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Nimodipine


Pronunciation: nye-MOE-di-peen
Generic Name: Nimodipine
Brand Name: Generic only. No brands available.

Nimodipine should only be taken by mouth. Life-threatening and sometimes fatal side effects may occur if Nimodipine is administered by injection.


Nimodipine is used for:

Reducing problems due to lack of oxygen caused by bleeding from a blood vessel in the brain. It may also be used for other conditions as determined by your doctor.

Nimodipine is a calcium channel blocking agent. Exactly how Nimodipine works is unknown.

Do NOT use Nimodipine if: you are allergic to any ingredient in Nimodipine

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

Before using Nimodipine:

Some medical conditions may interact with Nimodipine. 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 liver problems, heart problems (eg, slow heartbeat), shock due to serious heart problems, low blood pressure, fluid in your lungs, or if you have a history of heart attack

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

Calcium channel blockers (eg, amlodipine) or other blood pressure medicines because actions and side effects may be increased by Nimodipine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nimodipine 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 Nimodipine:

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

Take Nimodipine on an empty stomach at least 1 hour before or 2 hours after eating. Avoid eating grapefruit or drinking grapefruit juice while taking Nimodipine. If you miss a dose of Nimodipine, 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 Nimodipine.

Important safety information: Nimodipine may cause dizziness or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Nimodipine. Using Nimodipine alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. LAB TESTS, including blood pressure, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and laboratory appointments. Use Nimodipine with caution in the ELDERLY because they may be more sensitive to its effects. Use Nimodipine with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Nimodipine during pregnancy. It is unknown if Nimodipine is excreted in breast milk. Do not breast-feed while you are using Nimodipine. Possible side effects of Nimodipine:

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:

Diarrhea; flushing; headache; nausea.

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); black or bloody stools; depression; fast, slow, or irregular heartbeat; severe dizziness; shortness of breath; severe or persistent constipation; swelling of the feet or hands; unusual bruising or bleeding; unusual tiredness or weakness; 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: Nimodipine 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 fainting; loss of consciousness; rapid, slow, or irregular heartbeat; severe dizziness.

Proper storage of Nimodipine:

Store Nimodipine 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 in the original foil pack away from heat, moisture, and light. Do not store in the bathroom. Keep Nimodipine out of the reach of children and away from pets.

General information: If you have any questions about Nimodipine, please talk with your doctor, pharmacist, or other health care provider. Nimodipine 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 Nimodipine. 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 Nimodipine resources Nimodipine Side Effects (in more detail)Nimodipine DosageNimodipine Use in Pregnancy & BreastfeedingDrug ImagesNimodipine Drug InteractionsNimodipine Support Group2 Reviews for Nimodipine - Add your own review/rating Nimodipine Professional Patient Advice (Wolters Kluwer) Nimodipine Monograph (AHFS DI) Nimodipine Prescribing Information (FDA) Nimotop Prescribing Information (FDA) nimodipine Concise Consumer Information (Cerner Multum) nimodipine Advanced Consumer (Micromedex) - Includes Dosage Information Compare Nimodipine with other medications Ischemic StrokeMigraine PreventionSubarachnoid Hemorrhage
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Nimotop 30mg Tablets


1. Name Of The Medicinal Product

Nimotop 30mg Tablets

2. Qualitative And Quantitative Composition

Each film-coated tablet contains 30mg nimodipine.

3. Pharmaceutical Form

Film-coated tablet.

Yellow, round biconvex tablets with “SK” marked on one side and the Bayer cross marked on the other side.

4. Clinical Particulars 4.1 Therapeutic Indications

Nimodipine is indicated for the prevention of ischaemic neurological deficits following aneurysmal subarachnoid haemorrhage.

4.2 Posology And Method Of Administration

Aneurysmal subarachnoid haemorrhage:

Prophylactic administration - Adults

The recommended dose is two tablets at 4-hourly intervals (total daily dose 360 mg) to be taken with water. Prophylactic administration should commence within four days of onset of subarachnoid haemorrhage and should be continued for 21 days.

In the event of surgical intervention, administration of Nimotop tablets should be continued (dosage as above) to complete the 21 days treatment period.

In patients who develop adverse reactions the dose should be reduced as necessary or the treatment discontinued

Severely disturbed liver function, particularly liver cirrhosis, may result in an increased bioavailability of nimodipine due to a decreased first-pass capacity and a reduced metabolic clearance. The effects and side-effects, e.g. reduction in blood pressure, may be more pronounced in these patients. In such cases the dose should be reduced (depending on the blood pressure) or, if necessary, discontinuation of the treatment should be considered.

Upon co-administration with CYP 3A4 inhibitors or CYP 3A4 inducers a dose adaption may be necessary (see Section 4.5).

Administration:

In general, the tablets should be swallowed whole with a little liquid, with or without food. The interval between successive doses must not be less than 4 hours.

Grapefruit juice is to be avoided (see Section 4.5).

Traumatic subarachnoid haemorrhage:

Not recommended as a positive benefit to risk ratio has not been established (see Section 4.4)

Elderly: There are no special dosage requirements for use in the elderly.

Children: Paediatric dosage has not been established.

4.3 Contraindications

Known hypersensitivity to Nimodipine or any of the excipients.

Nimodipine should not be administered to patients during or within one month of a myocardial infarction or an episode of unstable angina.

The use of nimodipine in combination with rifampicin and the antiepileptic drugs, phenobarbital, phenytoin or carbamazepine is contraindicated as the efficacy of Nimotop tablets could be significantly reduced when concomitantly administered. (See section 4.5 Interaction with other medicinal products and other forms of interaction).

4.4 Special Warnings And Precautions For Use

Nimotop should not be used in patients with traumatic subarachnoid haemorrhage as a positive benefit to risk ratio has not been established and the specific patient groups that might benefit cannot be identified for this indication.

Nimotop tablets should be used with care when cerebral oedema or severely raised intracranial pressure are present. Although treatment with Nimotop has not been shown to be associated with increases in intracranial pressure, close monitoring is recommended in these cases or when the water content of the brain tissue is elevated (generalised cerebral oedema).

Caution is required in patients with hypotension.

Decreased drug clearance may occur in cirrhotic patients receiving Nimotop and, therefore, close monitoring of blood pressure is recommended in these patients.

Nimodipine is metabolised via the cytochrome P450 3A4 system. Drugs that are known to either inhibit or induce this enzyme system may, therefore, alter the first pass or the clearance of nimodipine (see section 4.5 Interaction with other medicinal products and other forms of interaction).

Drugs which are known inhibitors of the cytochrome P450 3A4 system and, therefore, may lead to increased plasma concentrations of nimodipine are macrolide antibiotics (e.g. erythromycin), anti-HIV protease inhibitors (e.g. ritonavir), azole antimycotics (e.g. ketoconazole), the antidepressants nefazodone and fluoxetine, quinupristin/dalfopristin, cimetidine and valproic acid.

Upon co-administration with these drugs, the blood pressure should be monitored and, if necessary, a reduction in the nimodipine dose should be considered.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Nimotop tablets should not be administered concomitantly with Nimotop solution.

Drugs that affect nimodipine

Nimodipine is metabolised via the cytochrome P450 3A4 system, located both in the intestinal mucosa and in the liver. Drugs that are known to either inhibit or induce this enzyme system may, therefore, alter the first pass or the clearance of nimodipine.

The extent as well as the duration of interactions should be taken into account when administering nimodipine together with the following drugs:

The concomitant use of oral nimodipine and rifampicin or cytochrome P450 3A4 system-inducing antiepileptic drugs such as phenobarbital, phenytoin or carbamazepine is contraindicated (see section 4.3 contraindications). The efficacy of Nimotop tablets could be reduced if these drugs are administered concomitantly.

Upon co-administration with the following inhibitors of the cytochrome P450 3A4 system the blood pressure should be monitored and, if necessary, an adaption in the nimodipine dose should be considered (see section 4.2 Posology and method of administration):

- macrolide antibiotics (e.g. erythromycin)

- anti-HIV protease inhibitors (e.g. ritonavir)

- azole anti-mycotics (e.g. ketoconazole)

- nefazodone.

Although no formal interaction studies have been performed to investigate the potential interaction between nimodipine and these drugs the potential for drug interaction and increased nimodipine plasma concentrations cannot be excluded. (See section 4.4 Special warnings and precautions for use).

Azithromycin, although structurally related to the class of macrolide antibiotics, is void of CYP3A4 inhibition.

Concurrent twice daily administration of 30mg nimodipine and daily administration of 20mg of the antidepressant fluoxetine to elderly patients resulted in an increase in nimodipine plasma levels, a reduction in fluoxetine levels and a trend towards increased norfluoxetine levels. The daily dose used in patients with subarachnoid haemorrhage is four times the daily dose used in this trial, and as a steady state norfluoxetine level was not achieved, the clinical significance of this interaction in the treatment of aneurysmal subarachnoid haemorrhage (aSAH) is uncertain.

Concurrent three times daily administration of 30mg nimodipine and three times daily administration of 10mg of the antidepressant nortriptyline to elderly patients resulted in a slight decrease in nimodipine plasma levels with no effect on nortriptyline plasma levels. The daily dose used in patients with subarachnoid haemorrhage is four times the daily dose used in this trial, thus the clinical significance of this interaction in the treatment of aneurysmal subarachnoid haemorrhage (aSAH) is uncertain.

The simultaneous administration of nimodipine with the anticonvulsant valproic acid or the H2-antagonist cimetidine can lead to an increase in the plasma concentration of nimodipine.

Based on experience with the calcium-antagonist, nifedipine, co-administration of quinupristin/dalfopristin may lead to increased plasma concentrations of nimodipine.

Effects of nimodipine on other drugs

Animal studies have shown that when nimodipine and zidovudine are administered concomitantly, the AUC for zidovudine was increased, and the volume of distribution and clearance rate decreased. The clinical relevance of this interaction is unknown, but since the side-effects profile of zidovudine is known to be dose-related, this interaction should be considered in patients receiving nimodipine and zidovudine concomitantly.

Other types of interaction

Blood pressure lowering drugs

Nimodipine may increase the blood pressure lowering effect of concomitant antihypertensives, such as diuretics, beta-blockers, ACE inhibitors, A1-antagonists, other calcium antagonists, alpha-adrenergic blocking agents, PDE5 inhibitors and alpha-methyldopa. If a combination of this type proves unavoidable particularly careful monitoring of the patient is necessary.

The intake of grapefruit juice is not recommended in combination with nimodipine as it can result in increased plasma nimodipine concentrations due to the inhibition of the oxidative metabolism of dihydropyridines. As a consequence, the blood pressure lowering effect may be increased. This effect may last for at least 4 days after the last ingestion of grapefruit juice.

Interactions shown not to exist

A study examining the effects of 90mg nimodipine (in divided doses) on elderly patients receiving haloperidol did not show evidence of potential interactions. It is unclear whether this study is relevant to use in subarachnoid haemorrhage because of the higher dose of nimodipine used.

Concomitant administration of oral nimodipine and diazepam, digoxin, glibenclamide, indometacin, ranitidine and warfarin did not reveal any potential for mutual interaction.

4.6 Pregnancy And Lactation

Pregnancy

There are no adequate and well controlled studies in pregnant women. Reproductive toxicology studies in animals using oral administration showed no teratogenic effect, although studies in animals have shown reproductive toxicity (see Section 5.3). If nimodipine is to be administered during pregnancy, the benefits and potential risks must be carefully weighed according to the severity of the clinical picture.

Lactation

Nimodipine and its metabolites have been shown to be present in human milk. Nursing mothers are advised not to breast-feed when taking this drug.

In-vitro fertilisation

In single cases of in-vitro fertilisation calcium antagonists have been associated with reversible biochemical changes in the spermatozoa's head section that may result in impaired sperm function.

4.7 Effects On Ability To Drive And Use Machines

In theory, the possibility of the occurrence of the side-effect dizziness may impair the patient's ability to drive or operate machinery.

4.8 Undesirable Effects

The following events have been mainly reported in clinical trials. The following definitions of frequencies are used:

Very common (

Blood and Lymphatic System Disorders

• Thrombocytopenia is uncommon.

Immune System Disorders

• Acute hypersensitivity reactions include uncommonly occurring mild to moderate allergic reactions.

• Associated clinical symptoms related to skin (uncommon rash).

Nervous System Disorders

• Unspecific cerebrovascular symptoms include uncommonly occurring headache.

Cardiac Disorders

• Unspecific cardiac arrhythmias: tachycardia is uncommon and bradycardia is rare.

Vascular Disorders

• Unspecific cardiovascular symptoms such as hypotension and vasodilatation (sweating, flushing and feeling of warmth) are uncommon.

Gastrointestinal Disorders

• Unspecific gastrointestinal and abdominal symptoms include uncommonly occurring nausea.

• Rarely ileus has been reported.

Hepatobiliary Disorders

• Liver reactions include a rarely occurring transient increase in liver enzymes (including an increase in transaminases, alkaline phosphatase and ?-GT).

4.9 Overdose

Symptoms of acute overdosage to be anticipated are marked lowering of the blood pressure, tachycardia, bradycardia and (after oral administration) gastro-intestinal complaints and nausea.

In the event of acute overdosage, treatment with Nimotop must be discontinued immediately. Emergency measures should be governed by the symptoms. Gastric lavage with addition of charcoal should be considered as an emergency therapeutic measure. If there is a marked fall in blood pressure, dopamine or noradrenaline can be administered intravenously. As no specific antidote is known, subsequent treatment for other side effects should be aimed at the most prominent symptoms.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC-Code: C08 CA06

Nimodipine is a calcium channel blocker of the dihydropyridine group with preferential activity on cerebral vessels. Nimodipine increases cerebral perfusion, particularly in poorly perfused areas, by arterial dilatation, an effect which is proportionately greater in smaller than in larger vessels.

Vasoconstrictions provoked in vitro by various vasoactive substances (e.g., serotonin, prostaglandins and histamine) or by blood and blood degradation products can be prevented or reduced by up to 75 % by nimodipine.

5.2 Pharmacokinetic Properties

The intravenous Nimotop solution is 100 % available to the tissues as the peripheral venous blood takes the drug to the lungs and heart and from there to all organs.

After oral ingestion, absorption is rapid. Peak plasma concentrations are observed 30 to 60 minutes following oral administration. Despite high gastrointestinal absorption of nimodipine, the absolute bioavailability is 5 – 15 %, which is attributed to extensive first pass metabolism (about 85 – 95 %).

The distribution volume (Vss, 2 compartment model) for i.v. administration is calculated to be 0.9 – 2.3 l/kg body weight. The total (systemic) clearance is 0.8 – 1.6 l/h/kg. Nimodipine is 97 – 99 % bound to plasma proteins.

The cytochrome P450 3A4 system plays a major role in the metabolic elimination of nimodipine. Nimodipine is eliminated as metabolites, mainly by dehydrogenation of the dihydropyridine ring and oxidative O-demethylation. Oxidative ester cleavage, hydroxylation of the 2- and 6-methyl groups, and glucuronidation as a conjugation reaction are other important metabolic steps. The three primary metabolites occurring in plasma show no or only therapeutically negligible residual activity.

Effects on liver enzymes by induction or inhibition are unknown. In humans the metabolites are excreted about 50% renally and 30% in the bile

For oral administration, the peak plasma concentration and the area under the curve increase proportionally to the dose up to the highest dose under test (90 mg). The elimination kinetics are linear. The half-life for nimodipine is between 1.1 and 1.7 hours. The terminal half-life is 5-10 hours, and is not relevant for establishing the recommended dosing interval for the medicinal product.

