Common Adverse Effects

Topical application to skin: Local effects such as erythema, irritation, stinging/burning, local allergic reactions, contact dermatitis, drying, pruritus, aggravated rosacea.1 47 180 184 207

Intravaginal administration: Vaginal discharge,183 symptomatic Candida cervicitis/vaginitis,183 fungal infection,214 vulvovaginal irritation,183 dysmenorrhea,214 GI effects (abdominal pain, GI discomfort, nausea, vomiting, diarrhea),183 214 headache,183 214 pruritus.214

Interactions for Metronidazole

Because metronidazole can be absorbed systemically following topical application to skin1 2 9 10 21 47 207 or following intravaginal administration,119 131 132 183 214 the possibility that drug and laboratory test interactions could occur with these routes should be considered.106 183 f

Specific Drugs and Laboratory Tests

Drug

Interaction

Comments

Alcohol

Disulfiram-like reactions reported rarely when alcohol ingested during intravaginal metronidazole treatment;106 183 214 such reactions not reported to date with topical application of metronidazole to skin21 47 61 99

Caution patients to avoid alcohol ingestion during intravaginal metronidazole treatment183 214

Anticoagulants, oral (warfarin)

Prolonged PT reported with systemic metronidazole 1 30 45 92 93 94 95 96 183 214

Consider possibility of potentiated anticoagulant effect if topical or intravaginal metronidazole used with oral anticoagulant therapy180 183 214

Cimetidine

Possible prolonged half-life and decreased clearance of metronidazole with concomitant cimetidine and oral or IV metronidazole182 183 214

Consider possibility of increased metronidazole adverse effects182

Disulfiram

Psychotic reactions reported in alcoholic patients receiving oral metronidazole and disulfiram concurrently92 97 168 169 183 214

Avoid concomitant use;92 97 214 do not initiate intravaginal metronidazole until 2 weeks after discontinuance of disulfiram183 214

Lithium

Increased lithium concentrations resulting in lithium toxicity reported after initiation of short-term oral metronidazole therapy in patients stabilized on relatively high lithium dosages181 183 214

Tests based on ultraviolet (UV) absorbance

Falsely decreased serum concentrations (including undetectable concentrations) of AST, ALT, LDH, triglycerides, or hexokinase glucose may be reported during metronidazole therapy if results are based on decreases in UV absorbance that occur during oxidation-reduction of NADH/NAD30 183 214

UV absorbance peaks of NADH and metronidazole are similar30 183 214

Use caution when interpreting test results based on UV absorbance during metronidazole therapy30 183 214

Metronidazole Pharmacokinetics Absorption Bioavailability

Absorbed systemically following topical application to skin; extent of absorption depends on formulation used (cream, gel, lotion).1 2 9 10 21 47 207

Absorbed systemically following intravaginal administration;119 131 132 183 214 systemic bioavailability of vaginal gel averages 50–56%.119 131 132 183 186

Following repeated topical application to the face of 1% cream (approximately 3.75 mg per dose) in adults with rosacea, serum concentrations were minimal or undetectable.9 Following topical application to the face of 1 g of 1% cream in healthy individuals, serum concentrations were minimal or undetectable and peak serum concentrations were attained within 8–12 hours after the dose.184

Following topical application to the face of 1 g of 1% topical gel in adults with rosacea, peak serum concentrations of metronidazole were attained 6–10 hours after the dose and were <1% of concentrations reported with a single 250-mg oral dose.1

Following topical application to the face of 1 g of 0.75% topical lotion (approximately 7.5 mg of metronidazole) twice daily for 4 days, drug was detectable in plasma of all patients and peak plasma concentrations were approximately 80 times lower than peak concentrations attained with a single 250-mg oral dose.207

Following intravaginal administration of 5 g of 0.75% vaginal gel (approximately 37.5 mg of metronidazole) in healthy women, peak serum concentrations were attained 4–17 hours after the dose and were approximately 2% of that attained after a single 500-mg oral dose.119 132 183 186 214

Distribution Extent

Not fully characterized following topical application to skin10 or intravaginal administration.176 177

Crosses placenta following oral or IV administration;1 30 45 56 131 180 183 184 207 not known whether crosses placenta following topical application to skin1 or intravaginal administration.183

Distributed into milk following oral or IV administration;1 30 45 56 131 180 183 184 207 214 not known whether distributed into milk following topical application to skin1 or intravaginal administration.183

Elimination Metabolism

Not fully characterized following topical application to skin10 or intravaginal administration.176 177

Elimination Route

Any systemically absorbed drug probably metabolized in liver and excreted in urine.10 61

Stability Storage Topical Cream

20–25°C.180 184

Gel

20–25°C (may be exposed to 15–30°C).1

Lotion

20–25°C; do not freeze.207

Intravaginal Gel

MetroGel-Vaginal: 15–30°C; do not freeze.183

Vandazole: 20–25°C; do not freeze.214

ActionsActions

Bactericidal, amebicidal, and trichomonacidal in action.2 30 48 52 56

Un-ionized at physiologic pH49 and readily taken up by anaerobic organisms or cells.48 49 50 56 72 In susceptible organisms or cells, metronidazole reduced by low-redox-potential electron transport proteins (e.g., nitroreductases such as ferredoxin);48 49 50 56 64 65 66 68 69 70 71 72 the reduction product(s) apparently are responsible for cytotoxic and antimicrobial effects of the drug (e.g., disruption of DNA, inhibition of nucleic acid synthesis).48 56 63 64 65 66 67 68 70 71 72

Has direct anti-inflammatory effects2 14 17 21 28 180 and effects on neutrophil motility, lymphocyte transformation, and some aspects of cell-mediated immunity.2 10 32 33 34 35

Mechanism of reducing inflammatory lesions (papules and pustules) and erythema in patients with rosacea not elucidated to date;1 2 6 10 11 17 19 21 28 29 184 207 these effects may result from anti-inflammatory or immunosuppressive actions of the drug.1 2 3 10 17 28 29 207

Suppression of skin bacteria does not appear to play a major role in the mechanism of action of the drug in treatment of inflammatory lesions of rosacea;2 10 11 29 inactive in vitro against Propionibacterium acnes,2 4 5 48 staphylococci, and streptococci,2 48 and has no appreciable effects on the aerobic or anaerobic microflora of the skin of patients with rosacea.2 10 29

Spectrum of activity includes most obligately anaerobic bacteria2 7 29 30 45 48 53 56 64 and many protozoa.2 29 30 48 52 64 Inactive against fungi2 3 48 and viruses48 and most aerobic or facultatively anaerobic bacteria.2 7 30 45 48 73 74

Gram-positive anaerobes: Active against Clostridium,2 30 45 48 53 55 C. difficile,54 55 C. perfringens,48 55 Eubacterium,2 30 45 48 53 54 Peptococcus,2 30 45 48 53 54 55 and Peptostreptococcus.2 7 30 45 48 53 55 124 128 Actinomyces, Lactobacillus,48 Propionibacterium acnes,2 4 5 48 P. avidum,5 and P. granulosum5 generally are resistant.

Gram-negative anaerobes: Active against Bacteroides fragilis,2 3 30 45 48 53 54 55 124 126 130 B. distasonis,30 45 54 55 124 B. ovatus,30 45 55 124 B. thetaiotaomicron,30 45 54 55 124 B. vulgatus,30 45 54 55 124 B. ureolyticus,124 126 Fusobacterium,2 7 30 45 48 53 55 Prevotella bivia,53 124 126 128 129 P. disiens,54 128 P. intermedia,7 124 P. melaninogenica,48 54 124 126 128 129 P. oralis,54 124 126 129 Porphyromonas,124 129 and Veillonella.7 54 55

Other organisms: Active against Campylobacter fetus.48 Most strains of Gardnerella vaginalis (formerly Haemophilus vaginalis) are susceptible only to relatively high concentrations in vitro.119 126 129 135 140 141 142 Concentrations readily achievable locally (750 mcg/mL) following intravaginal application of 0.75% vaginal gel have inhibited approximately 90% of strains tested in vitro.119 177

Natural and acquired resistance has been reported in some T. vaginalis.48 52 75 76 77 78 79 Resistance also reported rarely in B. fragilis and other anaerobic bacteria following long-term therapy.44 48 215

Advice to Patients

Importance of using topical or intravaginal metronidazole only as directed and only for the disorder for which drug was prescribed.1 180 183 184 207 f

Advise patients that topical cream, gel, and lotion are for external use only and to avoid contact with eyes.1 180 184 207 (See Administration under Dosage and Administration.)

Advise patients that vaginal gel is for intravaginal administration only and to avoid contact with eyes.183 214 (See Administration under Dosage and Administration.) If such contact occurs, importance of irrigating eyes with copious amounts of cool water.177 183

Instruct patients receiving vaginal gel regarding appropriate use of vaginal applicator.f

Advise women using vaginal gel not to engage in vaginal intercourse111


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Voriconazole Tablets


Pronunciation: VOR-i-KON-a-zole
Generic Name: Voriconazole
Brand Name: Vfend
Voriconazole is used for:

Treating certain fungal infections.

Voriconazole is an azole antifungal. It works by blocking fungal cell wall growth, resulting in the death of the fungus.

Do NOT use Voriconazole if: you are allergic to any ingredient in Voriconazole you have galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption you have untreated low blood calcium, magnesium, or potassium levels you are taking astemizole, a barbiturate (eg, phenobarbital), cabazitaxel, carbamazepine, cisapride, crizotinib, dronedarone, an ergot alkaloid (eg, ergotamine), erythromycin, everolimus, fluconazole, lurasidone, pimozide, quinidine, rifabutin, rifampin, rivaroxaban, sirolimus, St. John's wort, terfenadine, or ticagrelor

Contact your doctor or health care provider right away if any of these apply to you.

Before using Voriconazole:

Some medical conditions may interact with Voriconazole. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you are allergic to other azole antifungals (eg, fluconazole, itraconazole) if you have a history of heart problems (eg, cardiomyopathy, irregular heartbeat); an abnormal electrocardiogram (ECG) (a type of heart test); or low blood calcium, magnesium, or potassium levels if you have liver problems (eg, cirrhosis), kidney problems, pancreas problems, a weakened immune system, or a blood disease (eg, blood or bone marrow cancer) if you have trouble digesting dairy products or lactose if you have ever been on chemotherapy or have had a stem cell transplant if you have taken fluconazole within the last 24 hours if you are taking ritonavir. Voriconazole should not be taken with certain doses of ritonavir

Some MEDICINES MAY INTERACT with Voriconazole. Tell your health care provider if you are taking any other medicines, especially any of the following:

Medicines that may harm the kidney because the risk of kidney side effects may be increased. Ask your doctor or pharmacist if you are unsure if any of your medicines might affect the kidney Medicines that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat Many other prescription and nonprescription medicines (eg, used for aches and pains, anxiety, birth control, blood flow problems, blood thinning, cancer, diabetes, drug dependence, heartburn or reflux, high blood pressure, high cholesterol, HIV, immune system suppression, infections, irregular heartbeat or other heart problems, mental or mood problems, pain, seizures, stomach or bowel problems), multivitamin products, or herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) may interact with Voriconazole. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with Voriconazole

This may not be a complete list of all interactions that may occur. Ask your health care provider if Voriconazole may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Voriconazole:

Use Voriconazole as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Voriconazole. Talk to your pharmacist if you have questions about this information. Take Voriconazole by mouth on an empty stomach at least 1 hour before or 1 hour after eating. To clear up your infection completely, take Voriconazole for the full course of treatment. Keep taking it even if you feel better in a few days. If you miss a dose of Voriconazole, take it as soon as possible. If it is more than 6 hours after the missed dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Voriconazole.

