clobetasol propionate and salicylic acid ointment in the uk
 

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Salicylic Acid/Urea/White Petrolatum Ointment


Pronunciation: SAL-i-SIL-ik AS-id/ue-REE-a/PET-roe-LAY-tum
Generic Name: Salicylic Acid/Urea/White Petrolatum
Brand Name: Generic only. No brands available.
Salicylic Acid/Urea/White Petrolatum Ointment is used for:

Treating dry, scaly, or callused skin.

Salicylic Acid/Urea/White Petrolatum Ointment is a keratolytic and debriding combination. It works by breaking down dead skin and softening the skin.

Do NOT use Salicylic Acid/Urea/White Petrolatum Ointment if: you are allergic to any ingredient in Salicylic Acid/Urea/White Petrolatum Ointment

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

Before using Salicylic Acid/Urea/White Petrolatum Ointment:

Some medical conditions may interact with Salicylic Acid/Urea/White Petrolatum Ointment. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have diabetes

Some MEDICINES MAY INTERACT with Salicylic Acid/Urea/White Petrolatum Ointment. Because little, if any, of Salicylic Acid/Urea/White Petrolatum Ointment is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Salicylic Acid/Urea/White Petrolatum Ointment 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 Salicylic Acid/Urea/White Petrolatum Ointment:

Use Salicylic Acid/Urea/White Petrolatum Ointment as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Wash your hands before using Salicylic Acid/Urea/White Petrolatum Ointment. Wash the affected area with mild soap and warm water. Allow your skin to dry before applying the medicine. Gently massage the medicine in to the affected area as directed by your doctor or the package labeling. Wash your hands immediately after using Salicylic Acid/Urea/White Petrolatum Ointment, unless your hands are part of the treated area. If you miss a dose of Salicylic Acid/Urea/White Petrolatum Ointment, use it as soon as you remember. Continue to use it as directed by your doctor or on the package label.

Ask your health care provider any questions you may have about how to use Salicylic Acid/Urea/White Petrolatum Ointment.

Important safety information: Salicylic Acid/Urea/White Petrolatum Ointment is for external use only. Do not get it in your eyes, on your lips, or on the inside of your nose or mouth. If you get Salicylic Acid/Urea/White Petrolatum Ointment in any of these areas, rinse right away with cool water. Do not apply Salicylic Acid/Urea/White Petrolatum Ointment to open wounds or to broken, irritated, or infected skin. Talk with your doctor before you use any other medicines or cleansers on your skin. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Salicylic Acid/Urea/White Petrolatum Ointment while you are pregnant. It is not known if Salicylic Acid/Urea/White Petrolatum Ointment is found in breast milk. If you are or will be breast-feeding while you use Salicylic Acid/Urea/White Petrolatum Ointment, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Salicylic Acid/Urea/White Petrolatum Ointment:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Salicylic Acid/Urea/White Petrolatum Ointment. 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); excessive burning, itching, irritation, peeling, redness, or tenderness of your skin.

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

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. Salicylic Acid/Urea/White Petrolatum Ointment may be harmful if swallowed.

Proper storage of Salicylic Acid/Urea/White Petrolatum Ointment:

Store Salicylic Acid/Urea/White Petrolatum Ointment at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Do not freeze. Store away from heat, moisture, and light. Keep Salicylic Acid/Urea/White Petrolatum Ointment out of the reach of children and away from pets.

General information: If you have any questions about Salicylic Acid/Urea/White Petrolatum Ointment, please talk with your doctor, pharmacist, or other health care provider. Salicylic Acid/Urea/White Petrolatum Ointment 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 Salicylic Acid/Urea/White Petrolatum Ointment. 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 Salicylic Acid/Urea/White Petrolatum resources Salicylic Acid/Urea/White Petrolatum Use in Pregnancy & Breastfeeding Salicylic Acid/Urea/White Petrolatum Drug Interactions Salicylic Acid/Urea/White Petrolatum Support Group 0 Reviews for Salicylic Acid/Urea/White Petrolatum - Add your own review/rating Compare Salicylic Acid/Urea/White Petrolatum with other medications Foot Care
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POSALFILIN Ointment


POSALFILIN Ointment

Salicylic Acid BP 25% w/w and Podophyllum Resin BP 20%w/w

Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription but you still need to use POSALFILIN carefully to get the best results from it.

Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. You must contact a doctor if your symptoms worsen If any of the side effects become serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

If you need the information on this leaflet in an alternative format, such as large text, or Braille please ring from the UK: 0800 198 5000.

In this leaflet: 1. What POSALFILIN Ointment is and what it is used for 2. Before you use POSALFILIN Ointment 3. How to use POSALFILIN Ointment 4. Possible side effects 5. How to store POSALFILIN Ointment 6. Further information What Posalfilin Ointment Is And What It Is Used For

POSALFILIN Ointment is used to treat warts (verrucas) on the soles of the feet. Verrucas are infectious, small growths of the skin caused by a specific virus. If left untreated they can grow and spread.

POSALFILIN Ointment contains salicylic acid and podophyllum resin which work together to treat the verrucas by softening the skin (salicylic acid) and killing the virus (podophyllum resin).

Before You Use Posalfilin Ointment Do not use POSALFILIN if: You are pregnant, thinking of becoming pregnant or are breast-feeding You are diabetic, You have poor circulation, or have little feeling in your feet (peripheral neuropathy) The wart is bleeding or crumbling

POSALFILIN should not be used on the skin of the face, armpits, or the bottom or genital (sex) regions.

Take care when using POSALFILIN ointment as it may burn healthy skin. Stop using POSALFILIN if your skin becomes red and inflamed. If you do get any ointment on your healthy skin wipe off with a tissue immediately.

Taking/using other medicines

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

Pregnancy and breast-feeding

Do not use POSALFILIN Ointment if you are pregnant or thinking of becoming pregnant or are breast-feeding.

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

How To Use Posalfilin Ointment

Always use POSALFILIN Ointment exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. POSALFILIN ointment should be used daily.

To use POSALFILIN ointment: Place a corn ring (available from your pharmacist) around the wart. You may need to cut the ring to fit the area. Apply as little ointment as you can to the wart. Take care not to get any POSALFILIN ointment on your normal skin. If you do get any ointment on your healthy skin wipe off with a tissue immediately. Now cover the wart and corn ring with a plaster. Wash your hands. Repeat this every day until the wart is soft and spongy. Stop the treatment and do not cover with a plaster. After a few days the wart should drop off. If it does not, start using POSALFILIN ointment again. If you use more POSALFILIN ointment than you should

Using too much POSALFILIN ointment may burn your skin and you may need to see your doctor. If you do get any ointment on your healthy skin wipe off with a tissue immediately.