5.3 Preclinical Safety Data

Preclinical data reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity, genotoxicity, carcinogenicity and male and female fertility. However, several preclinical findings may be of relevance to the prescribing physician. In chronic repeat dose toxicity studies in dogs, doses of 1 and 2.5 mg/kg/day were shown to be tolerated without adverse effect. However, at the higher dose of 6.25 mg/kg/day significant changes in ECGs were noted due to disturbances in myocardial blood flow, but there was no indication of histopathological damage to the heart. In pregnant rats, doses of 30 mg/kg/day and higher inhibited fetal growth and resulted in reduced fetal weights. At 100 mg/kg/day embryolethality occurred. No evidence of teratogenicity was observed. In rabbits, equivocal evidence of teratogenicity was seen in one study at doses up to 10 mg/kg/day. In two subsequent studies (one at 30 mg/kg/day), these findings were not reproduced. In one peri-postnatal study in rats, mortality and delayed physical development were observed at doses of 10 mg/kg/day and higher. The findings were not confirmed in subsequent studies.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Microcrystalline cellulose, maize starch, povidone, crospovidone, magnesium stearate, hypromellose, macrogol 4000, titanium dioxide E171, iron oxide yellow E172.

6.2 Incompatibilities

None known.

6.3 Shelf Life

5 years.

6.4 Special Precautions For Storage

Do not store above 30OC.

6.5 Nature And Contents Of Container

PP/aluminium blister packs contained in cardboard outer, containing 100 x 30mg tablets.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Bayer plc

Bayer House

Strawberry Hill

Newbury, Berkshire

RG14 1JA

Trading as Bayer plc, Bayer Schering Pharma

8. Marketing Authorisation Number(S)

PL 00010/0137

9. Date Of First Authorisation/Renewal Of The Authorisation

23 February 1989/23 November 2003

10. Date Of Revision Of The Text

13th May 2010


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Nimotop


Generic Name: nimodipine (Oral route)

nye-MOE-di-peen

Oral route(Capsule, Liquid Filled)

Not for intravenous or parenteral administration. Deaths and serious, life threatening adverse events have occurred when the contents of nimodipine capsules have been injected parenterally .

Commonly used brand name(s)

In the U.S.

Nimotop

Available Dosage Forms:

Capsule, Liquid Filled Tablet

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Calcium Channel Blocker

Chemical Class: Dihydropyridine

Uses For Nimotop

Nimodipine is used to treat symptoms resulting from a ruptured blood vessel in the brain (subarachnoid hemorrhage). It works by increasing the blood flow to injured brain tissue .

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

Before Using Nimotop

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:

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 have not been performed on the relationship of age to the effects of nimodipine in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of nimodipine in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution in patients receiving nimodipine .

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. 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 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

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.

Acebutolol Alprenolol Atenolol Betaxolol Bevantolol Bisoprolol Bucindolol Carteolol Carvedilol Celiprolol Dalfopristin Dilevalol Esmolol Indinavir Itraconazole Labetalol Levobunolol Mepindolol Metipranolol Metoprolol Nadolol Nebivolol Oxprenolol Penbutolol Phenobarbital Pindolol Propranolol Quinupristin Rifapentine Sotalol St John's Wort Talinolol Tertatolol Timolol Valproic Acid 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 may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

food Grapefruit Juice 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:

Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body . Proper Use of Nimotop

Take this medicine exactly as directed even if you feel well and do not notice any symptoms. Do not take more of this medicine and do not take it more often than your doctor ordered. Do not miss any doses .

This medicine is usually given within 96 hours of having the condition. It is best to take this medicine not less than one hour before or two hours after a meal .

If the capsule cannot be swallowed or if you are using this medicine with a nasogastric tube (NGT), you may put a hole in both ends of the capsule and remove its contents using a syringe. Use the syringe to give the medicine orally or through the NGT. Do not use it to give the medicine as an injection through the veins, muscles, or skin .

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 oral dosage form (capsules): For subarachnoid hemorrhage: Adults—60 milligrams (mg) or two 30 mg capsules every 4 hours for 21 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 Nimotop

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .

Nimotop 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:

Less common Chest pain or discomfort decreased blood pressure difficult or labored breathing fast, pounding, or irregular heartbeat or pulse lightheadedness, dizziness, or fainting shortness of breath slow or irregular heartbeat swelling tightness in chest unusual tiredness wheezing

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 Abdominal or stomach cramps, discomfort, or pain back pain blemishes on the skin constipation diarrhea discouragement feeling sad or empty headache indigestion irritability lack or loss of appetite loss of interest or pleasure muscle pain nausea or vomiting pimples rash swollen mouth and tongue tiredness trouble concentrating trouble sleeping unpleasant taste urge to have bowel movement

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: Nimotop side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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More Nimotop resources Nimotop Side Effects (in more detail) Nimotop Use in Pregnancy & Breastfeeding Drug Images Nimotop Drug Interactions Nimotop Support Group 2 Reviews for Nimotop - Add your own review/rating Nimotop Prescribing Information (FDA) Nimotop MedFacts Consumer Leaflet (Wolters Kluwer) Nimotop Concise Consumer Information (Cerner Multum) Nimotop Monograph (AHFS DI) Nimodipine Prescribing Information (FDA) Nimodipine Professional Patient Advice (Wolters Kluwer) Compare Nimotop with other medications Ischemic Stroke Migraine Prevention Subarachnoid Hemorrhage
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Ampyra


Generic Name: dalfampridine (dal FAM pri deen)
Brand Names: Ampyra

What is dalfampridine?

Dalfampridine is a potassium channel blocker.

Dalfampridine is used to improve walking in patients with multiple sclerosis (MS).

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

What is the most important information I should know about dalfampridine? You should not use dalfampridine if you are allergic to it, or if you have moderate to severe kidney disease, if you have ever had a seizure (convulsions), or if you are also taking another multiple sclerosis drug called Fampridine.

Before you take dalfampridine, tell your doctor if you have kidney disease.

Do not take more than 2 tablets in a 24-hour period. Do not use a tablet that has been broken or crushed. A broken tablet can release too much of the drug at one time. This can increase your risk of having a seizure. Stop taking dalfampridine and call your doctor at once if you a seizure, pain or burning when you urinate, problems with your balance, numbness or tingly feeling, or a relapse of your MS symptoms. What should I discuss with my health care provider before taking dalfampridine? You should not use dalfampridine if you are allergic to it, or if you have:

moderate to severe kidney disease;

if you have ever had a seizure (convulsions); or

if you are also taking another MS drug called Fampridine (4-aminopyridine).

To make sure you can safely take dalfampridine, tell your doctor if you have kidney disease.

FDA pregnancy category C. It is not known whether dalfampridine 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 dalfampridine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using dalfampridine. Do not give this medication to anyone under 18 years old without the advice of a doctor. How should I take dalfampridine?

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.

Dalfampridine is usually taken once every 12 hours. Follow your doctor's instructions.

Do not take more than 2 tablets in a 24-hour period.

Dalfampridine may be taken with or without food.

Do not crush, chew, or break an extended-release tablet. Swallow it whole. Do not dissolve the tablet in liquid. Breaking or dissolving the pill may cause too much of the drug to be released at one time. Do not use a dalfampridine tablet that has been accidentally crushed or broken. This can increase your risk of having a seizure. Store at room temperature away from moisture and heat.

Throw away any leftover medicine after the expiration date on the label has passed.

See also: Ampyra 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 can cause confusion, problems with thinking or memory, tremors, sweating, or seizures.

What should I avoid while taking dalfampridine?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Dalfampridine 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 taking dalfampridine and call your doctor at once if you have a serious side effect such as:

seizure (convulsions);

pain or burning when you urinate;

problems with balance;

numbness, burning pain, or tingly feeling;

relapse or worsening of MS symptoms;

Less serious side effects may include:

headache, dizziness;

sleep problems (insomnia);

nausea, constipation, upset stomach;

weakness;

stuffy nose, sinus pain, sore throat; or

back pain.

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.

What other drugs will affect dalfampridine?

There may be other drugs that can interact with dalfampridine. 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 Ampyra resources Ampyra Side Effects (in more detail)Ampyra DosageAmpyra Use in Pregnancy & BreastfeedingAmpyra Drug InteractionsAmpyra Support Group17 Reviews for Ampyra - Add your own review/rating Ampyra Prescribing Information (FDA) Ampyra Monograph (AHFS DI) Ampyra Advanced Consumer (Micromedex) - Includes Dosage Information Ampyra Consumer Overview Ampyra MedFacts Consumer Leaflet (Wolters Kluwer) Dalfampridine Professional Patient Advice (Wolters Kluwer) Compare Ampyra with other medications Multiple Sclerosis Where can I get more information? Your pharmacist can provide more information about dalfampridine.

See also: Ampyra side effects (in more detail)


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Friars' Balsam BP


1. Name Of The Medicinal Product

Benzoin Tincture Compound BP or Friars Balsam BP

2. Qualitative And Quantitative Composition

Storax prepared BP 10.0% w/v

Benzoin sumatra crushed BP 10.0% w/v

3. Pharmaceutical Form

Tincture

4. Clinical Particulars 4.1 Therapeutic Indications

1. As an inhalant for relief of the symptoms of colds.

2. As a mild antiseptic dressing.

4.2 Posology And Method Of Administration

1. Through the mouth and nasal passages.

2. Topical.

1. As an inhalant

Adults, children over 3 months of age and the elderly: Add one 5ml spoonful to a pint of hot, but not boiling water.

The dose may be repeated after 4 hours if required.

The product is suitable for use under this clinical indication by adults, children over 3 months and the elderly.

Not suitable for children under 3 months of age.

2. As an antiseptic

Adults, children and the elderly: Apply undiluted to the affected area twice daily. The product is suitable for use under this clinical indication by adults, children and the elderly.

4.3 Contraindications

Contraindicated in patients with known sensitivity to sumatra benzoin or storax.

4.4 Special Warnings And Precautions For Use

Not suitable for children under 3 months when used as an inhalant.

For external use only.

Keep all medicines away from children.

Caution: Highly flammable. Keep away from a naked flame.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Use of this product by the indicated routes is not considered likely to cause any undesirable effects in the above conditions.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

None known.

4.9 Overdose

This product is for external use only. Accidental ingestion is likely to cause a severe burning sensation in the mouth and mucous membranes due to the high alcohol content and the bitter taste of the aloes and balsamic acids. Dilution of the product in the mouth will cause the separation of an unpleasant gummy residue. It is considered unlikely that a significant quantity could be swallowed. However the main effects would be those of alcohol intoxication.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Sumatra benzoin has been used as an ingredient in inhalations used in the treatment of catarrh of the upper respiratory tract for many years. It has also been used topically for its antiseptic and protective properties.

Storax has mild antiseptic action.

5.2 Pharmacokinetic Properties

No information available.

5.3 Preclinical Safety Data

None.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Aloes powdered BP, purified water BP, ethanol (96%) BP

6.2 Incompatibilities

None known.

6.3 Shelf Life

25ml: 36 months unopened.

50ml: 36 months unopened.

500ml: 36 months unopened.

2000ml: 36 months unopened.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container    

25ml:

glass bottle and plastic cap with liner.

50ml:

glass bottle and plastic cap with liner or white 28mm polypropylene cap with Tamper Evident band and EPE/Saranex liner.

500ml:

glass bottle and plastic cap with liner.

2000ml:

glass bottle and plastic cap with liner.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

L.C.M. Ltd.,

Linthwaite Laboratories

Huddersfield

HD7 5QH

England

8. Marketing Authorisation Number(S)

PL 12965/0002

9. Date Of First Authorisation/Renewal Of The Authorisation

11/10/93 19/11/98

10. Date Of Revision Of The Text

March 2005

11 DOSIMETRY (IF APPLICABLE)

Not Applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Not Applicable


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Gris-PEG


griseofulvin
Dosage Form: tablet, film coated
Gris-PEG®
(griseofulvin ultramicrosize)
Tablets, USP 125 mg; 250 mg Gris-PEG Description

Gris-PEG® Tablets contain ultramicrosize crystals of griseofulvin, an antibiotic derived from a species of Penicillium.

Each Gris-PEG tablet contains:

Active Ingredient: griseofulvin ultramicrosize 125 mg

Inactive Ingredients: colloidal silicon dioxide, lactose, magnesium stearate, methylcellulose, methylparaben, polyethylene glycol 400 and 8000, povidone, and titanium dioxide.

OR

Active Ingredient: griseofulvin ultramicrosize 250 mg

Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, methylcellulose, methylparaben, polyethylene glycol 400 and 8000, povidone, sodium lauryl sulfate, and titanium dioxide.

ACTION Microbiology

Griseofulvin is fungistatic with in vitro activity against various species of Microsporum, Epidermophyton and Trichophyton. It has no effect on bacteria or other genera of fungi.

Pharmacokinetics

Following oral administration, griseofulvin is deposited in the keratin precursor cells and has a greater affinity for diseased tissue. The drug is tightly bound to the new keratin which becomes highly resistant to fungal invasions.

The efficiency of gastrointestinal absorption of ultramicrocrystalline griseofulvin is approximately one and one-half times that of the conventional microsize griseofulvin. This factor permits the oral intake of two-thirds as much ultramicrocrystalline griseofulvin as the microsize form. However, there is currently no evidence that this lower dose confers any significant clinical differences with regard to safety and/or efficacy.

In a bioequivalence study conducted in healthy volunteers (N=24) in the fasted state, 250 mg ultramicrocrystalline griseofulvin tablets were compared with 250 mg ultramicrocrystalline griseofulvin tablets that were physically altered (crushed) and administered with applesauce. The 250 mg ultramicrocrystalline griseofulvin tablets were found to be bioequivalent to the physically altered (crushed) 250 mg ultramicrocrystalline griseofulvin tablets (See Table 1).

Table 1: Mean (± SD) of the Pharmacokinetic Parameters for Griseofulvin administered in applesauce as a Single Dose of Gris-PEG® 250-mg Tablets Uncrushed and Crushed to fasted Healthy Volunteers (N=24) 250 mg Ultramicrocrystalline Griseofulvin Tablets Unaltered 250 mg Ultramicrocrystalline Griseofulvin Tablets Physically Altered (Crushed and in Applesauce) Cmax (ng/mL) 600.61 (± 167.6) 672.61 (± 146.2) Tmax (hr) 4.04 (± 2.2) 3.08 (± 1.02) AUC (ng?hr/mL) 8618.89 (± 1907.2) 9023.71 (± 1911.5) INDICATIONS

Gris-PEG (griseofulvin ultramicrosize) is indicated for the treatment of the following ringworm infections; tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails), when caused by one or more of the following genera of fungi: Trichophyton rubrum, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton interdigitalis, Trichophyton verrucosum, Trichophyton megnini, Trichophyton gallinae, Trichophyton crateriform, Trichophyton sulphureum, Trichophyton schoenleini, Microsporum audouini, Microsporum canis, Microsporum gypseum and Epidermophyton floccosum. NOTE: Prior to therapy, the type of fungi responsible for the infection should be identified. The use of the drug is not justified in minor or trivial infections which will respond to topical agents alone. Griseofulvin is not effective in the following: bacterial infections, candidiasis (moniliasis), histoplasmosis, actinomycosis, sporotrichosis, chromoblastomycosis, coccidioidomycosis, North American blastomycosis, cryptococcosis (torulosis), tinea versicolor and nocardiosis.

Contraindications

Two cases of conjoined twins have been reported since 1977 in patients taking griseofulvin during the first trimester of pregnancy. Griseofulvin should not be prescribed to pregnant patients. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

This drug is contraindicated in patients with porphyria or hepatocellular failure and in individuals with a history of hypersensitivity to griseofulvin.