Important safety information: Voriconazole may cause blurred vision or sensitivity to light. These effects may be worse if you take it with alcohol or certain medicines. Use Voriconazole with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Avoid driving at night while you are using Voriconazole. Voriconazole may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Voriconazole. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. Certain types of skin cancers (eg, melanoma, squamous cell) have been reported in patients who became sensitive to sunlight while taking Voriconazole for a long period of time. Contact your doctor if you notice a change in the appearance of a mole or other unusual skin change or growth. Discuss any questions or concerns with your doctor. Voriconazole may make your eyes more sensitive to sunlight. It may help to wear sunglasses. Avoid strong, direct sunlight. Tell your doctor or dentist that you take Voriconazole before you receive any medical or dental care, emergency care, or surgery. If your symptoms do not improve within a few days or if they become worse, check with your doctor. Women who may become pregnant should use effective birth control (eg, birth control pills) while taking Voriconazole. Talk with your doctor if you have questions about effective birth control. Lab tests, including eye exams, liver and kidney function, and pancreas function, may be performed while you use Voriconazole. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Voriconazole should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: Voriconazole may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Voriconazole while you are pregnant. It is not known if Voriconazole is found in breast milk. Do not breast-feed while taking Voriconazole. Possible side effects of Voriconazole:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; headache; nausea; sensitivity to light; sensitivity to the sun; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal thoughts; black, tarry stools; bone pain; calf or leg pain, redness, swelling, or tenderness; change in the appearance of a mole; chest, jaw, or arm pain; confusion; decreased urination; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; flushing; hallucinations; mental or mood changes (eg, depression); mouth sores; one-sided weakness; red, swollen, peeling, or blistered skin; seizures; severe or persistent dizziness or headache; shortness of breath; speech changes; sudden, severe nausea or vomiting; suicidal thoughts or actions; swelling of the arms or legs; symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, vomiting, or stomach pain; loss of appetite; itching); symptoms of pancreatitis (eg, severe stomach or back pain, with or without nausea or vomiting); unusual bruising or bleeding; unusual skin change or skin growth; unusual sweating or weakness; unusual tiredness; unusual vaginal bleeding; vision changes (eg, color vision change, persistent or severe blurred vision or sensitivity to light).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Voriconazole side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Voriconazole:

Store Voriconazole at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Voriconazole out of the reach of children and away from pets.

General information: If you have any questions about Voriconazole, please talk with your doctor, pharmacist, or other health care provider. Voriconazole is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Voriconazole. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Voriconazole resources Voriconazole Side Effects (in more detail) Voriconazole Dosage Voriconazole Use in Pregnancy & Breastfeeding Drug Images Voriconazole Drug Interactions Voriconazole Support Group 1 Review for Voriconazole - Add your own review/rating Compare Voriconazole with other medications Aspergillosis, Invasive Blastomycosis Candida Infections, Systemic Coccidioidomycosis, Meningitis Cutaneous Fungal Infection Esophageal Candidiasis Eumycetoma Fungal Infection, Internal and Disseminated Fungal Meningitis Fungal Pneumonia Fusariosis Ocular Fungal Infection Pseudoallescheriosis Systemic Fungal Infection
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Mycobutin


1. Name Of The Medicinal Product

Mycobutin.

2. Qualitative And Quantitative Composition

Rifabutin INN

150.0 mg 3. Pharmaceutical Form

Opaque, red-brown, hard gelatin capsules Size N°. 0 containing 150 mg rifabutin in transparent PVC/Al blisters or in amber glass bottles.

The capsules are for oral administration.

4. Clinical Particulars 4.1 Therapeutic Indications

Mycobutin is indicated for:

- the prophylaxis of M. avium intracellulare complex (MAC) infections in patients with HIV disease with CD4 counts lower than 75 cells/mcl.

- the treatment of non-tuberculous mycobacterial disease (such as that caused by MAC and M. xenopi).

- pulmonary tuberculosis.

4.2 Posology And Method Of Administration

Mycobutin can be administered as a single, daily, oral dose at any time independently of meals.

Adults

- prophylaxis of M. avium intracellulare complex (MAC) infections in patients with HIV disease with CD4 counts lower than 75 cells/mcl.:

300 mg (2 capsules) as a single agent.

- treatment of non-tuberculous mycobaterial disease:

450 - 600 mg (3 - 4 capsules) in combination regimens for up to 6 months after negative cultures are obtained.

When Mycobutin is given in association with clarithromycin (or other macrolides) and/or fluconazole (or related compounds) the Mycobutin dosage may need to be reduced to 300 mg (see Section 4.5).

- treatment of pulmonary tuberculosis:

150 - 450 mg (1 - 3 capsules) in combination regimens for at least 6 months.

In accordance with the commonly accepted criteria for the treatment of mycobacterial infections, Mycobutin should always be given in combination with other anti-mycobacterial drugs not belonging to the family of rifamycins.

Children

There are inadequate data to support the use of Mycobutin in children at the present time.

Elderly

No specific recommendations for dosage alterations in the elderly are suggested.

4.3 Contraindications

Mycobutin is contra-indicated in patients with a history of hypersensitivity to rifabutin or other rifamycins (eg rifampicin).

Due to insufficient clinical experience in pregnant and breast-feeding women and in children, Mycobutin should not be used in these patients.

4.4 Special Warnings And Precautions For Use

Before starting Mycobutin prophylaxis, patients should be assessed to ensure that they do not have active disease caused by pulmonary tuberculosis or other mycobacteria.

Prophylaxis against MAC infection may need to be continued throughout the patient's lifetime.

Mycobutin may impart a red-orange colour to the urine and possibly to skin and body secretions. Contact lenses, especially soft, may be permanently stained.

Mild hepatic impairment does not require a dose modification. Mycobutin should be used with caution in cases of severe liver insufficiency. Mild to moderate renal impairment does not require any dosage adjustment.

Severe renal impairment (creatinine clearance below 30 ml/min) requires a dosage reduction of 50%.

It is recommended that white blood cell and platelet counts and liver enzymes be monitored periodically during treatment.

Because of the possibility of occurrence of uveitis, patients should be carefully monitored when rifabutin is given in combination with clarithromycin (or other macrolides) and/or fluconazole (and related compounds). If such an event occurs, the patient should be referred to an ophthalmologist and, if considered necessary, Mycobutin treatment should be suspended.

Uveitis associated with Mycobutin must be distinguished from other ocular complications of HIV.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including rifabutin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Rifabutin has been shown to induce the enzymes of the cytochrome P450 3A subfamily and therefore may affect the pharmacokinetic behaviour of drugs metabolised by the enzymes belonging to this subfamily. Upward adjustment of the dosage of such drugs may be required when administered with Mycobutin.

Similarly, Mycobutin might reduce the activity of analgesics, anticoagulants, corticosteroids, cyclosporin, digitalis (although not digoxin), oral hypoglycaemics, narcotics, phenytoin and quinidine.

Clinical studies have shown that Mycobutin does not affect the pharmacokinetics of didanosine (DDI), and isoniazid (however, for the latter refer also to undesirable effects). On the basis of the above metabolic considerations no significant interaction may be expected with ethambutol, theophylline, sulphonamides, pyrazinamide and zalcitabine (DDC).

As p-aminosalicylic acid has been shown to impede GI absorption of rifamycins it is recommended that when it and Mycobutin are both to be administered they be given with an interval of 8 - 12 hours.

The following table provides details of the possible effects of co-administration, on rifabutin and the co-administered drug, and risk-benefit statement.

Coadministered drugs

Effect on rifabutin

Effect on co-administered drug

Comments

ANTIVIRALS

     

Indinavir

20% increase in AUC.

32% decrease in AUC.

 

 

Saquinavir

No data.

40% decrease in AUC.

 

 

Ritonavir

4-fold increase in AUC, 2.5-fold increase in Cmax

No data

Due to this multifold increase in rifabutin concentrations and the subsequent risk of side effects, patients requiring both rifabutin and a protease inhibitor, other protease inhibitors should be considered.

Zidovudine

No significant change in kinetics

Approx. 32% decrease in Cmax and AUC.

A large clinical study has shown that these changes are of no clinical relevance.

ANTIFUNGALS

     

Fluconazole

82% increase in AUC.

No significant change in steady-state plasma concentrations

 

 

Itraconazole

No data.

70-75% decrease in Cmax and AUC.

A case report indicates an increase in rifabutin serum levels in the presence of itraconazole.

Ketoconazole/ miconazole

No data.

No data.

Co-administered medications, sucha s ketoconazole, that competitively inhibit the Cyt P450IIIA activity may increase circulating drug levels of rifabutin.

ANTI-PCP (Pneumocystis carinii pneumonia)

     

Dapsone

No data.

Approximately 27%-40% decrease in AUC.

Study conducted in HIV infected patients (rapid and slow acetylators)

Sulfamethoxazole-Trimethoprim

No significant change in Cmax and AUC.

Approx. 15-20% decrease in AUC.

In another study, only trimethoprim (not sulfamethoxazole had 14% decrease in AUC and 6% in Cmax but were not considered clinically significant.

ANTI-MAC (Mycobacterium avium intracellulare complex)

     

Clarithromycin

Approx. 77% increase in AUC.

Approx. 50% decrease in AUC.

Study conducted in HIV infected patients

OTHER

     

Methadone

No data.

No significant effect.

No apparent effect of rifabutin on either peak levels of methadone or systemic exposure based upon AUC. Rifabutin kinetics not evaluated.

Oral contraceptives

No data.

No data.

Contraceptive cover may not be adequate during concomitant therapy with rifabutin, therefore, patients should be advised to use other methods of contraception.

Tacrolimus

No data.

No data.

Rifabutin decreases tacrolimus trough blood levels.

4.6 Pregnancy And Lactation

Due to lack of data in pregnant women, as a precautionary measure, Mycobutin should not be administered to pregnant women or those breast-feeding children even though in experimental animal studies the drug was not teratogenic.

Mycobutin may interact with oral contraceptives (see Section 4.5).

4.7 Effects On Ability To Drive And Use Machines

There have been no reports of adverse effects on ability to drive and use machines.

4.8 Undesirable Effects

The tolerability of Mycobutin in multiple drug regimens, was assessed in both immunocompetent and immunocompromised patients, suffering from tuberculosis and non-tuberculous mycobacteriosis in long term studies with daily dosages up to 600 mg.

Bearing in mind that Mycobutin was often given in these studies as part of a multidrug regimen it is not possible to define with certainty a drug-event relationship. Treatment discontinuation was necessary only in a very few cases. The most commonly reported adverse events, were primarily related to:

- the gastro-intestinal system, such as nausea, vomiting, increase of liver enzymes, jaundice;

- the blood and lymphatic system, such as leucopenia, neutropenia, thrombocytopenia and anemia, where the frequency and severity of haematologic reactions could be increased by combined administration of isoniazid;

- the musculo-skeletal system: arthralgia and myalgia.

Also, fever, rash and rarely other hypersensitivity reactions such as eosinophilia, bronchospasm and shock might occur as has been seen with other antibiotics.

In addition, mild to severe, reversible uveitis has been reported. The risk appears to be low, when Mycobutin is used at 300 mg as monotherapy in MAC prophylaxis, but increases when Mycobutin is administered at higher doses in combination with clarithromycin (or other macrolides) for MAC treatment (see Section 4.4). The possible role of fluconazole (and related compounds) has not been established yet.

Asymptomatic corneal opacities have been reported after long term therapy.

Pseudojaundice (yellow skin discolouration with normal plasma bilirubin) has been reported with high doses of rifabutin. Flu-like syndrome, chest pressure or pain with dyspnoea and rarely hepatitis and haemolysis. Clostridium difficile diarrhoea has been reported rarely.