If you forget to use POSALFILIN ointment

Do not double the dose, use POSALFILIN ointment the next day when you remember.

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

POSALFILIN Ointment Side Effects

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

POSALFILIN ointment can burn healthy skin. If this happens stop using POSALFILIN Ointment until it heals. Tell your doctor if you think POSALFILIN ointment is causing a problem.

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

How To Store Posalfilin Ointment

Keep all medicines out of the reach and sight of children.

Do not store above 25°C.

Do not use POSALFILIN Ointment after the expiry date which is stated on the carton and tube as month/year. The expiry date refers to the last day of the month.

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

Further Information What POSALFILIN ointment contains

The active substances are podophyllum resin BP and salicylic acid BP. Each tube contains 20% w/w podophyllum resin BP and 25% w/w salicylic acid BP.

The other ingredients are yellow soft paraffin and liquid paraffin.

What POSALFILIN ointment looks like and contents of the pack

POSALFILIN ointment is a dark brown ointment that comes in a 10g tube. Each pack contains one tube.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is

Norgine Ltd. Moorhall Road Harefield Middlesex UB9 6NS UK

It is made by

Norgine Ltd. Hengoed Mid Glamorgan CF82 8SJ UK

UK Marketing Authorisation Holder: PL 00322/5901R

The leaflet was last approved in: 11 August 2008


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Clobetasol Solution


Pronunciation: kloe-BAY-ta-sol
Generic Name: Clobetasol
Brand Name: Examples include Embeline and Temovate
Clobetasol Solution is used for:

Treating inflammation and itching of the scalp due to certain skin conditions. It is also used to treat moderate to severe psoriasis. It may also be used for other conditions as determined by your doctor.

Clobetasol Solution is a topical adrenocortical steroid. It works by reducing skin inflammation (eg, redness, swelling, itching, irritation) in a way that is not clearly understood.

Do NOT use Clobetasol Solution if: you are allergic to any ingredient in Clobetasol Solution or to other corticosteroids (eg, prednisone)

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

Before using Clobetasol Solution:

Some medical conditions may interact with Clobetasol Solution. 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 any kind of skin infection of the scalp, cuts, scrapes, or lessened blood flow to your skin if you have had a recent vaccination; have measles, tuberculosis, chickenpox, or shingles; or have had a positive tuberculosis test if you are taking prednisone or similar medicines

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

Ask your health care provider if Clobetasol Solution 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 Clobetasol Solution:

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

Wash and completely dry the affected area before applying Clobetasol Solution. Apply a small amount of Clobetasol Solution to the affected area. Gently rub the medicine in until it is evenly distributed. Wash your hands after applying Clobetasol Solution. If applying to an area with hair, part the hair when applying so that Clobetasol Solution reaches the skin. Do not bandage or cover the treated skin area unless directed by your doctor. Do not wear tight-fitting clothes over the treated area. If you miss a dose of Clobetasol Solution, apply 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 apply 2 doses at once.

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

Important safety information: Clobetasol Solution is for external use only. Do not get Clobetasol Solution in your eyes, nose, mouth, or on your lips. If contact is made with the eyes, flush them immediately with tap water. Use Clobetasol Solution with extreme caution if treating the face, groin, diaper area, or underarms. Do not use Clobetasol Solution to treat rosacea or conditions around the mouth. Do NOT take more than the recommended dose or use for longer than 2 weeks without checking with your doctor. If your symptoms do not get better within 2 weeks or if they get worse, check with your doctor. Do not use Clobetasol Solution to treat large areas of your body without first checking with your doctor. Tell your doctor or dentist that you take Clobetasol Solution before you receive any medical or dental care, emergency care, or surgery. Check with your doctor before having vaccinations while using Clobetasol Solution. Do not use Clobetasol Solution for other skin conditions at a later time. Clobetasol Solution has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid (eg, hydrocortisone) in it too. If it does or if you are not sure, check with your doctor or pharmacist. Clobetasol Solution is flammable. Do not store or use near an open flame or while smoking. Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Clobetasol Solution. Clobetasol Solution should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these 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 Clobetasol Solution while you are pregnant. It is not known if Clobetasol Solution is found in breast milk after topical use. If you are or will be breast-feeding while you use Clobetasol Solution, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Clobetasol Solution:

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:

Dryness; itching; mild burning or stinging.

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); acne-like rash; burning, cracking, irritation, or peeling not present before you began using Clobetasol Solution; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; numbness of fingers; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

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: Clobetasol side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.

Proper storage of Clobetasol Solution:

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

General information: If you have any questions about Clobetasol Solution, please talk with your doctor, pharmacist, or other health care provider. Clobetasol Solution 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 Clobetasol Solution. 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 Clobetasol resources Clobetasol Side Effects (in more detail) Clobetasol Use in Pregnancy & Breastfeeding Clobetasol Drug Interactions Clobetasol Support Group 48 Reviews for Clobetasol - Add your own review/rating Compare Clobetasol with other medications Anal Itching Atopic Dermatitis Cutaneous T-cell Lymphoma Dermatitis Lichen Planus Lichen Sclerosus Necrobiosis Lipoidica Diabeticorum Psoriasis Seborrheic Dermatitis
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Clobetasol Spray


Pronunciation: kloe-BAY-ta-sol
Generic Name: Clobetasol
Brand Name: Clobex
Clobetasol Spray is used for:

Treating moderate to severe psoriasis. It may also be used for other conditions as determined by your doctor.

Clobetasol Spray is a topical adrenocortical steroid. It works by reducing skin inflammation (eg, redness, swelling, itching, irritation) in a way that is not clearly understood.

Do NOT use Clobetasol Spray if: you are allergic to any ingredient in Clobetasol Spray or to other corticosteroids (eg, prednisone)

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

Before using Clobetasol Spray:

Some medical conditions may interact with Clobetasol Spray. 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 any kind of skin infection, cuts, scrapes, or lessened blood flow to your skin if you have had a recent vaccination; have measles, tuberculosis, chickenpox, or shingles; or have had a positive tuberculosis test if you are taking prednisone or similar medicines

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

Ask your health care provider if Clobetasol Spray 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 Clobetasol Spray:

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

Spray medicine onto the affected area. Gently rub the medicine in until it is evenly distributed. Wash your hands after applying Clobetasol Spray, unless your hands are part of the treated area. Do not bandage or cover the treated skin area unless directed by your doctor. Do not wear tight-fitting clothes over the treated area. If you miss a dose of Clobetasol Spray, apply 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 apply 2 doses at once.

