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Pedi-Dri


Generic Name: nystatin topical (nye STAT in)
Brand Names: Mycostatin Topical, Nyamyc, Nystop, Pedi-Dri, Pediaderm AF

What is Pedi-Dri (nystatin topical)?

Nystatin is an antifungal medication. Nystatin prevents fungus from growing on your skin.

Nystatin topical (for the skin) is used to treat skin infections caused by yeast.

Nystatin topical is not for use to treat a vaginal yeast infection.

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

What is the most important information I should know about Pedi-Dri (nystatin topical)? Do not use nystatin topical to treat any skin condition that has not been checked by your doctor. Nystatin topical (for the skin) is not for use to treat a vaginal yeast infection. Avoid getting this medication in your eyes or mouth. If this does happen, rinse with water.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Call your doctor if your symptoms do not improve, or if they get worse while using nystatin topical. Do not share this medication with another person, even if they have the same symptoms you have. What should I discuss with my healthcare provider before using Pedi-Dri (nystatin topical)?

You should not use nystatin topical if you have ever had an allergic reaction to it.

FDA pregnancy category C. It is not known whether nystatin topical 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 nystatin topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use Pedi-Dri (nystatin topical)?

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

Do not use nystatin topical to treat any skin condition that has not been checked by your doctor. Wash your hands before and after using this medication.

Clean and dry the skin before you apply nystatin topical.

Do not cover treated skin with bandages or dressings that do not allow air circulation unless your doctor tells you to.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Call your doctor if your symptoms do not improve, or if they get worse while using nystatin topical. Do not share this medication with another person, even if they have the same symptoms you have. Store at room temperature away from moisture and heat. What happens if I miss a dose?

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

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

Avoid wearing tight-fitting, synthetic clothing (such as nylon) that doesn't allow air circulation. Wear clothing made of loose cotton and other natural fibers until your infection is healed.

Pedi-Dri (nystatin topical) 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. Stop using nystatin topical and call your doctor at once if you have severe burning, itching, rash, pain, or other irritation where the medicine is applied.

Less serious side effects may include mild itching or irritation.

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 Pedi-Dri (nystatin topical)?

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

More Pedi-Dri resources Pedi-Dri Side Effects (in more detail)Pedi-Dri Use in Pregnancy & BreastfeedingPedi-Dri Support Group1 Review for Pedi-Dri - Add your own review/rating Compare Pedi-Dri with other medications Cutaneous CandidiasisVaginal Yeast Infection Where can I get more information? Your pharmacist can provide more information about nystatin topical.

See also: Pedi-Dri side effects (in more detail)


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nystatin topical


Generic Name: nystatin topical (nye STAT in)
Brand Names: Mycostatin Topical, Nyamyc, Nystop, Pedi-Dri, Pediaderm AF

What is nystatin topical?

Nystatin is an antifungal medication. Nystatin prevents fungus from growing on your skin.

Nystatin topical (for the skin) is used to treat skin infections caused by yeast.

Nystatin topical is not for use to treat a vaginal yeast infection.

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

What is the most important information I should know about nystatin topical? Do not use nystatin topical to treat any skin condition that has not been checked by your doctor. Nystatin topical (for the skin) is not for use to treat a vaginal yeast infection. Avoid getting this medication in your eyes or mouth. If this does happen, rinse with water.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Call your doctor if your symptoms do not improve, or if they get worse while using nystatin topical. Do not share this medication with another person, even if they have the same symptoms you have. What should I discuss with my healthcare provider before using nystatin topical?

You should not use nystatin topical if you have ever had an allergic reaction to it.

FDA pregnancy category C. It is not known whether nystatin topical 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 nystatin topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use nystatin topical?

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

Do not use nystatin topical to treat any skin condition that has not been checked by your doctor. Wash your hands before and after using this medication.

Clean and dry the skin before you apply nystatin topical.

Do not cover treated skin with bandages or dressings that do not allow air circulation unless your doctor tells you to.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Call your doctor if your symptoms do not improve, or if they get worse while using nystatin topical. Do not share this medication with another person, even if they have the same symptoms you have. Store at room temperature away from moisture and heat. What happens if I miss a dose?

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

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

Avoid wearing tight-fitting, synthetic clothing (such as nylon) that doesn't allow air circulation. Wear clothing made of loose cotton and other natural fibers until your infection is healed.

Nystatin topical 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. Stop using nystatin topical and call your doctor at once if you have severe burning, itching, rash, pain, or other irritation where the medicine is applied.

Less serious side effects may include mild itching or irritation.

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.

Nystatin topical Dosing Information

Usual Adult Dose for Cutaneous Candidiasis:

Apply nystatin topical cream, ointment or powder in a quantity sufficient to cover the affected area and immediately surrounding skin 2 to 4 times a day.
The powder formulation is useful for the treatment of moist areas or lesions.
Therapy should be continued for 2 to 8 weeks, depending on the nature and severity of the infection.

Usual Adult Dose for Vaginal Candidiasis:

Insert one nystatin vaginal tablet (100,000 units) vaginally once a day, preferably at bedtime, for a total of 14 days.

Usual Pediatric Dose for Cutaneous Candidiasis:

Apply nystatin topical cream, ointment or powder in a quantity sufficient to cover the affected area and immediately surrounding skin 2 to 4 times a day.
The powder formulation is useful for the treatment of moist areas or lesions.
Therapy should be continued for 2 to 8 weeks, depending on the nature and severity of the infection.

Usual Pediatric Dose for Vaginal Candidiasis:

>13

What other drugs will affect nystatin topical?

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

More nystatin topical resources Nystatin topical Use in Pregnancy & Breastfeeding Nystatin topical Support Group 6 Reviews for Nystatin - Add your own review/rating Compare nystatin topical with other medications Cutaneous Candidiasis Vaginal Yeast Infection Where can I get more information? Your pharmacist can provide more information about nystatin topical.
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Nystatin/Triamcinolone


Pronunciation: nye-STAT-in/trye-am-SIN-oh-lone
Generic Name: Nystatin/Triamcinolone
Brand Name: Examples include Mycolog II and Mycogen II
Nystatin/Triamcinolone is used for:

Treating or preventing fungal infections of the skin.

Nystatin/Triamcinolone is an antifungal and steroid combination. It works by stopping fungus growth and reducing inflammation.

Do NOT use Nystatin/Triamcinolone if: you are allergic to any ingredient in Nystatin/Triamcinolone you are taking mifepristone

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

Before using Nystatin/Triamcinolone:

Some medical conditions may interact with Nystatin/Triamcinolone. 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 measles, had a positive skin tuberculin skin test, tuberculosis (TB), chickenpox, shingles, or wasting of the skin (skin atrophy) if you have had a vaccination with an inactivated or live vaccine

Some MEDICINES MAY INTERACT with Nystatin/Triamcinolone. Because little, if any, of Nystatin/Triamcinolone is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Nystatin/Triamcinolone 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 Nystatin/Triamcinolone:

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

To prevent reinfection, wash your hands thoroughly before and after using Nystatin/Triamcinolone. Wash and completely dry the affected area. Gently rub the medicine in until it is evenly distributed. Do not bandage, cover, or wrap the treated skin unless directed to do so by your doctor. Nystatin/Triamcinolone works best if used at the same time each day. To clear up your infection completely, use Nystatin/Triamcinolone for the full course of treatment. Keep using it even if you feel better in a few days. Nystatin/Triamcinolone is for external use only. Do not get it your eyes. If you miss a dose of Nystatin/Triamcinolone, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Nystatin/Triamcinolone.

Important safety information: If Nystatin/Triamcinolone is to be applied to the groin area, apply sparingly and wear loose-fitting clothing. If Nystatin/Triamcinolone is to be applied to skin covered by a diaper, do not use tight-fitting diapers or plastic pants. Nystatin/Triamcinolone should not be used if irritation occurs or if symptoms worsen or have not improved within 25 days of use. Nystatin/Triamcinolone should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nystatin/Triamcinolone while you are pregnant. It is unknown if Nystatin/Triamcinolone is found in breast milk. If you are or will be breast-feeding while you use Nystatin/Triamcinolone, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Nystatin/Triamcinolone:

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:

Acne; burning; cracking and stinging of the skin; dryness; excessive hair growth; inflamed skin around the mouth; inflammation of hair follicles; irritation; itching; loss of skin color; secondary infection; skin wasting; streaking of skin.

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).

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: Nystatin/Triamcinolone 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. Nystatin/Triamcinolone may be harmful if swallowed.

Proper storage of Nystatin/Triamcinolone:

Store Nystatin/Triamcinolone at controlled room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not freeze. Keep Nystatin/Triamcinolone out of the reach of children and away from pets.

General information: If you have any questions about Nystatin/Triamcinolone, please talk with your doctor, pharmacist, or other health care provider. Nystatin/Triamcinolone 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 Nystatin/Triamcinolone. 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 Nystatin/Triamcinolone resources Nystatin/Triamcinolone Side Effects (in more detail) Nystatin/Triamcinolone Use in Pregnancy & Breastfeeding Nystatin/Triamcinolone Drug Interactions Nystatin/Triamcinolone Support Group 4 Reviews for Nystatin/Triamcinolone - Add your own review/rating Compare Nystatin/Triamcinolone with other medications Cutaneous Candidiasis
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Mycostatin Pastilles


Generic Name: nystatin (oral) (nye STAH tin)
Brand Names: Bio-Statin, Mycostatin, Mycostatin Pastilles, Nilstat

What is nystatin?

Nystatin is an antifungal medication.

Oral nystatin is used to treat yeast infections of the mouth.

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

What is the most important information I should know about nystatin? Take all of the nystatin that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated. What should I discuss with my healthcare provider before taking nystatin?

Nystatin is not absorbed through your stomach. It will not treat fungal infections in any part of your body other than your mouth. Talk to your doctor if you have another type of fungal infection such as athlete's foot, jock itch, ringworm, or a vaginal yeast infection.

Oral nystatin is in the FDA pregnancy category C. This means that it is not known whether nystatin will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. It is not known whether nystatin will harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. How should I take nystatin?

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

Take the oral tablets with a full glass of water.

The troches, or pastilles, should be allowed to dissolve in your mouth. Do not chew or swallow them. Suck on one troche at a time until it is completely dissolved.

Shake the suspension well before measuring a dose.

Use a dose-measuring cup, spoon, or dropper to measure the specified dose of the suspension. Swish the suspension around in your mouth, then either spit it out or swallow it, depending upon the instructions given by your doctor.

Take all of the nystatin that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated. Store the Bio-Statin brand of nystatin tablets and powder and the Mycostatin Pastilles in the refrigerator. Store all other nystatin capsules, tablets, and suspension 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 regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose? Seek emergency medical attention.

Symptoms of a nystatin overdose include nausea, stomach upset, vomiting, and diarrhea.

What should I avoid while taking nystatin?

There are no restrictions on foods, beverages, or activities during treatment with nystatin unless your doctor directs otherwise.