4.9 Overdose

Gastric lavage and diuretic treatment should be carried out. Supportive care and symptomatic treatment should be administered.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

In vitro activity of rifabutin against laboratory strains and clinical isolates of M. tuberculosis has been shown to be very high. In vitro studies carried out so far have shown that from one-third to half of M.tuberculosis strains resistant to rifampicin are susceptible to rifabutin, indicating that cross-resistance between the two antibiotics is incomplete.

The in vivo activity of rifabutin on experimental infections caused by M. tuberculosis was about 10 times greater than that of rifampicin in agreement with the in vitro findings.

Rifabutin was seen to be active against non-tuberculous (atypical) mycobacteria including M. avium-intracellulare (MAC), in vitro as well as in experimental infections caused by these pathogens in mice with induced immuno-deficiency.

5.2 Pharmacokinetic Properties

In man, rifabutin is rapidly absorbed and maximum plasma concentrations are reached around 2-4 hours after oral administration. The pharmacokinetics of rifabutin is linear after single administration of 300, 450, and 600 mg to healthy volunteers. With these doses, C max is in the range of 0.4-0.7 µg/ml. Plasma concentrations are maintained above the MIC values for M. tuberculosis up to about 30 hours from administration.

Rifabutin is widely distributed in various animal organs with the exception of the brain. In particular, in human lung tissue the concentrations measured up to 24 hours after dosing were about 5-10 times higher than the plasma levels.

The intracellular penetration of rifabutin is very high as demonstrated by intracellular/extracellular concentration ratios which ranged from 9 in neutrophils to 15 in monocytes, both obtained from human sources.

The high intracellular concentration is likely to play a crucial role in sustaining the efficacy of rifabutin against intracellular pathogens such as mycobacteria.

Rifabutin and its metabolites are eliminated mainly by the urinary route. The t? of rifabutin in man is approximately 35-40 hours.

5.3 Preclinical Safety Data

Preclinical safety studies of rifabutin indicate a good safety margin in rodents and in monkeys.

In repeated dose studies, target organs were identified at doses producing blood levels higher than those achieved with recommended doses for human therapy. The main target organs are liver and, to a lesser degree, erythrocytes.

Rifabutin did not show any teratogenic, mutagenic or carcinogenic potential.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Microcrystalline cellulose

Sodium lauryl sulphate

Magnesium stearate

Silica gel

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months at room temperature.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Transparent PVC/Al blisters in cardboard cartons containing 30 capsules or amber glass bottles containing 30 or 100 capsules.

6.6 Special Precautions For Disposal And Other Handling

There are no special instructions for handling.

Administrative Data 7. Marketing Authorisation Holder

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

8. Marketing Authorisation Number(S)

PL 00057/1017

9. Date Of First Authorisation/Renewal Of The Authorisation

15th January 2003.

10. Date Of Revision Of The Text

February 2010

Ref: MY_4_0


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cerivastatin


Generic Name: cerivastatin (seh RIH va stah tin)
Brand Names: Baycol

What is cerivastatin?

Cerivastatin was withdrawn from the U.S. market in 2001.

Cerivastatin blocks the production of cholesterol (a type of fat) in the body.

Cerivastatin is used to reduce the amounts of LDL (bad) cholesterol and total cholesterol in your blood. Cerivastatin also reduces the amounts of triglycerides (another type of fat) and apolipoprotein B (a protein needed to make cholesterol) in your blood and increases the amount of HDL (good) cholesterol in your blood. These actions are important in reducing the risk of hardening of the arteries, which can lead to heart attacks, stroke, and peripheral vascular disease.

Cerivastatin may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about cerivastatin?

Cerivastatin was withdrawn from the U.S. market in 2001.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if it is accompanied by a fever or flu-like symptoms or yellowing of your skin or eyes. Do not take cerivastatin without first talking to your doctor if you have liver disease. Alcohol and cerivastatin can both damage your liver. Discuss with your doctor the amount of alcohol that you drink so that it can be determined if cerivastatin is the best choice for lowering your cholesterol. Do not take cerivastatin if you are pregnant, if you are planning a pregnancy, or if you are breast-feeding a baby. Who should not take cerivastatin? Do not take cerivastatin without first talking to your doctor if you have liver disease.

Before taking cerivastatin, tell your doctor if you

drink alcoholic beverages,

have kidney disease,

have a chronic muscular disease, or

have seizures or epilepsy.

You may not be able to take cerivastatin, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Cerivastatin is in the FDA pregnancy category X. This means that cerivastatin will cause birth defects if it is taken during pregnancy. Cholesterol is very important for the proper development of a baby. Do not take cerivastatin if you are pregnant or are planning a pregnancy. Cerivastatin passes into breast milk and can harm a nursing infant. Do not take cerivastatin if you are breast-feeding a baby. How should I take cerivastatin?

Take cerivastatin exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Eat a low-fat, low-cholesterol diet. To see beneficial effects from cerivastatin, avoid fatty, high-cholesterol foods. Follow your doctor's directions.

Your doctor may want to monitor your liver function with blood tests before starting treatment with cerivastatin, at six and twelve weeks after both the start of your treatment and any increase in dose, and periodically (every 6 months) thereafter. Depending on the results of these tests, your doctor can determine how much monitoring you will require.

Grapefruit and grapefruit juice may interact with cerivastatin. The interaction could lead to potentially dangerous effects. Discuss the use of grapefruit and grapefruit juice with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Do not stop taking cerivastatin without first talking to your doctor. It may be weeks or months before beneficial effects from this medication are seen.

Store cerivastatin at room temperature away from moisture and heat. What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of cerivastatin.

What happens if I overdose? Seek emergency medical attention.

Symptoms of an overdose of cerivastatin are not known.

What should I avoid while taking cerivastatin? Alcohol and cerivastatin can both damage your liver. Discuss with your doctor the amount of alcohol that you drink so that it can be determined if cerivastatin is the best choice for lowering your cholesterol.

Grapefruit and grapefruit juice may interact with cerivastatin. The interaction could lead to potentially dangerous effects. Discuss the use of grapefruit and grapefruit juice with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Cerivastatin side effects If you experience any of the following serious side effects, stop taking cerivastatin and call your doctor immediately:

an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

muscle aches, pain, or weakness;

a fever;

"flu-like" symptoms;

decreased urine or rust-colored urine;

blurred vision; or

yellowing of your skin or eyes.

Other, less serious side effects may be more likely to occur. Continue to take cerivastatin and talk to your doctor if you experience

gas, bloating, nausea, stomach upset, heartburn, abdominal pain, constipation, or diarrhea;

dizziness;

headache; or

a rash.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect cerivastatin? Do not take cerivastatin without first talking to your doctor if you are taking any of the following medicines:

cyclosporine (Sandimmune, Neoral);

gemfibrozil (Lopid), clofibrate (Atromid-S), or fenofibrate (Tricor);

niacin (Nicolar, Nicobid, Slo-Niacin, others);

erythromycin (E-Mycin, E.E.S., Ery-Tab, others) or clarithromycin (Biaxin); or

itraconazole (Sporanox), fluconazole (Diflucan), or ketoconazole (Nizoral).

The medications listed above may interact with cerivastatin and damage your muscles. Generally, these medicines are not used together.

Drugs other than those listed here may also interact with cerivastatin. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More cerivastatin resources Cerivastatin Side Effects (in more detail)Cerivastatin Use in Pregnancy & BreastfeedingCerivastatin Drug InteractionsCerivastatin Support Group0 Reviews for Cerivastatin - Add your own review/rating Baycol Consumer Overview Compare cerivastatin with other medications High CholesterolHyperlipoproteinemia Type IIa, Elevated LDL Where can I get more information? Your pharmacist has additional information about cerivastatin written for health professionals that you may read. What does my medication look like?

Cerivastatin was withdrawn from the U.S. market in 2001.

See also: cerivastatin side effects (in more detail)


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terconazole vaginal


Generic Name: terconazole vaginal (ter KON a zole VAJ in al)
Brand Names: Terazol 3, Terazol 7, Zazole

What is terconazole vaginal?

Terconazole is an antifungal antibiotic that fights infections caused by fungus.

Terconazole vaginal is used to treat candida (yeast) infections of the vagina.

Terconazole vaginal may also be used for purposes not listed in this medication guide.

What is the most important information I should know about terconazole vaginal?

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Terconazole vaginal will not treat a viral infection such as the common cold or flu.

Avoid wearing tight-fitting, synthetic clothing (e.g., panty hose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water. What should I discuss with my healthcare provider before using terconazole vaginal? You should not use terconazole vaginal if you are allergic to it, or if you have:

a fever;

stomach pain; or

foul-smelling vaginal discharge.

To make sure you can safely use terconazole vaginal, tell your doctor if you have any of these other conditions:

diabetes;

HIV or AIDS.; or

if you have ever had an allergic reaction to similar medications such as butoconazole (Femstat, Mycelex), clotrimazole (Lotrimin, Femcare), econazole (Spectazole), fluconazole (Diflucan), ketoconazole (Nizoral), itraconazole (Sporanox), miconazole (Monistat), and others.

FDA pregnancy category C. It is not known whether terconazole vaginal will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether terconazole passes into breast milk. Do not use terconazole vaginal without first talking to your doctor if you are breast-feeding a baby. How should I use terconazole vaginal?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Terconazole vaginal is usually applied once daily at bedtime for 3 days in a row. Follow your doctor's instructions.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Wash your hands before and after using this medication.

Insert the suppository or cream into the vagina using the applicator as directed.

You can use a sanitary napkin to prevent the medication from staining clothing but do not use a tampon.

Use this medication for the full prescribed length of time, even during your menstrual period. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Terconazole vaginal will not treat a viral infection such as the common cold or flu.

Call your doctor if your symptoms do not improve, or if they get worse while using terconazole vaginal. Do not use terconazole vaginal to treat any vaginal condition that has not been checked by your doctor. Store at room temperature away from moisture and heat. What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while using terconazole vaginal? Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water.

Avoid using other vaginal medications or douches during your treatment with terconazole vaginal, unless you doctor tells you to.

Avoid wearing tight-fitting, synthetic clothing (e.g., panty hose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Avoid sexual intercourse or use a condom to prevent the infection from spreading to a sexual partner.

Avoid exposure to sunlight or tanning beds. Terconazole can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Terconazole vaginal side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using terconazole vaginal and call your doctor at once if you have a serious side effect such as:

severe vaginal burning or irritation; or

fever, chills, flu symptoms.

Less serious side effects may include:

headache; or

menstrual cramps.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Terconazole vaginal Dosing Information

Usual Adult Dose for Vaginal Candidiasis:

Vaginal suppositories: 1 suppository intravaginally once a day at bedtime for 3 consecutive days
0.8% vaginal cream: 1 applicatorful intravaginally once a day at bedtime for 3 consecutive days
0.4% vaginal cream: 1 applicatorful intravaginally once a day at bedtime for 7 consecutive days

What other drugs will affect terconazole vaginal?

It is not likely that other drugs you take orally or inject will have an effect on vaginally applied terconazole. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More terconazole vaginal resources Terconazole vaginal Side Effects (in more detail) Terconazole vaginal Dosage Terconazole vaginal Use in Pregnancy & Breastfeeding Terconazole vaginal Support Group 6 Reviews for Terconazole - Add your own review/rating Compare terconazole vaginal with other medications Vaginal Yeast Infection Where can I get more information? Your pharmacist can provide more information about terconazole vaginal.

See also: terconazole side effects (in more detail)


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Sufenta


Pronunciation: soo-FEN-ta-nil
Generic Name: Sufentanil
Brand Name: Sufenta
Sufenta is used for:

Producing anesthesia for surgery. It may also be used with other medicines as part of epidural anesthesia during labor and delivery to decrease pain.