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

Important safety information: Clobetasol Spray is for external use only. Do not get Clobetasol Spray in your eyes, nose, mouth, or on your lips. If contact is made with the eyes, flush them immediately with tap water. Do not use Clobetasol Spray on the face, groin, diaper area, or underarms. Do not use Clobetasol Spray to treat rosacea or conditions around the mouth. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. If your symptoms do not get better within 2 weeks or if they get worse, check with your doctor. Do not use Clobetasol Spray to treat large areas of your body without first checking with your doctor. Tell your doctor or dentist that you take Clobetasol Spray before you receive any medical or dental care, emergency care, or surgery. Check with your doctor before having vaccinations while using Clobetasol Spray. Do not use Clobetasol Spray for other skin conditions at a later time. Check with your doctor if you experience nausea, vomiting, fever, dizziness, or chest pain after you have stopped using Clobetasol Spray. Clobetasol Spray has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid (eg, hydrocortisone) in it too. If it does or if you are not sure, check with your doctor or pharmacist. Clobetasol Spray is flammable. Do not store or use near an open flame or while smoking. Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Clobetasol Spray. Clobetasol Spray should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these 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 Clobetasol Spray while you are pregnant. It is not known if Clobetasol Spray is found in breast milk after topical use. If you are or will be breast-feeding while you use Clobetasol Spray, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Clobetasol Spray:

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:

Dryness; itching; mild burning or stinging.

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); acne-like rash; burning, cracking, irritation, or peeling not present before you began using Clobetasol Spray; dark red blotches on the skin; excessive hair growth; general feeling of being unwell; inflamed hair follicles; inflammation around the mouth; muscle weakness; numbness of fingers; persistent sore throat, cough, or congestion; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

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: Clobetasol side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.

Proper storage of Clobetasol Spray:

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

General information: If you have any questions about Clobetasol Spray, please talk with your doctor, pharmacist, or other health care provider. Clobetasol Spray 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 Clobetasol Spray. 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 Clobetasol resources Clobetasol Side Effects (in more detail) Clobetasol Use in Pregnancy & Breastfeeding Clobetasol Drug Interactions Clobetasol Support Group 48 Reviews for Clobetasol - Add your own review/rating Compare Clobetasol with other medications Anal Itching Atopic Dermatitis Cutaneous T-cell Lymphoma Dermatitis Lichen Planus Lichen Sclerosus Necrobiosis Lipoidica Diabeticorum Psoriasis Seborrheic Dermatitis
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Clobetasol Gel



Dosage Form: gel
Clobetasol Propionate Gel, 0.05%

FOR TOPICAL DERMATOLOGIC USE ONLY –

NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE

Rx Only

Clobetasol Gel Description

Clobetasol Propionate Gel, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.

Chemically, clobetasol propionate is (11?,16?) - 21 - chloro - 9 - fluoro - 11 - hydroxy - 16 - methyl - 17 - (1 - oxopropoxy) - pregna - 1,4 - diene - 3,20 - dione, and it has the following structural formula:

Clobetasol propionate has the empirical formula C25H32ClFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water.

Clobetasol Propionate Gel, 0.05% contains clobetasol propionate 0.5 mg/g in a base of carbomer homopolymer type B, propylene glycol, purified water, and sodium hydroxide.

Clobetasol Gel - Clinical Pharmacology

Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Pharmacokinetics -

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusive dressing with hydrocortisone for up to 24 hours has not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Greater absorption was observed for the clobetasol propionate gel formulation as compared to the cream formulation in in vitro human skin penetration studies.

Studies performed with clobetasol propionate gel, 0.05% indicate that it is in the super-high range of potency as compared with other topical corticosteroids.

Indications and Usage for Clobetasol Gel

Clobetasol Propionate Gel, 0.05% is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended.

Contraindications

Clobetasol Propionate Gel, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Precautions General -

Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at doses as low as 2 g/day.

Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal from treatment. Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on therapy.

Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests. Patients receiving super-potent corticosteroids should not be treated for more than 2 weeks at a time, and only small areas should be treated at any one time due to the increased risk of HPA axis suppression.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur that require supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (seePRECAUTIONS: Pediatric Use).

If irritation develops, Clobetasol Propionate Gel, 0.05% should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Clobetasol Propionate Gel, 0.05% should be discontinued until the infection has been adequately controlled.

Clobetasol Propionate Gel, 0.05% should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.

Information for Patients -

Patients using topical corticosteroids should receive the following information and instructions:

1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

2. This medication should not be used for any disorder other than that for which it was prescribed.

3. The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician.

4. Patients should report any signs of local adverse reactions to the physician.

5. Patients should inform their physicians that they are using Clobetasol Propionate Gel, 0.05% if surgery is contemplated.

Laboratory Tests -

The following tests may be helpful in evaluating patients for HPA axis suppression:

  ACTH stimulation test   A.M. plasma cortisol test   Urinary free cortisol test Carcinogenesis, Mutagenesis, Impairment of Fertility -

Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate.

Studies in the rat following subcutaneous administration at dosage levels up to 50 mcg/kg/day revealed that the females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose.

Clobetasol propionate was nonmutagenic in 3 different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay, and the E. coli B WP2 fluctuation test.

Pregnancy: Teratogenic Effects: Pregnancy Category C -

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals.

Clobetasol propionate has not been tested for teratogenicity when applied topically; however, it is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and mouse. Clobetasol propionate has greater teratogenic potential than steroids that are less potent.

Teratogenicity studies in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and teratogenicity at all dose levels tested down to 0.03 mg/kg. These doses are approximately 1.4 and 0.04 times, respectively, the human topical dose of clobetasol propionate gel. Abnormalities seen included cleft palate and skeletal abnormalities.

In rabbits, clobetasol propionate was teratogenic at doses of 3 and 10 mcg/kg. These doses are approximately 0.02 and 0.05 times, respectively, the human topical dose of clobetasol propionate gel. Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities.

There are no adequate and well-controlled studies of the teratogenic potential of clobetasol propionate in pregnant women. Clobetasol Propionate Gel, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers -

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Clobetasol Propionate Gel, 0.05% is administered to a nursing woman.

Pediatric Use -

Safety and effectiveness of Clobetasol Propionate Gel, 0.05% in children and infants have not been established; therefore, use in children under 12 years of age is not recommended. Because of a higher ratio of skin surface area to body mass, children are at a greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency after withdrawal of treatment and of Cushing’s syndrome while on treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children (see PRECAUTIONS).

HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Geriatric Use -

Clinical studies of clobetasol propionate gel, 0.05% in US clinical trials did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious.

Adverse Reactions

In a controlled trial with clobetasol propionate gel, 0.05%, the only reported adverse reaction that was considered to be drug related was a report of burning sensation (1.8% of treated patients).

In larger controlled clinical trials with other clobetasol propionate formulations, the most frequently reported adverse reactions have included burning, stinging, irritation, pruritus, erythema, folliculitis, cracking and fissuring of the skin, numbness of fingers, skin atrophy, and telangiectasia (all less than 2%).

Cushing’s syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations.

The following additional local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with super-high potency corticosteroids such as Clobetasol Propionate Gel, 0.05%. These reactions are listed in approximate decreasing order of occurrence: dryness, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria.

Overdosage

Topically applied Clobetasol Propionate Gel, 0.05% can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

Clobetasol Gel Dosage and Administration

Apply a thin layer of Clobetasol Propionate Gel, 0.05% to the affected skin areas twice daily and rub in gently and completely (see INDICATIONS AND USAGE).

Clobetasol Propionate Gel, 0.05% is a super-high potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used.

As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Clobetasol Propionate Gel, 0.05% should not be used with occlusive dressings.

How is Clobetasol Gel Supplied

Clobetasol Propionate Gel, 0.05% is available as follows:

15 g tube (NDC 45802-925-14)

30 g tube (NDC 45802-925-94)

60 g tube (NDC 45802-925-96)

STORAGE

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].  Clobetasol Propionate Gel, 0.05% should not be refrigerated.

Manufactured by Perrigo

Yeruham 80500, Israel

Made in Israel

Distributed By

Perrigo

Allegan, MI 49010 • www.perrigo.com

Rev. 02/11

2P100 RC J3

PRINCIPAL DISPLAY PANEL - Carton

Rx Only

Clobetasol Propionate Gel, 0.05%

For Dermatologic Use Only - Not for Ophthalmic Use

Clobetasol Propionate Gel, 0.05% Carton Image 1

Clobetasol Propionate Gel, 0.05% Carton Image 2

PRINCIPAL DISPLAY PANEL - Tube

Rx Only

Clobetasol Propionate Gel, 0.05%

For Dermatologic Use Only - Not for Ophthalmic Use

Clobetasol Propionate Gel, 0.05% Tube


CLOBETASOL PROPIONATE 
clobetasol propionate  gel Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 45802-925 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOBETASOL PROPIONATE (CLOBETASOL) CLOBETASOL PROPIONATE 0.05 mg  in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE B   PROPYLENE GLYCOL   WATER   SODIUM HYDROXIDE   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 45802-925-14 1 TUBE In 1 CARTON contains a TUBE 1 15 g In 1 TUBE This package is contained within the CARTON (45802-925-14) 2 45802-925-94 1 TUBE In 1 CARTON contains a TUBE 2 30 g In 1 TUBE This package is contained within the CARTON (45802-925-94) 3 45802-925-96 1 TUBE In 1 CARTON contains a TUBE 3 60 g In 1 TUBE This package is contained within the CARTON (45802-925-96)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075027 07/30/2008
Labeler - Perrigo New York Inc (078846912) Registrant - L Perrigo Company (006013346) Establishment Name Address ID/FEI Operations Perrigo Israel Pharmaceuticals LTD 600093611 MANUFACTURE Revised: 11/2011Perrigo New York Inc More Clobetasol Gel resources Clobetasol Gel Side Effects (in more detail) Clobetasol Gel Use in Pregnancy & Breastfeeding Clobetasol Gel Drug Interactions Clobetasol Gel Support Group 48 Reviews for Clobetasol - Add your own review/rating Compare Clobetasol Gel with other medications Anal Itching Atopic Dermatitis Cutaneous T-cell Lymphoma Dermatitis Lichen Planus Lichen Sclerosus Necrobiosis Lipoidica Diabeticorum Psoriasis Seborrheic Dermatitis
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Kerasal


Generic Name: salicylic acid and urea topical (sal ih SILL ik AH sid and you REE ah)
Brand Names: Kerasal

What is Kerasal (salicylic acid and urea topical)?

Salicylic acid is a keratolytic (peeling agent). Salicylic acid causes shedding of the outer layer of skin.

Urea is an emollient (skin softening agent). Urea helps to moisturize the skin.

Salicylic acid and urea topical is used to soften rough, scaly skin and calluses on the feet.

Salicylic acid and urea topical may also be used for purposes other than those listed here.

What is the most important information I should know about Kerasal (salicylic acid and urea topical)? Do not use salicylic acid and urea topical on other areas or for purposes other than those directed on the package or by your doctor. What should I discuss with my healthcare provider before using Kerasal (salicylic acid and urea topical)? Do not use salicylic acid and urea topical on other areas or for purposes other than those directed on the package or by your doctor. It is not known whether salicylic acid and urea topical will be harmful to an unborn baby. Do not use salicylic acid and urea topical without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether salicylic acid and urea topical passes into breast milk. Do not use salicylic acid and urea topical without first talking to your doctor if you are breast-feeding a baby. How should I use Kerasal (salicylic acid and urea topical)?

Use salicylic acid and urea topical exactly as directed by your healthcare provider or as directed on the package. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Gently clean and dry the affected area.

Apply the medication to the affected area(s) as directed.

It is important to use salicylic acid and urea topical regularly to get the most benefit. Do not stop using the medication if you do not see results immediately. Use the medication for the full amount of time directed. Store salicylic acid and urea topical at room temperature away from moisture and heat. What happens if I miss a dose?

Use the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and use only the next regularly scheduled dose.

Do not apply a double dose of the medication.

What happens if I overdose? An overdose of salicylic acid and urea topical is unlikely to be harmful. If you do suspect an overdose, or if the medication has been ingested, call a poison control center or emergency room for advice. What should I avoid while using Kerasal (salicylic acid and urea topical)?

Do not use other topical preparations on the treated area unless otherwise directed by your healthcare provider. Other topical products may interfere with treatment or cause skin irritation.

Kerasal (salicylic acid and urea topical) side effects Serious side effects are expected to occur with the use of salicylic acid and urea topical. If you do experience any of the following rare serious side effects, stop using salicylic acid and urea topical and seek emergency medical attention or contact your doctor:

an rare but serious allergic reaction (shortness of breath; closing of the throat; swelling of the lips, face, or tongue; or hives); or

severe skin irritation.

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 Kerasal (salicylic acid and urea topical)?

Do not use other topical preparations on the treated area unless otherwise directed by your healthcare provider. Other topical products may interfere with treatment or cause skin irritation.