Warnings Prophylactic Usage

Safety and efficacy of griseofulvin for prophylaxis of fungal infections have not been established.

Serious Skin Reactions

Severe skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis) and erythema multiforme have been reported with griseofulvin use. These reactions may be serious and may result in hospitalization or death. If severe skin reactions occur, griseofulvin should be discontinued (see ADVERSE REACTIONS section).

Hepatotoxicity

Elevations in AST, ALT, bilirubin, and jaundice have been reported with griseofulvin use. These reactions may be serious and may result in hospitalization or death. Patients should be monitored for hepatic adverse events and discontinuation of griseofulvin considered if warranted (see ADVERSE REACTIONS section).

Animal Toxicology

Chronic feeding of griseofulvin, at levels ranging from 0.5%-2.5% of the diet resulted in the development of liver tumors in several strains of mice, particularly in males. Smaller particle sizes result in an enhanced effect. Lower oral dosage levels have not been tested. Subcutaneous administration of relatively small doses of griseofulvin once a week during the first three weeks of life has also been reported to induce hepatomata in mice. Thyroid tumors, mostly adenomas but some carcinomas, have been reported in male rats receiving griseofulvin at levels of 2.0%, 1.0% and 0.2% of the diet, and in female rats receiving the two higher dose levels. Although studies in other animal species have not yielded evidence of tumorigenicity, these studies were not of adequate design to form a basis for conclusion in this regard. In subacute toxicity studies, orally administered griseofulvin produced hepatocellular necrosis in mice, but this has not been seen in other species. Disturbances in porphyrin metabolism have been reported in griseofulvin-treated laboratory animals. Griseofulvin has been reported to have a colchicine-like effect on mitosis and cocarcinogenicity with methylcholanthrene in cutaneous tumor induction in laboratory animals.

Usage in Pregnancy

see CONTRAINDICATIONS section.

Animal Reproduction Studies

It has been reported in the literature that griseofulvin was found to be embryotoxic and teratogenic on oral administration to pregnant rats. Pups with abnormalities have been reported in the litters of a few bitches treated with griseofulvin. Suppression of spermatogenesis has been reported to occur in rats, but investigation in man failed to confirm this.

Precautions

Patients on prolonged therapy with any potent medication should be under close observation. Periodic monitoring of organ system function, including renal, hepatic and hematopoietic, should be done. Since griseofulvin is derived from species of Penicillium, the possibility of cross-sensitivity with penicillin exists; however, known penicillin-sensitive patients have been treated without difficulty. Since a photosensitivity reaction is occasionally associated with griseofulvin therapy, patients should be warned to avoid exposure to intense natural or artificial sunlight. Lupus erythematosus or lupus-like syndromes have been reported in patients receiving griseofulvin. Griseofulvin decreases the activity of warfarin-type anticoagulants so that patients receiving these drugs concomitantly may require dosage adjustment of the anticoagulant during and after griseofulvin therapy. Barbiturates usually depress griseofulvin activity and concomitant administration may require a dosage adjustment of the antifungal agent. There have been reports in the literature of possible interactions between griseofulvin and oral contraceptives. The effect of alcohol may be potentiated by griseofulvin, producing such effects as tachycardia and flush.

Adverse Reactions

There have been post-marketing reports of severe skin and hepatic adverse events associated with griseofulvin use (see WARNINGS section).

When adverse reactions occur, they are most commonly of the hypersensitivity type such as skin rashes, urticaria, erythema multiforme-like drug reactions, and rarely, angioneurotic edema, and may necessitate withdrawal of therapy and appropriate countermeasures. Paresthesia of the hands and feet have been reported after extended therapy. Other side effects reported occasionally are oral thrush, nausea, vomiting, epigastric distress, diarrhea, headache, fatigue, dizziness, insomnia, mental confusion, and impairment of performance of routine activities. Proteinuria and leukopenia have been reported rarely. Administration of the drug should be discontinued if granulocytopenia occurs. When rare, serious reactions occur with griseofulvin, they are usually associated with high dosages, long periods of therapy, or both.

Gris-PEG Dosage and Administration

Accurate diagnosis of infecting organism is essential. Identification should be made either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide or by culture on an appropriate medium. Medication must be continued until the infecting organism is completely eradicated as indicated by appropriate clinical or laboratory examination. Representative treatment periods are tinea capitis, 4 to 6 weeks; tinea corporis, 2 to 4 weeks; tinea pedis, 4 to 8 weeks; tinea unguium-depending on rate of growth-fingernails, at least 4 months; toenails, at least 6 months.

General measures in regard to hygiene should be observed to control sources of infection or reinfection. Concomitant use of appropriate topical agents is usually required, particularly in treatment of tinea pedis. In some forms of athlete's foot, yeasts and bacteria may be involved as well as fungi. Griseofulvin will not eradicate the bacterial or monilial infection.

Gris-PEG® tablets may be swallowed whole or crushed and sprinkled onto 1 tablespoonful of applesauce and swallowed immediately without chewing.

Adults

Daily administration of 375 mg (as a single dose or in divided doses) will give a satisfactory response in most patients with tinea corporis, tinea cruris, and tinea capitis. For those fungal infections more difficult to eradicate, such as tinea pedis and tinea unguium, a divided dose of 750 mg is recommended.

Pediatric Use

Approximately 3.3 mg per pound of body weight per day of ultramicrosize griseofulvin is an effective dose for most pediatric patients. On this basis, the following dosage schedule is suggested: Children weighing 35-60 pounds - 125 mg to 187.5 mg daily. Pediatric patients weighing over 60 pounds - 187.5 mg to 375 mg daily. Children and infants 2 years of age and younger - dosage has not been established.

Clinical experience with griseofulvin in children with tinea capitis indicates that a single daily dose is effective. Clinical relapse will occur if the medication is not continued until the infecting organism is eradicated.

How is Gris-PEG Supplied

Gris-PEG® (griseofulvin ultramicrosize) Tablets, 125 mg, white scored, elliptical-shaped, embossed "Gris-PEG" on one side and "125" on the other. Gris-PEG (griseofulvin ultramicrosize) Tablets, 250 mg, white scored, capsule-shaped, embossed "Gris-PEG" on one side and "250" on the other. The 125 mg strength is available in bottles of 100 (NDC 0884-0763-04). The 250 mg strength is available in bottles of 100 (NDC 0884-0773-04). Both strengths are film-coated.

Rx ONLY

STORAGE

Store Gris-PEG tablets at controlled room temperature 15° - 30°C (59° - 86°F) in tight, lightresistant containers.

Manufactured for:
PEDiNOL™ PHARMACAL INC.
Farmingdale, NY 11735 U.S.A.

By: NOVARTIS CONSUMER HEALTH INC.
Lincoln, NE 68501

Printed in U.S.A. REV 10/10

PRINCIPAL DISPLAY PANEL - 250 mg Bottle Label

NDC 0884-0773-50

GRIS•PEG®
(griseofulvin
ultramicrosize)

Tablets USP

250mg

500 Tablets

Active Ingredient:
Griseofulvin ultramicrosize...250mg

CAUTION: Federal (U.S.A.) law prohibits
dispensing without prescription.


Gris-PEG 
griseofulvin  tablet, film coated Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0884-0773 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Griseofulvin (Griseofulvin) Griseofulvin 250 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE   MAGNESIUM STEARATE   METHYLCELLULOSE (15 CPS)   METHYLPARABEN   POLYETHYLENE GLYCOL 400   POLYETHYLENE GLYCOL 8000   POVIDONE   SODIUM LAURYL SULFATE   TITANIUM DIOXIDE   Product Characteristics Color WHITE Score 2 pieces Shape OVAL (capsule-shaped) Size 16mm Flavor Imprint Code GRIS;PEG;250 Contains          Packaging # NDC Package Description Multilevel Packaging 1 0884-0773-50 500 TABLET In 1 BOTTLE, PLASTIC None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA050475 06/01/2000 06/30/2013
Labeler - Pedinol Pharmacal, Inc. (064737125) Establishment Name Address ID/FEI Operations Novartis Consumer Health 129836151 ANALYSIS, MANUFACTURE Revised: 05/2011Pedinol Pharmacal, Inc. More Gris-PEG resources Gris-PEG Side Effects (in more detail) Gris-PEG Dosage Gris-PEG Use in Pregnancy & Breastfeeding Drug Images Gris-PEG Drug Interactions Gris-PEG Support Group 3 Reviews for Gris-PEG - Add your own review/rating Gris-PEG Advanced Consumer (Micromedex) - Includes Dosage Information Gris-PEG Ultramicrosize Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Gris-PEG Concise Consumer Information (Cerner Multum) Griseofulvin Professional Patient Advice (Wolters Kluwer) Griseofulvin Monograph (AHFS DI) Grifulvin V Microsize MedFacts Consumer Leaflet (Wolters Kluwer) Grisactin 250 Concise Consumer Information (Cerner Multum) Compare Gris-PEG with other medications Dermatophytosis Onychomycosis, Fingernail Onychomycosis, Toenail Tinea Barbae Tinea Capitis Tinea Corporis Tinea Cruris Tinea Pedis
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DHC Continus prolonged release tablets 60mg, 90mg and 120 mg


1. Name Of The Medicinal Product

DHC® Continus® prolonged release tablets 60 mg, 90 mg, 120 mg.

2. Qualitative And Quantitative Composition

Dihydrocodeine tartrate 60 mg, 90 mg, 120 mg.

3. Pharmaceutical Form

Prolonged release tablet.

White capsule shaped tablets, 60 mg are marked DHC 60, 90 mg are marked DHC 90 and 120 mg are marked DHC 120.

4. Clinical Particulars 4.1 Therapeutic Indications

For the relief of severe pain in cancer and other chronic conditions.

4.2 Posology And Method Of Administration

Adults and children over 12 years: 60 mg - 120 mg every 12 hours.

Elderly: Dosage should be reduced.

Children 12 years or under: Not recommended.

Method of administration

Oral.

4.3 Contraindications

Hypersensitivity to dihydrocodeine or any of the tablet constituents; respiratory depression; obstructive airways disease; paralytic ileus; head injury; raised intracranial pressure; acute alcoholism. As dihydrocodeine may cause the release of histamine, it should not be given during an asthma attack and should be given with caution to asthmatics.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.4 Special Warnings And Precautions For Use

Dosage should be reduced in the elderly, in hypothyroidism, chronic hepatic disease and renal insufficiency.

Dihydrocodeine should be administered with caution to patients with a history of opioid abuse, biliary tract disorders, prostatic hypertrophy, pancreatitis, constipation, obstructive bowel disorder and severe cor pulmonale.

Dihydrocodeine has a recognised abuse and addiction profile similar to other opioids. Tolerance to analgesic effects may develop upon repeated administration.

The risk-benefit of continued use should be assessed regularly by the prescriber, and in particular the prescriber should take care to avoid any unnecessary increase in dosage especially where there is evidence of a previous history of drug dependence or abuse.

DHC Continus tablets must be swallowed whole, and not broken, chewed or crushed. The administration of broken, chewed or crushed tablets may lead to a rapid release and absorption of a potential overdose of dihydrocodeine (see Section 4.9).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Other central nervous system depressants, including sedatives or hypnotics, phenothiazines, other tranquillisers and alcohol, may result in respiratory depression or sedation. Dihydrocodeine should be used with caution in patients taking monoamine oxidase inhibitors or within two weeks of such therapy.

4.6 Pregnancy And Lactation

There is little published evidence on safety in human pregnancy but dihydrocodeine has been used for many years without apparent ill effects. Dihydrocodeine has not been reported to be excreted in breast milk. However, it is advisable that dihydrocodeine only be administered to breast-feeding mothers if considered essential.

4.7 Effects On Ability To Drive And Use Machines

Dihydrocodeine may cause drowsiness and, if affected, patients should not drive or operate machinery.

4.8 Undesirable Effects

Common adverse drug reactions seen during therapy are constipation, nausea, vomiting, headache, somnolence, pruritus and rash.

Uncommon adverse reactions are urinary retention, ureteric or biliary spasm, dry mouth, mood changes, blurred vision, sweating, decreased libido, flushing, abdominal pain, hypotension, paraesthesia, confusion, dizziness, hallucinations, urticaria, paralytic ileus and respiratory depression.

Dependence may occur. Regular prolonged use of dihydrocodeine is known to lead to addiction and tolerance. Symptoms of restlessness and irritability may result when treatment is stopped.

Prolonged use of a painkiller for headaches can make them worse.

4.9 Overdose

Acute overdosage with dihydrocodeine can be manifested by somnolence progressing to stupor or coma, miotic pupils, rhabdomyolysis, non-cardiac pulmonary oedema, bradycardia, hypotension and respiratory depression or apnoea.

Primary attention should be given to the establishment of a patent airway and institution of assisted or controlled ventilation.

In the case of massive overdosage, administer naloxone intravenously (0.4 to 2 mg for an adult and 0.01 mg/kg body weight for children) if the patient is in a coma or respiratory depression is present. Repeat the dose at 2 minute intervals if there is no response, or by an infusion. An infusion of 60% of the initial dose per hour is a useful starting point. A solution of 10 mg made up in 50 ml dextrose will produce 200 micrograms/ml for infusion using an IV pump (dose adjusted to the clinical response). Infusions are not a substitute for frequent review of the patient's clinical state. Intramuscular naloxone is an alternative in the event that IV access is not possible.

As the duration of action of naloxone is relatively short, the patient must be carefully monitored until spontaneous respiration is reliably re-established. Naloxone is a competitive antagonist and large doses (4 mg) may be required in seriously poisoned patients. For less severe overdosage, administer naloxone 0.2 mg intravenously followed by increments of 0.1 mg every 2 minutes if required.

Naloxone should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to dihydrocodeine overdosage. Naloxone should be administered cautiously to persons who are known, or suspected, to be physically dependent on dihydrocodeine. In such cases, an abrupt or complete reversal of opioid effects may precipitate pain and an acute withdrawal syndrome.

Additional/other considerations:

• Consider activated charcoal (50 g for adults, 10-15 g for children), if a substantial amount has been ingested within 1 hour, provided the airway can be protected. It may be reasonable to assume that late administration of activated charcoal may be beneficial for prolonged release preparations but there is no evidence to support this.

DHC Continus tablets will continue to release and add to the dihydrocodeine load for up to 12 hours after administration and the management of overdosage should be modified accordingly. Gastric contents may therefore need to be emptied, as this can be useful in removing unabsorbed drug, particularly when a prolonged release formulation has been taken.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Dihydrocodeine is a semisynthetic narcotic analgesic with a potency between morphine and codeine. It acts on opioid receptors in the brain to reduce the patient's perception of pain and improve the psychological reaction to pain by reducing the associated anxiety.

5.2 Pharmacokinetic Properties

Dihydrocodeine is well absorbed from the gastrointestinal tract following administration of DHC Continus tablets and plasma levels are maintained throughout the twelve hour dosing interval.

Like other phenanthrene derivatives, dihydrocodeine is mainly metabolised in the liver with the resultant metabolites being excreted mainly in the urine. Metabolism of dihydrocodeine includes o-demethylation, n-demethylation and 6-keto reduction.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Lactose (anhydrous)

Hydroxyethylcellulose

Cetostearyl alcohol

Magnesium stearate

Purified talc

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Polypropylene containers with polyethylene lids (56 tablets)

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge

CB4 0GW

8. Marketing Authorisation Number(S)

PL 16950/0019 - 0021

9. Date Of First Authorisation/Renewal Of The Authorisation

60 mg

5 November 1986 / 5 March 2001

90 mg and 120 mg

12 July 1990 / 5 March 2001

10. Date Of Revision Of The Text

February 2007

Legal Category

POM

® The Napp device, DHC and DHC CONTINUS are Registered Trade Marks

© Napp Pharmaceuticals Ltd 2007.