Nystatin side effects Stop taking nystatin 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).

Side effects are not likely to occur with nystatin. Continue to take nystatin and talk to your doctor if you experience

nausea or stomach upset,

vomiting, or

diarrhea.

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 nystatin?

Since nystatin is not absorbed by your body, drug interactions are not expected. Talk to your doctor and pharmacist before taking other prescription or over-the-counter medicines.

More Mycostatin Pastilles resources Mycostatin Pastilles Side Effects (in more detail) Mycostatin Pastilles Use in Pregnancy & Breastfeeding Mycostatin Pastilles Drug Interactions Mycostatin Pastilles Support Group 0 Reviews for Mycostatin Pastilles - Add your own review/rating Nystatin MedFacts Consumer Leaflet (Wolters Kluwer) Nystatin Professional Patient Advice (Wolters Kluwer) Nystatin Monograph (AHFS DI) Bio-Statin Advanced Consumer (Micromedex) - Includes Dosage Information Bio-Statin Powder MedFacts Consumer Leaflet (Wolters Kluwer) Mycostatin Prescribing Information (FDA) Mycostatin MedFacts Consumer Leaflet (Wolters Kluwer) Mycostatin Topical Advanced Consumer (Micromedex) - Includes Dosage Information Compare Mycostatin Pastilles with other medications Gastrointestinal Candidiasis Oral Thrush Where can I get more information? Your pharmacist has additional information about nystatin written for health professionals that you may read.

See also: Mycostatin Pastilles side effects (in more detail)


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Nystan Oral Suspension (Ready -Mixed )


1. Name Of The Medicinal Product

NYSTAN ORAL SUSPENSION (READY-MIXED)

2. Qualitative And Quantitative Composition

Ready mixed oral suspension containing 100,000 units nystatin per ml.

3. Pharmaceutical Form

Oral suspension

4. Clinical Particulars 4.1 Therapeutic Indications

The prevention and treatment of candidal infections of the oral cavity, oesophagus and intestinal tract. The suspension provides effective prophylaxis against oral candidosis in those born of mothers with vaginal candidosis.

4.2 Posology And Method Of Administration

Adults:

For the treatment of denture sores, and oral infections in adults caused by C.albicans, 1ml of the suspension should be dropped into the mouth four times daily; it should be kept in contact with the affected areas as long as possible.

Children:

In intestinal and oral candidosis (thrush) in infants and children, 1ml should be dropped into the mouth four times a day. The longer the suspension is kept in contact with the affected area in the mouth, before swallowing, the greater will be its effect.

For prophylaxis in the newborn the suggested dose is 1ml once daily.

Elderly:

No specific dosage recommendations or precautions.

4.3 Contraindications

Contra-indicated in patients with a history of hypersensitivity to any of the components.

4.4 Special Warnings And Precautions For Use

Nystan Oral Suspension contains sugar.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Nystan oral preparations should not be used for treatment of systemic mycoses.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Animal reproductive studies have not been conducted with nystatin.

It is not known whether nystatin can cause foetal harm when administered to a pregnant women, however absorption of nystatin from the gastro-intestinal tract is negligible. Nystatin should be prescribed during pregnancy only if the potential benefits to be derived outweigh the possible risks involved.

Nursing Mothers:

Though gastro-intestinal absorption is insignificant, it is not known whether nystatin is excreted in human breast milk and caution should be exercised when nystatin is prescribed for nursing women.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Nystatin is generally well tolerated by all age groups, even during prolonged use. Rarely hypersensitivity,oral irritation or sensitisation may occur. Nausea has been reported occasionally during therapy.

Large oral doses of Nystatin have occasionally produced diarrhoea, gastrointestinal distress, nausea and vomiting. Rash, including urticaria, and face oedema has been reported rarely. Steven-Johnson Syndrome has been reported very rarely.

4.9 Overdose

Since the absorption of nystatin from the gastro-intestinal tract is negligible, overdosage or accidental ingestion causes no systemic toxicity.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Nystatin is an antifungal antibiotic active against a wide range of yeasts and yeast-like fungi, including Candida albicans.

5.2 Pharmacokinetic Properties

Nystatin is formulated in oral and topical dosage forms and is not systemically absorbed from any of these preparations.

5.3 Preclinical Safety Data

No further relevant information.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Ethanol, flavours, glycerin, methyl parahydroxybenzoate, pH adjusters (hydrochloric acid, sodium hydroxide), propyl parahydroxybenzoate, sodium carboxymethylcellulose, sodium phosphate, sucrose, water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months

6.4 Special Precautions For Storage

Do not store above 25°C

6.5 Nature And Contents Of Container

30ml amber glass bottle, packed in a cardboard carton with a graduated, polyethylene dropper.

6.6 Special Precautions For Disposal And Other Handling

Shake well before use.

Dilution is not recommended as this may reduce therapeutic efficacy.

7. Marketing Authorisation Holder

E. R. Squibb & Sons Limited

Uxbridge Business Park

Sanderson Road

Uxbridge

Middlesex UB8 1DH

8. Marketing Authorisation Number(S)

PL 0034/0130R

9. Date Of First Authorisation/Renewal Of The Authorisation

08/02/2010

10. Date Of Revision Of The Text

08/02/2010


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Nystatin Powder


Dosage Form: powder
Nystatin Topical Powder, USP

FOR TOPICAL USE ONLY
NOT FOR OPTHALMIC USE

Rx Only
P5196 04/06

Nystatin Powder Description

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei.

Structural formula:

Nystatin topical powder is for dermatologic use.

Nystatin topical powder contains 100,000 USP nystatin units per gram dispersed in talc.

Nystatin Powder - Clinical Pharmacology Phamacokinetics

Nystatin is not absorbed from intact skin or mucous membrane.

Microbiology

Nystatin is an antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi, including Candida albicans, C. parapsilosis, C. tropicalis, C. guilliermondi, C. pseudotropicalis, C. krusei, Torulopsis glabrata, Tricophyton rubrum, T. mentagrophytes.

Nystatin acts by binding to sterols in the cell membrane of susceptible species resulting in a change in membrane permeability and the subsequent leakage of intracellular components. On repeated subculturing with increasing levels of nystatin, Candida albicans does not develop resistance to nystatin. Generally, resistance to nystatin does not develop during therapy. However, other species of Candida (C. tropicalis, C. guilliermondi, C. krusei, and C. stellatoides) become quite resistant on treatment with nystatin and simultaneously become cross resistant to amphotericin as well. This resistance is lost when the antibiotic is removed.

Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

Indications and Usage for Nystatin Powder

Nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.

This preparation is not indicated for systemic, oral, intravaginal, or ophthalmic use.

Contraindications

Nystatin topical powder is contraindicated in patients with a history of hypersensitivity to any of its components.

Precautions General

Nystatin topical powder should not be used for the treatment of systemic, oral, intravaginal, or ophthalmic infections.

If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. It is recommended that KOH smears, cultures, or other diagnostic methods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens.

Information for Patients

Patients using this medication should receive the following information and instructions:

The patient should be instructed to use this medication as directed (including the replacement of missed doses). This medication is not for any disorder other than that for which it is prescribed. Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt or discontinue therapy until the prescribed course of treatment is completed. If symptoms of irritation develop, the patient should be advised to notify the physician promptly. Laboratory Tests

If there is a lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be repeated.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. No studies have been performed to determine the mutagenicity of nystatin or its effects on male or female fertility.

Pregnancy

Teratogenic Effects - Category C

Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether these preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin topical preparations should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.

Nursing Mothers

It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.

Pediatric Use

Safety and effectiveness have been established in the pediatric population from birth to 16 years (see DOSAGE AND ADMINISTRATION).

Geriatric Use

Clinical studies with nystatin topical powder did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Adverse Reactions

The frequency of adverse events reported in patients using nystatin topical preparations is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application (see PRECAUTIONS, General).

Nystatin Powder Dosage and Administration

Very moist lesions are best treated with the topical dusting powder.

Adults and Pediatric Patients (Neonates and Older):

Apply to candidal lesions two or three times daily until healing is complete. For fungal infection of the feet caused by Candida species, the powder should be dusted on the feet, as well as in all footwear.

How is Nystatin Powder Supplied

Nystatin topical powder, USP, is supplied as 100,000 units nystatin per gram, packaged as follows:

NDC 58177-839-45 15 gram bottle

NDC 58177-839-46 30 gram bottle

NDC 58177-839-61 60 gram bottle

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.] Avoid excessive heat 40°C (104°F). Keep tightly closed.

Manufactured by
KV Pharmaceutical Co. for
ETHEX Corporation
St. Louis, MO 63044

P5196 4/06

Principal Displacy Panel 15 g Bottle Label

NDC 58177-839-45

Nystatin Topical
Powder,USP

100,000 USP
units per gram

15 grams Rx Only

P5194-1 01/06

ETHEX ETHEX

Principal Displacy Panel 30 g Bottle Label

NDC 58177-839-46

Nystatin Topical
Powder,USP

100,000 USP
units per gram

30 grams Rx Only

ETHEX ETHEX

Principal Displacy Panel 60 g Bottle Label

NDC 58177-839-61

Nystatin Topical
Powder,USP

100,000 USP
units per gram

60 grams Rx Only

ETHEX ETHEX


NYSTATIN 
nystatin  powder Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 58177-839 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Nystatin (Nystatin) Nystatin 100000 [USP'U]  in 1 g Inactive Ingredients Ingredient Name Strength Talc   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 58177-839-45 15 g In 1 BOTTLE None 2 58177-839-46 30 g In 1 BOTTLE None 3 58177-839-61 60 g In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065321 10/13/2009
Labeler - Ethex Corporation (615424686) Registrant - KV Pharmaceutical Co. (006291405) Establishment Name Address ID/FEI Operations KV Pharmaceutical Co. (Westport) 152053658 manufacture Establishment Name Address ID/FEI Operations KV Pharmaceutical Co. (ECI) 034060843 analysis Revised: 10/2010Ethex Corporation More Nystatin Powder resources Nystatin Powder Use in Pregnancy & Breastfeeding Nystatin Powder Support Group 6 Reviews for Nystatin - Add your own review/rating Compare Nystatin Powder with other medications Cutaneous Candidiasis Vaginal Yeast Infection
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Timodine


TIMODINE

PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE. IF YOU ARE NOT SURE ABOUT ANYTHING ASK YOUR PHARMACIST OR DOCTOR.

What Is Timodine?

Timodine is a pale yellow cream which is applied thinly to the inflamed skin. It contains an antifungal agent, a corticosteroid, an antiseptic and a water-repellent.

Each tube of Timodine contains 30 g.

The active ingredients are nystatin BP 100,000 IU/g, hydrocortisone Ph Eur 0.5% w/w, dimeticone 350 BP 10% w/w and benzalkonium chloride solution BP 0.2% w/w.

The other ingredients are butylated hydroxyanisole, cetostearyl alcohol, cellulose nitrate, dibutyl phthalate, glyceryl monostearate, methyl hydroxybenzoate, propyl hydroxybenzoate, sorbic acid, stearic acid, sodium metabisulphite and water.