Drugs other than those listed here may also interact with salicylic acid and urea topical. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

More Kerasal resources Kerasal Side Effects (in more detail) Kerasal Use in Pregnancy & Breastfeeding Kerasal Drug Interactions Kerasal Support Group 0 Reviews for Kerasal - Add your own review/rating Salvax Duo Foam MedFacts Consumer Leaflet (Wolters Kluwer) Salvax Duo Plus Foam MedFacts Consumer Leaflet (Wolters Kluwer) Compare Kerasal with other medications Foot Care Where can I get more information? Your pharmacist has additional information about salicylic acid and urea topical written for health professionals that you may read.

See also: Kerasal side effects (in more detail)


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Clobetasol Cream Emulsion



Clobetasol Propionate Cream-Emollient 0.05%

FOR TOPICAL DERMATOLOGIC USE ONLY -
NOT FOR OPHTHALMIC, ORAL, OR
INTRAVAGINAL USE.

Clobetasol Cream Emulsion Description

Clobetasol Propionate Cream-Emollient contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.

Chemically, clobetasol propionate is (11 B,16 B)-21-chloro-9-fluoro-11- hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1 ,4-diene-3,20-dione, and it has the following structural formula:

Clobetasol propionate has the empirical formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water.

Clobetasol Propionate Cream-Emollient contains clobetasol propionate 0.5 mg/g in an emollient base of cetostearyl alcohol, isopropyl myristate, propylene glycol, cetomacrogol 1000, dimethicone 360, citric acid, sodium citrate, purified water, and imidurea as a preservative.

Clobetasol Cream Emulsion - Clinical Pharmacology

Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammattory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and integrity of the epidermal barrier. Occlusive dressing with hydrocortisone for up to 24 hours has not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Studies performed with Clobetasol Propionate Cream-Emollient indicate that it is in the super-high range of potency as compared with other topical corticosteroids.

Indications and Usage for Clobetasol Cream Emulsion

Clobetasol Propionate Cream-Emollient is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended.

In the treatment of moderate to severe plaque-type psoriasis, Clobetasol Propionate Cream - Emollient applied to 5% to 10% of body surface area can be used up to 4 consecutive weeks. The total dosage should not exceed 50 g/week. When dosing for more than 2 weeks, any additional benefits of extending treatment should be weighed against the risk of HPA suppression. Treatment beyond 4 consecutive weeks is not recommended. Patients should be instructed to use Clobetasol Propionate Cream-Emollient for the minimum amount of time necessary to achieve the desired results (see PRECAUTIONS and INDICATIONS AND USAGE). Use in pediatric patients under 16 years of age has not been studied.

Contraindications

Clobetasol Propionate Cream-Emollient is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Precautions General

Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at doses as low as 2 g/day.

Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal from treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on therapy.

Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests. Patients receiving super-potent corticosteroids should not be treated for more than 2 weeks at a time, and only small areas should be treated at anyone time due to the increased risk of HPA suppression.

In a controlled clinical trial involving patients with moderate to severe plaque-type psoriasis, Clobetasol Propionate Cream-Emollient applied to 5% to 10% of body surface area resulted in additional benefits in the treatment of patients for 4 consecutive weeks. In this trial, there were no clobetasol-treated patients with clinically significant decreases in morning cortisol levels after 4 weeks of treatment; however, morning cortisol levels may not identify patients with adrenal dysfunction. Therefore, the additional benefits of extending treatment beyond 2 weeks should be weighed against the potential for HPA suppression. Therapy should be discontinued when control has been achieved. Treatment beyond 4 consecutive weeks is not recommended.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur that require supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (see PRECAUTIONS: Pediatric use). The use of Clobetasol Propionate Cream-Emollient for 4 consecutive weeks has not been studied in pediatric patients under 16 years of age.

If irritation develops, Clobetasol Propionate Cream-Emollient should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to healrather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Clobetasol Propionate Cream-Emollient should be discontinued until the infection has been adequately controlled.

Clobetasol Propionate Cream-Emollient should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.

Information for patients

Patients using topical corticosteroids should receive the following information and instructions.

This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. This medication should not be used for any disorder other than that for which it was prescibed. The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions to the physician. Patients should inform their physicians that they are using Clobetasol Propionate Cream-Emollient if surgery is contemplated. This medication should not be used on the face, underarms, or groin area. As with other corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, contact the physician. Laboratory tests

The following tests may be helpful in evaluating patients for HPA axis suppression.

ACTH stimulation test

A.M. plasma cortisol test

Urinary free cortisol test

Carcinogenesis, mutagenesis, impairment of fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate.

Studies in the rat following subcutaneous administration at dosage levels up to 50 mcg/kg per day revealed that females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose.

Clobetasol propionate was nonmutagenic in 3 different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay, and the E. coli B WP2 fluctuation test.

Pregnancy Teratogenic effects

Pregnancy Category C. Corticosteroids have been shown to be teratogenic in laboratory Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals.

Clobetasol propionate has not been tested for teratogenicity when applied topically; however, it is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and mouse. Clobetasol propionate has greater teratogenic potential than steroids that are less potent.

Teratogenicity studies in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1mg/kg) and teratogenicity at all dose levels down to 0.03 mg/kg. Thse doses are approximately 1.4 and 0.04 times, respectively, the human topical dose of Clobetasol Propionate Cream-Emollient. Abnormalities seen included cleft palate and skeletal abnormalities.

In rabbits, c1obetasol propionate was teratogenic at doses of 3 and 10 mcg/kg. These doses are approximately 0.02 and 0.05 times, respectively, the himan topical dose of Clobetasol Propionate Cream-Emollient. Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities.

There are no adequate and well-controlled studies of the teratogenic potential of clobetasol propionate in pregnant women. Clobetasol Propionate Cream-Emollient should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Clobetasol Propionate Cream-Emollient is administered to a nursing woman.

Pediatric use

Safety and effectiveness of Clobetasol Propionate Cream-Emollient in pediatric patients have not been established. Use in pediatric patients under 12 years of age is not recommended. For continued use beyond 2 consecutive weeks, the safety of Clobetasol Propionate Cream-Emollient has not been studied. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Geriatric use

Clinical studies of c1obetasol propionate emollient cream, 0.05% in US clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious.

Adverse Reactions

In controlled trials with all clobetasol propionate formulations, the following adverse reactions have been reported: burning/stinging, pruritus, irritation, erythema, folliculitis, cracking and fissuring of the skin, numbness of the fingers, tenderness in the elbow, skin atrophy, and telangiectasia. The incidence of local adverse reactions reported in the trials with clobetasol propionate emollient cream was <2% of patients treated with the exception of burning/stinging, which occurred in 5% of treated patients.