Sufenta is a narcotic (opioid) analgesic. It works in the brain and nervous system to cause anesthesia and decrease pain.

Do NOT use Sufenta if: you are allergic to any ingredient in Sufenta or any related medicine (eg, sufentanil)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Sufenta:

Some medical conditions may interact with Sufenta. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have diabetes, asthma or other breathing problems, fever, increased pressure or unusual growths in the brain, heart problems, liver or kidney disease, pancreatitis, or a recent head injury if you have a history of slow or irregular heartbeat or blood pressure problems

Some MEDICINES MAY INTERACT with Sufenta. Tell your health care provider if you are taking any other medicines, especially any of the following:

Naltrexone because the effectiveness of Sufenta may be decreased Amiodarone, azole antifungals (eg, fluconazole), beta-blockers (eg, propranolol), benzodiazepines (eg, alprazolam), calcium channel blockers (eg, verapamil), cimetidine, HIV protease inhibitors (eg, ritonavir), macrolide antibiotics (eg, erythromycin), monoamine oxidase (MAO) inhibitors (eg, phenelzine), phenothiazines (eg, chlorpromazine), sibutramine, or sodium oxybate (GHB) because the risk of side effects may be increased Barbiturate anesthetics (eg, thiopental), benzodiazepines (eg, alprazolam), sibutramine, or sodium oxybate (GHB) because actions and side effects of these medicines may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sufenta may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Sufenta:

Use Sufenta as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Sufenta is usually administered as an injection at your doctor's office, hospital, or clinic. If Sufenta contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it. Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal. If you miss a dose of Sufenta, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Sufenta.

Important safety information: Sufenta may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Sufenta. Using Sufenta alone, with certain other medicines or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. Avoid drinking alcohol while taking Sufenta. Use Sufenta with caution in the ELDERLY because they may be more sensitive to its effects. Use Sufenta with extreme caution in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed. PREGNANCY and BREAST-FEEDING: If you are pregnant or plan on becoming pregnant, discuss with your doctor the benefits and risks of using Sufenta during pregnancy. Sufenta is excreted in breast milk. If you are or will be breast-feeding while you are using Sufenta, check with your doctor to discuss the risk to your baby.

When used for long periods of time or at high doses, some people develop a need to continue taking Sufenta. This is known as DEPENDENCE or "addiction."

Possible side effects of Sufenta:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anxiety; confusion; constipation; difficulty walking; dizziness; drowsiness; dry mouth; headache; indigestion; itching; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); hallucinations; muscle rigidity; seizures; slow or irregular heartbeat; slowed breathing; trouble breathing; weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Sufenta side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Sufenta:

Sufenta is usually handled and stored by a health care provider. If you are using Sufenta at home, store Sufenta as directed by your pharmacist or health care provider. Keep Sufenta out of the reach of children and away from pets.

General information: If you have any questions about Sufenta, please talk with your doctor, pharmacist, or other health care provider. Sufenta is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Sufenta. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Sufenta resources Sufenta Side Effects (in more detail) Sufenta Use in Pregnancy & Breastfeeding Sufenta Drug Interactions Sufenta Support Group 0 Reviews for Sufenta - Add your own review/rating Sufenta Monograph (AHFS DI) Sufenta Prescribing Information (FDA) Sufentanil Prescribing Information (FDA) Compare Sufenta with other medications Anesthesia
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aliskiren and amlodipine


Generic Name: aliskiren and amlodipine (AL is KYE ren and am LOE de peen)
Brand Names: Tekamlo

What is this drug?

Aliskiren is an anti-hypertensive (blood pressure lowering) medication. It works by decreasing substances in the body that narrow blood vessels and raise blood pressure.

Amlodipine is in a group of drugs called calcium channel blockers. Amlodipine relaxes (widens) blood vessels and improves blood flow.

The combination of aliskiren and amlodipine is used to treat high blood pressure (hypertension).

Aliskiren and amlodipine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about this drug? Do not use aliskiren and amlodipine if you are pregnant. It could harm the unborn baby. Stop using this medication and tell your doctor right away if you become pregnant. You should not take this medication if you are allergic to aliskiren or amlodipine, or if you are also using cyclosporine (Gengraf, Neoral, Sandimmune) or itraconazole (Sporanox).

Before you take aliskiren and amlodipine, tell your doctor if you have kidney or liver disease, congestive heart failure, coronary artery disease, an electrolyte imbalance (such as low potassium or magnesium), if you are on a low-salt diet, or if you have ever had an allergic reaction to a blood pressure medication.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life. What should I discuss with my health care provider before taking this drug? You should not take this medication if you are allergic to aliskiren or amlodipine, or if you are also using cyclosporine (Gengraf, Neoral, Sandimmune) or itraconazole (Sporanox).

To make sure you can safely take aliskiren and amlodipine, tell your doctor if you have any of these other conditions:

kidney disease (or if you are on dialysis);

liver disease;

congestive heart failure;

coronary artery disease (hardened arteries);

an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

if you are on a low-salt diet; or

if you have ever had an allergic reaction to a blood pressure medication, such as benazepril (Lotensin), candesartan (Atacand), enalapril (Vasotec), lisinopril (Prinivil, Zestril), losartan (Cozaar, Hyzaar), olmesartan (Benicar, Azor), quinapril (Accupril), ramipril (Altace), telmisartan (Micardis, Twynsta), valsartan (Diovan, Exforge), and others.

FDA pregnancy category D. Do not use aliskiren and amlodipine if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. Aliskiren and amlodipine can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control while taking aliskiren and amlodipine. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking aliskiren and amlodipine. How should I take this drug?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your chest pain may become worse when you first start taking amlodipine or when your dose is increased. Call your doctor if your chest pain is severe or ongoing.

Aliskiren and amlodipine may be taken with or without food, but take it the same way each time.

Your blood pressure will need to be checked often. Visit your doctor regularly.

Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life. Store at room temperature away from moisture and heat.

See also: Aliskiren and amlodipine dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include rapid heartbeats, severe dizziness, warmth or tingly feeling, and fainting.

What should I avoid while taking this drug?

Avoid taking this medication with foods that are high in fat, which can make it harder for your body to absorb aliskiren.

This drug side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

swelling in your hands, ankles, or feet;

feeling like you might pass out; or

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Less serious side effects may include:

diarrhea;

stomach pain, upset stomach; or

cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Aliskiren and amlodipine Dosing Information

Usual Adult Dose for Hypertension:

Initial or add-on therapy: 150 mg/5 mg orally once a day. Titrate as needed up to a maximum of 300 mg/10 mg.
The blood pressure lowering effect is largely attained within 1 to 2 weeks.
Maximum dose: 300 mg/10 mg

What other drugs will affect this drug?

Tell your doctor about all other heart or blood pressure medications you are taking.

Tell your doctor about all other medicines you use, especially:

atorvastatin (Lipitor, Caduet), simvastatin (Zocor, Simcor, Vytorin, Juvisync);

antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);

a potassium supplement such as K-Dur, Klor-Con;

salt substitutes that contain potassium; or

a diuretic (water pill).

This list is not complete and other drugs may interact with aliskiren and amlodipine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More aliskiren and amlodipine resources Aliskiren and amlodipine Side Effects (in more detail) Aliskiren and amlodipine Dosage Aliskiren and amlodipine Use in Pregnancy & Breastfeeding Aliskiren and amlodipine Drug Interactions Aliskiren and amlodipine Support Group 0 Reviews for Aliskiren and amlodipine - Add your own review/rating Compare aliskiren and amlodipine with other medications High Blood Pressure Where can I get more information? Your pharmacist can provide more information about aliskiren and amlodipine.

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Zonalon Cream


Pronunciation: DOX-e-pin
Generic Name: Doxepin
Brand Name: Zonalon
Zonalon Cream is used for:

Relieving moderate itching caused by certain skin conditions.

Zonalon Cream is an antipruritic cream. It is not known exactly how it works. It may block histamine to relieve itching.

Do NOT use Zonalon Cream if: you are allergic to any ingredient in Zonalon Cream you have certain prostate problems (eg, asymptomatic prostatic hypertrophy), uncontrolled glaucoma, or trouble urinating (urinary retention) you are taking clonidine, an H1 antagonist (eg, astemizole, terfenadine), or ibutilide you have taken linezolid, methylene blue, or a monoamine oxidase inhibitor (MAOI) (eg, furazolidone, phenelzine, isocarboxazid) within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Zonalon Cream:

Some medical conditions may interact with Zonalon Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of heart problems, seizures (eg, epilepsy), overactive thyroid, glaucoma or increased pressure in the eyes, prostate problems (eg, benign prostatic hypertrophy [BPH]), certain blood problems (eg, porphyria), suicidal thoughts or attempts, or a history of alcohol abuse

Some MEDICINES MAY INTERACT with Zonalon Cream. Tell your health care provider if you are taking any other medicines, especially any of the following:

Antiarrhythmics (eg, quinidine, propafenone, flecainide), antifungal medicines (eg, fluconazole, terbinafine), carbamazepine, cimetidine, mibefradil, phenothiazines (eg, chlorpromazine, thioridazine), or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, sertraline) because they may increase the risk of Zonalon Cream's side effects Anticoagulants (eg, warfarin), clonidine, guanadrel, H1 antagonists (eg, astemizole, terfenadine), ibutilide, sulfonylureas (eg, tolazamide, glipizide), sympathomimetics (eg, phenylephrine, pseudoephedrine), or tramadol because the risk of their side effects may be increased by Zonalon Cream Clonidine, guanadrel, guanethidine, or guanfacine because their effectiveness may be decreased by Zonalon Cream Linezolid, MAOIs (eg, furazolidone, phenelzine, isocarboxazid), or methylene blue because severe toxic effects may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zonalon Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Zonalon Cream:

Use Zonalon Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Zonalon Cream is for external use only. Wash and completely dry the affected area. Apply a thin film to the affected area and gently rub it in. Wash your hands immediately after using Zonalon Cream, unless they are part of the treated area. Do not bandage or otherwise cover the treated area unless directed to do so by your doctor. Avoid tight-fitting clothes on the treated area. If you miss a dose of Zonalon Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Ask your health care provider any questions you may have about how to use Zonalon Cream.

Important safety information: Zonalon Cream may cause drowsiness. This effect may be worse if you take it with alcohol or certain medicines. Use Zonalon Cream with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Zonalon Cream will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants. Limit your alcohol consumption while taking Zonalon Cream. Avoid getting Zonalon Cream in your eyes or on the inside of your nose or mouth. Use Zonalon Cream with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness and confusion. Zonalon Cream should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zonalon Cream while you are pregnant. It is not known if Zonalon Cream is found in breast milk. Do not breast-feed while taking Zonalon Cream. Possible side effects of Zonalon Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal skin sensations; burning and stinging at the application site; changes in emotions; confusion; dizziness; drowsiness; dry and tight skin; dry mouth and lips; fatigue; headache; itching; swelling; taste changes; thirst.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; rapid or pounding heartbeat; severe burning and stinging at the application site.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Zonalon side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Zonalon Cream may be harmful if swallowed.

Proper storage of Zonalon Cream:

Store Zonalon Cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Zonalon Cream out of the reach of children and away from pets.