Marketing Authorisation Holder:

Alliance Pharmaceuticals Ltd Avonbridge House Bath Road Chippenham Wiltshire SN15 2BB UK

Manufacturer:

Reckitt Benckiser Healthcare (UK) Limited Dansom Lane Hull HU8 7DS What Is Timodine Used For?

Timodine is a medicine to treat inflamed skin conditions, particularly where infection by a germ called Candida albicans can occur.

Where two folds of skin rub together, chafing can occur, leading to a sore inflamed area of skin. This particularly happens in places such as the groin or under the breasts where frequent sweating occurs. This combination of irritated skin and wetness is called intertrigo. The same condition happens under babies’ nappies when it is known as nappy rash. In both intertrigo and nappy rash the inflamed skin is easily infected by germs, in particular a fungus called Candida albicans.

Timodine is specially formulated to ease the soreness and treat the infections in intertrigo and inflamed nappy rash.

Nystatin kills Candida albicans. Hydrocortisone reduces the pain and soreness. Dimeticone stops wetting and chafing. Benzalkonium chloride kills bacteria.

Timodine can also be used to treat the following conditions when there is infection with Candida albicans:

Eczema. “Housewives’ hands”, a skin irritation caused by chemicals such as washing powders. Seborrhoeic dermatitis: inflammation of the scalp with excessive amounts of dandruff scales and oily secretions. Pruritis ani and vulvae: irritation of the external area around the anus and the vagina. Before Using Timodine

As with all medicines, Timodine may not be suitable for everybody:

Do not use this medicine if you are allergic to the product or any of its ingredients. You should ask your doctor before using Timodine if you are pregnant. Avoid prolonged exposure on the face and keep away from eyes. How To Use Timodine

For intertrigo, seborrhoeic dermatitis and “housewives’ hands”

Apply a thin layer of Timodine to the sore area and rub into the skin gently until the cream disappears. The treatment should be repeated three times a day until the skin is healed.

For severe nappy rash

Remove the soiled nappy, then clean and dry your baby’s skin. Rub a thin layer of Timodine into the sore areas until the cream disappears. The treatment should be repeated after every napkin change.

Do not use Timodine for more than seven days unless your doctor tells you to. Once the infection has cleared up, use a barrier cream instead of Timodine.

In the case of a missed dose, simply apply when the next dose is due. In the case of accidental ingestion, seek medical advice.

How Much To Use

A finger-tip length of cream should be enough for each inflamed area.

What Side-Effects May Occur?

Tell your doctor or pharmacist if any side-effects occur after use of this product.

Storage

Keep all medicines away from children. Do not use after the expiry date shown on the pack.

Keep Timodine below 15°C.

Further Information

You may find a yellow stain on terry cotton nappies after using Timodine. This will disappear after soaking in bleach or nappy bucket solution followed by rinsing and normal washing.

Timodine is a registered trademark of Alliance Pharmaceuticals Limited.

Alliance and associated devices are registered trademarks of Alliance Pharmaceuticals Limited.

Leaflet last revised March 2010.

xxxxxx

UK 002


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Mycostatin Ointment Topical


Generic Name: nystatin (Topical route)

nye-STAT-in

Commonly used brand name(s)

In the U.S.

Mycostatin Nystop Pedi-Dri

In Canada

Mycostatin Cream Mycostatin Ointment Mycostatin Powder Nadostine Nilstat Topical Cream Nilstat Topical Ointment Nyaderm Cream Nyaderm Ointment

Available Dosage Forms:

Powder Cream Ointment

Therapeutic Class: Antifungal

Chemical Class: Polyene

Uses For Mycostatin Ointment

Nystatin belongs to the group of medicines called antifungals. Topical nystatin is used to treat some types of fungus infections of the skin.

Nystatin is available in the U.S. only with your doctor's prescription.

Before Using Mycostatin Ointment

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

Although there is no specific information comparing use of topical nystatin in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of topical nystatin in the elderly with use in other age groups.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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.

Proper Use of nystatin

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

Topical nystatin should not be used in the eyes.

Apply enough nystatin to cover the affected area.

For patients using the powder form of this medicine on the feet:

Sprinkle the powder between the toes, on the feet, and in socks and shoes.

The use of any kind of occlusive dressing (airtight covering, such as kitchen plastic wrap) over this medicine may increase the chance of irritation. Therefore, do not bandage, wrap, or apply any occlusive dressing over this medicine unless directed to do so by your doctor. When using this medicine on the diaper area of children, avoid tight-fitting diapers and plastic pants.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your condition has improved. Do not miss any doses.

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 topical dosage forms (cream or ointment): For fungus infections: Adults and children—Apply to the affected area(s) of the skin two times a day. For topical dosage form (powder): For fungus infections: Adults and children—Apply to the affected area(s) of the skin two or three times a day. 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.

Mycostatin Ointment 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 as soon as possible if any of the following side effects occur:

Skin irritation not present before use of this medicine

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.

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.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Mycostatin Ointment Topical resources Mycostatin Ointment Topical Use in Pregnancy & Breastfeeding Mycostatin Ointment Topical Support Group 6 Reviews for Mycostatin Topical - Add your own review/rating Compare Mycostatin Ointment Topical with other medications Cutaneous Candidiasis Vaginal Yeast Infection
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Mycostatin Vaginal Cream


Generic Name: nystatin (Vaginal route)

nye-STAT-in

Commonly used brand name(s)

In Canada

Mycostatin Mycostatin Vaginal Cream Nadostine Nilstat Vaginal Cream Nilstat Vaginal Tablet Nyaderm Vaginal Cream

Available Dosage Forms:

Cream Tablet

Therapeutic Class: Antifungal

Chemical Class: Polyene

Uses For Mycostatin Vaginal Cream

Nystatin belongs to the group of medicines called antifungals. Vaginal nystatin is used to treat fungus infections of the vagina. Nystatin vaginal cream or tablets may also be used for other problems as determined by your doctor.

Nystatin is available only with your doctor's prescription.

Before Using Mycostatin Vaginal Cream

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

Studies on this medicine have been done only in adults, and there is no specific information comparing use of vaginal nystatin in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of vaginal nystatin in the elderly with use in other age groups.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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.

Proper Use of nystatin

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

Nystatin usually comes with patient directions. Read them carefully before using this medicine.

This medicine is usually inserted into the vagina with an applicator. However, if you are pregnant, check with your doctor before using the applicator to insert the vaginal tablet.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your condition has improved. Also, keep using this medicine even if you begin to menstruate during the time of treatment. Do not miss any doses.

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 treating fungus (yeast) infections: For vaginal cream dosage form: Adults and teenagers—One 100,000-unit applicatorful inserted into the vagina one or two times a day for two weeks. Or, your doctor may want you to insert one 500,000-unit applicatorful into the vagina once a day. Children—Dose must be determined by your doctor. For vaginal tablet dosage form: Adults and teenagers—One 100,000-unit tablet inserted into the vagina one or two times a day for two weeks. Children—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.

Precautions While Using Mycostatin Vaginal Cream

To help cure the infection and to help prevent reinfection, good health habits are required.

Wear cotton panties (or panties or pantyhose with cotton crotches) instead of synthetic (for example, nylon, rayon) underclothes. Wear freshly laundered underclothes.

If you have any questions about this, check with your health care professional.

If you have any questions about douching or intercourse during the time of treatment with nystatin, check with your doctor.

Since there may be some vaginal drainage while you are using this medicine, a sanitary napkin may be worn to protect your clothing.

Mycostatin Vaginal Cream 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 as soon as possible if any of the following side effects occur:

Rare Vaginal burning or itching not present before use of this medicine

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.

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.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Mycostatin Vaginal Cream resources Mycostatin Vaginal Cream Use in Pregnancy & BreastfeedingMycostatin Vaginal Cream Support Group6 Reviews for Mycostatin Vaginal - Add your own review/rating Compare Mycostatin Vaginal Cream with other medications Cutaneous CandidiasisVaginal Yeast Infection
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Anugesic HC Cream


ANUGESIC HC CREAM

Pramocaine hydrochloride, Hydrocortisone acetate, Zinc oxide, Balsam peru, Benzyl benzoate, Bismuth oxide

In this leaflet: 1. What Anugesic HC Cream is and what it is used for 2. Before you use Anugesic HC Cream 3. How to use Anugesic HC Cream 4. Possible side effects 5. How to store Anugesic HC Cream 6. Further information Important things that you SHOULD know about your medicine: Anugesic HC Cream is used to treat severe pain and discomfort associated with haemorrhoids (piles), and pruritus ani (itching around the anus) in adults. Anugesic HC Cream may be used for either of these conditions. Anugesic HC Cream is for topical use and should only be used as directed. Do not swallow the cream or use on other areas of the skin. If you accidentally swallow Anugesic HC Cream, tell your doctor immediately. Anugesic HC Cream can sometimes cause burning, itching or stinging around the anus (See Section 4 for more details). See your doctor immediately if these symptoms do not go away

Please read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine that might be especially important to you.

What ANUGESIC HC Cream is and what it is used for Anugesic HC Cream contains several active ingredients. One of these is Pramocaine hydrochloride which is an anaesthetic which acts on the skin and mucous membranes to relieve pain and itching. Another of the active ingredients is Hydrocortisone acetate which is one of the group of medicines called corticosteroids which help to relieve inflammation. The other active ingredients of Anugesic HC Cream have astringent, protective, soothing and mild antiseptic properties. The cream may also provide lubrication for the insertion of suppositories. (For Other ingredients see Section 6). Anugesic HC Cream is used to treat the severe pain and discomfort associated with haemorrhoids (piles), and pruritus ani (itching around the anus). Haemorrhoids (piles) are enlarged or swollen blood vessels around the anus, which can cause varying degrees of discomfort, itching and irritation, particularly after a bowel movement. They may either be internal (inside the anus) or external (outside the anus). Anugesic HC Cream is used in adults only and not recommended for children. Before you use Anugesic HC Cream Do not use Anugesic HC Cream if you have : tubercular, fungal or viral lesions e.g genital warts had a reaction to Anugesic HC Cream or any of the individual ingredients had a reaction to other similar medicines containing balsam peru Important information about some of the ingredients of Anugesic HC Cream

Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) may cause allergic reactions. Propylene glycol and balsam peru may cause skin irritation.

Take special care with Anugesic HC Cream:

Tell your doctor if any of these apply to you, to help him or her decide if Anugesic HC Cream is suitable for you:

If you suffer from any rectal bleeding (bleeding from the back passage). Although bleeding, (shown as streaks of blood on toilet paper), is not uncommon in people with piles, it may be a sign of a more serious condition and you should see your doctor to check this. If you have any cuts or infection around the anus. Ask your pharmacist or doctor if you are in any doubt about this as it is important not to use Anugesic HC Cream if the area around the anus is infected. If you are pregnant, trying to become pregnant now, or likely to want to try to become pregnant in the future. If you have chicken pox or shingles If you have recently had a smallpox vaccination. Taking other medicines:

There are no known interactions with other medicines but it is wise to inform your doctor or pharmacist if you are taking, or have recently taken any other medicine –including those bought without a prescription.