Cushing's syndrome has been reported in infants and adults as a result of prolonged use of other topical clobetasol propionate formulations.

The following additional local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with super-high potency corticosteroids such as Clobetasol Propionate Cream-Emollient. These reactions are listed in an approximately decreasing order of occurrence: dryness, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria.

Overdosage

Topically applied Clobetasol Propionate Cream-Emollient can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

Clobetasol Cream Emulsion Dosage and Administration

Apply a thin layer of Clobetasol Propionate Cream-Emollient to the affected skin areas twice daily and rub in gently and completely (See INDICATIONS AND USAGE).

Clobetasol Propionate Cream-Emollient is a super-high potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used.

In moderate to severe plaque-type psoriasis, Clobetasol Propionate Cream-Emollient applied to 5% to 10% of body surface area can be used up to 4 weeks. The total dosage should not exceed 50 g/week. When dosing for more than 2 weeks, any additional benefits of extending treatment should be weighed against the risk of HPA suppression. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Treatment beyond 4 consecutive weeks is not recommended. Use in pediatric patients under 16 years of age has not been studied.

Clobetasol Propionate Cream-Emollient should not be used with occlusive dressings.

How is Clobetasol Cream Emulsion Supplied

Clobetasol Propionate Cream-Emollient, 0.05% is supplied in 15 g (NDC 68462-363-17), 30 g (NDC 68462-363-35), and 60 g (NDC 68462-363-65) tubes.

Store at controlled room temperature 20° - 25°C (68° - 77OF).

Clobetasol Propionate Cream-Emollient should not be refrigerated

Rx Only

Manufactured by:

DPT Laboratories, Ltd.
San Antonio, Texas 78215

Manufactured for:

Glenmark Generics Inc., USA
Mahwah, NJ 07430

Questions? 1 (888) 721-7115
www.glenmarkgenerics.com

April 2008

Principal Display Panel
CLOBETASOL PROPIONATE 
clobetasol propionate  emulsion Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68462-363 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOBETASOL PROPIONATE (CLOBETASOL) CLOBETASOL PROPIONATE 0.5 mg  in 1 g Inactive Ingredients Ingredient Name Strength CETOSTEARYL ALCOHOL   ISOPROPYL MYRISTATE   PROPYLENE GLYCOL   POLYETHYLENE GLYCOL 1000   CITRIC ACID   SODIUM CITRATE   WATER   IMIDUREA   DIMETHICONE 350   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 68462-363-17 15 g In 1 TUBE None 2 68462-363-35 30 g In 1 TUBE None 3 68462-363-65 60 g In 1 TUBE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075325 03/01/2008 01/31/2011
Labeler - Glenmark Generics Inc., USA (835917282) Establishment Name Address ID/FEI Operations DPT Laboratories 832224526 ANALYSIS, MANUFACTURE Revised: 07/2010Glenmark Generics Inc., USA More Clobetasol Cream Emulsion resources Clobetasol Cream Emulsion Side Effects (in more detail) Clobetasol Cream Emulsion Use in Pregnancy & Breastfeeding Clobetasol Cream Emulsion Drug Interactions Clobetasol Cream Emulsion Support Group 48 Reviews for Clobetasol - Add your own review/rating Compare Clobetasol Cream Emulsion with other medications Anal Itching Atopic Dermatitis Cutaneous T-cell Lymphoma Dermatitis Lichen Planus Lichen Sclerosus Necrobiosis Lipoidica Diabeticorum Psoriasis Seborrheic Dermatitis
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Etrivex 500 micrograms / g Shampoo


1. Name Of The Medicinal Product

Etrivex500 micrograms/g shampoo

2. Qualitative And Quantitative Composition

One gram of shampoo contains 500 micrograms of clobetasol propionate.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Shampoo.

Viscous, translucent, colourless to pale yellow liquid shampoo with alcoholic odour.

4. Clinical Particulars 4.1 Therapeutic Indications

Topical treatment of moderate scalp psoriasis in adults.

4.2 Posology And Method Of Administration

For cutaneous use on the scalp only.

Etrivex 500 micrograms/g shampoo should be applied directly on dry scalp once daily taking care to well cover and massage the lesions. An amount equivalent to around a half tablespoon (around 7.5 ml) per application is sufficient to cover all the scalp. Etrivex 500 micrograms/g shampoo should be then kept in place without covering for 15 minutes before rinsing. Hands should be washed carefully after application. After 15 minutes, the product must be rinsed with water and / or hair can be washed by using an additional amount of regular shampoo if needed to facilitate washing. Then, hair can be dried as usual.

The treatment duration should be limited to a maximum of 4 weeks. As soon as clinical results are observed, applications should be spaced out or replaced, if needed, by an alternative treatment. If no improvement is seen within four weeks, reassessment of the diagnosis may be necessary.

Repeated courses of Etrivex 500 micrograms/g shampoo may be used to control exacerbations provided the patient is under regular medical supervision.

Paediatric population

The experience in the paediatric population is limited. Etrivex 500 micrograms/g shampoo is not recommended for use in children and adolescents below 18 years of age. It is contraindicated in children under 2 years of age (see sections 4.3 and 4.4).

4.3 Contraindications

- Hypersensitivity to the active substance or to any of the excipients

- Skin areas affected by bacterial, viral (varicella, herpes simplex, herpes zoster), fungal or parasitic infections and specific skin diseases (skin tuberculosis, skin diseases caused by lues).

- Etrivex 500 micrograms/g shampoo must not be applied to the eye (risk of glaucoma) or to ulcerous wounds.

- Children under 2 years of age

4.4 Special Warnings And Precautions For Use

Topical corticosteroids should be used with caution for a number of reasons including post treatment rebound relapses, development of tolerance (tachyphylaxis) and development of local or systemic toxicity. In rare instances, treatment of psoriasis with corticosteroids (or its withdrawal) is thought to have provoked generalised pustular psoriasis in case of intensive and prolonged topical use. In very rare cases, hypersensitivity to corticosteroids can be observed. This can be suspected in case of resistance to treatment.

In general, long-term continuous therapy with corticosteroids, use of occlusive mobcaps or treatment of children can lead to a higher risk of systemic effects. In such cases, medical supervision should be increased and patients may be evaluated periodically for evidence of HPA axis suppression. Such systemic effects disappear when treatment is stopped. However, abrupt discontinuation can lead to acute adrenal insufficiency, especially in children. If Etrivex 500 micrograms/g shampoo is required for use in children and adolescents below 18 years of age, it is recommended that the treatment should be reviewed weekly.