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Adizem-XL capsules


Adizem-XL 120 mg, 180 mg, 200 mg, 240 mg and 300 mg prolonged-release capsules

Diltiazem hydrochloride

Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet:

1. What Adizem-XL capsules are and what they are used for
2. Before you take Adizem-XL capsules
3. How to take Adizem-XL capsules
4. Possible side effects
5. How to store Adizem-XL capsules
6. Further information

What Adizem-XL capsules are and what they are used for

These capsules have been prescribed for you to treat angina (chest pain caused by a reduction of oxygen to the heart muscle) or high blood pressure (hypertension). They contain the active ingredient diltiazem. Diltiazem belongs to a group of medicines called calcium antagonists. Calcium antagonists help more blood to reach the heart and reduce blood pressure. The other ingredients of Adizem-XL capsules are listed in section 6 of this leaflet.

Adizem-XL capsules are designed to work properly over 24 hours. If the capsules are crushed or chewed, the entire 24-hour dose may be absorbed rapidly into your body. This can be dangerous, causing serious problems such as an overdose.

Before you take Adizem-XL capsules Do not take Adizem-XL capsules if you: are allergic (hypersensitive) to diltiazem or any of the other ingredients of the capsules (see section 6 ‘Further Information’); have a slow or irregular heart beat; have heart failure (which can cause shortness of breath or ankle swelling).

Children should not take these capsules.

Take special care with Adizem-XL capsules

Before treatment with Adizem-XL capsules tell your doctor or pharmacist if you have porphyria (a rare disease of the blood pigments).

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you take Adizem-XL capsules with some other medicines, the effect of Adizem-XL capsules or the other medicine may be changed.

Tell your doctor or pharmacist if you are taking:

any other medicines for high blood pressure, such as beta blockers (for example atenolol), diuretics (for example bendrofluazide) or ACE inhibitors (examples include captopril and enalapril); medicines known as alpha blockers, which you may be taking to treat high blood pressure or prostate disorders (for example prazosin); any medicines which may cause low blood pressure or slow heart beat (for example aldesleukin to treat cancer of the kidneys, or antipsychotics to treat mental and behavioural disorders); ivabradine to treat angina; anti-arrhythmic medicines to treat an irregular or rapid heart beat (for example digoxin, amiodarone or beta-blockers); cilostazol to treat intermittent claudication (a condition that causes leg pain due to a restriction in blood supply to the muscles); medicines known as statins to reduce cholesterol levels in your blood (examples include simvastatin, atorvastatin or lovastatin); medicines known as H2 antagonists to treat stomach ulcers, indigestion or heartburn, such as cimetidine or ranitidine; carbamazepine or phenytoin to treat seizures, fits or convulsions; medicines known as benzodiazepines to treat anxiety or help you sleep (examples include midazolam or triazolam); medicines known as barbiturates to either treat fits or to help you sleep (examples include phenobarbital or primidone); a specific type of antidepressant known as a tricyclic antidepressant (examples include amitriptyline or imipramine); rifampicin to treat tuberculosis; ciclosporin, sirolimus or tacrolimus to prevent organ transplant rejection or treat other immune system disorders; a specific type of medicine known as a protease inhibitor to treat HIV (examples include atazanavir or ritonavir); dantrolene (a muscle relaxant); theophylline to treat breathing problems such as asthma.

Also tell your doctor if you have recently been given an anaesthetic.

Taking Adizem-XL capsules with alcohol

Do not take Adizem-XL capsules at the same time as an alcoholic drink.

Pregnancy and breastfeeding

Do not take Adizem-XL capsules if you are pregnant, likely to become pregnant or are breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

The capsules may cause a number of side effects such as dizziness which could affect your ability to drive (see section 4 for a full list of side effects). These are usually most noticeable when you start taking the capsules, or when changing to higher dose. If you are affected you should not drive or operate machinery.

Important information about some of the ingredients of Adizem-XL capsules

These capsules contain soya oil. If you are allergic to peanuts or soya do not take these capsules.

How to take Adizem-XL capsules

Always take Adizem-XL capsules exactly as your doctor has told you. The label on your medicine will tell you how many capsules to take and how often.

The usual starting dose for adults is one 240 mg capsule every 24 hours. However, if you are elderly or have kidney problems then your doctor will probably suggest a lower starting dose of one 120 mg capsule every 24 hours. Your doctor will decide how many capsules you should take.

Children should not take these capsules.

Do not exceed the dose recommended by your doctor. You should check with your doctor or pharmacist if you are not sure.

Swallow your capsules whole with a glass of water. Do not chew or crush the capsules.

You should take your capsules every 24 hours. For instance, if you take a capsule at 8 o’clock in the morning, you should take your next capsule at 8 o’clock the next morning.

If you take more Adizem-XL capsules than you should or if someone accidentally swallows your capsules

Call your doctor or hospital straight away. People who have taken an overdose may become very unwell, feel faint, have a slow heart beat and lose consciousness. They may need emergency treatment in hospital. When seeking medical attention make sure that you take this leaflet and any remaining capsules with you to show to the doctor.

If you forget to take Adizem-XL capsules

If you remember within 4 hours of the time your capsule was due, take your capsule straight away. Take your next capsule at your normal time. If you are more than 4 hours late, please call your doctor or pharmacist for advice. Do not take a double dose to make up for a forgotten capsule.

If you stop taking Adizem-XL capsules

You should not stop taking these capsules unless your doctor tells you to. If you want to stop taking your capsules, discuss this with your doctor first.

If you have any further questions on the use of Adizem-XL capsules ask your doctor or pharmacist.

Adizem-XL capsules Side Effects

Like all medicines, Adizem-XL capsules can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although serious allergic reactions are rare. Tell your doctor immediately if you get swelling of the face or throat.

Common side effects (probably affecting more than 1 in 100 people taking Adizem-XL capsules)

Gastrointestinal disorders (e.g. upset stomach), feeling sick. Dizziness, headache. Tiredness. Swelling of the legs. Facial flushing (redness of the face). Low blood pressure.

Uncommon side effects (probably affecting fewer than 1 in 100 people taking Adizem-XL capsules)

A reduction in blood platelets which increases the risk of bleeding or bruising. Changes in muscle tone and/or abnormalities of movement. Skin problems such as an increased sensitivity to sunlight, itching, rash, redness, swelling, severe flaking or peeling of the skin. Inflammation of blood vessels (often with skin rash). A fast, slow or irregular heart beat. Bleeding, tender or enlarged gums. Breast enlargement in men. Inflammation of the liver.

Uncommonly, Adizem-XL capsules may affect the results of blood tests to check that your liver is working properly.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Adizem-XL capsules

Keep out of the reach and sight of children.

Do not use any capsules after the expiry date which is stated on the carton. EXP 08 2010 means that you should not take the capsules after the last day of that month i.e. August 2010.

Do not store your capsules above 25oC.

Do not take your capsules if they are broken or crushed as this can be dangerous and can cause serious problems such as overdose.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information What Adizem-XL capsules contain

The active ingredient is diltiazem hydrochloride. Each capsule contains 120 mg, 180 mg, 200 mg, 240 mg or 300 mg of diltiazem hydrochloride.

The other ingredients are:

Microcrystalline cellulose Ethylcellulose Colloidal anhydrous silica Polysorbate 80 Dibutyl sebacate Magnesium stearate Sodium dodecyl sulphate Gelatin Shellac Soya lecithin 2-ethoxyethanol Dimeticone Iron oxide (E172) Titanium dioxide (E171)

The capsules also contain the following colourants:

120 mg, 180 mg and 240 mg – Erythrosine (E127) and indigo carmine (E132)

300 mg - Erythrosine (E127), indigo carmine (E132) and patent blue V (E131)

What Adizem-XL capsules look like and the contents of the pack

Adizem-XL capsules are marked DCR followed by the strength (e.g. 120, 180 etc.) and are coloured as follows: 120 mg - pale pink/navy blue, 180 mg - dark pink/royal blue, 200 mg - brown, 240 mg - dark red/blue, 300 mg - dark maroon/pale blue.

In each box there are 28 capsules.

Marketing Authorisation Holder and Manufacturer

The capsules are made by

Bard Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW UK

for the marketing authorisation holder

Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW UK

This leaflet is also available in large print, Braille or as an audio CD. To request a copy, please call the RNIB Medicine Information line (free of charge) on:

0800 198 5000

You will need to give details of the product name and reference number.

These are as follows:

Product name: Adizem-XL prolonged-release capsules
Reference number: 16950/0010

This leaflet was last approved in July 2009

Adizem-XL capsules are protected by UK Patent No. 2258613.

Adizem and the NAPP device (logo) are Registered Trade Marks.

© 2009 Napp Pharmaceuticals Limited.

P0077-A UK AW R4V2 10-07-09

Adizem XL P0077-A R4V2 UK AW 10-07-09 (Approved)


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sumatriptan and naproxen


Generic Name: sumatriptan and naproxen (soo ma TRIP tan and na PROX en)
Brand Names: Treximet

What is sumatriptan and naproxen?

Sumatriptan is a headache medicine. It is believed to work by narrowing the blood vessels around the brain.

Naproxen is a nonsteroidal anti-inflammatory drugs (NSAID). Naproxen works by reducing hormones that cause inflammation and pain in the body.

The combination of sumatriptan and naproxen is used to treat migraine headaches.

Sumatriptan and naproxen will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Sumatriptan and naproxen may also be used for purposes not listed in this medication guide.

What is the most important information I should know about sumatriptan and naproxen

Do not take more than 2 sumatriptan and naproxen tablets in 24 hours.

You should not use this medication if you are allergic to sumatriptan (Imitrex) or naproxen (Aleve, Anaprox, Naprosyn), or if you have a history of asthma or allergic reaction caused by aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs). Do not take if you have liver disease, uncontrolled high blood pressure, or a history of heart disease, angina (chest pain), blood circulation problems, heart attack, stroke, or heart bypass surgery. Do not take sumatriptan and naproxen within 24 hours before or after taking any of the following medications: almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt, Maxalt-MLT), sumatriptan (Imitrex), or zolmitriptan (Zomig), or ergot medicine such as ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine). What should I discuss with my health care provider before taking sumatriptan and naproxen? You should not use this medication if you are allergic to sumatriptan (Imitrex), naproxen (Aleve, Anaprox, Naprosyn), or if you have a history of asthma or allergic reaction caused by aspirin or other NSAIDs such as ibuprofen (Motrin, Advil), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), and others.

Do not take sumatriptan and naproxen if you have:

liver disease;

untreated or uncontrolled high blood pressure; or

a history of heart disease, angina (chest pain), blood circulation problems, heart attack, stroke, or heart bypass surgery (also called coronary artery bypass graft, or CABG).

Do not take sumatriptan and naproxen if you have taken a monoamine oxidase inhibitor (MAOI) such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the past 14 days. Do not take sumatriptan and naproxen within 24 hours before or after taking any of the following medicines:

almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt, Maxalt-MLT), sumatriptan (Imitrex), or zolmitriptan (Zomig); or

ergot medicine such as ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).

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

epilepsy or other seizure disorder;

kidney disease;

high blood pressure, congestive heart failure; or

coronary artery disease (or risk factors that include diabetes, menopause, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

FDA pregnancy category C. Taking naproxen during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Sumatriptan and naproxen can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking this medication. How should I take sumatriptan and naproxen? Use exactly as prescribed by your doctor. Follow the directions on your prescription label. Never use more than the recommended dose. Overuse of migraine headache medicine can actually make your headaches worse. Tell your doctor if the medicine seems to stop working as well.

Take one (1) sumatriptan and naproxen tablet as soon as you notice headache symptoms, or after an attack has already begun. You may take the medicine with or without food.

Do not crush, chew, or break the tablet. Swallow the pill whole.

After taking a tablet: If your headache does not completely go away, or goes away and comes back, you may take a second tablet two (2) hours after the first.

You must wait at least 2 hours before taking a second tablet. Do not take more than 2 sumatriptan and naproxen tablets in 24 hours. If your symptoms have not improved, contact your doctor before taking any more tablets.

Contact your doctor if you have more than five headaches in one month (30 days).

Naproxen can cause unusual results with certain medical tests. Tell any doctor who treats you if you have taken sumatriptan and naproxen within the past 72 hours.

Store at room temperature away from moisture and heat.

See also: Sumatriptan and naproxen dosage (in more detail)

What happens if I miss a dose?

Since sumatriptan and naproxen is taken only when needed, it does not have a daily dosing schedule. Do not take more than 2 sumatriptan and naproxen tablets in 24 hours.

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

Overdose symptoms may include dizziness, drowsiness, heartburn, stomach pain, nausea, vomiting, breathing problems, black or bloody stools, coughing up blood, and seizure (convulsions).

What should I avoid while taking sumatriptan and naproxen? Ask a doctor or pharmacist before using any other over-the-counter cold, allergy, or pain medicine. Many combination medicines contain medicines similar to naproxen (such as ibuprofen or ketoprofen). Taking certain products together can cause you to get too much of this type of medicine. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen. Avoid drinking alcohol. It may increase your risk of stomach bleeding caused by naproxen. This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Sumatriptan and naproxen side effects Get emergency medical help if you have any of these signs of an allergic reaction: runny or stuffy nose; hives; wheezing or trouble breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you a serious side effect such as:

chest pain or pressure, tight feeling in your neck or jaw, pain spreading to your arm or shoulder;

sudden numbness or weakness, confusion, problems with vision, speech, or balance;

bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

swelling or rapid weight gain, urinating less than usual or not at all;

pale skin, weakness, easy bruising, flu symptoms;

numbness, tingling, pale or blue-colored appearance in your fingers or toes;

severe blistering, peeling, and red skin rash;

seizure (convulsions); or

(if you are also taking an antidepressant) -- agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Less serious side effects may include:

dizziness, drowsiness;

constipation, upset stomach, dry mouth;

warmth or tingly feeling, redness in your face;

tight muscles; or

mild pressure or heavy feeling in any part of your body.

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.

Sumatriptan and naproxen Dosing Information

Usual Adult Dose for Migraine:

Dose: 1 tablet orally once (Note: The fixed combination tablet contains naproxen sodium (500 mg) and sumatriptan (85 mg).
Maximum Dose: 2 naproxen-sumatriptan tablets in 24 hours. Dosing of tablets should be at least 2 hours apart. The safety of treating an average of more than 5 migraine headaches in a 30 day period has not been established.
Naproxen-sumatriptan may be administered with or without food. Tablets should not be split, crushed, or chewed.

Usual Geriatric Dose for Migraine:

Naproxen-sumatriptan is contraindicated for use in elderly patients who have abnormal hepatic function. Naproxen-sumatriptan is not recommended for use in elderly patients who have decreased renal function, higher risk for unrecognized CAD, and increases in blood pressure that may be more pronounced in the elderly.
Dose: 1 tablet orally once (Note: The fixed combination tablet contains naproxen sodium (500 mg) and sumatriptan (85 mg).
Maximum Dose: 2 naproxen-sumatriptan tablets in 24 hours. Dosing of tablets should be at least 2 hours apart. The safety of treating an average of more than 5 migraine headaches in a 30 day period has not been established.
Naproxen-sumatriptan may be administered with or without food. Tablets should not be split, crushed, or chewed.

What other drugs will affect sumatriptan and naproxen?