Pregnancy and Breast-feeding:

If you are pregnant, trying to become pregnant or breastfeeding, ask your doctor or pharmacist for advice before using Anugesic HC cream as there may be better alternative treatments for you.

How to use Anugesic HC Cream Wash the anal area thoroughly and then dry carefully with a soft towel. Apply a small amount of Anugesic HC cream to the affected area at night, again in the morning and after each bowel movement. For internal application, use the plastic applicator nozzle provided. After use the nozzle should be washed each time in hot soapy water and then thoroughly rinsed in cold water. Do not use the cream for longer than seven days unless your doctor tells you to. If the condition gets worse, or if rectal bleeding starts, consult a doctor immediately. Anugesic HC Cream is for topical use only. Do not swallow the cream or apply it to any part of the body except for the area around the anus (bottom) or into the rectum (back passage) using the applicator. If you accidentally swallow any cream or use more than your prescribed dose, tell your doctor or pharmacist immediately. Possible side effects

Like all medicines Anugesic HC Cream can sometimes cause side effects, although not everybody gets them. The following side effects that have been seen with Anugesic HC Cream mostly affect the skin and tissues around the anus. These side effects are usually mild and go away after a short time:

A burning, itching or stinging is occasionally felt around the anus, especially if the skin is broken. Very rarely there are sensitivity reactions, such as a rash. Continuous use for long periods of time (longer than seven days) can be harmful, causing the skin to thin, develop a stripy appearance or affect the blood vessels just below the skin. If you use Anugesic HC Cream regularly and are at all worried, speak to your doctor or pharmacist immediately.

If you experience any of the above side effects or notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist at once.

How to store Anugesic HC Cream Keep out of the reach and sight of children. Anugesic HC Cream should not be used after the expiry date printed on the tube and on the carton. Store in the original container. Do not store above 25?C. Further information What Anugesic HC Cream contains and the contents of the pack

Each 100 g of cream contains the active ingredients: Pramocaine hydrochloride, Hydrocortisone acetate, Zinc oxide, Balsam peru, Benzyl benzoate, Bismuth oxide.

Anugesic HC Cream also contains the inactive ingredients: liquid paraffin, propylene glycol, polysorbate 60, sorbitan stearate, glyceryl monostearate, titanium dioxide (E171), the preservatives methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) and purified water.

Anugesic HC Cream is a buff coloured cream with an antiseptic odour.

Marketing Authorisation Holder:

The Marketing Authorisation Holder in the United Kingdom is

Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom

The Marketing Authorisation holder in Ireland is

Pfizer Healthcare Ireland 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 Manufacturer: McNeil Manufacturing 5 Avenue de Concyr 45071 Orleans Cedex 2 France Company contact address:

For further information on your medicine, please contact Medical Information at the address below

Pfizer Limited Walton Oaks Dorking Road Tadworth Surrey KT20 7NS Telephone:01304 616161

Leaflet last updated: May 2008

Ref: AU 6_0


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Tri-Adcortyl Ointment


TRI-ADCORTYL OINTMENT

Your doctor has prescribed Tri-Adcortyl Ointment for you. This leaflet gives a summary of information about your medicine. If you want to know more, or are not sure about anything, ask your doctor or pharmacist.

REMEMBER: This medicine is for YOU. Only a doctor can prescribe it. Never give it to anyone else. It may harm them even if they have the same symptoms as you.

What Is In Tri-Adcortyl Ointment?

This ointment contains four active ingredients: triamcinolone acetonide which belongs to a group of medicines called steroids which are used to reduce inflammation, nystatin which is a member of a group of medicines called anti-fungal agents, neomycin and gramicidin which are antibiotics.

Each gram of Tri-Adcortyl contains 0.1% of triamcinolone acetonide, nystatin 100,000 units, neomycin 1625 units (0.25%) and gramicidin 0.025% and is supplied in tubes of 30g.

The other ingredients are: liquid paraffin and polyethylene resin.

Who Supplies This Ointment? Product Licence Holder: E. R. Squibb & Sons Ltd Uxbridge Business Park Sanderson Road Uxbridge Middlesex UB8 1DH England Tel:0800 7311736 Manufacturer: Bristol-Myers Squibb SpA Contrada Fontana Del Ceraso 03012 Anagni (Fr) Italy What Is This Medicine For ?

Tri-Adcortyl Ointment is prescribed for infected and inflammed skin conditions including eczema.

Before Using Your Medicine Should you be using Tri-Adcortyl Ointment?

This ointment has been prescribed to treat the skin problem that you showed your doctor. DO NOT use it on any other skin problems as it may make them worse.

DO NOT use Tri-Adcortyl Ointment if you have any of the following skin conditions:

Tuberculosis (TB) of the skin; viral infections e.g. cold sores, herpes, chickenpox acne inflammation around the mouth (perioral dermatitis) a condition called rosacea (flushed, red face)

Tri-Adcortyl Ointment should not be used:

inside the ears of patients with perforated eardrums (holes in eardrums) for long periods of time over large areas of the body in the eyes

This ointment should not be used if you have had an allergic reaction to any product containing the same ingredients as Tri-Adcortyl Ointment. If Tri-Adcortyl Ointment is to be used on the face, or on children, treatment should not be longer than 5 days and the treated area should not be covered with any airtight or waterproof plasters/dressings.

This medicine should not be used in children under one year of age.

What if I am pregnant or breast feeding ?

You should always tell your doctor if you are pregnant, planning to become pregnant or breast feeding and let him decide if it is wise for you to use this medicine.

Do you have problems with your ears or hearing?

Make sure that your doctor knows about any problems you have with your ears before you start using Tri-Adcortyl Ointment. Neomycin, which is one of the active ingredients, may be harmful to the ears, particularly if used in large amounts and for long periods of time.

Using Your Medicine How should I apply Tri-Adcortyl Ointment?

This ointment should be applied to the affected area two or occasionally three times daily. In the elderly this ointment should be used sparingly and for short periods of time. If after 7 days little or no improvement occurs then tell your doctor.

If you are using this ointment on burnt skin that has become infected or ulcerated skin, make sure you use a small amount of ointment, as these skin conditions may make it easier for the active ingredients in the ointment to pass through the skin into the blood stream and may increase the possibility of side-effects.

Are there special directions for children?

As children are more likely to get side effects, they should not normally be treated for longer than 5 days, unless your doctor has told you to to do so.

What if Tri-Adcortyl Ointment is swallowed?

If this ointment is swallowed tell your doctor immediately or go to your nearest hospital casualty department.

What happens if you miss an application?

If you forget to use your ointment, apply it as soon as possible. However, if it is nearly time for your next application skip the missed dose and continue as before.

What should you do if you put Tri-Adcortyl Ointment on areas of normal or healthy skin?

Remove the ointment with a clean tissue and wash the area with plenty of water.

Undesirable Effects Are there any unwanted effects of Tri-Adcortyl Ointment?

If absorbed into the bloodstream, the active ingredient neomycin can damage the ears or kidney.

Check with your doctor if you notice any of the following side effects: blistering, burning, itching, peeling, dryness or other signs of skin irritation not present before using this ointment.

If the ointment is used for a long time additional side effects may occur. Check with your doctor as soon as possible if you notice any of these: acne or oily skin, increased facial hair growth, increased sweating, lightheadedness on standing, reddish purple lines on arms, face, legs, trunk or groin; thinning of skin with easy bruising or wounds that are slow to heal, rashes consisting of slightly raised rounded red patches. It may also cause changes in your body's sugar levels. If you have skin reaction tests, eg for allergies, the steroid contained in this ointment may affect the result by reducing the reaction. If you notice any other unwanted effect tell your doctor or pharmacist.

Looking After Your Medicine

Do not use your medicine after the expiry date which you will find on both the ointment tube and carton.

Keep all your medicines out of reach and sight of children, preferably in a locked cupboard or medicine cabinet. Do not store Tri-Adcortyl Ointment above 25°C.

If your doctor decides to stop the ointment, ask your pharmacist to tell you what to do with any you have left.

DATE OF LAST REVISION June 2005


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Tri-Adcortyl Otic Ointment


The wording of leaflets is regularly updated. This electronic text is the most up-to-date version and may differ from the leaflet in your pack. If you have any questions about the information provided, please ask your doctor or pharmacist.

TRI-ADCORTYL OTIC OINTMENT

Your doctor has prescribed Tri-Adcortyl Otic Ointment for you. This leaflet gives a summary of information about your medicine. If you want to know more, or are not sure about anything, ask your doctor or pharmacist.

REMEMBER: This medicine is for YOU. Only a doctor can prescribe it. Never give it to anyone else. It may harm them even if they have the same symptoms as you.

What Is In Tri-Adcortyl Otic Ointment?

This ointment contains four active ingredients: triamcinolone acetonide which belongs to a group of medicines called steroids which are used to reduce inflammation, nystatin which is a member of a group of medicines called anti-fungal agents, neomycin and gramicidin which are antibiotics.

Each gram of Tri-Adcortyl Otic contains 0.1% of triamcinolone acetonide, nystatin 100,000 units, Neomycin 1625 units (0.25%) and Gramicidin 0.025% and is supplied in tubes of 10g. The other ingredients are: liquid paraffin and polyethylene resin.

Product Licence Holder: E. R. Squibb & Sons Ltd. Uxbridge Business Park Sanderson Road Uxbridge Middlesex UB8 1DH England Tel:0800 7311736 Manufacturer: Bristol-Myers Squibb SpA Contrada Fontana del Ceraso 03012 Anagni (Fr) Italy What Is This Medicine For ?

Tri-Adcortyl Otic ointment is prescribed to treat infection and inflammation of the external ear.

Before Using Your Medicine Should you be using Tri-Adcortyl Otic ointment?

This ointment has been prescribed to treat the skin problem that you showed your doctor. DO NOT use it on any other skin problems as it may make them worse.

This ointment is NOT for Use in the Eyes

DO NOT use Tri-Adcortyl Otic ointment if you have any of the following skin conditions:

Tuberculosis (TB) of the skin; viral infections e.g. cold sores, herpes, chickenpox fungal skin conditions unless a suitable antifungal preparation has also been given acne inflammation around the mouth (perioral dermatitis) a condition called rosacea (flushed, red face)

Tri-Adcortyl Otic ointment should not be used

inside the ears of patients with perforated eardrums (holes in eardrums) for long periods of time over large areas of the body in the eyes.

This ointment should not be used if you have had an allergic reaction to any product containing the same ingredients as Tri-Adcortyl Otic ointment.

If Tri-Adcortyl Otic ointment is to be used on the face, or on children, treatment should not be longer than 5 days and the treated area should not be covered with any airtight or waterproof plasters/dressings.

This medicine should not be used in children under one year of age.