General information: If you have any questions about Zonalon Cream, please talk with your doctor, pharmacist, or other health care provider. Zonalon Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Zonalon Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Zonalon resources Zonalon Side Effects (in more detail)Zonalon Use in Pregnancy & BreastfeedingZonalon Drug InteractionsZonalon Support Group0 Reviews for Zonalon - Add your own review/rating Compare Zonalon with other medications Atopic DermatitisDermatitisEczemaLichen Simplex ChronicusPruritus
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Ergotamine


Pronunciation: er-GOT-a-meen
Generic Name: Ergotamine
Brand Name: Ergomar

A serious and sometimes fatal decrease in blood flow to the extremities (eg, hands, feet) or brain may occur if Ergotamine is taken with certain medicines that affect liver metabolism. Do not take Ergotamine if you also take macrolide antibiotics (eg, erythromycin), certain HIV protease inhibitors (eg, ritonavir), or certain azole antifungals (eg, ketoconazole, itraconazole). Tell your doctor if you take any of these medicines. This is not a complete list of all interactions that may occur. Check with your doctor or pharmacist to see if Ergotamine may interact with other medicines that you take.


Ergotamine is used for:

Preventing or treating acute migraine headache with or without aura (flashing lights, wavy lines, dark spots).

Ergotamine is an ergot derivative. It works by narrowing blood vessels in the brain, which helps to relieve migraine headaches.

Do NOT use Ergotamine if: you are allergic to any ingredient in Ergotamine or to other ergot derivatives (eg, dihydroergotamine) you are pregnant, planning to become pregnant, or are breast-feeding you have heart disease, blood vessel problems, high blood pressure, decreased liver or kidney function, or severe infection you are taking certain azole antifungals (eg, itraconazole, ketoconazole), certain HIV protease inhibitors (eg, ritonavir, nelfinavir, indinavir), delavirdine, efavirenz, macrolide antibiotics (eg, clarithromycin, erythromycin, troleandomycin), telithromycin, or voriconazole you have taken a 5-HT1 agonist (eg, sumatriptan) within the past 24 hours

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ergotamine:

Some medical conditions may interact with Ergotamine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have blood circulation problems or other blood problems (eg, porphyria) if you have a history of liver or kidney problems, heart problems, lung problems, high cholesterol, or diabetes if you get other types of headaches, or if your migraine headache is different from previous migraines

Some MEDICINES MAY INTERACT with Ergotamine. Tell your health care provider if you are taking any other medicines, especially any of the following:

Azole antifungals (eg, ketoconazole), beta-blockers (eg, propranolol), clotrimazole, delavirdine, efavirenz, fluconazole, fluoxetine, fluvoxamine, HIV protease inhibitors (eg, ritonavir), 5-HT1 agonists (eg, sumatriptan), macrolide antibiotics (eg, erythromycin), metronidazole, nefazodone, telithromycin, voriconazole, or zileuton because they may increase the risk of Ergotamine's side effects Droxidopa or sympathomimetics (eg, ephedrine) because severe high blood pressure may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ergotamine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ergotamine:

Use Ergotamine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Ergotamine at the first sign of a migraine attack as directed by your doctor. Do not swallow, crush, or chew sublingual tablets. Place the tablet under your tongue and allow it to slowly dissolve. Do not eat, drink, or smoke while the tablet is dissolving. If you need more than 1 dose of Ergotamine to treat a migraine attack, take the second dose at least 30 minutes after the first dose. Do not take more than 2 tablets for any migraine attack. Do not take more than 3 tablets in a 24 hour period. Do not take more than 5 tablets within a 7 day period, unless otherwise directed by your doctor. Do not use Ergotamine daily on a regular basis. Check with your doctor before including grapefruit or grapefruit juice in your diet while you take Ergotamine. If you miss a dose of Ergotamine and you still have a headache, follow your doctor's dosing instructions. Contact your doctor immediately if you are unsure of what to do if you miss a dose. Do not take Ergotamine more often than prescribed. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ergotamine.

Important safety information: Ergotamine may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Ergotamine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Use Ergotamine with caution in the ELDERLY; they may be more sensitive to its effects. Ergotamine should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: Do not use Ergotamine if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Ergotamine is found in breast milk. Do not breast-feed while taking Ergotamine. Possible side effects of Ergotamine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fast, slow, or irregular heartbeat; muscle pain or weakness in the arms and legs; numb, cold, blue, pale, or tingling hands or feet; persistent headache; severe or persistent dizziness; shortness of breath; unusual swelling or weakness.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

See also: Ergotamine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; fainting; fast or slowed heartbeat; persistent headache; seizures; severe or persistent dizziness; vomiting; weak pulse.

Proper storage of Ergotamine:

Store Ergotamine between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ergotamine out of the reach of children and away from pets.

General information: If you have any questions about Ergotamine, please talk with your doctor, pharmacist, or other health care provider. Ergotamine is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Ergotamine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Ergotamine resources Ergotamine Side Effects (in more detail) Ergotamine Use in Pregnancy & Breastfeeding Ergotamine Drug Interactions Ergotamine Support Group 2 Reviews for Ergotamine - Add your own review/rating ergotamine Concise Consumer Information (Cerner Multum) Ergomar Monograph (AHFS DI) Compare Ergotamine with other medications Migraine
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Fluvastatin


Pronunciation: FLOO-va-STAT-in
Generic Name: Fluvastatin
Brand Name: Lescol
Fluvastatin is used for:

Lowering high cholesterol and triglycerides in certain patients. It also increases high-density lipoprotein (HDL, "good") cholesterol levels. It is used along with an appropriate diet. It is used in certain patients to slow blood vessel blockage and to reduce the need for medical procedures to open blocked heart blood vessels. It may also be used for other conditions as determined by your doctor.

Fluvastatin is an HMG-CoA reductase inhibitor, also known as a "statin." It works by reducing the production of certain fatty substances in the body, including cholesterol.

Do NOT use Fluvastatin if: you are allergic to any ingredient in Fluvastatin you have liver problems or unexplained abnormal liver function tests you are pregnant or breast-feeding

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fluvastatin:

Some medical conditions may interact with Fluvastatin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have low blood pressure, a serious infection, kidney problems, diabetes, or a history of seizures if you have metabolism, hormonal, or electrolyte problems if you drink alcohol or have a history of liver problems or alcohol abuse if you have recently had major surgery or a serious injury if you have a certain type of high cholesterol (homozygous familial hypercholesterolemia)

Some MEDICINES MAY INTERACT with Fluvastatin. Tell your health care provider if you are taking any other medicines, especially any of the following:

Azole antifungals (eg, fluconazole), colchicine, erythromycin, fibrates (eg, clofibrate, gemfibrozil), H2 blockers (eg, ranitidine), immunosuppressants (eg, cyclosporine), niacin, or omeprazole because they may increase the risk of muscle or kidney problems Anticoagulants (eg, warfarin) because the risk of bleeding may be increased Rifampin because it may decrease Fluvastatin's effectiveness Cimetidine, digoxin, glyburide, ketoconazole, phenytoin, or spironolactone because the risk of their side effects may be increased by Fluvastatin

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fluvastatin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fluvastatin:

Use Fluvastatin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Fluvastatin by mouth with or without food. If you take cholestyramine or colestipol, ask your doctor or pharmacist how to take it with Fluvastatin. Continue to take Fluvastatin even if you feel well. Do not miss any doses. If you miss a dose of Fluvastatin, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Fluvastatin.

Important safety information: Fluvastatin may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Fluvastatin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Drinking alcohol daily or in large amounts may increase the risk of liver problems with Fluvastatin. Check with your doctor before drinking alcohol while you are taking Fluvastatin. Follow the diet and exercise program given to you by your health care provider. Tell your doctor or dentist that you take Fluvastatin before you receive any medical or dental care, emergency care, or surgery. Women who may become pregnant should use effective birth control while taking Fluvastatin. Check with your doctor if you have questions about using birth control. Do NOT take more than the recommended dose without checking with your doctor. Report any unexplained muscle pain, tenderness, or weakness to your doctor right away, especially if you also have a fever or general body discomfort. Lab tests, including blood cholesterol levels and liver function tests, may be performed while you use Fluvastatin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Fluvastatin should be used with extreme caution in CHILDREN younger than 9 years old and in those who have been having a menstrual period for less than one year; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: Do not use Fluvastatin if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Fluvastatin is found in breast milk. Do not breast-feed while you are taking Fluvastatin. Possible side effects of Fluvastatin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; stomach pain or upset.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine produced; chest pain; dark urine; fever, chills, or persistent sore throat; flu-like symptoms; joint pain; mental or mood changes; muscle pain, tenderness, or weakness (with or without fever or fatigue); numbness or tingling of the skin, arm, or leg; painful or frequent urination; pale stools; red, swollen, blistered, or peeling skin; severe stomach pain; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Fluvastatin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Fluvastatin:

Store Fluvastatin at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Keep Fluvastatin out of the reach of children and away from pets.

General information: If you have any questions about Fluvastatin, please talk with your doctor, pharmacist, or other health care provider. Fluvastatin is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Fluvastatin. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Fluvastatin resources Fluvastatin Side Effects (in more detail) Fluvastatin Dosage Fluvastatin Use in Pregnancy & Breastfeeding Fluvastatin Drug Interactions Fluvastatin Support Group 2 Reviews for Fluvastatin - Add your own review/rating Fluvastatin Professional Patient Advice (Wolters Kluwer) fluvastatin Advanced Consumer (Micromedex) - Includes Dosage Information Fluvastatin Sodium Monograph (AHFS DI) Lescol Prescribing Information (FDA) Lescol Consumer Overview Compare Fluvastatin with other medications High Cholesterol High Cholesterol, Familial Heterozygous Hyperlipoproteinemia Hyperlipoproteinemia Type IIa, Elevated LDL Hyperlipoproteinemia Type IIb, Elevated LDL VLDL
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Sertaconazole Nitrate


Class: Azoles
VA Class: DE102
Chemical Name: (±)-1-[2,4-Dichloro-?-[(7-chlorobenzo[b]thien-3-yl)methoxy]phenylethyl]-imidazole mononitrate
Molecular Formula: C20H15Cl3N2OSH NO3
CAS Number: 99592-32-2
Brands: Ertaczo

Introduction

Antifungal; azole (imidazole derivative).1

Uses for Sertaconazole Nitrate Dermatophytoses

Treatment of interdigital tinea pedis (athlete’s foot) caused by Epidermophyton floccosum, Trichophyton mentagrophytes, or T. rubrum in immunocompetent adults and children ?12 years of age.1 2 16

Topical antifungals usually effective for treatment of uncomplicated tinea pedis;13 25 an oral antifungal usually necessary for treatment of hyperkeratotic areas on the palms and soles, for chronic moccasin-type (dry-type) tinea pedis, and for treatment of tinea unguium (onychomycosis).13 23 25

Treatment of tinea corporis† (ringworm of the body),16 tinea cruris† (jock itch),16 or tinea manuum† (hand ringworm)16 caused by E. floccosum, Microsporum (including M. canis), or Trichophyton (including T. mentagrophytes, T. rubrum, and T. schonleinii).16 19

Topical antifungals usually effective for uncomplicated tinea corporis, tinea cruris, and tinea manuum; an oral antifungal usually necessary when tinea corporis or tinea cruris is extensive, dermatophyte folliculitis is present, infection is chronic or does not respond to topical therapy, or patient is immunocompromised because of coexisting disease or concomitant therapy.13 20 23 25

Pityriasis (Tinea) Versicolor

Treatment of pityriasis (tinea) versicolor† caused by Malassezia furfur (Pityrosporum orbiculare or P. ovale).17 19

Topical treatment usually effective; an oral antifungal (alone or in conjunction with a topical agent) may be necessary in patients who have extensive or severe infections or who fail to respond to or have frequent relapses with topical therapy.21 22 23

Cutaneous Candidiasis

Treatment of superficial cutaneous candidiasis caused by Candida albicans†.18 19

Sertaconazole Nitrate Dosage and Administration Administration Topical Administration