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

a blood thinner such as warfarin (Coumadin, Jantoven);

lithium (Eskalith, Lithobid);

methotrexate (Rheumatrex, Trexall);

probenecid (Benemid);

a diuretic (water pill) such as furosemide (Lasix);

steroids (prednisone and others);

aspirin or other NSAIDs such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others;

heart or blood pressure medication such as atenolol (Tenormin, Tenoretic), benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), metoprolol (Dutoprol, Lopressor, Toprol), propranolol (Inderal, InnoPran), quinapril (Accupril), and others; or

an antidepressant such as citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor).

This list is not complete and other drugs may interact with sumatriptan and naproxen. 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 sumatriptan and naproxen resources Sumatriptan and naproxen Dosage Sumatriptan and naproxen Use in Pregnancy & Breastfeeding Sumatriptan and naproxen Drug Interactions Sumatriptan and naproxen Support Group 58 Reviews for Sumatriptan and naproxen - Add your own review/rating Compare sumatriptan and naproxen with other medications Migraine Where can I get more information? Your pharmacist can provide more information about sumatriptan and naproxen.
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Propecia


Generic Name: finasteride (Oral route)

fin-AS-ter-ide

Commonly used brand name(s)

In the U.S.

Propecia Proscar

Available Dosage Forms:

Tablet

Therapeutic Class: Alopecia Agent

Pharmacologic Class: 5-Alpha Reductase Inhibitor

Uses For Propecia

Note: Women who are pregnant or may become pregnant should not use finasteride or handle the crushed or broken tablets. Finasteride can cause birth defects in male babies.

Finasteride is used to treat men with benign prostatic hyperplasia (BPH) and male pattern hair loss, also called androgenetic alopecia. BPH is caused by an enlarged prostate. Men with BPH usually have difficulty urinating, a decreased flow of urination, hesitation at the beginning of urination, and a need to get up at night to urinate. Finasteride will make these symptoms less severe and reduce the chance that prostate surgery will be needed. It may be used alone or in combination with other medicines such as an alpha-blocker (doxazosin, Cardura®) to treat BPH. For men with hair loss, finasteride will increase the number of scalp hairs but will not increase the amount of body hair.

Finasteride blocks the action of an enzyme called 5-alpha-reductase. This enzyme changes testosterone to another hormone that causes the prostate to grow or hair loss in males. It will increase testosterone levels in the body, which decreases prostate size and increases hair growth on the scalp. The effect of finasteride on the prostate and scalp will only last as long as the medicine is taken. When it is stopped, the prostate begins to grow again and the hair will be lost.

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

Before Using Propecia

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:

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

Finasteride is not indicated for use in the pediatric population. Safety and efficacy have not been established.

Geriatric

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

Pregnancy Pregnancy Category Explanation All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit. 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 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.

St John's Wort 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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body. Proper Use of finasteride

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

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

If you are taking this medicine for male pattern hair loss, it may take at least 3 months to see an effect. The medicine will not cure hair loss, but it will cause scalp hair to grow. The hair growth will only last as long as the medicine is used. The new hair will be lost within 1 year after the medicine is stopped.

If you are taking this medicine for benign prostatic hyperplasia (BPH), it may take up to 6 months to see the full effect. The medicine will not cure BPH, but it does help reduce the size of the prostate and improve symptoms. The effect on the prostate will only last as long as the medicine is used. When it is stopped, the prostate begins to grow again within a few months.

Take this medicine at the same time each day.

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 oral dosage form (tablets): For benign prostatic hyperplasia: Adults—5 milligrams (mg) once a day. Children—Use is not recommended. For male pattern hair loss: Adults—1 milligram (mg) once a day. Children—Use is not recommended. Missed Dose

If you miss a dose of this medicine, 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 Propecia

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Women and children should not use this medicine. Women who are pregnant or may become pregnant should not handle crushed or broken tablets. Finasteride can be absorbed through the skin and cause birth defects in male babies. If a woman does come in contact with this medicine, the affected area should be washed right away with soap and water.

This medicine may cause changes to the breast tissue. Tell your doctor if you have any lumps, pain, tenderness, or an enlargement of the breasts while using this medicine.

This medicine will not prevent prostate cancer but may increase your risk of developing high-grade prostate cancer. Tell your doctor if you have concerns about this risk.

This medicine may affect the results of the prostate specific antigen (PSA) test, which may be used to detect prostate cancer. Make sure you tell all of your doctors that you are using this medicine.

This medicine may cause a decrease in the amount of semen you ejaculate during sex. This will not affect your sperm count or your ability to have children.

Propecia 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 Chills cold sweats confusion dizziness, faintness, or lightheadedness when getting up from a lying or sitting position Less common Bloating or swelling of the face, arms, hands, lower legs, or feet breast enlargement and tenderness hives or welts itchy skin rapid weight gain redness of the skin skin rash swelling of the lips and face tingling of the hands or feet unusual weight gain or loss Incidence not known Clear or bloody discharge from the nipple dimpling of the breast skin inverted nipple lump in the breast or under the arm persistent crusting or scaling of the nipple redness or swelling of the breast sore on the skin of the breast that does not heal

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:

More common Decreased interest in sexual intercourse inability to have or keep an erection loss in sexual ability, desire, drive, or performance Less common Runny nose sleepiness or unusual drowsiness sneezing stuffy nose Less common or rare Abdominal or stomach pain back pain decreased amount of semen diarrhea dizziness headache Incidence not known Testicular pain

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: Propecia side effects (in more detail)

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More Propecia resources Propecia Side Effects (in more detail) Propecia Dosage Propecia Use in Pregnancy & Breastfeeding Drug Images Propecia Drug Interactions Propecia Support Group 3 Reviews for Propecia - Add your own review/rating Propecia Consumer Overview Propecia Prescribing Information (FDA) Propecia MedFacts Consumer Leaflet (Wolters Kluwer) Finasteride Prescribing Information (FDA) Finasteride Professional Patient Advice (Wolters Kluwer) Finasteride Monograph (AHFS DI) Finasteride MedFacts Consumer Leaflet (Wolters Kluwer) Proscar Prescribing Information (FDA) Proscar Consumer Overview Compare Propecia with other medications Androgenetic Alopecia
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MXL capsules 30 mg, 60 mg, 90 mg, 120 mg, 150 mg, 200 mg


MXL 30 mg, 60 mg, 90 mg, 120 mg, 150 mg and 200 mg prolonged-release capsules

Morphine sulphate

Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet:

1. What MXL capsules are and what they are used for
2. Before you take MXL capsules
3. How to take MXL capsules
4. Possible side effects
5. How to store MXL capsules
6. Further information

What MXL capsules are and what they are used for

These capsules have been prescribed for you by your doctor to relieve severe pain over a period of 24 hours. They contain the active ingredient morphine which belongs to a group of medicines called strong analgesics or ‘painkillers’.

Before you take MXL capsules Do not take MXL capsules if: you are allergic (hypersensitive) to morphine or any of the other ingredients of the capsules (see section 6 ‘Further Information’); you have breathing problems, such as obstructive airways disease or respiratory depression. Your doctor will have told you if you have these conditions. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected; you have a head injury that causes a severe headache or makes you feel sick. This is because the capsules may make these symptoms worse or hide the extent of the head injury; you have a condition where the small bowel (part of your gut) does not work properly (paralytic ileus), your stomach empties more slowly than it should (delayed gastric emptying) or you have severe pain in your abdomen; you have recent onset liver disease; you are taking a type of medicine known as a monoamine oxidase inhibitor (examples include tranylcypromide, phenelzine, isocarboxazid, moclobemide and linezolid), or you have taken this type of medicine in the last two weeks; the patient is under one year of age.

If you are going to have an operation, please tell the doctor at the hospital that you are taking these capsules.

Take special care with MXL capsules

Before treatment with these capsules tell your doctor or pharmacist if you:

have breathing problems, such as impaired lung function. Your doctor will have told you if you have this condition. Symptoms may include breathlessness and coughing; have an under-active thyroid gland (hypothyroidism), kidney or long-term liver problems as you may need a lower dose; have a severe headache or feel sick as this may indicate that the pressure in your skull is increased; suffer from seizures, fits or convulsions; have low blood pressure; have a severe heart problem after long-term lung disease (severe cor pulmonale); have inflammation of the pancreas (which causes severe pain in the abdomen and back) or problems with your gall bladder; have an inflammatory bowel disorder; have prostate problems; have poor adrenal gland function (your adrenal gland is not working properly which may cause symptoms including weakness, weight loss, dizziness, feeling or being sick); are or have ever been addicted to alcohol or drugs; have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, upon stopping taking alcohol or drugs. Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you take these capsules with some other medicines, the effect of the capsules or the other medicine may be changed.

These capsules must not be used together with a monoamine oxidase inhibitor, or if you have taken this type of medicine in the last two weeks (see section 2 ‘Do not take…’).

Tell your doctor or pharmacist if you are taking:

medicines to help you sleep (for example tranquillisers, hypnotics or sedatives); medicines to treat psychiatric or mental disorders (such as phenothiazines); muscle relaxants; medicines to treat high blood pressure; cimetidine to treat stomach ulcers, indigestion or heartburn; other strong analgesics or ‘painkillers’ (such as buprenorphine, nalbuphine or pentazocine); rifampicin to treat tuberculosis; ritonavir to treat HIV.

Also tell your doctor if you have recently been given an anaesthetic.

Taking MXL capsules with alcohol

Drinking alcohol during your treatment with these capsules may make you sleepy. If you are affected you should avoid drinking alcohol.

Pregnancy and breastfeeding

Do not take these capsules if you are pregnant or breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

These capsules may cause a number of side effects such as drowsiness which could affect your ability to drive or use machinery (see section 4 for a full list of side effects). These are usually most noticeable when you first start taking the capsules, or when changing to a higher dose. If you are affected you should not drive or use machinery.

How to take MXL capsules

Always take the capsules exactly as your doctor has told you. The label on your medicine will tell you how many capsules to take and how often.

Swallow your capsules whole with a glass of water. If you prefer, you can open your capsules and sprinkle the contents on to cold soft food, such as yogurt. Do not crush, dissolve or chew the capsule contents.

MXL capsules are designed to work properly over 24 hours. If the capsule contents are crushed, dissolved or chewed, the entire 24-hour dose may be absorbed rapidly into your body. This can be dangerous, causing serious problems such as an overdose, which may be fatal.

You should take your capsules every 24 hours. For instance, if you take a capsule at 8 o’clock in the morning, you should take your next capsule at 8 o’clock the next morning.

You must only take the capsules by mouth.

Adults

The usual starting dose is one 60 mg capsule every 24 hours. However, the dose will depend on your age, weight and the severity of your pain. If you are elderly or weigh less that 70 kg your doctor may suggest a starting dose of one 30 mg capsule every 24 hours. Your doctor will decide how many capsules you should take.

Children over one year of age

Children over one year of age can take these capsules. The required dose will depend on their weight and severity of pain. This should be discussed with your doctor or pharmacist.

If you find that you are still in pain whilst taking these capsules discuss this with your doctor.

Do not exceed the dose recommended by your doctor. You should check with your doctor or pharmacist if you are not sure.

If you take more MXL capsules than you should or if someone accidentally swallows your capsules

Call your doctor or hospital straight away. People who have taken an overdose may feel very sleepy, sick or dizzy. They may also have breathing difficulties leading to unconsciousness or even death and may need emergency treatment in hospital. When seeking medical attention make sure that you take this leaflet and any remaining capsules with you to show to the doctor.

If you forget to take MXL capsules

If you remember within 16 hours of the time your capsule was due, take your capsule straight away. Take your next capsule at your normal time. If you are more than 16 hours late, please call your doctor for advice. Do not take a double dose to make up for a forgotten capsule.

If you stop taking MXL capsules

You should not suddenly stop taking these capsules unless your doctor tells you to. If you want to stop taking your capsules, discuss this with your doctor first. They will tell you how to do this, usually by reducing the dose gradually so you do not experience unpleasant effects. Withdrawal symptoms such as agitation, anxiety, shaking or sweating may occur if you suddenly stop taking these capsules.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, these capsules can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although serious allergic reactions are uncommon. Tell your doctor immediately if you get any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching especially those covering your whole body.

The most serious side effect is a condition where you breathe more slowly or weakly than expected (respiratory depression).

As with all strong painkillers, there is a risk that you may become addicted or reliant on these capsules.

Common side effects (probably affecting more than 1 in 100 people taking these capsules)

Constipation (your doctor can prescribe a laxative to overcome this problem). Feeling or being sick (this should normally wear off after a few days, however your doctor can prescribe an anti-sickness medicine if it continues to be a problem). Drowsiness (this is most likely when you first start taking your capsules or when your dose is increased, but it should wear off after a few days). Dry mouth, loss of appetite, indigestion, abdominal pain or discomfort. Headache, confusion, difficulty in sleeping, abnormal thoughts. A feeling of unusual weakness. Difficulty in breathing or wheezing, decreased cough reflex. Involuntary muscle contractions or spasms. An increase in the severity of symptoms associated with inflammation of the pancreas (severe pain in the abdomen and back). Rash or itchy skin. Sweating.

Uncommon side effects (probably affecting fewer than 1 in 100 people taking these capsules)

Gastrointestinal disorders (e.g. upset stomach), changes in taste. A feeling of dizziness or ‘spinning’, fainting, seizures, fits or convulsions. Agitation, unpleasant or uncomfortable mood, mood changes, hallucinations, a feeling of extreme happiness. Generally feeling unwell. Tingling or numbness. Difficulty in passing urine. Impotence, decreased sexual drive, absence of menstrual periods. High or low blood pressure, facial flushing (redness of the face). A fast or slow heart beat, palpitations. Swelling of the hands, ankles or feet. Blurred vision, reduction in size of the pupils in the eye.

Uncommonly, these capsules may affect the results of blood tests to check that your liver is working properly.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store MXL capsules

Keep out of the reach and sight of children.

Do not use any capsules after the expiry date which is stated on the blister and carton. EXP 08 2010 means that you should not take the capsules after the last day of that month i.e. August 2010.

Do not store your capsules above 25°C.

Do not take your capsules if they are broken or crushed as this can be dangerous and can cause serious problems such as overdose.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information What MXL capsules contain

The active ingredient is morphine sulphate. Each capsule contains 30 mg, 60 mg, 90 mg, 120 mg, 150 mg or 200 mg of morphine sulphate.

The other ingredients are:

Hydrogenated vegetable oil Macrogol Talc Magnesium stearate Gelatin Sodium dodecyl sulphate Shellac Iron oxide (E172) Propylene glycol Titanium dioxide (E171)

The capsules also contain the following colourants:

30 mg, 60 mg & 120 mg - Indigo carmine (E132)

90 mg - Erythrosine (E127)

150 mg - Erythrosine (E127) and indigo carmine (E132)

What MXL capsules look like and the contents of the pack

The capsules are marked MS OD followed by the strength (e.g. 30, 60 etc).

The capsules are coloured as follows: 30 mg - light blue, 60 mg - brown, 90 mg - pink, 120 mg - olive, 150 mg - blue, 200 mg - rust.

In each box there are 28 capsules.

Marketing Authorisation Holder and Manufacturer

The capsules are made by

Bard Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW UK

for the marketing authorisation holder

Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW UK

This leaflet is also available in large print, Braille or as an audio CD. To request a copy, please call the RNIB Medicine Information line (free of charge) on:

0800 198 5000

You will need to give details of the product name and reference number.

These are as follows:

Product name: MXL prolonged-release capsules
Reference number: 16950/0042

This leaflet was last revised in 06/2009

MXL capsules are protected by European Patent (UK) Nos. 0636370 and

0654263.