What if I am pregnant or breast feeding ?

You should always tell your doctor if you are pregnant, planning to become pregnant or breast feeding and let him decide if it is wise for you to use this medicine.

Do you have problems with your ears or hearing?

Make sure that your doctor knows about any problems you have with your ears before you start using Tri-Adcortyl Otic ointment. Neomycin, which is one of the active ingredients, may be harmful to the ears, particularly if used in large amounts and for long periods of time.

Using Your Medicine How should I apply Tri-Adcortyl Otic ointment?

This ointment should be applied to the affected area two or occasionally three times daily. In the elderly this ointment should be used sparingly and for short periods of time. If after 7 days little or no improvement occurs then tell your doctor.

If you are using this ointment on burnt skin that has become infected or ulcerated skin, make sure you use a small amount of ointment, as these skin conditions may make it easier for the active ingredient in the ointment to pass through the skin into the blood stream and may increase the possibility of side-effects.

Are there special directions for children?.

As children are more likely to get side effects, they should not normally be treated for longer than 5 days, unless your doctor has told you to to do so.

What if Tri-Adcortyl Otic ointment is swallowed?

If this ointment is swallowed tell your doctor immediately or go to your nearest hospital casualty department.

What happens if you miss an application?

If you forget to use your ointment, apply it as soon as possible. However, if it is nearly time for your next application skip the missed dose and continue as before.

What should you do if you put Tri-Adcortyl Otic ointment on areas of normal or healthy skin?

Remove the ointment with a clean tissue and wash the area with plenty of water.

Undesirable Effects Are there any unwanted effects of Tri-Adcortyl Otic ointment?

If absorbed into the bloodstream, the active ingredient neomycin can damage the ears or the kidneys.

Check with your doctor if you notice any of the following side effects: blistering, burning, itching, peeling, dryness or other signs of skin irritation not present before using this ointment.

If the ointment is used for a long time additional side effects may occur. Check with your doctor as soon as possible if you notice any of these: acne or oily skin, increased facial hair growth, increased sweating, lightheadedness on standing, reddish purple lines on arms, face, legs, trunk or groin; thinning of skin with easy bruising or wounds that are slow to heal, rashes consisting of slightly raised rounded red patches. It may also cause changes in your body's sugar levels. If you have skin reaction tests, eg. for allergies, the steroid contained in this ointment may affect the result by reducing the reaction. If you notice any other unwanted effect tell your doctor or pharmacist.

Looking After Your Medicine

Do not use your medicine after the expiry date which you will find on both the Ointment tube and box.

Keep all your medicines where children cannot reach them, preferably in a locked cupboard or medicine cabinet. Do not store Tri-Adcortyl Otic ointment above 25°C.

If your doctor decides to stop the ointment, ask your pharmacist to tell you what to do with any you have left.

DATE OF LAST REVISION June 2005


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Timodine (Alliance Pharmaceuticals)


1. Name Of The Medicinal Product

Timodine Cream.

2. Qualitative And Quantitative Composition

Active ingredient

%w/w

Nystatin*

3.00

Dimeticone 350

10.00

Hydrocortisone**

0.50

Benzalkonium chloride solution (equivalent to benzalkonium chloride 0.10g)

0.20

*An overage of 15% is added at manufacture. The 3% w/w is approximate only to achieve an activity of nystatin in the final formulation of 100,000 IU/g.

**An overage of 8% is added at manufacture.

Excipients

%w/w

Cetostearyl alcohol

1.51

Butylated hydroxyanisole compound (containing butylated hydroxyanisole (E320) 20%, propyl gallate 10% and citric acid 10%)

0.40

Methyl hydroxybenzoate (E218)

0.10

Propyl hydroxybenzoate (E216)

0.10

Sorbic acid

0.10

For a full list of excipients, see Section 6.1.

3. Pharmaceutical Form

Cream.

A pale yellow cream.

4. Clinical Particulars 4.1 Therapeutic Indications

For the treatment of dermatoses, including intertrigo, eczema, seborrhoeic dermatitis, “Housewife's” eczema, and pruritis ani et vulvae, in which infection with Candida albicans is a factor. For the treatment of severe nappy rash in which infection with C. albicans is a factor.

4.2 Posology And Method Of Administration

For topical application to the skin.

Adults (including the elderly) and children.

Dermatoses: Sufficient Timodine Cream should be applied to cover the lesion in a thin layer. It should then be massaged into the skin until the cream disappears.

The treatment should be repeated three times a day until the lesion has healed.

There is no indication that dosage need be modified for the elderly.

Nappy rash: After removal of the soiled nappy, the affected area should be cleaned and dried, and a thin layer of Timodine Cream applied. The treatment should be repeated after every nappy change. In infants long-term continuous topical steroid therapy should be avoided since this can lead to adrenal suppression even without occlusion. A course of treatment should not normally exceed seven days.

4.3 Contraindications

Timodine Cream is contra-indicated for use in the following conditions:

• rosacea

• perioral dermatitis

• untreated bacterial, fungal or viral skin infections

• ulcerated skin

Known hypersensitivity to nystatin, dimeticone 350, hydrocortisone or benzalkonium chloride solution, or to any of the excipients (see Section 6.1 'List of excipients')

4.4 Special Warnings And Precautions For Use

In order to minimise the side effects of a topical corticosteroid, it is important to apply it thinly to the affected areas only. Topical corticosteroids should not be applied with an occlusive dressing to large areas of the body. Absorption is greatest on thin/raw skin, intertriginous areas, and under occlusion. Skin thinning is more likely if corticosteroids are applied under occlusion.

Absorption of topical corticosteroids through the skin can rarely cause adrenal suppression and even Cushing's syndrome (see Section 4.8 'Undesirable effects'and Section 4.9 'Overdose'), depending on the area of the body being treated and the duration of treatment.

Avoid prolonged exposure on the face and keep away from the eyes. Use with caution on broken skin.

On discontinuation of topical corticosteroids a rebound exacerbation of the condition may occur. Prolonged use of compound preparations such as Timodine Cream can increase the likelihood of resistance and of sensitization. Mixing topical preparations on the skin should be avoided where possible; several minutes should elapse between application of different preparations.

Topical corticosteroids are not recommended for acne vulgaris, may worsen secondary infected lesions, and should not be used indiscriminately in pruritis.

Timodine Cream contains butylated hydroxyanisole (E320), cetostearyl alcohol, and sorbic acid which may cause local skin reactions (e.g. contact dermatitis). Butylated hydroxyanisole (E320) may cause irritation to the eyes and mucous membranes. Timodine Cream also contains propyl hydroxybenzoate (E216) and methyl hydroxybenzoate (E218), both of which may cause allergic reactions, which may be delayed. Nystatin can rarely cause contact dermatitis, and allergic reactions can occur after use of benzalkonium chloride.

The elderly

The skin of the elderly is often relatively atrophic so that local and systemic side effects of hydrocortisone are more likely.

Patients with hepatic failure

The reduced metabolism of hydrocortisone in patients with hepatic failure increases the theoretical risk of adrenal suppression.

Paediatric population

Avoid prolonged use in children.

Caution is required in dermatoses of infancy including nappy rash. Care should be taken as the nappy can act as an occlusive dressing and thus allow an increase in absorption of the steroid component of the cream.

In infants, long-term continuous topical steroid therapy should be avoided since this can lead to adrenal suppression even without occlusion. A course of treatment should not normally exceed seven days.

Use of hydrocortisone should be avoided in neonates. Any proposed use of hydrocortisone in neonates should be carefully assessed, as the high body surface area:weight ratio allows a proportionate increase in percutaneous absorption. Consideration should be given to the relative fragility of neonatal skin.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Fertility

No data available

Pregnancy

Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established. However, topical steroids should not be used extensively in pregnancy, i.e. in large amounts or for prolonged periods.

Lactation

Although poorly absorbed, it is not known whether nystatin enters breast milk. Caution should be exercised when nystatin is prescribed for nursing mothers.

Corticosteroids cross the placenta to varying degrees and may be distributed in small amounts in breast milk. Any topically applied hydrocortisone should be wiped off thoroughly prior to nursing if it is being applied to the breast or nipple area.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Undesirable effects are listed by MedRA System Organ Classes.

Assessment of undesirable effects is based on the following frequency groupings:

Very common:

Common:

Uncommon:

Rare:

Very rare: <1/10,000

Not known: cannot be estimated from the available data

System Organ Class

Frequency

Undesirable Effect

Endocrine disorders

Not known

• adrenal suppression (see Section 4.4 'Special warnings and precautions for use')

Immune system disorders

Not known

• hypersensitivity reactions1

Infections and infestations

Not known

• spread and worsening of untreated infection (see Section 4.4 'Special warnings and precautions for use')

Metabolism and nutrition disorders

Not known

• Cushing's syndrome (see Section 4.4 'Special warnings and precautions for use')

Skin and subcutaneous tissue disorder

Not known

• thinning of the skin2 (see Section 4.4 'Special warnings and precautions for use' and Section 4.9 'Overdose')

• irreversible striae atrophicae (see Section 4.9 'Overdose')

• telangiectasia (see Section 4.9 'Overdose')

• contact dermatitis (see Section 4.4 'Special warnings and precautions for use')

• perioral dermatitis

• acne or worsening of acne

• rosacea

• mild depigmentation3

• hypertrichosis

• contact sensitisation

• purpura

• loss of skin collagen and subcutaneous atrophy

1. if signs of hypersensitivity appear, application should stop immediately

2. thinning of the skin may be restored over a period after stopping treatment but the original structure may never return

3. mild depigmentation may be reversible

Exacerbation of symptoms may occur.

4.9 Overdose

Prolonged administration of hydrocortisone, especially to sensitive areas, such as the face and flexures, may result in irreversible adverse effects such as epidermal thinning, telangiectasia and striae. Chronic administration of hydrocortisone may lead to systemic absorption and thereby suppression of the pituitary-adrenal axis. High doses of corticosteroids can cause Cushing's syndrome.

It is possible that nausea and vomiting or diarrhoea may occur after ingestion of this product. Treat symptomatically. A small glass of milk or water may be helpful.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Antifungals for topical use

ATC code: D01A

Nystatin

Nystatin is a polyene antifungal antibiotic that interferes with the permeability of the cell membrane of sensitive fungi by binding to sterols, chiefly ergosterol. Nystatin is used for the prophylaxis and treatment of candidiasis of the skin and mucous membranes. It is both fungistatic and fungicidal against a wide range of yeasts and yeast-like fungi.

Dimeticone 350

Dimeticones and other silicones are water-repellent and have a low surface tension. They are used in topical barrier preparations for protecting the skin against water-soluble irritants.

Hydrocortisone

Hydrocortisone is a mild, but effective anti-inflammatory agent.

Benzalkonium chloride solution

Benzalkonium chloride is a quaternary ammonium antiseptic with a broad spectrum of antibacterial activity.

5.2 Pharmacokinetic Properties

Nystatin

Nystatin is poorly absorbed.