Apply topically to the skin as a 2% cream.1

Do not apply to the eye or administer orally or intravaginally.1

Avoid contact with the nose, mouth, and other mucous membranes.1 19 20 21

Do not use with occlusive dressings or wrappings, unless otherwise directed by clinician.1

Apply a sufficient amount of cream twice daily; rub gently into affected area (e.g., between the toes) and immediately surrounding healthy skin.1

Dosage

Available as sertaconazole nitrate; dosage expressed in terms of sertaconazole nitrate.1

Pediatric Patients Dermatophytoses Tinea Pedis (Interdigital) Topical

Children ?12 years of age: Apply twice daily for 4 weeks.1

If clinical improvement does not occur after 2 weeks of treatment, reevaluate the diagnosis.1

Adults Dermatophytoses Tinea Pedis (Interdigital) Topical

Apply twice daily for 4 weeks.1

If clinical improvement does not occur after 2 weeks of treatment, reevaluate the diagnosis.1

Tinea Corporis,†Tinea Cruris†, andTinea Manuum† Topical

Has been applied twice daily for 4 weeks.16 17

Pityriasis (Tinea) Versicolor† Topical

Has been applied twice daily for 4 weeks.17

Cutaneous Candidiasis† Topical

Has been applied twice daily for 4 weeks.18

Cautions for Sertaconazole Nitrate Contraindications

Known hypersensitivity to sertaconazole, other imidazoles, or any ingredient in the formulation.1

Warnings/Precautions Sensitivity Reactions Hypersensitivity Reactions

Contact dermatitis reported rarely following topical application.1 5

If irritation or sensitivity occurs, discontinue the drug and initiate appropriate therapy.1 5

Possible cross-sensitization among the imidazoles.1 5

General Precautions Selection and Use of Antifungals

Prior to initiation of therapy, confirm diagnosis by direct microscopic examination of scrapings from infected tissue mounted in potassium hydroxide (KOH) or by culture.1

Specific Populations Pregnancy

Category C.1

Lactation

Not known whether distributed into milk following topical application of 2% cream.1 Use with caution.1

Pediatric Use

Safety and efficacy not established in children <12 years of age.1

Geriatric Use

Insufficient experience in patients ?65 years of age to determine whether geriatric patients respond differently than younger adults.1

Common Adverse Effects

Contact dermatitis, dry skin, burning skin, application site reaction, skin tenderness.1

Sertaconazole Nitrate Pharmacokinetics Absorption Bioavailability

Does not appear to be appreciably absorbed systemically following topical application to skin.1

Not detected in plasma following repeated application of 2% cream to diseased skin.1

Distribution Extent

Not known whether distributed into milk following topical application of 2% cream.1

Stability Storage Topical Cream

25°C (may be exposed to 15–30°C).1

Actions and SpectrumActions

Imidazole-derivative azole antifungal.1 10 11

Usually fungistatic; may be fungicidal at high concentrations.6 12

Presumably exerts its antifungal activity by altering cellular membranes, resulting in increased membrane permeability, secondary metabolic effects, and growth inhibition.1 6 11

Fungistatic activity may result from interference with ergosterol synthesis.1 6 8 10 11 12 Fungicidal activity at high concentrations may result from a direct physiochemical effect on the fungal cell membrane.6 8 12

Spectrum of antifungal activity includes many fungi, including dermatophytes and yeasts.1 3 4 6 8 10 14 15 Also has in vitro activity against some gram-positive bacteria.4

Dermatophytes: Active in vitro against Epidermophyton floccosum,1 7 8 9 14 Microsporum audouini,7 8 9 14 M. canis,7 8 9 14 15 M. gypseum,7 8 9 14 15 M. racemosum,9 Trichophyton erinacei,9 T. interdigitale,7 9 14 T. mentagrophytes,1 7 8 9 14 15 T. rubrum,1 7 8 9 14 15 T. schoenleinii,7 9 T. soudanese,9 T. terreste,9 T. tonsurans,7 9 T. verrucosum,7 and T. violaceum.7 9

Also active in vitro against Malassezia furfur (Pityrosporum orbiculare or P. ovale).10 14

Candida: Active in vitro against C. albicans,4 6 8 14 15 C. beigelii,6 14 C. dubliniensis,4 C. famata,8 C. glabrata (formerly Torulopsis glabrata),4 6 7 8 14 C. guilliermondii,4 6 7 8 C. holmii,4 C. humicola,4 7 8 C. inconspicua,4 C. intermedia,4 8 C. krusei,4 6 8 14 15 C. lambica, 4 C. lipolytica,4 C. lusitaniae,4 6 C. parapsilosis,4 6 8 15 C. pulcherrima,4 C. pseudotropicalis,6 14 15 C. rugosa,4 and C. tropicalis.4 6 8 14 15

Although clinical importance unknown, T. mentagrophytes, T. rubrum, and M. canis clinical isolates with in vitro resistance to sertaconazole reported.9 Some of these also were resistant to other imidazoles (e.g., clotrimazole, fluconazole, ketoconazole, miconazole, tioconazole).9

C. albicans serotype B vaginal isolate with in vitro resistance to sertaconazole and other imidazoles (e.g., econazole, fluconazole, itraconazole, ketoconazole miconazole) reported.4

Advice to Patients

Importance of applying to affected areas as directed and avoiding contact with eyes, nose, mouth, or other mucous membranes.1 Importance of not using occlusive dressings, unless otherwise directed by clinician.1

Importance of washing hands after applying the cream.1

Advise patients to dry affected areas thoroughly before applying cream if it is used after bathing.1

Use only for condition prescribed.1

Importance of completing full course of therapy, even if symptoms improve; importance of contacting clinician if skin condition worsens during therapy or if improvement does not occur after completing full course of therapy.1

Importance of discontinuing drug and consulting clinician if treated area becomes irritated (e.g., redness, itching, burning, blistering, swelling, or oozing).1

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.1

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Sertaconazole Nitrate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Cream

2%

Ertaczo (with methylparaben)

OrthoNeutrogena

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Ertaczo 2% Cream (ORTHO DERM): 30/$95.99 or 90/$259.98

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions July 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Orthoneutrogena. Ertaczo (sertaconazole nitrate) cream 2% prescribing information. Skillman, NJ. 2003 Dec.

2. Anon. Topical sertaconazole (ertaczo)--another azole for tinea pedis. Med Lett Drugs Ther. 2004; 46:50-1. [PubMed 15211288]

3. Center for Drug Evaluation and Research, Application Number: 21-385, Medical Review for Sertaconazole (Ertaczo). Food and Drug Administration website. Available at: . Accessed 2005 Jan 21.

4. Carrillo-Munoz AJ, Brio S, Quindos G et al. Sertaconazole: in-vitro antifungal activity against vaginal and other superficial yeast isolates. J Chemother. 2001;13:555-62.

5. Goday JJ, Yanguas I, Aguirre A et al. Allergic contact dermatitis from sertaconazole with cross-sensitivity to miconazole and econazole. Contact Dermatitis. 1995;32:370-1.

6. Palacin C, Tarrago C, Ortiz JA. Sertaconazole: pharmacology of a gynecological antifungal agent. Int J Gynaecol Obstet. 2000;71:S37-46.

7. Carrillo-Munoz AJ, Fernandez-Torres B, Guarro J. In vitro antifungal activity of sertaconazole against 309 dermatophyte clinical isolates. J Chemother. 2003;15:555-7.

8. Carillo-Munoz AJ, Tur-Tur C. Comparative study of antifungal activity of sertaconazole, terbinafine, and bifonazole against clinical isolates of Candida spp., Cryptococcus neoformans and dermatophytes. Chemotherapy. 1997;43:387-92.

9. Carrillo-Munoz AJ, Guglietta A, Palacin C, et al. In vitro antifungal activity of sertaconazole compared with nine other drugs against 250 clinical isolates of dermatophytes and Scopulariopsis brevicaulis. Chemotherapy. 2004;50:308-13.

10. Torres-Rodriguez JM. New topical antifungal drugs. Arch Med Res. 1993;24:371-5.

11. Agut J, Palacin C, Sacristan A, Ortiz JA. Inhibition of ergosterol synthesis by sertaconazole in Candida albicans. Arzneimittelforschung. 1992;42:718-20.

12. Agut J, Palacin C, Salgado Jet al. Direct membrane-damaging effect of sertaconazole on Candida albicans as a mechanism of its fungicidal activity. Arzneimittelforschung. 1992;42:721-4.

13. Pi?rard GE, Arrese JE, Pi?rard-Franchimont C. Treatment and prophylaxis of tinea infections. Drugs. 1996; 52:209-24. [PubMed 8841739]

14. Drouhet E, Dupont B. In vitro antifungal activity of sertaconazole. Arzneimittelforschung. 1992; 42:705-10. [PubMed 1627187]

15. Palacin C, Sacristan A, Ortiz JA. In vitro activity of sertaconazole. Arzneimittelforschung. 1992;42:699-705.

16. Alomar C, Bassas S, Casas M et al. Multi-centre double-blind trial on the efficacy and safety of sertaconazole 2% cream in comparison with miconazole 2% cream on patients suffering from cutaneous mycoses. Arzneimittelforschung. 1992 May;42:767-73.

17. Nasarre J, Umbert P, Herrero E et al. Therapeutic efficacy and safety of the new antimycotic sertaconazole in the treatment of Pityriasis versicolor. Arzneimittelforschung. 1992;42:764-7.

18. Umbert P, Nasarre J, Bello A et al. Phase II study of the therapeutic efficacy and safety of the new antimycotic sertaconazole in the treatment of superficial mycoses caused by Candida albicans. Arzneimittelforschung. 1992;42:757-60.

19. Torres J, Marquez M, Camps F. Sertaconazole in the treatment of mycoses: from dermatology to gynecology. Int J Gynaecol Obstet. 2000;71:S3-20.

20. Gupta AK, Einarson TR, Summerbell RC et al. An overview of topical antifungal therapy in dermatomycoses: a North American perspective. Drugs. 1998; 55:645-74. [PubMed 9585862]

21. Sunenshine PJ, Schwartz RA, Janniger CK. Tinea versicolor: an update. Cutis. 1998; 61:65-72. [PubMed 9515210]

22. Assaf RR, Weil ML. The superficial mycoses. Dermatol Clin. 1996; 14:57-67. [PubMed 8821158]

23. Hay RJ. Dermatophytosis and other superficial mycoses. In: Mandel GL, Douglas RG Jr, Bennett JE, eds. Principles and practices of infectious disease. 4th ed. New York: Churchill Livingston; 1995: 2375-86.

24. Drake LA, Dinehart SM, Farmer ER et al. Guidelines of care for superficial mycotic infections of the skin: pityriasis (tinea) versicolor. J Am Acad Dermatol. 1996; 34:287-9. [IDIS 363963] [PubMed 8642095]

25. Drake LA, Dincehart SM, Farmer ER et al. Guidelines of care for superficial mycotic infections of the skin: tinea corporis, tinea cruris, tinea faciei, tinea manuum, and tinea pedis. J Am Acad Dermatol. 1996; 34:282-6. [IDIS 363962] [PubMed 8642094]

26. Reviewers’ comments (personal observations) on Sulconazole 84:04.08.

27. Orthoneutrogena. Los Angeles, CA: Personal communication.

More Sertaconazole Nitrate resources Sertaconazole Nitrate Side Effects (in more detail) Sertaconazole Nitrate Dosage Sertaconazole Nitrate Use in Pregnancy & Breastfeeding Sertaconazole Nitrate Support Group 0 Reviews for Sertaconazole Nitrate - Add your own review/rating Compare Sertaconazole Nitrate with other medications Tinea Pedis
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Cyclobenzaprine Extended-Release Capsules


Pronunciation: SYE-kloe-BEN-za-preen
Generic Name: Cyclobenzaprine
Brand Name: Amrix
Cyclobenzaprine Extended-Release Capsules are used for:

Treating muscle spasms caused by painful muscle conditions. It should be used along with rest and physical therapy. It may also be used for other conditions as determined by your doctor.