Etrivex 500 micrograms/g shampoo is only intended for the treatment of scalp psoriasis and should not be used to treat other skin areas. In particular, Etrivex 500 micrograms/g shampoo is not recommended for use in the face, eyelids, intertriginous areas (axillae and genitoanal regions) and on other erosive skin surfaces as this could increase the risk of topical adverse events such as atrophic changes, telangectasia or cortico-induced dermatitis.

If Etrivex 500 micrograms/g shampoo does enter the eye, the affected eye should be rinsed with copious amounts of water.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No interaction studies have been performed

4.6 Pregnancy And Lactation

Pregnancy

There are no adequate data from the use of topical clobetasol propionate in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown.

Etrivex 500 micrograms/g shampoo should not be used during pregnancy unless clearly necessary.

Lactation

Systemically administered corticosteroids pass into breast milk. Damage to the infant is not reported to date. Nevertheless, as there are no adequate data on the possible milk transfer of topical clobetasol propionate and its biological or clinical repercussions, Etrivex 500 micrograms/g shampoo should not be prescribed to breastfeeding women unless clearly indicated.

4.7 Effects On Ability To Drive And Use Machines

As a topical corticosteroid, Etrivex 500 micrograms/g shampoo has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable Effects

During clinical development of Etrivex 500 micrograms/g shampoo, in a total of 558 patients receiving Etrivex 500 micrograms/g shampoo, the most commonly reported adverse drug reaction was skin discomfort.Its incidence was about 5%. Most adverse events were rated as mild to moderate and they were not affected by race or gender. Clinical signs of irritation wereuncommon (0.5%). No serious drug-related adverse events were reported during any of the clinical trials.

If signs of local intolerance appear, application should be suspended until they disappear. If signs of hypersensitivity appear, application should be stopped immediately.

The table below reports the adverse reactions related to treatment by body system and by absolute frequency:

Body System

Incidence

Adverse reactions

 

Skin and subcutaneous tissue disorders

 

 

 

 

 

 

Eye disorders

 

Common

(

 

Uncommon

(

 

 

 

 

Common

(

 

Skin discomfort

Acne/folliculitis

 

Local signs of irritation

Pruritus

Urticaria

Telangiectasia

Skin atrophy

 

Eye stinging/burning

 

As a class attribution, prolonged use of topical corticosteroids, treatment of extensive areas or use of large amounts can result in sufficient systemic absorption to produce the features of hypercortisolism (Cushing syndrome) or of Hypothalamus-Pituitary-Adrenal (HPA) axis suppression. Should HPA axis suppression occur, it is likely to be transient with a rapid return to normal values.However, as Etrivex 500 micrograms/g shampoo is to be kept in place for only 15 minutes before rinsing, systemic absorption is seldom observed (see section 5.2) and therefore, the risk of appearance of HPA axis suppression is very low compared to non rinsed potent corticosteroids products. No HPA axis suppression has been observed during clinical trials with Etrivex 500 micrograms/g shampoo.

Prolonged and/or intensive treatment with potent corticosteroid preparations may cause local atrophic changes, such as local skin atrophy, striae, telangiectasia, erythema, purpura, contact dermatitis. When applied to the face, very potent corticosteroids can induce perioral dermatitis, skin atrophy or worsen rosacea. During development of Etrivex 500 micrograms/g shampoo, skin atrophy was assessed using ultrasound measurement of skin thickness in a specific clinical trial involving 13 patients. After 4 weeks of treatment with Etrivex 500 micrograms/g shampoo, no skin thinning was observed.

There are reports of pigmentation changes, acne, pustular eruptions and hypertrichosis with topical corticosteroids.

4.9 Overdose

Acute overdose is very unlikely to occur, however, in the case of chronic overdose or misuse, the features of hypercortisolism may appear and in this situation, treatment should be discontinued gradually. However, because of the risk of acute adrenal suppression, this should be done under medical supervision.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Corticosteroids, Very Potent (Group IV)

ATC code: D07AD01

Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of topical corticosteroids in general is unclear. However, corticosteroids are thought to act by induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

5.2 Pharmacokinetic Properties

In vitro liberation –penetration studies on human skin showed that only a small percentage (0.1 %) of the applied dose of Etrivex Shampoo can be found in the epidermis (including the stratum corneum) when applied for 15 minutes and then rinsed. The very low topical absorption of clobetasol propionate from Etrivex Shampoo when applied according to the recommended clinical use (15 minutes before rinse off) resulted in negligible systemic exposure in animal studies and in clinical trials. Available clinical data revealed that only 1 of 141 subjects had a quantifiable clobetasol propionate plasma concentration (0.43 ng/ml).

The present pharmacokinetic data indicate that systemic effects following clinical treatment with Etrivex Shampoo are highly unlikely due to the low systemic bioavailability of clobetasol propionate.

5.3 Preclinical Safety Data

Non clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single, repeated dose toxicity and genotoxicity. The carcinogenicity of clobetasol has not been studied.

In rabbits, Etrivex Shampoo was slightly irritating to the skin and eyes, but no delayed-type hypersensitivity was seen on guinea pigs' skin.

In developmental toxicity studies in the rabbit and the mouse, clobetasol propionate was shown to be teratogenic when administered subcutaneously at low doses. In a topical embryotoxicity study of clobetasol in the rat, foetal immaturity and skeletal and visceral malformations were observed at relatively low dosage levels. In addition to malformations, studies in animals exposed to high systemic levels of glucocorticoids during pregnancy have also shown other effects on the offspring, such as intrauterine growth retardation.

The clinical relevance of the effects of clobetasol and other corticosteroids in developmental animal studies is unknown.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Ethanol

Coco alkyl dimethyl betaine

Sodium laurethsulfate

Polyquaternium-10

Sodium citrate

Citric acid monohydrate

Purified water

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

3 years

Shelf life after first opening: 4 weeks

6.4 Special Precautions For Storage

Store in the original container

6.5 Nature And Contents Of Container

The product is packaged in high density polyethylene (HDPE) bottles of 60 ml or 125 ml fitted with polypropylene snap closures. The HDPE bottle of 30 ml is fitted with polypropylene screw closure.

Bottles contain 30 ml, 60 ml or 125 ml of shampoo.