Dimeticone 350

Dimeticone is a silicone polymer that is not absorbed.

Hydrocortisone

Hydrocortisone is absorbed through the skin, metabolised in the liver, kidneys and most other body tissues. It is metabolised to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol, which are excreted in the urine mainly conjugated as glucuronides, together with a small proportion of unchanged hydrocortisone (<1%).

Hydrocortisone is extensively bound to plasma proteins, >90%, and has a small volume of distribution, 0.31.kg-1.

It has a short biological half-life of about 100 minutes and elimination is rapid, with about 90% of the absorbed dose excreted within 24 hours.

Absorption through the skin is greatest where the skin is thin or raw, and from intertriginous areas; it is increased by occlusion.

Benzalkonium chloride solution

Quaternary ammonium salts, such as benzalkonium chloride, are poorly absorbed through the skin.

5.3 Preclinical Safety Data

No preclinical findings of relevance to the prescriber have been reported.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Dibutyl phthalate

Glyceryl monostearate SE

Purified water

Stearic acid

Sodium metabisulphite

Cellulose nitrate

Cetostearyl alcohol

Butylated hydroxyanisole compound (containing butylated hydroxyanisole (E320), propyl gallate and citric acid)

Methyl hydroxybenzoate (E218)

Propyl hydroxybenzoate (E216)

Sorbic acid

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

2 years.

6.4 Special Precautions For Storage

Store below 15?C.

6.5 Nature And Contents Of Container

Collapsible aluminium tubes with diaphragm and an internal lacquer coating of araldite resin.

Pack sizes: 5.5 g, 7.5 g and 30 g.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Timodine Cream may cause yellow staining on terry cotton nappies. This will disappear after soaking in bleach or nappy solution followed by rinsing and normal washing.

ADMINISTRATIVE DATA 7. Marketing Authorisation Holder

Alliance Pharmaceuticals Ltd.,

Avonbridge House,

Bath Road,

Chippenham,

Wiltshire,

SN15 2BB

8. Marketing Authorisation Number(S)

PL 16853/0103

9. Date Of First Authorisation/Renewal Of The Authorisation

16th February 2010

10. Date Of Revision Of The Text

1st September 2011


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Tri-Adcortyl Cream


The wording of leaflets is regularly updated. This electronic text is the most up-to-date version and may differ from the leaflet in your pack. If you have any questions about the information provided, please ask your doctor or pharmacist.

TRI-ADCORTYL CREAM

Your doctor has prescribed Tri-Adcortyl cream for you. This leaflet gives a summary of information about your medicine. If you want to know more, or are not sure about anything, ask your doctor or pharmacist.

REMEMBER: This medicine is for YOU. Only a doctor can prescribe it. Never give it to anyone else. It may harm them even if they have the same symptoms as you.

What Is In Tri-Adcortyl Cream?

This cream contains four active ingredients: triamcinolone acetonide which belongs to a group of medicines called steroids which are used to reduce inflammation, nystatin which is a member of a group of medicines called anti-fungal agents, neomycin and gramicidin which are antibiotics.

Each gram of Tri-Adcortyl contains 0.1% of triamcinolone acetonide, nystatin 100,000 units, neomycin 1625 units (0.25%) and gramicidin 0.025% and is supplied in tubes of 30g.

The other ingredients are: aluminium hydroxide, antifoam emulsion, benzyl alcohol, ethanol, ethylenediamine, hydrochloric acid, macrogol ether, perfume verley, polysorbate 60, propylene glycol, sorbitol, titanium dioxide, white soft paraffin, water.

Who Supplies This Cream? Product Licence Holder: E. R. Squibb & Sons Ltd Uxbridge Business Park Sanderson Road Uxbridge Middlesex UB8 1DH England Tel:0800 7311736 Manufacturer: Bristol-Myers Squibb SpA Contrada Fontana Del Ceraso 03012 Anagni (Fr) Italy What is this medicine for ?

Tri-Adcortyl cream is prescribed for infected and inflammed skin conditions including eczema.

Before Using Your Medicine Should you be using Tri-Adcortyl cream?

This cream has been prescribed to treat the skin problem that you showed your doctor. DO NOT use it on any other skin problems as it may make them worse.

DO NOT use Tri-Adcortyl cream if you have any of the following skin conditions:

Tuberculosis (TB) of the skin; viral infections e.g. cold sores, herpes, chickenpox acne inflammation around the mouth (perioral dermatitis) a condition called rosacea (flushed, red face)

Tri-Adcortyl cream should not be used:

inside the ears of patients with perforated eardrums (holes in eardrums) for long periods of time over large areas of the body in the eyes

This cream should not be used if you have had an allergic reaction to any product containing the same ingredients as Tri-Adcortyl cream. If Tri-Adcortyl cream is to be used on the face, or on children, treatment should not be longer than 5 days and the treated area should not be covered with any airtight or waterproof plasters/dressings.

This medicine should not be used in children under one year of age.

What if I am pregnant or breast feeding ?

You should always tell your doctor if you are pregnant, planning to become pregnant or breast feeding and let him decide if it is wise for you to use this medicine.

Do you have problems with your ears or hearing?

Make sure that your doctor knows about any problems you have with your ears before you start using Tri-Adcortyl. Neomycin, which is one of the active ingredients, may be harmful to the ears, particularly if used in large amounts and for long periods of time.

Using Your Medicine How should I apply Tri-Adcortyl cream?

This cream should be applied to the affected area two or occasionally three times daily. In the elderly this cream should be used sparingly and for short periods of time. If after 7 days little or no improvement occurs then tell your doctor.

If you are using this cream on burnt skin that has become infected or ulcerated skin, make sure you use a small amount of cream, as these skin conditions may make it easier for the active ingredients in the cream to pass through the skin into the blood stream and may increase the possibility of side-effects.

Are there special directions for children?

As children are more likely to get side effects, they should not normally be treated for longer than 5 days, unless your doctor has told you to to do so.

What if Tri-Adcortyl cream is swallowed?

If this cream is swallowed tell your doctor immediately or go to your nearest hospital casualty department.

What happens if you miss an application?

If you forget to use your cream, apply it as soon as possible. However, if it is nearly time for your next application skip the missed dose and continue as before.

What should you do if you put Tri-Adcortyl cream on areas of normal or healthy skin?

Remove the cream with a clean tissue and wash the area with plenty of water.

Undesirable Effects Are there any unwanted effects of Tri-Adcortyl cream?

If absorbed into the bloodstream, the active ingredient neomycin can damage the ears or kidney. Check with your doctor if you notice any of the following side effects: blistering, burning, itching, peeling, dryness or other signs of skin irritation not present before using this cream.

If the cream is used for a long time additional side effects may occur. Check with your doctor as soon as possible if you notice any of these: acne or oily skin, increased facial hair growth, increased sweating, lightheadedness on standing, reddish purple lines on arms, face, legs, trunk or groin; thinning of skin with easy bruising or wounds that are slow to heal, rashes consisting of slightly raised rounded red patches. It may also cause changes in your body's sugar levels. If you have skin reaction tests, eg for allergies, the steroid contained in this cream may affect the result by reducing the reaction. If you notice any other unwanted effect tell your doctor or pharmacist.

Looking After Your Medicine

Do not use your medicine after the expiry date which you will find on both the Cream tube and carton.

Keep all your medicines out of reach and sight of children, preferably in a locked cupboard or medicine cabinet. Do not store Tri-Adcortyl cream above 25°C and avoid freezing.

If your doctor decides to stop the cream, ask your pharmacist to tell you what to do with any you have left.

DATE OF LAST REVISION June 2005


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Elimite


Generic Name: permethrin topical (per METH rin)
Brand Names: Elimite, Lice Bedding Spray, Nix Complete Lice Treatment System, Nix Cream Rinse, Nix Lice Control, RID Home Lice Control Spray for Surfaces

What is Elimite (permethrin topical)?

Permethrin is an anti-parasite medication.

Permethrin topical (for the skin) is used to treat head lice and scabies.

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

What is the most important information I should know about Elimite (permethrin topical)?

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

Do not take this medication by mouth. It is for use only on the skin, hair, fabrics, or other surfaces. Do not apply permethrin topical to open cuts or wounds. Do not use this medication if you are allergic to permethrin or to chrysanthemums. For the most complete treatment of lice or scabies and to prevent reinfection, you must treat your environment (clothing, bedding, pillows, furniture, hats, hair brushes and accessories, etc) at the same time you treat your body.

Avoid sexual or intimate contact with others until your lice or scabies infection has cleared up. Avoid sharing hair brushes, combs, hair accessories, hats, clothing, bed linens, and other articles of personal use. Lice and scabies infections are highly contagious.

What should I discuss with my healthcare provider before using Elimite (permethrin topical)? Do not use this medication if you are allergic to permethrin or to chrysanthemums. FDA pregnancy category B. Permethrin topical is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Permethrin 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. Do not use this medication on an infant younger than 2 months without the advice of a doctor. How should I use Elimite (permethrin topical)? Do not take this medication by mouth. It is for use only on the skin, hair, fabrics, or other surfaces.

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

You may need to shake the medication before each use. Follow the directions on the medicine label. Do not apply permethrin topical to open cuts or wounds.

To treat scabies:

Make sure your skin is clean and dry. Apply a thin layer of permethrin topical to all body parts from the neck down to the soles of the feet. Rub in completely. Leave the medication on for 8 to 14 hours, then wash it off completely.

When using permethrin topical on an infant, also apply the medication to the scalp, temples, and forehead. Avoid applying close to the eyes, nose, mouth, or genitals.

If your condition does not clear up within 14 days after applying permethrin topical, use another application.

To treat head lice:

When using the shampoo, apply it to dry hair only. Cover all hair completely and leave the shampoo in for 10 minutes. Then work into a lather using warm water and rinse out thoroughly.

When using the cream rinse, wash your hair using shampoo only (no conditioner or 2-in-1 shampoo). Rinse thoroughly and towel dry the hair, leaving it damp. Apply enough of the cream rinse to completely saturate all hair. Leave the cream rinse in your hair for 10 minutes.

Use a towel or washcloth to protect your eyes while the medication is left in your hair.

Use a second application if lice are still seen 7 days after your first treatment.

You may also use a nit comb to remove lice eggs from the hair. Your hair should be slightly damp while using a nit comb. Work on only one section of hair at a time, combing through 1- to 2-inch strands from the scalp to the ends.

Rinse the nit comb often during use. Place removed nits into a sealed plastic bag and throw it into the trash to prevent re-infestation.

Check the scalp again daily to make sure all nits have been removed.

To treat pubic lice (crabs):

Wash and dry the treatment area. Apply permethrin topical to all pubic hair and any surrounding hairs on the thighs and around the anus.

Avoid getting this medication inside the rectum or vagina.

Leave the medication in for 10 minutes. Then work into a lather using warm water and rinse out thoroughly.

You may also use a nit comb to remove lice eggs from pubic hair (hair should be slightly damp).

All sexual partners should also be treated to prevent re-infestation of crabs.