MXL and the NAPP device (logo) are Registered Trade Marks.

© 2009 Napp Pharmaceuticals Limited

P0072-A R1V7 UK AW 05-02-09


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Mebendazole


Pronunciation: me-BEN-da-zole
Generic Name: Mebendazole
Brand Name: Generic only. No brands available.
Mebendazole is used for:

Treating certain worm infections (eg, pinworm, roundworm, whipworm, hookworm).

Mebendazole is an anthelmintic agent. It works by killing sensitive worms and causing them to be expelled from the body.

Do NOT use Mebendazole if: you are allergic to any ingredient in Mebendazole

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

Before using Mebendazole:

Some medical conditions may interact with Mebendazole. 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 certain problems resulting from worm infection (eg, hydatid disease) if others in your home also have worm infection

Some MEDICINES MAY INTERACT with Mebendazole. However, no specific interactions with Mebendazole are known at this time.

Ask your health care provider if Mebendazole 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 Mebendazole:

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

An extra patient leaflet is available with Mebendazole. Talk to your pharmacist if you have questions about this information. Take Mebendazole by mouth with or without food. Chew thoroughly before swallowing. Mebendazole may also be crushed and mixed with food. Wear tight underwear both day and night while taking Mebendazole. If you miss a dose of Mebendazole, 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 Mebendazole.

Important safety information: If your symptoms do not get better within 3 weeks, or if they get worse, check with your doctor. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Pinworm infection spreads easily to family members and close contacts. To prevent reinfection: Disinfect toilet and change and wash underwear, bed linens, towels, clothes, and pajamas daily. Do not shake clothes, towels, or bed linens before washing. Wash hands with soap often during the day, especially before eating and after using the toilet. Do not scratch the infected area or place your fingers in your mouth. Wear shoes. The entire household may need to be treated if one individual in the household has pinworms. Check with your doctor for more information. For several days after treatment with Mebendazole, clean the bedroom floor by vacuuming or damp mopping. Avoid dry sweeping because it may stir up dust. LAB TESTS, including complete blood cell counts and liver function, may be performed while you use Mebendazole. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Mebendazole should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: Mebendazole 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 Mebendazole while you are pregnant. It is not known if Mebendazole is found in breast milk. If you are or will be breast-feeding while you use Mebendazole, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Mebendazole:

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:

Diarrhea; stomach pain.

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); fever, chills, or persistent sore throat; hoarseness; seizures; 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: Mebendazole 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 Mebendazole:

Store Mebendazole 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 Mebendazole out of the reach of children and away from pets.

General information: If you have any questions about Mebendazole, please talk with your doctor, pharmacist, or other health care provider. Mebendazole 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 Mebendazole. 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 Mebendazole resources Mebendazole Side Effects (in more detail)Mebendazole Use in Pregnancy & BreastfeedingDrug ImagesMebendazole Drug InteractionsMebendazole Support Group0 Reviews for Mebendazole - Add your own review/rating Mebendazole Prescribing Information (FDA) Mebendazole Professional Patient Advice (Wolters Kluwer) Mebendazole Monograph (AHFS DI) mebendazole Advanced Consumer (Micromedex) - Includes Dosage Information Vermox Consumer Overview Compare Mebendazole with other medications AngiostrongylosisAscariasisCapillariasisDracunculiasisEchinococcusFilariasis, ElephantiasisHookworm Infection, Necator or AncylostomaHydatid DiseasePinworm Infection, Enterobius vermicularisTrichinosisTrichostrongylosisVisceral Larva Migrans, ToxicariasisWhipworm Infection
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Creon


1. Name Of The Medicinal Product

Creon® 10000 Capsules

Creon® 25000 Capsules

Creon® 40000 Capsules

2. Qualitative And Quantitative Composition

Creon 10000

Each capsule contains pancreatin 150 mg equivalent to:

Lipase 10,000 PhEur units

Amylase 8,000 PhEur units

Protease 600 PhEur units

Creon25000

Each capsule contains pancreatin PhEur 300 mg equivalent to:

Lipase 25,000 PhEur units

Amylase 18,000 PhEur units

Protease 1,000 PhEur units

Creon40000

Each capsule contains pancreatin PhEur 400 mg equivalent to:

Lipase 40,000 PhEur units

Amylase 25,000 PhEur units

Protease 1,600 PhEur units

3. Pharmaceutical Form

Creon 10000

Brown/clear capsules containing gastro-resistant granules.

Creon25000

Orange/colourless capsules filled with brownish minimicrospheres.

Creon 40000

Brown/clear size 00 capsules containing light brown, gastro-resistant granules.

4. Clinical Particulars 4.1 Therapeutic Indications

For the treatment of pancreatic exocrine insufficiency.

4.2 Posology And Method Of Administration

Adults (including the elderly) and children:

Creon 40000 should only be used if the patient requires equal to or more than 40,000 lipase units per meal or snack. Creon 40000 should only be used in patients in whom the minimum effective dose has already been determined using lower strength pancreatic enzyme products.

Initially one or two capsules with meals. Dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology.

Creon 10000 and 25000

The capsules can be swallowed whole, or for ease of administration they may be opened and the granules taken with fluid or soft food. If the granules are mixed with food, it is important that they are taken immediately, otherwise dissolution of the enteric coating may result. In order to protect the enteric coating, it is important that the granules are not crushed or chewed.

Creon 40000 only

The capsules should be swallowed whole.

It is important to ensure adequate hydration of patients at all times whilst dosing Creon .

Colonic damage has been reported in patients with cystic fibrosis taking in excess of 10,000 units of lipase/kg/day (see Undesirable Effects).

4.3 Contraindications

Patients with known hypersensitivity to porcine proteins.

4.4 Special Warnings And Precautions For Use

The product is of porcine origin.

Oral medications should not be administered during the early stages of acute pancreatitis.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

There is inadequate evidence of safety in use during pregnancy and lactation. However, as enzymes are not absorbed, it is unlikely that there would be any effect on the nursing infant.

4.7 Effects On Ability To Drive And Use Machines

Creon has no influence on the ability to drive or use machines.

4.8 Undesirable Effects

Diarrhoea, constipation, gastric discomfort, nausea and skin reactions have been reported occasionally in patients receiving enzyme replacement therapy.

Rarely cases of hyper-uricosuria and hyper-uricaemia have been reported with very high doses of pancreatin.

Stricture of the ileo-caecum and large bowel and colitis has been reported in children with cystic fibrosis taking high doses of pancreatic enzyme supplements. To date, Creon 10000 and 25000 have not been implicated in the development of colonic damage. Experience with Creon 40000 in clinical use is limited. However, unusual abdominal symptoms or changes in abdominal symptoms should be reviewed to exclude the possibility of colonic damage - especially if the patient is taking in excess of 10,000 units of lipase/kg/day.

4.9 Overdose

Most cases respond to supportive measures including stopping enzyme therapy, ensuring adequate rehydration.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

The ATC code is A09A A (Enzyme preparations).

Replacement therapy in pancreatic enzyme deficiency states. The enzymes have hydrolytic activity on fat, carbohydrates and proteins.

5.2 Pharmacokinetic Properties

Pharmacokinetic data are not available as the enzymes act locally in the gastro-intestinal tract. After exerting their action, the enzymes are digested themselves in the intestine.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Granules: Macrogol 4000, liquid paraffin, hypromellose phthalate, dibutyl phthalate, dimeticone.

Capsule shell: Gelatin, iron oxide (E172), titanium dioxide (E171).

6.2 Incompatibilities None known. 6.3 Shelf Life

Creon 10000 and 25000:

2 years

Creon 40000: 3

years

6.4 Special Precautions For Storage

Creon 10000:

Do not store above 30°C

Creon 25000:

Store below 25°C.

Creon 40000:

Do not store above 25°C. Keep container tightly closed.

6.5 Nature And Contents Of Container

Creon 10000, 25000 and 40000: HDPE tablet container with LDPE closure. Each container contains 100 capsules.

6.6 Special Precautions For Disposal And Other Handling

6.5

No special instructions.

Administrative Data 7. Marketing Authorisation Holder Solvay Healthcare Limited

Mansbridge Road

West End

Southampton

SO18 3JD

United Kingdom

8. Marketing Authorisation Number(S)

Creon 10000:

PL 00512/0149

Creon 25000:

PL 00512/0150

Creon 40000:

PL 00512/0177

9. Date Of First Authorisation/Renewal Of The Authorisation

Creon 10000 and 25000:

1 January 2001

Creon 40000:

5 July 2002

10. Date Of Revision Of The Text

Creon 10000: May 2002

Creon 25000: June 2003

Creon 40000: October 2002

Legal Category

Creon 10000: P

Creon 25000 and 40000: POM


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Slo-Niacin nicotinic acid


Generic Name: niacin (nicotinic acid) (NYE a sin (NIK oh TIN ik AS id))
Brand Names: B-3-50, B3-500-Gr, Niacin SR, Niacor, Niaspan ER, Slo-Niacin

What is niacin?

Niacin, also called nicotinic acid, is a B vitamin (vitamin B3). It occurs naturally in plants and animals, and is also added to many foods as a vitamin supplement. Niacin is also present in many multiple vitamins and nutritional supplements.

Niacin is used to treat and prevent a lack of natural niacin in the body, and to lower cholesterol and triglycerides (types of fat) in the blood. It is also used to lower the risk of heart attack in people with high cholesterol who have already had a heart attack. Niacin is sometimes used to treat coronary artery disease (also called atherosclerosis).

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

What is the most important information I should know about niacin? Do not take this medication if you are allergic to niacin, or if you have severe liver disease, a stomach ulcer, or active bleeding.

Niacin can cause certain side effects, such as flushing (warmth, itching, redness, or tingly feeling under your skin). These effects can be made worse if you drink alcohol or hot beverages shortly after you take niacin. These effects should disappear over time as you keep taking the medication.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid taking colestipol (Colestid) or cholestyramine (Locholest, Prevalite, Questran) at the same time you take niacin. If you take either of these other medications, take them at least 4 to 6 hours before or after you take niacin.

Niacin is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.

What should I discuss with my healthcare provider before taking niacin ? Do not take this medication if you are allergic to niacin, or if you have severe liver disease, a stomach ulcer, or active bleeding.

Before taking niacin, tell your doctor if you are allergic to any drugs, or if you have:

liver or kidney disease;

heart disease or uncontrolled angina (chest pain);

a stomach ulcer;

diabetes;

gout; or

a muscle disorder such as myasthenia gravis.

If you have any of these conditions, you may not be able to use niacin, or you may need dosage adjustments or special tests during treatment.

FDA pregnancy category C. Niacin may be harmful to an unborn baby when the medication is taken at doses to treat high cholesterol or other conditions. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Niacin can 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 take niacin ?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Niacin is sometimes taken at bedtime with a low-fat snack. Follow your doctor's instructions.

Niacin can cause certain side effects, such as flushing (warmth, itching, redness, or tingly feeling under your skin). These effects can be made worse if you drink alcohol or hot beverages shortly after you take niacin. These effects should disappear over time as you keep taking the medication.

Take niacin with a full glass of cold or cool water. Taking the medication with a hot drink may increase your risk of side effects such as flushing. Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time. Niacin extended-release tablets and capsules contain higher strengths of the medicine than the regular niacin tablets. Take only the dose that is correct for the type of niacin tablet or capsule you are using.

Niacin can cause you to have unusual results with certain medical tests (urine tests). Tell any doctor who treats you that you are using niacin.

If you stop taking niacin for any length of time, talk with your doctor before starting the medication again. You may need to restart the medication at a lower dose.

Niacin is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any scheduled appointments.

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

Take the missed dose as soon as you remember. Be sure to take the missed dose with food if you normally take your niacin dose with a meal or snack.

If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take 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.

Overdose symptoms may include nausea, dizziness, itching, vomiting, upset stomach, and flushing.

What should I avoid while taking niacin ?

Avoid drinking hot beverages shortly after taking niacin. Hot drinks can worsen niacin's flushing effect (warmth, itching, redness, or tingly feeling under your skin).

Avoid drinking alcohol while taking niacin. Alcohol may increase your risk of liver damage, and can also worsen the flushing effects of niacin.

Avoid taking colestipol (Colestid) or cholestyramine (Locholest, Prevalite, Questran) at the same time you take niacin. If you take either of these other medications, take them at least 4 to 6 hours before or after you take niacin.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Niacin 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 any of these serious side effects:

feeling light-headed, fainting;

fast, pounding, or uneven heart beats;

feeling short of breath;

swelling;

jaundice (yellowing of your skin or eyes); or

muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine.

If you are diabetic, tell your doctor about any changes in your blood sugar levels.

Less serious side effects of niacin include:

mild dizziness;

warmth, redness, or tingly feeling under your skin;

itching, dry skin;

sweating or chills;

nausea, diarrhea, belching, gas;

muscle pain, leg cramps; or

sleep problems (insomnia).

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 niacin ?

Tell your doctor about all other cholesterol-lowering drugs you are taking with niacin, especially atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), or simvastatin (Zocor).

Before taking niacin, tell your doctor if you are also using any of the following drugs:

a blood thinner such as warfarin (Coumadin);

multivitamins or mineral supplements that contain niacin;

blood pressure or heart medications such as amlodipine (Norvasc), diltiazem (Tiazac, Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), nifedipine (Procardia, Adalat), nimodipine (Nimotop), nisoldipine (Sular), or verapamil (Calan, Covera, Isoptin, Verelan); or

heart medications such as doxazosin (Cardura), isosorbide (Dilatrate, Imdur, Isordil, Monoket, Sorbitrate), nitroglycerin (Nitro-Bid, Nitro-Dur, Nitrostat), prazosin (Minipress), or terazosin (Hytrin).

This list is not complete and there may be other drugs that can interact with niacin. 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 Slo-Niacin resources Slo-Niacin Side Effects (in more detail) Slo-Niacin Use in Pregnancy & Breastfeeding Drug Images Slo-Niacin Drug Interactions Slo-Niacin Support Group 1 Review for Slo-Niacin - Add your own review/rating Compare Slo-Niacin with other medications High Cholesterol Hyperlipoproteinemia Hyperlipoproteinemia Type IV, Elevated VLDL Hyperlipoproteinemia Type V, Elevated Chylomicrons VLDL Niacin Deficiency Pellagra Where can I get more information? Your pharmacist can provide more information about niacin.

See also: Slo-Niacin side effects (in more detail)


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Locholest Light


Generic Name: cholestyramine (koe le STYE ra meen)
Brand Names: Cholestyramine Light, Prevalite, Questran, Questran Light

What is Locholest Light (cholestyramine)?

Cholestyramine helps reduce cholesterol (fatty acids) in the blood. High cholesterol is associated with an increased risk of heart disease and atherosclerosis (clogged arteries).

Cholestyramine is used to lower high levels of cholesterol in the blood, especially low-density lipoprotein (LDL) ("bad" cholesterol).

Cholestyramine powder is also used to treat itching caused by a blockage in the bile ducts of the gallbladder.

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

What is the most important information I should know about Locholest Light (cholestyramine)? You should not take this medication if you are allergic to cholestyramine, or if you have a blockage in your stomach or intestines.

Before taking cholestyramine, tell your doctor if you have a thyroid disorder, diabetes, kidney or liver disease, or chronic constipation.

Avoid taking other medications at the same time you take cholestyramine. Wait at least 4 to 6 hours after taking cholestyramine before you take any other medications. What should I discuss with my healthcare provider before taking Locholest Light (cholestyramine)? You should not take this medication if you are allergic to cholestyramine, or if you have a blockage in your stomach or intestines.