Cyclobenzaprine Extended-Release Capsules are a muscle relaxant. It works in parts of the brain and nervous system to help reduce muscle spasms.

Do NOT use Cyclobenzaprine Extended-Release Capsules if: you are allergic to any ingredient in Cyclobenzaprine Extended-Release Capsules you have an overactive thyroid, liver problems, or certain heart problems (eg, irregular heartbeat, congestive heart failure, heart block, conduction problems), or if you have recently had a heart attack you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine, rasagiline) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Cyclobenzaprine Extended-Release Capsules:

Some medical conditions may interact with Cyclobenzaprine Extended-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of liver problems, heart problems, cerebral palsy, brain or spinal cord disease, or stroke if you have a history of glaucoma, increased pressure in the eye, or trouble urinating

Some MEDICINES MAY INTERACT with Cyclobenzaprine Extended-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

MAOIs (eg, phenelzine, rasagiline) because serious, sometimes fatal reactions, including high fever and severe seizures, may occur Tramadol because the risk of seizures may be increased Droperidol or fluoxetine because severe heart problems, including irregular heartbeat, may occur Anticholinergics (eg, methscopolamine, benztropine), barbiturates (eg, phenobarbital), cimetidine, fluconazole, fluvoxamine, mibefradil, naproxen, or phenothiazines (eg, chlorpromazine) because they may increase the risk of Cyclobenzaprine Extended-Release Capsules's side effects Carbamazepine because it may decrease Cyclobenzaprine Extended-Release Capsules's effectiveness or increase the risk of Cyclobenzaprine Extended-Release Capsules's side effects Guanethidine or guanfacine because their effectiveness may be decreased by Cyclobenzaprine Extended-Release Capsules Sympathomimetics (eg, albuterol, epinephrine, phenylephrine) because their effectiveness may be decreased or the risk of their side effects may be increased by Cyclobenzaprine Extended-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cyclobenzaprine Extended-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Cyclobenzaprine Extended-Release Capsules:

Use Cyclobenzaprine Extended-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Cyclobenzaprine Extended-Release Capsules by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Swallow Cyclobenzaprine Extended-Release Capsules whole. Do not break, crush, or chew before swallowing. Cyclobenzaprine Extended-Release Capsules works best if it is taken at the same time each day. Do not suddenly stop taking Cyclobenzaprine Extended-Release Capsules without checking with your doctor. If you miss a dose of Cyclobenzaprine Extended-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Cyclobenzaprine Extended-Release Capsules.

Important safety information: Cyclobenzaprine Extended-Release Capsules may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Cyclobenzaprine Extended-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Talk with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Cyclobenzaprine Extended-Release Capsules; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. Do NOT take more than the recommended dose or use for longer than 2 to 3 weeks without checking with your doctor. If your symptoms (eg, pain, tenderness, decreased range of motion) do not get better within 2 to 3 weeks or if they get worse, contact your doctor. Do not become overheated in hot weather or while you are being active; heatstroke may occur. If you experience dry mouth, use sugarless candy or gum, or melt bits of ice in your mouth. If dry mouth continues for more than 2 weeks, contact your dentist or doctor. Use of Cyclobenzaprine Extended-Release Capsules are not recommended in the ELDERLY; they may be more sensitive to its effects. Cyclobenzaprine Extended-Release Capsules has not been approved for use in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cyclobenzaprine Extended-Release Capsules while you are pregnant. It is not known if Cyclobenzaprine Extended-Release Capsules are found in breast milk. If you are or will be breast-feeding while you use Cyclobenzaprine Extended-Release Capsules, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Cyclobenzaprine Extended-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; dry mouth; fatigue; nausea; stomach pain or upset.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; fainting; fast or irregular heartbeat; mental or mood changes; numbness of an arm or a leg; one-sided weakness; seizures; severe dizziness or vomiting; speech or vision problems; sudden severe stomach pain; trouble urinating; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Cyclobenzaprine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; chest pain; coma; confusion; fast or irregular heartbeat; hallucinations; loss of coordination; seizures; severe drowsiness, dizziness, or nausea; slurred speech; tremor; vomiting.

Proper storage of Cyclobenzaprine Extended-Release Capsules:

Store Cyclobenzaprine Extended-Release Capsules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cyclobenzaprine Extended-Release Capsules out of the reach of children and away from pets.

General information: If you have any questions about Cyclobenzaprine Extended-Release Capsules, please talk with your doctor, pharmacist, or other health care provider. Cyclobenzaprine Extended-Release Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Cyclobenzaprine Extended-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Cyclobenzaprine resources Cyclobenzaprine Side Effects (in more detail) Cyclobenzaprine Dosage Cyclobenzaprine Use in Pregnancy & Breastfeeding Drug Images Cyclobenzaprine Drug Interactions Cyclobenzaprine Support Group 169 Reviews for Cyclobenzaprine - Add your own review/rating Compare Cyclobenzaprine with other medications Fibromyalgia Migraine Muscle Spasm Sciatica Temporomandibular Joint Disorder
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cabazitaxel


Generic Name: cabazitaxel (ka BAZ i TAX el)
Brand Names: Jevtana

What is cabazitaxel?

Cabazitaxel is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Cabazitaxel is used together with prednisone to treat prostate cancer that has spread to other parts of the body (metastatic).

Cabazitaxel is usually given after other cancer medicines have been tried without successful treatment.

Cabazitaxel may also be used for purposes not listed in this medication guide.

What is the most important information I should know about cabazitaxel? Do not use cabazitaxel if you are pregnant. It could harm the unborn baby. You should not use this medication if you are allergic to cabazitaxel, or if you have liver disease, low white blood cell counts, or an allergy to any medicine that contains polysorbate 80. You should not breast-feed while you are receiving cabazitaxel.

Before you receive cabazitaxel, tell your doctor if you have ever had a severe allergic reaction to any medication.

Cabazitaxel is used together with prednisone, and you may also be given other medications to help prevent certain side effects. Use all medications as directed by your doctor.

To make sure cabazitaxel is helping your condition and not causing harmful effects, your blood will need to be tested often. What should I discuss with my health care provider before receiving cabazitaxel? You should not use this medication if you are allergic to cabazitaxel, or if you have:

liver disease;

low white blood cell counts; or

an allergy to any medicine that contains polysorbate 80.

To make sure you can safely receive cabazitaxel, tell your doctor if you have ever had a severe allergic reaction to any medication.

FDA pregnancy category D. Do not use cabazitaxel if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether cabazitaxel passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are receiving cabazitaxel. Serious side effects may be more likely in older adults receiving cabazitaxel. How is cabazitaxel given?

Cabazitaxel is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Cabazitaxel must be given slowly, and the IV infusion can take about 1 hour to complete.

Cabazitaxel is usually given once every 3 weeks. You will most likely take prednisone by mouth every day throughout your cabazitaxel treatment. Follow your doctor's dosing instructions very carefully.

Do not stop taking prednisone without your doctor's advice, or you could have unpleasant side effects caused by cabazitaxel. Tell your doctor if you have missed any doses or have stopped taking prednisone for any reason.

About 30 minutes before you receive cabazitaxel, you may be given other medications to help prevent certain side effects.

Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

To make sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests. Do not miss any follow-up visits to your doctor.

Your doctor may tell you to check your temperature at home throughout your treatment with cabazitaxel.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while receiving cabazitaxel, which can lead to a serious electrolyte imbalance.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your cabazitaxel injection.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include some of the serious side effects listed in this medication guide.

What should I avoid while receiving cabazitaxel? Avoid taking an herbal supplement containing St. John's wort while you are being treated with cabazitaxel. Cabazitaxel side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives, red skin rash; difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

fever, cough, chills, muscle aches, flu symptoms, sores in your mouth and throat, rapid and shallow breathing, fainting;

pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

severe or ongoing diarrhea;

trouble breathing;

feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

swelling or rapid weight gain; or

blood in your urine, pain or burning when you urinate.

Less serious side effects may include:

nausea, vomiting, stomach pain;

constipation, mild diarrhea;

weakness, tired feeling;

joint pain, back pain;

numbness, burning pain, or tingly feeling en your hands or feet;

changes in your sense of taste; or

hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Cabazitaxel Dosing Information

Usual Adult Dose for Prostate Cancer:

Initial dose: 25 mg/m2 IV every 3 weeks in combination with prednisone 10 mg orally once daily.

What other drugs will affect cabazitaxel?

Many drugs can interact with cabazitaxel. Below is just a partial list. Tell your doctor if you are using:

conivaptan (Vaprisol);

imatinib (Gleevec);

isoniazid (for treating tuberculosis);

aprepitant (Emend);

cimetidine (Tagamet);

cyclosporine (Gengraf, Neoral, Sandimmune);

haloperidol (Haldol);

lidocaine (Xylocaine);

an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), doxycycline (Adoxa, Alodox, Avidoxy, Oraxyl, Doryx, Oracea, Vibramycin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), metronidazole (Flagyl), norfloxacin (Noroxin), telithromycin (Ketek), or tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap);

antifungal medication such as clotrimazole (Mycelex Troche), fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), or voriconazole (Vfend);

an antidepressant such as nefazodone, desipramine (Norpramin), or sertraline (Zoloft);

heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others; or

HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir).

This list is not complete and there are many other drugs that can interact with cabazitaxel. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you. More cabazitaxel resources Cabazitaxel Side Effects (in more detail) Cabazitaxel Dosage Cabazitaxel Use in Pregnancy & Breastfeeding Cabazitaxel Drug Interactions Cabazitaxel Support Group 0 Reviews for Cabazitaxel - Add your own review/rating cabazitaxel Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information Cabazitaxel Professional Patient Advice (Wolters Kluwer) Cabazitaxel MedFacts Consumer Leaflet (Wolters Kluwer) Cabazitaxel Monograph (AHFS DI) Jevtana Prescribing Information (FDA) Jevtana Consumer Overview Compare cabazitaxel with other medications Prostate Cancer Where can I get more information? Your doctor or pharmacist can provide more information about cabazitaxel.

See also: cabazitaxel side effects (in more detail)


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Fungizone For Tissue Culture


Generic Name: amphotericin B (am foe TER i sin)
Brand Names: Fungizone, Fungizone For Tissue Culture

What is Fungizone For Tissue Culture (amphotericin B)?

Amphotericin B is an antibiotic that fights fungal infections in the body.

Amphotericin B is used to treat serious, life-threatening fungal infections. It is not for use in treating a minor fungal infection such as a yeast infection of the mouth, esophagus, or vagina.

Amphotericin is usually given after other antifungal antibiotics have been tried without successful treatment of symptoms.

Amphotericin B may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Fungizone For Tissue Culture (amphotericin B)? Do not receive this medication if you are allergic to any formulation of amphotericin B (Abelcet, AmBisome, Amphotec, or Fungizone).

Before you receive amphotericin B, tell your doctor if you are allergic to any drugs, or if you have kidney disease or heart disease.

Amphotericin B is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting.

The medicine must be given slowly through an IV infusion, and can take up to 6 hours to complete.

Amphotericin B may need to be given for up to several weeks or months, depending on the infection being treated.