To prevent reinfection, wash all clothing, hats, bed clothes, bed linens, and towels in hot water and dry in high heat. Dry-clean any non-washable clothing. Hair brushes, combs, and hair accessories should be soaked in hot water for at least 10 minutes.

Use permethrin surface spray to disinfect non-washable items such as:

furniture;

mattresses and pillows;

stuffed toys;

hats, gloves, and scarves;

headphones or headbands;

the inside of a bike helmet; or

seats and carpets inside your car.

Stuffed toys or pillows that cannot be washed should be sealed in air-tight plastic bags for 4 weeks.

Vacuum all rugs and carpets and throw away the vacuum cleaner bag.

For the most complete treatment of lice or scabies, you must treat your environment (clothing, bedding, etc) at the same time you treat your body. Store permethrin topical at room temperature away from moisture and heat. What happens if I miss a dose?

Since permethrin topical is usually needed only once, you are not likely to be on a dosing schedule. Wait at least 7 days before using a second application.

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

Symptoms of a permethrin topical overdose are unknown.

What should I avoid while using Elimite (permethrin topical)? Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water.

Do not use other medicated skin products unless your doctor has told you to.

Avoid sexual or intimate contact with others until your lice or scabies infection has cleared up. Avoid sharing hair brushes, combs, hair accessories, hats, clothing, bed linens, and other articles of personal use. Lice and scabies infections are highly contagious.

Elimite (permethrin topical) 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 severe burning, stinging, redness, or swelling after applying permethrin topical.

Less serious side effects may include:

itching or mild skin rash;

mild burning, stinging, or redness; or

numbness or tingling where the medication was applied.

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 Elimite (permethrin topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied permethrin. But many drugs can interact with each other. 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 Elimite resources Elimite Side Effects (in more detail) Elimite Use in Pregnancy & Breastfeeding Elimite Support Group 1 Review for Elimite - Add your own review/rating Elimite Prescribing Information (FDA) Elimite Topical Advanced Consumer (Micromedex) - Includes Dosage Information Elimite Cream MedFacts Consumer Leaflet (Wolters Kluwer) Compare Elimite with other medications Head Lice Lice Scabies Where can I get more information? Your pharmacist has additional information about permethrin topical written for health professionals that you may read.

See also: Elimite side effects (in more detail)


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Full Marks Lotion


1. Name Of The Medicinal Product

Full Marks Lotion.

2. Qualitative And Quantitative Composition

Full Marks Lotion contains:

Phenothrin 0.2% w/v

3. Pharmaceutical Form

Lotion

4. Clinical Particulars 4.1 Therapeutic Indications

For the treatment of head lice and pubic lice infestation.

4.2 Posology And Method Of Administration

For topical external use only.

The source of infestation should be sought and treated.

For adults, the elderly, and children aged over 6 months

For head lice:

1. Sprinkle the lotion on the hair and rub gently onto the head until the entire scalp is moistened. Pay special attention to the back of the neck and the area behind the ears. Take care to avoid the eyes.

2. Allow to dry naturally. Use no heat.

3. The hair may be washed with a standard shampoo 2 hours after application.

4. Whilst still wet, comb the hair with an ordinary comb. A fine-toothed louse comb can then be used to remove the dead lice and eggs.

For pubic lice:

Application and dosage etc. are as for the head. Apply the lotion to the pubic hair and the hair between the legs and around the anus. Allow to dry naturally, using no heat.

4.3 Contraindications

A history of sensitivity to pyrethroid insecticides.

4.4 Special Warnings And Precautions For Use

Do not use in children aged under 6 months except under medical supervision.

Do not use on broken or secondarily infected skin.

Full Marks Lotion contains isopropyl alcohol which may cause wheezing in asthmatic patients or cause inflammation of the skin in patients with severe eczema. If such effects are apparent, patients should use a shampoo formulation.

Contains flammable alcohol. Apply and dry with care. Avoid naked flames or lighted objects. Do not use artificial heat (e.g. electric hairdryers). Dry in a well ventilated room. Do not cover the head before the lotion has dried completely. The hair should be dry before retiring to bed.

When Full Marks Lotion is used by a school nurse or other health officer in the mass treatment of large numbers of children, it is advisable that protective plastic or rubber gloves be worn.

Prolonged repeated use with this product should be avoided. It should not be used more than once a week, and for not more than three consecutive weeks.

This treatment may affect permed, pre-rinsed, coloured or bleached hair. If your hair has been permed, pre-rinsed, coloured or bleached, Full Marks Lotion should be applied to a small section of hair for 30 minute, and checked for any reaction, before applying the treatment to a full head.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

There are no known effects in pregnancy and lactation. However, as with all drugs, Full Marks Lotion should be used with caution in pregnant or lactating women.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Some patients may experience stinging or inflammation of the skin due to the alcohol content.

4.9 Overdose

In the event of deliberate or accidental ingestion, as for ethyl alcohol, empty the stomach by gastric lavage and treat symptomatically.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Phenothrin is a synthetic pyrethroid insecticide, highly effective against human lice but with an exceptionally low mammalian toxicity.

5.2 Pharmacokinetic Properties

Full Marks Lotion is applied topically to the affected area. A pharmacokinetic study has shown absorption of the active constituent is negligible.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Herbal Green Bouquet P15312

Isopropanol

Purified Water

6.2 Incompatibilities

None stated.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

Store bottle in carton at or below 30oC protected from light.

6.5 Nature And Contents Of Container

Cartoned, clear or amber glass bottles with polyethylene caps and polypropylene sprinkler inserts containing either 50, 55, 110, 160 or 200 ml of product.

Not all pack sizes may be marketed

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Seton Products Ltd

Tubiton House

Oldham

OL1 3HS

8. Marketing Authorisation Number(S)

PL 11314/0047.

9. Date Of First Authorisation/Renewal Of The Authorisation

27/11/1995.

10. Date Of Revision Of The Text

September 2006


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sinecatechins Topical application


sin-e-KAT-e-kins

Commonly used brand name(s)

In the U.S.

Veregen

Available Dosage Forms:

Ointment

Therapeutic Class: Keratolytic

Uses For sinecatechins

Sinecatechins is used to treat external warts around the genital and rectal areas called condylomata acuminata. It is not used to treat warts that occur inside the vagina, penis, or rectum .

sinecatechins is available only with your doctor's prescription .

Before Using sinecatechins

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 sinecatechins, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to sinecatechins 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 sinecatechins in the pediatric population. Safety and efficacy have not been established .

Geriatric

Insufficient information is available on the relationship of age to the effects of sinecatechins in geriatric patients. It may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people .

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 sinecatechins. Make sure you tell your doctor if you have any other medical problems, especially:

Inflamed, irritated, or infected skin—Use with caution. sinecatechins may make this condition worse . Weakened immune system—It is not known if sinecatechins is safe to use with this condition . Proper Use of sinecatechins

Use the medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it longer than directed .

Wash your hands with soap and water before and after using sinecatechins .

sinecatechins is for use on the skin only. Do not get it inside your eyes, nose, mouth, vagina, or anus. Do not use on open wounds or on skin areas that have cuts or scrapes. If it does get on these areas, rinse it off right away .

Do not use sinecatechins on moles, birthmarks, or any other warts until you discuss it with your doctor .

Women using tampons should insert the tampon first before applying the ointment. If the tampon needs to be changed while the ointment is on the skin, avoid getting the ointment into the vagina .

Men who are not circumcised and treating genital warts under the foreskin should draw back the foreskin and clean the area daily .

Do not wash off the ointment from the treated area before you apply the next dose. When you wash the treatment area or bathe, apply the ointment afterwards .

Do not cover the treated area with a bandage unless your doctor has told you to. You may wear loose-fitting underwear after applying sinecatechins .

Keep using sinecatechins until all the warts have cleared up. However, you should not use sinecatechins for longer than 16 weeks .

Dosing

The dose of sinecatechins 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 sinecatechins. 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 topical dosage form (ointment): For warts on the genital or rectal areas: Adults—Apply a thin layer (about an 0.5 cm strand) to the affected area three times a day. Rub it in gently. Children—Use and dose must be determined by your doctor . Missed Dose

If you miss a dose of sinecatechins, apply 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.

Storage

Store in the refrigerator. Do not freeze.

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

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using sinecatechins

sinecatechins may make your skin more sensitive to sunlight. Do not expose the area being treated with sinecatechins to sunlight, sunlamps, or tanning beds .

Avoid having genital, oral, or anal sex while the medicine is on your skin. Make sure you wash the ointment off your skin before you engage in any sexual activity. Also, the medicine contains oils that can weaken latex (rubber) condoms, or diaphragms causing them not to work properly .

Sinecatechins will not keep you from spreading genital warts to other people. Talk with your doctor about safe sex practices .

sinecatechins is not a cure for genital or anal warts. You may still develop new warts during or after your treatment .

sinecatechins may stain your clothes and bedding .

Do not use cosmetics or any other skin care products on the same skin area on which you use sinecatechins, unless directed otherwise by your doctor .

If your condition does not improve within 16 weeks, or if it becomes worse, check with your doctor .

Many patients experience redness, swelling, sores or blisters, burning, or itching after using sinecatechins. If you experience a severe skin reaction, remove the ointment by washing the area with mild soap and water and contact your doctor right away .

sinecatechins 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 Blistering, peeling, or loosening of the skin breakdown of skin burning of skin cracking of skin flushing, redness of skin hardening or thickening of skin irritation of skin itching skin pain or discomfort in skin swelling of skin unusually warm skin Less common Bleeding of skin blood in urine break in the skin, especially associated with blue-black discoloration, swelling, or drainage of fluid burning or itching around anus changes in skin coloring discharge from skin dryness of skin increased frequency of urination increased sensitivity to pain increased sensitivity to touch pain or burning during urination peeling of one area of skin pelvic pain problems with foreskin of penis rash with flat lesions or small raised lesions on the skin scarring of skin skin rash, encrusted, scaly and oozing skin rash on the face swollen, painful, or tender lymph glands in neck, armpit, or groin tingling in the hands and feet

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: sinecatechins Topical application 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.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More sinecatechins Topical application resources Sinecatechins Topical application Side Effects (in more detail) Sinecatechins Topical application Use in Pregnancy & Breastfeeding Sinecatechins Topical application Support Group 0 Reviews for Sinecatechins Topical application - Add your own review/rating Compare sinecatechins Topical application with other medications Condylomata Acuminata
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Proctofoam HC


Proctofoam HC 1% w/w & 1% w/w Rectal Foam

(Hydrocortisone acetate & pramocaine hydrochloride)

Read all of this leaflet carefully before you start using 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 Throughout this leaflet Proctofoam HC 1 % w/w & 1 % w/w Rectal Foam is called Proctofoam. Important: Proctofoam is a steroid medicine, prescribed for many different conditions, including serious illnesses You need to use it regularly to get the maximum benefit Don't stop using this medicine without talking to your doctor - you may need to reduce the dose gradually Proctofoam can cause side effects in some people (read section 4 below). Some problems such as mood changes (feeling depressed, or 'high'), or stomach problems can happen straight away. If you feel unwell in any way, keep using your medicine, but see your doctor straight away Some side effects only happen after weeks or months. These include weakness of arms and legs, or developing a rounder face (read section 4 for more information) Keep away from people who have chicken-pox or shingles, if you have never had them. They could affect you severely. If you do come into contact with chicken pox or shingles, see your doctor straight away. Now read the rest of this leaflet.