Before taking this medication, tell your doctor if you are allergic to any drugs, or if you have:

a thyroid disorder;

diabetes,

kidney disease, liver disease, or

chronic constipation.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take cholestyramine.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking cholestyramine can make it harder for your body to absorb certain vitamins your body needs while you are nursing a baby. Do not take cholestyramine without telling your doctor if you are breast-feeding.

This medication may contain phenylalanine. Talk to your doctor before using cholestyramine if you have phenylketonuria (PKU).

How should I take Locholest Light (cholestyramine)?

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

Cholestyramine is sometimes taken up to 6 times per day. Follow your doctor's instructions.

Take cholestyramine with meals unless your doctor tells you otherwise.

Mix the cholestyramine powder with 2 to 6 ounces of water or other non-carbonated beverage. You may also mix the powder with a brothy soup, crushed pineapple, or applesauce. Measure the powder using the scoop provided with your medication. Do not use any other scoop or measuring cup to measure your cholestyramine dose.

Drink extra fluids to prevent constipation while you are taking cholestyramine.

It is important to take cholestyramine regularly to get the most benefit.

Cholestyramine is only part of a complete program of treatment that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

To be sure this medication is helping your condition, your blood may need to be tested on a regular basis. Do not miss any scheduled appointments.

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

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take 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.

Overdose symptoms may include severe stomach pain or constipation.

What should I avoid while taking Locholest Light (cholestyramine)? Avoid taking other medications at the same time you take cholestyramine. Wait at least 4 to 6 hours after taking cholestyramine before you take any other medications. Locholest Light (cholestyramine) 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:

blood in your urine;

severe stomach pain;

ongoing constipation;

feeling short of breath;

black, bloody, or tarry stools; or

easy bruising or bleeding.

Less serious side effects may include:

mild constipation, diarrhea;

stomach pain, nausea, loss of appetite, weight changes;

bloating or gas;

hiccups or a sour taste in your mouth;

skin rash or itching;

irritation of your tongue;

itching or irritation around your rectal area;

muscle or joint pain; or

dizziness, spinning sensation; ringing in your ears.

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 Locholest Light (cholestyramine)?

Cholestyramine can make it harder for your body to absorb other medications, such as:

a blood thinner such as warfarin (Coumadin);

digoxin (digitalis, Lanoxin);

propranolol (Inderal);

a diuretic (water pill);

thyroid hormones such as levothyroxine (Synthroid, Levoxyl, Levothroid);

birth control pills or hormone replacement;

seizure medicines such as phenytoin (Dilantin) and phenobarbital (Luminal, Solfoton); or

an antibiotic such as amoxicillin (Amoxil, Trimox, others), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), penicillin (BeePen-VK, Pen-Vee K, Veetids, others), tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

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

More Locholest Light resources Locholest Light Side Effects (in more detail) Locholest Light Use in Pregnancy & Breastfeeding Locholest Light Drug Interactions 0 Reviews for Locholest Light - Add your own review/rating Cholestyramine Prescribing Information (FDA) Cholestyramine Powder MedFacts Consumer Leaflet (Wolters Kluwer) Cholestyramine Professional Patient Advice (Wolters Kluwer) cholestyramine Advanced Consumer (Micromedex) - Includes Dosage Information Cholestyramine Light Prescribing Information (FDA) Cholestyramine Resin Monograph (AHFS DI) Prevalite Prescribing Information (FDA) Questran Prescribing Information (FDA) Compare Locholest Light with other medications Crohn's Disease Hyperlipoproteinemia Hyperlipoproteinemia Type IIa, Elevated LDL Hyperlipoproteinemia Type IIb, Elevated LDL VLDL Irritable Bowel Syndrome Pruritus of Partial Biliary Obstruction Where can I get more information? Your pharmacist can provide more information about cholestyramine.

See also: Locholest Light side effects (in more detail)


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Quin-G


Generic Name: quinidine (KWIH nih deen)
Brand Names: Quin-G

What is Quin-G (quinidine)?

Quinidine affects the way that the heart beats.

Quinidine is used to help keep the heart beating normally in people with certain heart rhythm disorders.

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

What is the most important information I should know about Quin-G (quinidine)? You should not take this medication if you have ever had an allergic reaction to quinidine or quinine (Qualaquin), including easy bruising or unusual bleeding. You should not take quinidine if you have myasthenia gravis or certain heart conditions, especially "AV block" (unless you have a pacemaker).

Before you take quinidine, tell your doctor if you have a slow heart rate, congestive heart failure, a serious heart condition such as "sick sinus syndrome," kidney or liver disease, low levels of potassium or magnesium in your blood, a history of "Long QT syndrome," if you are on a low-salt diet, or if you have ever had an abnormal electrocardiogram or ECG (sometimes called an EKG).

If you need surgery, tell the surgeon ahead of time that you are using quinidine. You may need to stop using the medicine for a short time. Ask your doctor how to adjust your quinidine dose if needed. Do not change your medication dose or schedule without your doctor's advice. Call your doctor at once if you have a serious side effect such as: vomiting and diarrhea, ringing in the ears, hearing loss, severe dizziness, changes in vision, pain behind your eyes, white patches or cloudiness in your eyes, pale or yellowed skin, dark urine, easy bruising or bleeding, wheezing, trouble breathing, or a new or a worsening irregular heartbeat pattern. There are many other drugs that can interact with quinidine. 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. What should I discuss with my healthcare provider before taking Quin-G (quinidine)? You should not take this medication if you have ever had an allergic reaction to quinidine or quinine (Qualaquin), including easy bruising or unusual bleeding. You should not take quinidine if you have myasthenia gravis or certain heart conditions, especially "AV block" (unless you have a pacemaker).

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

slow heart rate;

congestive heart failure;

a serious heart condition such as "sick sinus syndrome";

kidney disease;

liver disease;

low levels of potassium or magnesium in your blood;

a history of "Long QT syndrome";

if you are on a low-salt diet; or

if you have ever had an abnormal electrocardiogram or ECG (sometimes called an EKG).

FDA pregnancy category C. It is not known whether quinidine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Quinidine can 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 take Quin-G (quinidine)?

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 doctor may occasionally change your dose to make sure you get the best results.

Do not crush or chew an extended-release tablet. Swallow it whole. You may break the tablet in half if your doctor instructs you to. If you need surgery, tell the surgeon ahead of time that you are using quinidine. You may need to stop using the medicine for a short time. Ask your doctor how to adjust your quinidine dose if needed. Do not change your medication dose or schedule without your doctor's advice.

Use quinidine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

While using quinidine, you may need blood tests at your doctor's office. Visit your doctor regularly.

Store at room temperature away from moisture and heat. 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 vomiting, diarrhea, ringing in your ears or hearing problems, dizziness or spinning sensation, blurred vision, irregular heartbeat, confusion, or feeling like you might pass out.

What should I avoid while taking Quin-G (quinidine)?

Do not change the amount of salt in your diet unless your doctor tells you to.

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

Quin-G (quinidine) 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. Call your doctor at once if you have a serious side effect such as:

vomiting and diarrhea;

ringing in the ears, hearing loss, severe dizziness;

feeling like you might pass out;

changes in vision, pain behind your eyes, increased sensitivity of your eyes to light;

white patches on your eyes;

cloudiness in the pupils or iris of your eyes;

a new or a worsening irregular heartbeat pattern;

pale or yellowed skin, dark colored urine, fever, confusion or weakness;

nausea, stomach pain, low fever, loss of appetite, clay-colored stools;

seizure (convulsions);

easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or

bronchospasm (wheezing, chest tightness, trouble breathing).

Less serious side effects may include:

mild nausea, vomiting, or diarrhea;

heartburn;

depressed mood;

muscle or joint pain;

headache, dizziness;

mild skin rash;

skin dryness, peeling, or flaking; or

flushing (warmth, redness, or tingly feeling).

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.

What other drugs will affect Quin-G (quinidine)?

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

cimetidine (Tagamet);

digoxin (Lanoxin);

ketoconazole (Extina, Ketozole, Nizoral, Xolegal);

rifampin (Rifater, Rifadin, Rifamate);

warfarin (Coumadin);

a diuretic (water pill);

glaucoma medication such as acetazolamide (Diamox) or methazolamide (Glauctabs, Neptazane);

heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), nimodipine, Nimotop), nifedipine (Nifedical, Procardia), propranolol (Inderal), or verapamil (Calan, Covera, Isoptin, Verelan);

medicines to treat psychiatric disorders, such as haloperidol (Haldol), and others;

narcotic medication such as codeine or hydrocodone (Lortab, Vicodin);

other heart rhythm medications such as amiodarone (Cordarone, Pacerone), mexiletine (Mexitil), disopyramide (Norpace), or procainamide (Procan SR, Procanbid, Pronestyl);

a phenothiazine such as chlorpromazine (Thorazine), promethazine (Phenergan, Promethegan), prochlorperazine (Compazine), and others;

seizure medication such as phenytoin (Dilantin) or phenobarbital (Solfoton);

sodium bicarbonate, potassium citrate (K-Lyte, Urocit-K), sodium citrate and citric acid (Bicitra, Oracit), or sodium citrate and potassium (Citrolith, Polycitra); or

an antidepressant such as amitriptyline (Elavil), doxepin (Sinequan), clomipramine (Anafranil), imipramine (Tofranil), and others.

This list is not complete and there are many other drugs that can interact with quinidine. 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 Quin-G resources Quin-G Side Effects (in more detail) Quin-G Use in Pregnancy & Breastfeeding Quin-G Drug Interactions Quin-G Support Group 0 Reviews for Quin-G - Add your own review/rating Cardioquin Advanced Consumer (Micromedex) - Includes Dosage Information Quinidine Professional Patient Advice (Wolters Kluwer) Quinidine Prescribing Information (FDA) Quinidine Gluconate Monograph (AHFS DI) Compare Quin-G with other medications Arrhythmia Malaria Where can I get more information? Your pharmacist can provide more information about quinidine.

See also: Quin-G side effects (in more detail)


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Palladone SR capsules


1. Name Of The Medicinal Product

PALLADONE®SR capsules 2 mg, 4 mg, 8 mg, 16 mg, 24 mg.

2. Qualitative And Quantitative Composition

The capsules contain Hydromorphone Hydrochloride USP 2 mg, 4 mg, 8 mg, 16 mg, 24 mg.

For excipients, see 6.1.

3. Pharmaceutical Form

Prolonged release capsule.

Hard gelatin capsule containing spherical prolonged release pellets.

PALLADONE SR capsules 2 mg are yellow/white capsules marked HCR 2.

PALLADONE SR capsules 4 mg are pale blue/clear capsules marked HCR 4.

PALLADONE SR capsules 8 mg are pink/clear capsules marked HCR 8.

PALLADONE SR capsules 16 mg are brown/clear capsules marked HCR 16.

PALLADONE SR capsules 24 mg are dark blue/clear capsules marked HCR 24.

4. Clinical Particulars 4.1 Therapeutic Indications

For the relief of severe pain in cancer.

4.2 Posology And Method Of Administration

Route of administration

The capsules can be swallowed whole or opened and their contents sprinkled on to cold soft food.

Dosage and administration

Adults and children over 12 years

PALLADONE SR capsules should be used at 12-hourly intervals. The dosage is dependent upon the severity of the pain and the patient's previous history of analgesic requirements. 4 mg of hydromorphone has an efficacy approximately equivalent to 30 mg of morphine sulphate given orally. A patient presenting with severe pain should normally be started on a dosage of 4 mg PALLADONE SR capsules 12-hourly. Increasing severity of pain will require increased dosage of hydromorphone to achieve the desired relief.

Elderly and patients with renal impairment

The elderly and patients with renal impairment should be dose titrated with PALLADONE SR capsules in order to achieve adequate analgesia. It should be noted, however, that these patients may require a lower dosage to achieve adequate analgesia.

Patients with hepatic impairment

Contra-indicated.

Children under 12 years

Not recommended.

4.3 Contraindications

Hydromorphone is contra-indicated in patients with known hypersensitivity to hydromorphone or other ingredients in the formulation.

It is also contra-indicated in respiratory depression with hypoxia or elevated carbon dioxide levels in the blood, pregnancy, coma, acute abdomen, hepatic impairment, paralytic ileus, concurrent administration of monoamine oxidase inhibitors or within 2 weeks of discontinuation of their use. Use of PALLADONE SR capsules should be avoided in patients with raised intracranial pressure or head injury, and also in patients with convulsive disorders or acute alcoholism.

Pre-operative administration of PALLADONE SR capsules is not recommended and is not an approved indication.

4.4 Special Warnings And Precautions For Use

The major risk of opioid excess is respiratory depression. As with all narcotics, a reduction in dosage may be advised in the elderly or infirm patients with severely impaired pulmonary function, toxic pyschosis, delirium tremens, pancreatitis, hypothyroidism, hypotension with hypovolaemia, chronic obstructive airways disease, renal or adrenocortical insufficiency, prostatic hypertrophy, shock or reduced respiratory reserve. PALLADONE SR capsules are not recommended in the first 24 hours post-operatively. After this time they should be used with caution, particularly following abdominal surgery.

PALLADONE SR capsules should not be used where there is the possibility of paralytic ileus occurring. Should paralytic ileus be suspected or occur during use, PALLADONE SR capsules should be discontinued.

Patients about to undergo cordotomy or other pain relieving surgical procedures should not receive PALLADONE SR capsules for 24 hours prior to surgery. If further treatment with PALLADONE SR capsules is indicated, then the dosage should be adjusted to the new post-operative requirement.

The patient may develop tolerance to the drug with chronic use and require progressively higher doses to maintain pain control. The patient may develop physical dependence; an abstinence syndrome may be seen following abrupt cessation.

When a patient no longer requires therapy with hydromorphone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

Hydromorphone has a morphine-like abuse profile and may be sought and abused by people with latent or manifest addiction disorders. Hydromorphone should be used with particular care in patients with a history of alcohol and drug abuse.

The prolonged release capsules may be opened and their contents sprinkled on to soft cold food. However the capsule contents should not be chewed or crushed. The administration of chewed or crushed hydromorphone pellets may lead to a rapid release and absorption of a potentially fatal dose of hydromorphone (see section 4.9).

Concomitant use of alcohol and Palladone SR capsules may increase the undesirable effects of Palladone SR capsules; concomitant use should be avoided.

Abuse of oral dosage forms by parenteral administration can be expected to result in serious adverse events, which may be fatal.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Centrally acting drugs such as major and minor tranquillisers, anaesthetics, barbiturates, antiemetics, antidepressants, neuroleptics, hypnotics, other opioids, monoamine oxidase inhibitors (see section 4.3) and sedatives may interact with hydromorphone, and potentiate the effects of either drug, e.g. sedation, respiratory depression, etc.

Alcohol may enhance the pharmacodynamic effects of Palladone SR capsules; concomitant use should be avoided.

4.6 Pregnancy And Lactation

PALLADONE SR capsules are not recommended in pregnancy or in the breast-feeding mother as there are insufficient animal or human data to justify such use.

4.7 Effects On Ability To Drive And Use Machines

Hydromorphone may cause drowsiness and patients should not drive or operate machinery if affected.