Some people receiving an amphotericin B injection have had a reaction to the infusion (either when the medicine is injected into the vein or within 1 to 3 hours afterward). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, feverish or cold, or if have a slow heartbeat, chest tightness, or trouble breathing. What should I discuss with my health care provider before I receive Fungizone For Tissue Culture (amphotericin B)? You should not receive this medication if you are allergic to any formulation of amphotericin B (Abelcet, AmBisome, Amphotec, or Fungizone).

Before you receive amphotericin B, tell your doctor if you are allergic to any drugs, or if you have:

kidney disease; or

heart disease.

If you have any of these conditions, you may need a dose adjustment or special tests to safely receive amphotericin B.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether amphotericin B passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby. How is amphotericin B given?

Amphotericin B is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting.

The medicine must be given slowly through an IV infusion, and can take up to 6 hours to complete.

While you are receiving your amphotericin B infusion, your caregivers will check your blood pressure, pulse, temperature, and lung function about every 30 minutes.

To be sure this medication is not causing harmful effects, your blood cells, kidney function, and liver function may need to be tested on a regular basis. Amphotericin B can have long-lasting effects on your body. Do not miss any follow-up visits to your doctor for blood or urine tests.

Amphotericin B may need to be given for up to several weeks or months, depending on the infection being treated.

What happens if I miss a dose?

Since amphotericin B is usually given while you are in the hospital, it is not likely you will miss a dose of this medication.

If you are receiving amphotericin B in an outpatient clinic, call your doctor if you will miss an appointment for your amphotericin B injection.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include slow heart rate, and shallow breathing that slows or stops.

What should I avoid while receiving Fungizone For Tissue Culture (amphotericin B)?

Amphotericin B may lower the blood cells that help your body fight other infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Fungizone For Tissue Culture (amphotericin B) side effects Some people receiving an amphotericin B injection have had a reaction to the infusion (either when the medicine is injected into the vein or within 1 to 3 hours afterward). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, feverish or cold, or if you have a slow heartbeat, chest tightness, or trouble breathing. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your doctor at once if you have any of these serious side effects:

dry mouth, increased thirst, nausea, vomiting;

extreme drowsiness, restless feeling, confusion;

urinating more or less than usual, or not at all;

muscle pain or weakness, fast or uneven heart rate, feeling light-headed, fainting;

seizure (convulsions);

fever, chills, body aches, flu symptoms;

pale skin, easy bruising or bleeding, unusual weakness; or

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

pain, swelling, or other irritation where the needle is placed;

mild nausea, vomiting, diarrhea, upset stomach, loss of appetite;

weight loss;

muscle or joint aches;

headache;

warmth, redness, or tingly feeling under your skin; or

skin itching or mild rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Fungizone For Tissue Culture (amphotericin B)?

Before receiving amphotericin B, tell your doctor if you are using any of the following drugs:

flucytosine (Ancobon);

digoxin (digitalis, Lanoxin, Lanoxicaps);

pentamidine (Nebupent, Pentam);

tacrolimus (Prograf);

muscle relaxers;

steroids (prednisone and others);

antifungal antibiotics such as clotrimazole (Mycelex Troche), fluconazole (Diflucan), ketoconazole (Nizoral), or itraconazole (Sporanox);

antibiotics such as capreomycin (Capastat), rifampin (Rifadin, Rimactane, Rifater), vancomycin (Vancocin, Vancoled);

antiviral medicines such as acyclovir (Zovirax), adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or

cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), plicamycin (Mithracin), streptozocin (Zanosar), or tretinoin (Vesanoid).

This list is not complete and there may be other drugs that can interact with amphotericin B. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Fungizone For Tissue Culture resources Fungizone For Tissue Culture Side Effects (in more detail)Fungizone For Tissue Culture Use in Pregnancy & BreastfeedingFungizone For Tissue Culture Drug Interactions0 Reviews for Fungizone For Tissue Culture - Add your own review/rating Amphocin MedFacts Consumer Leaflet (Wolters Kluwer) Amphocin Advanced Consumer (Micromedex) - Includes Dosage Information Amphotericin B Prescribing Information (FDA) Amphotericin B Monograph (AHFS DI) Amphotericin B Professional Patient Advice (Wolters Kluwer) Fungizone Prescribing Information (FDA) Compare Fungizone For Tissue Culture with other medications Aspergillosis, AspergillomaAspergillosis, InvasiveBlastomycosisCandida Infections, SystemicCandida Urinary Tract InfectionCoccidioidomycosisCoccidioidomycosis, MeningitisCryptococcal Meningitis, Immunocompetent HostCryptococcal Meningitis, Immunosuppressed HostCryptococcosisEsophageal CandidiasisFungal EndocarditisFungal Infection ProphylaxisHistoplasmosis, Immunocompenent HostHistoplasmosis, MeningitisLeishmaniasisOral ThrushParacoccidioidomycosisSporotrichosis Where can I get more information? Your pharmacist can provide more information about amphotericin B.

See also: Fungizone For Tissue Culture side effects (in more detail)


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Phenytoin 250mg / 5ml Solution for Injection (Beacon Pharmaceuticals)


Phenytoin 250mg/5ml Solution For Injection

(Referred to in this leaflet as Phenytoin Injection)

Please read this leaflet carefully before receiving Phenytoin Injection. If you have already received Phenytoin Injection because of the urgency of your condition, you should still read this leaflet. This is particularly important if you are to continue to be given phenytoin Keep the leaflet in case you want to refer to it again If you want to know more about Phenytoin Injection or have any questions, you should ask your doctor. In this leaflet: 1. What Phenytoin Injection is used for 2. Before you are given Phenytoin Injection 3. How Phenytoin Injection should be given 4. Possible side effects 5. Storing Phenytoin Injection 6. Further information What Phenytoin Injection Is Used For

Phenytoin belongs to a group of medicines called anti-epileptic drugs.

Phenytoin injection is used to treat: severe epileptic seizures or fits (status epilepticus) and prevent seizures for short periods of time when anti-epileptics drugs cannot be taken by mouth or prevent seizures during or after brain surgery and/or severe head injury specific changes in the rhythm of the heart (cardiac arrhythmias), particularly when these are caused by the drug digoxin. Before You Are Given Phenytoin Injection You must NOT be given Phenytoin Injection and you should talk to your doctor immediately if you have: shown signs of hypersensitivity (severe allergy) to phenytoin, phenytoin sodium, other similar drugs (hydantoins) or any of the other ingredients in this medicine a heart condition called heart block Before you are given Phenytoin Injection, tell your doctor if you: have low blood pressure or heart failure have liver disease have diabetes have porphyria (an inherited blood disease) are due to have a surgical procedure, or if you are to be given the anaesthetic agent halothane as this may increase phenytoin levels are (or think you might be) pregnant or are breast-feeding drink large amounts of alcohol. You should limit the amount of alcohol you drink whilst being treated with phenytoin as the concentration in your blood can be altered with excess alcohol.

A small number of people being treated with anti-epileptics such as phenytoin have had thoughts of harming themselves. If at any time you have these thoughts, immediately contact your doctor. Taking/using other medicines

Before you are given Phenytoin Injection, tell your doctor if you taking medicines used to treat: epilepsy (carbamazepine, lamotrigine, phenobarbital, sodium valproate, succinimides e.g. ethosuximide, and vigabatrin) fungal infections (amphotericin B, fluconazole, itraconazole, ketoconazole, miconazole) tuberculosis or other infections (chloramphenicol, isoniazid, rifampicin, sulphonamides, doxycycline and ciprofloxacin) pain and inflammation (phenylbutazone, steroids and salicylates e.g.aspirin) stomach ulcers (omeprazole, sucralfate, medicines known as H2 antagonists e.g. cimetidine, and some antacids) sleeplessness, depression or psychiatric disorders (chlordiazepoxide, clozapine, diazepam, disulfiram, fluoxetine, methylphenidate, paroxetine, phenothiazines, trazodone, tricyclic antidepressants and viloxazine) heart and circulatory problems (dicoumarol, amiodarone, reserpine, digitoxin, furosemide, quinidine, warfarin and calcium channel blockers e.g. diltiazem, nifedipine) diabetes (tolbutamide), cancer, asthma or bronchitis (theophylline) Phenytoin may also interact with: hormone replacement therapy (oestrogens) the pill (oral contraceptive) methadone halothane (anaesthetic) muscle relaxants used in surgery ciclosporin (to prevent rejection of organ transplants) vitamin supplements such as Vitamin D and folic acid the herbal preparation St John’s wort.

Tell your doctor if you are taking, or have recently taken, any other medicines, including ones you have bought yourself.

Phenytoin may also interfere with certain laboratory tests that you may be given.

How Phenytoin Injection Should Be Given

You will be in hospital when you are given this medicine. Your doctor will decide on the dose and how it will be given to you.

A diluted solution will be either injected into one of your veins or, more rarely, into your muscle. The medicine is injected slowly into your vein or given as an infusion (drip) over a period of time.

Your heart rhythm, blood pressure and breathing will be monitored.

As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too much, however tell your doctor or nurse if you have any concerns.

Possible Side Effects

As with all medicines, phenytoin may cause some side effects in some patients.

Serious side effects

If any of the following happen, tell a doctor or nurse IMMEDIATELY as you may need urgent medical attention:

symptoms of a severe hypersensitivity syndrome which may include: itchy rash, swelling of the face, lips, tongue or throat (which may cause difficulty in swallowing or breathing), raised red patches on the skin, joint pain or fever irritation or burning sensation at the site of the injection rashes, which may be severe, resulting in painful reddening and blistering of the skin, eyes, mouth, anus or genital region and may lead to skin shedding. chest pains, palpitations or feeling faint joint pains If you experience any of the following side effects tell your doctor or nurse as soon as possible:

Effects on the nervous system including:

difficulty in controlling movements unsteadiness, shaking, nervousness uncoordinated movements unusual eye movements confusion, dizziness, slurred speech pins and needles, twitching muscles drowsiness, headaches sleeplessness loss of feeling in the hands and feet.

These effects may occur when the amount of phenytoin in your blood is too high. If you suffer with kidney or liver disease or are elderly you may experience these side effects at lower doses of phenytoin.

Very high amounts can cause extreme confusion, psychosis or encephalopathy (a brain disease), which may lead to irreversible brain injury. Your doctor should measure the amount of phenytoin in your blood and adjust your dose if necessary.

Effects on the skin:

minor skin rashes such as measles-like rash or dermatitis.

Tell your doctor if a rash does not clear up, recurs or you show signs of a serious reaction.

Other side effects: disorders or swelling of the lymph glands (part of your body’s defence system) blood disorders, which may be noticed as bruising, paleness, fever or sore throat liver damage or inflammation which may be recognised by yellowing of the eyes and skin inflammation of the kidneys breathing problems feeling sick, vomiting or constipation increased levels of blood sugar, decreased levels of folic acid and calcium the amount of vitamin D in your body may be altered. Other rare side effects: changes in the hand with difficulty straightening the fingers changes to facial features, enlarged gums or lips abnormal facial or body hair changes to the shape of the penis and painful erection.

Tell your doctor or nurse as soon as possible if you notice these or any side effect not mentioned in this leaflet.

Storing Phenytoin Injection

Keep out of the sight and reach of children.

Keep in the original packaging.

Do not use after the expiry date printed on the carton.

Further Information What is in this medicine:

Each 5 ml ampoule contains 250mg of the active ingredient phenytoin sodium.

The ampoules also contain propylene glycol, ethanol, sodium hydroxide and water.

What this medicine looks like and contents of the pack:

Phenytoin Injection is a clear liquid. Each pack contains 1 or 50 ampoules.

Marketing authorisation holder: Beacon Pharmaceuticals Ltd. Tunbridge Wells Kent TN1 1YG Manufacturer: Laboratorio Reig Jofr?, S.A Spain

Date of approval: 09/09/2008


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