It includes other important information on the safe and effective use of this medicine that might be especially important for you.

In this leaflet: 1. What Proctofoam is for 2. Before you use Proctofoam 3. How to use Proctofoam 4. Possible side effects 5. How to store Proctofoam 6. Further information What Proctofoam is for Proctofoam - benefit information

Proctofoam belongs to a group of medicines called steroids. Their full name is corticosteroids. These corticosteroids occur naturally in the body, and help to maintain health and well-being. Boosting your body with extra corticosteroid (such as Proctofoam) is an effective way to treat various illnesses involving inflammation in the body.

Proctofoam reduces this inflammation, which could otherwise go on making your condition worse You must use this medicine regularly to get maximum benefit from it. Proctofoam is used for the relief of inflammation, itching, pain, swelling and irritation associated with haemorrhoids (piles) and certain other conditions of the anus (bottom) and anal region.

Before you use Proctofoam Do not use Proctofoam: If you are allergic to pramocaine hydrochloride or to any other ingredient in Proctofoam (see section 6) If you are suffering from a bacterial infection, viral infection or fungal infection

Proctofoam is not for use in children

If any of the above applies to you talk to your doctor or pharmacist.

Check with your doctor first: If you have ever had severe depression or manic-depression (bipolar disorder). This includes having had depression before while using steroid medicines like Proctofoam. If any of your close family has had these illnesses If you have diseases of the bowel (rectum).

If any of these applies to you, talk to your doctor before using Proctofoam.

Taking other medicines

Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

If you are pregnant, trying to become pregnant or breast-feeding ask your doctor or pharmacist for advice before using Proctofoam.

How to use Proctofoam

Always use Proctofoam exactly as your doctor has told you.

Important:

Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it is not, or you are not sure, ask your doctor or pharmacist.

Remember: Do not use Proctofoam for more than 7 days Talk to your doctor if symptoms worsen, or do not improve within 7 days or if bleeding occurs You need to use your medicine regularly to get the maximum benefit. Adult dose

Proctofoam can be applied in the rectum (internal use) or to the skin around the anus (external use).

The usual dose into the rectum is one applicator of foam two or three times per day and after each bowel evacuation up to a maximum of 4 times daily For the anal area expel a small amount of foam onto two fingers and apply to the affected area. For internal use 1. Shake the canister vigorously for 30 seconds before each use. 2. Withdraw the plunger until it stops at the catch line. 3. Hold the applicator upright and insert the canister top into the applicator tip. Make sure you hold the plunger and applicator body FIRMLY with your fingers. 4. Press down gently on the canister top with your fingers, so that the foam fills about ? of the applicator body. Only a short press is needed to do this. 5. Wait for a few seconds until the foam stops expanding.
DO NOT fill the applicator in one go. Always release the canister top after a short press. 6. Repeat steps 4 & 5 above until the foam expands to just reach the 'Fill' line. This normally takes 2 to 4 short press/wait. 7. Stand with one leg raised on a chair, or lie down on your side. Hold the applicator as shown. Insert gently into the back passage and push the plunger fully into the applicator. For topical use

Shake the canister vigorously for 30 seconds before each use. Expel a small quantity of foam onto a tissue, pad or two fingers and apply the foam to the affected area.

After using the applicator Always take the applicator apart and wash it thoroughly after use The canister top should also be removed and washed Replace the canister top with care. Make sure it is placed vertically on top of the canister, and not at an angle. If you use more Proctofoam than you should

If you use too much go to your doctor as soon as possible.

If you repeatedly use too much Proctofoam you may experience fattening of the face, neck and body, hair growing on your body (women), a dusky complexion with purple patches and skin thinning.

If you forget to use Proctofoam

Do not use double the dose to make up for a missed dose. Simply take your next dose as planned.

If you stop using Proctofoam

Do not stop using Proctofoam without talking to your doctor. Your doctor may reduce your dose gradually.

Mental problems while using Proctofoam

Mental health problems can happen while using steroids like Proctofoam (see also section 4 Possible Side Effects).

These illnesses can be serious Usually they start within a few days or weeks of starting the medicine. They are more likely to happen at high doses. Most of these problems go away if the dose is lowered or the medicine is stopped. However, if problems do happen they might need treatment.

Talk to a doctor if you (or someone using this medicine), show any signs of mental problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases, mental problems have happened when doses are being lowered or stopped.

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

Proctofoam HC Side Effects

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

Serious effects: tell your doctor straight away

Steroids can cause serious mental health problems. These are common in both adults and children. They can affect about 5 in every 100 people taking medicines that contain steroids.

Feeling depressed, including thinking about suicide Feeling high (mania) or moods that go up and down Feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone.

If you notice any of these problems talk to a doctor straight away.

Other side effects

If you get any of the following, keep using the medicine but tell your doctor:

Unexpected fattening of the face, neck and body Irregular periods Hair starts to grow on your body (women) Dusky complexion with purple patches Skin thinning Allergic skin reaction Infection Burning sensation Itching.

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

How to store Proctofoam

Keep out of the reach and sight of children.

Do not use Proctofoam after the expiry date which is stated on the canister and carton. The expiry date refers to the last day of that month.

Do not expose to temperatures above 50°C. Keep in the original packaging to protect from sunlight Do not refrigerate Keep away from sources of ignition Do not spray on a naked flame or anything hot Do not pierce or burn the container even after use.

Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.

Further information What Proctofoam contains:

The active substances in Proctofoam are hydrocortisone acetate (1 % w/w) and pramocaine hydrochloride (1% w/w).

The other ingredients are cetyl alcohol, emulsifying wax (cetyl alcohol, sorbitan solution), methyl parahydroxybenzoate (E218), polyoxyethylene (10); stearyl ether, propylene glycol, propyl parahydroxybenzoate (E216), trolamine, purified water and propellant HP-70 consisting of isobutane and propane.

What Proctofoam looks like

Proctofoam is a white rectal foam contained in a pressurised canister.

Contents of the pack

Each pack contains canister and a plastic applicator.

Each canister contains approximately 40 doses.

Marketing Authorisation Holder in the UK: Meda Pharmaceuticals Ltd Skyway House Parsonage Road Takeley Bishop's Stortford CM22 6PU UK Manufacturer Pharmasol Limited North Way Walworth Industrial Estate Andover SP10 5AZ UK

This leaflet was last approved in January 2010.

If this leaflet is difficult to see or read or you would like it in a different format, please contact:

In the UK -

Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road
Takeley
Bishop's Stortford
CM22 6PU
UK

Proctofoam is a registered trademark of Meda AB.

MP00697


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Tyrosine kinase inhibitors


Tyrosine kinase inhibitors are drugs that inhibit enzymes called tyrosine kinase that are critical in the proliferation pathway of cells. Tyrosine kinases are found in certain receptors or inside the cells. Inhibition of tyrosine kinase stops cell growth and multiplication, making them targets in the treatment of cancers.

Tyrosine kinase inhibitors are used to treat cancers that rely on growth factors or particular receptors that have tyrosine kinase domains for activation.

Drug List:
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Calamine Plain topical


Generic Name: calamine (topical) (KAL a mine)
Brand Names: Calamine Plain

What is calamine?

Calamine topical (for the skin) is used to treat itching and skin irritation caused by chicken pox, insect bites or stings, measles, eczema, sunburn, poison ivy, and other minor skin conditions.

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

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

Calamine is an anti-itch medication that works by causing a cooling sensation as it evaporates on your skin. Calamine also dries oozing or weeping from minor skin irritation.

Before you apply this medication, wash the skin area with soap and water and then dry it thoroughly.

Apply calamine directly to the skin and rub in gently, allowing the medicine to dry on your skin. You may also use a cotton ball to smooth the medicine onto your skin. Calamine may leave a thin film on the skin as it dries. You may cover the treated area with loose clothing, but calamine can stain fabrics it comes in contact with.

This medication can be applied 3 to 4 times each day.

Call your doctor if your skin condition does not get better after using calamine regularly for 1 week. Contact your doctor at any time if your symptoms get worse.

Calamine can cause nausea, vomiting, stomach pain, and diarrhea if it is swallowed. Call your doctor or a poison control center right away if anyone accidentally swallows this medicine. What should I discuss with my health care provider before using calamine?

Before using this medication, tell your doctor if you have any allergies. Do not use calamine if the product contains any ingredient you may be allergic to.

Call your doctor if your skin condition does not get better after using calamine regularly for 1 week. Contact your doctor at any time if your symptoms get worse.

It is not known if using calamine while you are pregnant will be harmful to the unborn baby. Do not use this medication without telling your doctor if you are pregnant. It is not known if calamine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use calamine?

Use calamine exactly as directed on the label, or as your doctor has prescribed it for you. Do not use more of the medication than recommended. Do not use calamine for longer than recommended.

Before you apply this medication, wash the skin area with soap and water and then dry it thoroughly.

Shake the calamine lotion well just before each use.

Apply calamine directly to the skin and rub in gently, allowing the medicine to dry on your skin. You may also use a cotton ball to smooth the medicine onto your skin. Wash your hands with soap and water after applying the medicine.

Calamine may leave a thin film on the skin as it dries. You may cover the treated area with loose clothing, but calamine can stain fabrics it comes in contact with.

This medication can be applied 3 to 4 times each day.

If your skin condition does not improve after using calamine for 7 days, talk with your doctor about another treatment. Store calamine at room temperature away from hot or cold temperatures. What happens if I miss a dose?

Apply the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not apply extra medicine to make up the missed dose.

What happens if I overdose?

This medicine is not usually absorbed through the skin in amounts large enough to cause an overdose. Call your doctor if you think you have used too much of this medication.

Calamine can cause nausea, vomiting, stomach pain, and diarrhea if it is swallowed. Call your doctor or a poison control center right away if anyone accidentally swallows this medicine. What should I avoid while using calamine?

Calamine is for use only on your skin. Avoid getting this medicine in your eyes or inside your mouth or nose. If the medicine does get into these areas, rinse thoroughly with water.

Avoid applying other creams, lotions, ointments, or other medicated skin products to the same areas you treat with calamine.

Calamine side effects Stop using this medication and 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 redness, rash, pus, or other signs of infection.

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 calamine?

There may be other drugs that can affect calamine. 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 Calamine Plain resources Calamine Plain Use in Pregnancy & Breastfeeding Calamine Plain Support Group 0 Reviews for Calamine Plain - Add your own review/rating Compare Calamine Plain with other medications Pruritus Where can I get more information? Your pharmacist can provide more information about calamine topical.
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