4.8 Undesirable Effects

Hydromorphone may cause constipation, nausea and vomiting. Constipation may be treated with appropriate laxatives. When nausea and vomiting are troublesome, PALLADONE SR capsules can be readily combined with anti-emetics

Common (incidence of

 

Common

Uncommon

Cardiac and vascular disorders

Hypotension

 

Eye disorders

 

Blurred vision

Miosis

Gastrointestinal and hepatobiliary disorders

Constipation

Dry mouth

Nausea

Vomiting

Biliary colic

Paralytic ileus

General disorders

Asthenic conditions

Drug withdrawal syndrome

Drug tolerance

Peripheral oedema

Immune system disorders

 

Hypersensitivity reactions (including oropharyngeal swelling)

Nervous system disorders

Dizziness

Somnolence

Convulsions

Dyskinesia

Headache

Sedation

Tremor

In particular in high doses hyperalgesia that will not respond to a further dose of hydromorphone (possibly dose reduction or change in opioid required).

Psychiatric disorders

Confusion

Drug addiction

Agitation

Dysphoria

Euphoria

Hallucination

Renal and urinary disorders

Urinary retention

 

Respiratory, thoracic and mediastinal disorders

 

Respiratory depression

Skin and subcutaneous tissue disorders

Pruritus

Rash

Sweating

Urticaria

4.9 Overdose

Signs of hydromorphone toxicity and overdosage are pin-point pupils, respiratory depression and hypotension. Circulatory failure and somnolence progressing to stupor or deepening coma, skeletal muscle flaccidity, bradycardia and death may occur in more severe cases. Rhabdomylosis progressing to renal failure has been reported in opioid overdosage.

Treatment of overdosage:

Primary attention should be given to the establishment of a patent airway and institution of assisted or controlled ventilation.

In the case of massive overdosage, administer naloxone intravenously (0.4 to 2 mg for an adult and 0.01mg/kg body weight for children), if the patient is in a coma or respiratory depression is present. Repeat the dose at 2 minute intervals if there is no response. If repeated doses are required then an infusion of 60% of the initial dose per hour is a useful starting point. A solution of 10 mg made up in 50 ml dextrose will produce 200 micrograms/ml for infusion using an IV pump (dose adjusted to the clinical response). Infusions are not a substitute for frequent review of the patient's clinical state.

Intramuscular naloxone is an alternative in the event IV access is not possible. As the duration of action of naloxone is relatively short, the patient must be carefully monitored until spontaneous respiration is reliably re-established. Naloxone is a competitive antagonist and large doses (4 mg) may be required in seriously poisoned patients. For less severe overdosage, administer naloxone 0.2 mg intravenously followed by increments of 0.1 mg every 2 minutes if required.

Naloxone should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to hydromorphone overdosage. Naloxone should be administered cautiously to persons who are known, or suspected, to be physically dependent on hydromorphone. In such cases, an abrupt or complete reversal of opioid effects may precipitate an acute withdrawal syndrome.

Other supportive measures as indicated by the patient's progress and clinical condition should be considered.

Additional/other considerations:

Consider activated charcoal (50 g for adults, 1g/kg for children), if a substantial amount has been ingested within 1 hour, provided the airway can be protected. It may be reasonable to assume that late administration of activated charcoal may be beneficial for prolonged release preparations; however there is no evidence to support this.

PALLADONE SR capsules will continue to release and add to the hydromorphone load for up to 12 hours after administration and management of hydromorphone overdosage should be monitored accordingly. Gastric contents may need to be emptied as this can be useful in removing unabsorbed drug, particularly when a prolonged release formulation has been taken.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Natural opium alkaloid

ATC code: NO2A A03

Like morphine, hydromorphone is an agonist of mu receptors. The pharmacological actions of hydromorphone and morphine do not differ significantly. The oral analgesic potency ratio of hydromorphone to morphine is approximately 5-10:1. Hydromorphone and related opioids produce their major effects on the central nervous system and bowel. The effects are diverse and include analgesia, drowsiness, changes in mood, respiratory depression, decreased gastrointestinal motility, nausea, vomiting and alteration of the endocrine and autonomic nervous system.

5.2 Pharmacokinetic Properties

Hydromorphone is absorbed from the gastrointestinal tract and undergoes pre-systemic elimination resulting in an oral bioavailability of about 50%. It is metabolised and excreted in the urine mainly as conjugated hydromorphone and with smaller amounts of unchanged hydromorphone, dihydroisomorphine and dihydromorphine. PALLADONE SR capsules have been formulated to produce therapeutic plasma levels following 12-hourly dosing.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Microcrystalline cellulose

Hypromellose

Ethylcellulose (N10)

Colloidal anhydrous silica

Dibutyl sebacate

Capsule shells

Gelatin

Sodium dodecylsulphate

Titanium dioxide (E171)

Black Printing ink

Shellac

Propylene glycol

Iron oxide (E172)

The following colours are included in the capsule shells:

2 mg Quinoline yellow (E104);

4 mg Erythrosine (E127), indigo carmine (E132);

8 mg Erythrosine (E127);

16 mg Iron oxide (E172);

24 mg Indigo carmine (E132).

6.2 Incompatibilities

None known.

6.3 Shelf Life

Eighteen months.

6.4 Special Precautions For Storage

Do not store above 25oC. Store in the original package.

6.5 Nature And Contents Of Container

PVdC/PVC blister packs with aluminium backing foil containing 56 capsules.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge

CB4 0GW

8. Marketing Authorisation Number(S)

PL 16950/0051-0055

9. Date Of First Authorisation/Renewal Of The Authorisation

12 February 1997 / 17 January 2006

10. Date Of Revision Of The Text

May 2011


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Neutra-Phos


Generic Name: potassium phosphate and sodium phosphate (poe TASS ee um FOSS fate and SEW dee um FOSS fate)
Brand Names: K-Phos M.F., K-Phos Neutral, K-Phos No. 2, Neutra-Phos, Uro-KP-Neutral

What are Neutra-Phos (potassium phosphate and sodium phosphate)?

Phosphorus is a naturally occurring substance that is important in every cell in the body. The majority of phosphorus in the body is found in the bones. The potassium and sodium salt forms of phosphorus are called phosphates.

Potassium phosphate and sodium phosphate is used to acidify the urine and lower the urinary calcium concentration. This may reduce rash and odor caused by ammonium in the urine. Potassium phosphate and sodium phosphate may also increase the antibiotic effect of methenamine (Hiprex, Urex). Potassium phosphate and sodium phosphate is also used as a phosphorus supplement to prevent and/or treat a phosphorus deficiency.

Potassium phosphate and sodium phosphate may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Neutra-Phos (potassium phosphate and sodium phosphate)? Do not take antacids containing aluminum, calcium, or magnesium while taking potassium phosphate and sodium phosphate, except under the supervision of your doctor. Antacids may decrease phosphate absorption.

If you have kidney stones, there is a possibility that you will pass old stones after starting treatment with potassium phosphate and sodium phosphate.

Who should not take Neutra-Phos (potassium phosphate and sodium phosphate)? You cannot take potassium phosphate and sodium phosphate if you have

high levels of potassium in your body,

high levels of phosphorus in your body,

infected phosphate stones, or

severe kidney disease.

Before taking potassium phosphate and sodium phosphate, tell your doctor if you have

Addison's disease,

a bowel obstruction,

heart disease,

high blood pressure,

kidney disease, liver disease or cirrhosis,

swelling or water retention,

high levels of sodium in your body,

low levels of calcium in your body,

hypoparathyroidism,

pancreatitis, or

rickets.

You may not be able to take potassium phosphate and sodium phosphate, or you may require a lower dose or special monitoring if you have any of the conditions listed above.

Potassium phosphate and sodium phosphate is in the FDA pregnancy category C. This means that it is not known whether potassium phosphate and sodium phosphate will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. It is also not known whether potassium phosphate and sodium phosphate will harm a nursing infant. Do not take potassium phosphate and sodium phosphate without first talking to your doctor if you are breast-feeding baby. How should I take Neutra-Phos (potassium phosphate and sodium phosphate)?

Take potassium phosphate and sodium phosphate exactly as directed by your doctor or as directed on the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each tablet with a full glass of water.

The K-Phos Original tablets should be dissolved in 6 to 8 ounces (180 to 240 mL) of water. Let the tablets soak for 2 to 5 minutes, or more if necessary, and stir. If tablet particles remain, they can be crushed and stirred to speed dissolution. Drink the solution once the tablets are completely dissolved.

Do not swallow the Neutra-Phos capsules whole. They must be opened, and the contents mixed with water. Mix the Neutra-Phos powder and capsule contents with 75 mL (approximately one-third cup) of water, and drink the solution. Do not take more of this medication than is recommended. If your symptoms are not being treated, notify your doctor. Store potassium phosphate and sodium phosphate 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 the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed.

What happens if I overdose? Seek emergency medical attention.

Most commonly, symptoms of an overdose include nausea, vomiting, diarrhea, dehydration, and severe and prolonged muscle cramps or paralysis.

What should I avoid while taking Neutra-Phos (potassium phosphate and sodium phosphate)? Do not take antacids containing aluminum, calcium, or magnesium while taking potassium phosphate and sodium phosphate, except under the supervision of your doctor. Antacids may decrease phosphate absorption. Neutra-Phos (potassium phosphate and sodium phosphate) side effects Stop taking potassium phosphate and sodium phosphate and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may also to occur. Nausea, vomiting, stomach pain, and diarrhea are among the most common. These side effects usually lessen after a few days of therapy. Notify your doctor if you develop these side effects.

If you have kidney stones, there is a possibility that you will pass old stones after starting treatment with potassium phosphate and sodium phosphate.

Less commonly, the following side effects have been reported:

headache;

dizziness or confusion;

weakness or heaviness of the legs;

diarrhea;

seizures;

unusual tiredness or weakness;

muscle cramps;

numbness, tingling, pain, or weakness of the hands or feet;

swelling of the feet or lower legs;

unusual weight gain;

increased thirst;

decreased urine; or

bone or joint pain.

Notify your doctor if you develop any of the side effects listed above.

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. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Neutra-Phos (potassium phosphate and sodium phosphate)? Do not take antacids containing aluminum, calcium, or magnesium while taking potassium phosphate and sodium phosphate, except under the supervision of your doctor. Antacids may decrease phosphate absorption.

Before taking potassium phosphate and sodium phosphate, tell your doctor if you are taking any of the following medicines

calcium and/or vitamin D supplements;

potassium supplements or salt substitutes;

a diuretic (water pill) such as triamterene (Dyrenium, Dyazide, Maxzide), spironolactone (Aldactone), or amiloride (Midamor);

a heart medication such as guanethidine (Ismelin), diazoxide (Hyperstat, Proglycem), hydralazine (Apresoline), methyldopa (Aldomet), or reserpine (Ser-Ap-Es); or

a steroid medicine such as corticotropin (ACTH, Acthar), cortisone (Cortone), hydrocortisone (Cortef, others), prednisone (Orasone, Deltasone, others), prednisolone (Prelone, Pediapred, Delta-Cortef, others), methylprednisolone (Medrol, others), triamcinolone (Aristocort, Kenalog, Tri-Kort, Trilog, others), dexamethasone (Decadron), or betamethasone (Celestone).

You may require a dosage adjustment or special monitoring if you are taking any of the medicines listed above.

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

More Neutra-Phos resources Neutra-Phos Side Effects (in more detail) Neutra-Phos Use in Pregnancy & Breastfeeding Neutra-Phos Drug Interactions Neutra-Phos Support Group 0 Reviews for Neutra-Phos - Add your own review/rating K-Phos Neutral Advanced Consumer (Micromedex) - Includes Dosage Information K-Phos Neutral MedFacts Consumer Leaflet (Wolters Kluwer) Compare Neutra-Phos with other medications Hypophosphatemia Urinary Acidification Where can I get more information? Your pharmacist has more information about potassium phosphate and sodium phosphate written for health professionals that you may read.

See also: Neutra-Phos side effects (in more detail)


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Antabuse


Pronunciation: dye-SUL-fi-ram
Generic Name: Disulfiram
Brand Name: Antabuse

Antabuse must not be given to patients under the influence of alcohol or without their permission.


Antabuse is used for:

Treating alcoholism.

Antabuse is an alcohol-abuse deterrent. It works by blocking the breakdown of alcohol, causing unpleasant side effects (eg, vomiting, upset stomach) when even a small amount of alcohol is consumed.

Do NOT use Antabuse if: you are allergic to any ingredient in Antabuse or other similar medicines you are under the influence of alcohol you have severe heart disease, a blockage of your heart arteries, or a mental disorder (eg, psychosis) you are taking metronidazole or an alcohol-containing medicine (eg, certain HIV protease inhibitors [eg, amprenavir], cough syrups, other liquid medicines)

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

Before using Antabuse:

Some medical conditions may interact with Antabuse. 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 (eg, latex rubber) if you have brain damage, diabetes, heart or lung disease, mental or mood problems (eg, depression), an underactive thyroid, seizures, or liver or kidney problems

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

Alcohol-containing medicines (eg, certain HIV protease inhibitors [eg, amprenavir], cough syrups, other liquid medicines) or metronidazole because the risk of severe side effects may be increased Anticoagulants (eg, warfarin), benzodiazepines (eg, diazepam), isoniazid, or phenytoin because side effects may be increased by Antabuse

This may not be a complete list of all interactions that may occur. Ask your health care provider if Antabuse 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 Antabuse:

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

Antabuse may be taken with or without food. Antabuse may be swallowed whole, chewed, or crushed and mixed with food. Do not take the first dose of Antabuse for at least 12 hours after drinking alcohol. If you miss a dose of Antabuse, 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 Antabuse.

Important safety information: Antabuse may cause drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Antabuse. Using Antabuse alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks. Avoid all alcohol including alcohol found in sauces, vinegar, mouthwash, liquid medicines, lotions, after shave, or backrub products. A reaction to alcohol may cause flushing, nausea, thirst, abdominal pain, chest pain, dizziness, vomiting, fast breathing, fast heartbeat, fainting, difficulty breathing, or confusion. Use caution when using topical products containing alcohol, such as cologne or perfume. Before using alcohol-containing products on the skin, test the product by applying some to a small area of the skin. If no redness, itching, headache, or nausea occurs after 1 or 2 hours, you should be able to use the product. You may have a reaction if you drink alcohol or use a product that contains alcohol for 2 weeks after your last dose of Antabuse. Notify your doctor immediately if you experience yellowing of the skin or eyes, dark urine, weakness, tiredness, loss of appetite, or nausea and vomiting. These may be signs of a liver problem. Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Antabuse. Carry an identification card at all times that says you are taking Antabuse. LAB TESTS, including liver function tests and complete blood cell counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments. Use Antabuse with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Antabuse during pregnancy. It is unknown if Antabuse is excreted in breast milk. Do not breast-feed while taking Antabuse. Possible side effects of Antabuse:

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:

Drowsiness; headache; metallic or garlic taste in mouth.

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); blurred vision; changes in color vision; dark urine; loss of appetite; mental or mood problems; nausea; numbness or tingling of the arms or legs; seizures; tiredness; vomiting; weakness; 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: Antabuse 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 Antabuse:

Store Antabuse at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Antabuse out of the reach of children and away from pets.

General information: If you have any questions about Antabuse, please talk with your doctor, pharmacist, or other health care provider. Antabuse 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 Antabuse. 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 Antabuse resources Antabuse Side Effects (in more detail) Antabuse Use in Pregnancy & Breastfeeding Drug Images Antabuse Drug Interactions Antabuse Support Group 17 Reviews for Antabuse - Add your own review/rating Antabuse Prescribing Information (FDA) Antabuse Consumer Overview Antabuse Monograph (AHFS DI) Antabuse Advanced Consumer (Micromedex) - Includes Dosage Information Disulfiram Prescribing Information (FDA) Disulfiram Professional Patient Advice (Wolters Kluwer) Compare Antabuse with other medications Alcohol Dependence
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