1 g of shampoo corresponds to 1 millilitre of shampoo.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Galderma (UK) Limited

Meridien House

69-71 Clarendon Road

Watford

Herts

WD17 1DS

UK

8. Marketing Authorisation Number(S)

PL 10590/0052

9. Date Of First Authorisation/Renewal Of The Authorisation 10. Date Of Revision Of The Text

January 2007


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Halobetasol Propionate Ointment


Generic Name: halobetasol propionate
Dosage Form: ointment
Halonate (halobetasol Propionate ointmanet 0.05%)

Halonate Halobetasol Propionate Ointment, 0.05% contains halobetasol propionate, a synthetic corticosteroid
for topical dermatological use. The corticosteroids constitute a class of primarily synthetic
steroids used topically as an anti-inflammatory and anti-pruritic agent.

Chemically halobetasol propionate is 21-chloro-6?, 9-difluoro-11?,17-dihydroxy-16?-methylpregna-1,
4-diene-3-20-dione, 17-propionate, C25H31ClF2O5. It has the following structural formula:


Halobetasol propionate has the molecular weight of 485. It is a white crystalline powder insoluble in water.
Each gram of Halobetasol Propionate Ointment contains 0.5 mg/g of halobetasol propionate in a
base of aluminum stearate, beeswax, pentaerythritol cocoate, petrolatum, propylene glycol, sorbitan
sesquioleate, and stearyl citrate.
Like other topical corticosteroids, halobetasol propionate has anti-inflammatory, antipruritic and
vasoconstrictive actions. The mechanism of the anti-inflammatory activity of the topical corticosteroids,
in general, is unclear. However, corticosteroids are thought to act by the induction of
phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins
control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes
by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is
released from membrane phospholipids by phospholipase A2. The extent of percutaneous absorption of topical corticosteroids is determined by many factors
including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone
for up to 24 hours have not been demonstrated to increase penetration; however, occlusion
of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed
from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous
absorption.
Human and animal studies indicate that less than 6% of the applied dose of halobetasol propionate
enters the circulation within 96 hours following topical administration of the ointment.
Studies performed with Halobetasol Propionate Ointment indicate that it is in the super-high range
of potency as compared with other topical corticosteroids. Halobetasol Propionate Ointment 0.05% is a superhigh potency corticosteroid indicated for the relief
of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment
beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week
because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use
in children under 12 years of age is not recommended.
As with other highly active corticosteroids, therapy should be discontinued when control has been
achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be
necessary.

Halobetasol Propionate Ointment is contraindicated in those patients with a history of hypersensitivity
to any of the components of the preparation.

General:  Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal
(HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of
treatment. Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced
in some patients by systemic absorption of topical corticosteroids while on treatment.
Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated
periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation,
A.M. plasma cortisol, and urinary free-cortisol tests.  Patients receiving super potent corticosteroids
should not be treated for more than 2 weeks at a time and only small areas should be treated at any one
time due to the increased risk of HPA suppression.
Halobetasol Propionate Ointment produced HPA axis suppression when used in divided doses at 7
grams per day for one week in patients with psoriasis. These effects were reversible upon discontinuation
of treatment.
If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the
frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function
is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms
of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids.
For information on systemic supplementation, see prescribing information for those products.
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their
larger skin surface to body mass ratios (see PRECAUTIONS:Pediatric Use).
If irritation develops, Halobetasol Propionate Ointment should be discontinued and appropriate
therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing
failure to heal rather than noting a clinical exacerbation as with most topical products not containing
corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.
If concomitant skin infections are present or develop, an appropriate antifungal or anti-bacterial
agent should be used. If a favorable response does not occur promptly, use of Halobetasol Propionate
Ointment should be discontinued until the infection has been adequately controlled.
Halobetasol Propionate Ointment should not be used in the treatment of rosacea or perioral dermatitis,
and it should not be used on the face, groin,or in the axillae.

Patients using topical corticosteroids should receive the following information and instructions:
1) The medication is to be used as directed by the physician. It is for external use only. Avoid contact
with the eyes.
2) The medication should not be used for any disorder other than that for which it was prescribed.
3) The treated skin area should not be bandaged, otherwise covered or wrapped, so as to be
occlusive unless directed by the physician.
4) Patients should report to their physician any signs of local adverse reactions.
The following tests may be helpful in evaluating patients for HPA axis suppression: ACTH-stimulation
test; A.M. plasma cortisol test; Urinary freecortisol test.

Long-term animal studies have not been performed to evaluate the carcinogenic potential of halobetasol
propionate.

Positive mutagenicity effects were observed in two genotoxicity assays. Halobetasol propionate
was positive in a Chinese hamster micronucleus test, and in a mouse lymphoma gene mutation
assay in vitro.

Studies in the rat following oral administration at dose levels up to 50 ?g/kg/day indicated no impairment
of fertility or general reproductive performance.

In other genotoxicity testing, halobetasol propionate was not found to be genotoxic in the
Ames/Salmonella assay, in the sister chromatid exchange test in somatic cells of the Chinese hamster,
in chromosome aberration studies of germinal and somatic cells of rodents, and in a mammalian spot
test to determine point mutations.

Teratogenic effects: Pregnancy Category C: Corticosteroids have been shown to be teratogenic
in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids
have been shown to be teratogenic after dermal application in laboratory animals.
Halobetasol propionate has been shown to be teratogenic in SPF rats and chinchilla-type rabbits
when given systemically during gestation at doses of 0.04 to 0.1 mg/kg in rats and 0.01 mg/kg in
rabbits. These doses are approximately 13, 33 and 3 times, respectively, the human topical dose of
Halobetasol Propionate Ointment. Halobetasol propionate was embryotoxic in rabbits but not in rats.
Cleft palate was observed in both rats and rabbits. Omphalocele was seen in rats, but not in rabbits.
There are no adequate and well-controlled studies of the teratogenic potential of halobetasol propionate
in pregnant women. Halobetasol Propionate Ointment should be used during pregnancy only if
the potential benefit justifies the potential risk to the fetus.

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere
with endogenous corticosteroid production, or cause other untoward effects. It is not known
whether topical administration of corticosteroids could result in sufficient systemic absorption to
produce detectable quantities in human milk. Because many drugs are excreted in human milk,
caution should be exercised when Halobetasol Propionate Ointment is administered to a nursing
woman.

Safety and effectiveness of Halobetasol Propionate Ointment in pediatric patients have not been established
and use in pediatric patients under 12 is not recommended. Because of a higher ratio of skin
surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression
and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at
greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse effects including
striae have been reported with inappropriate use of topical corticosteroids in infants and children.

HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain and
intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations
of adrenal suppression in children include low plasma cortisol levels and an absence of
response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles,
headaches, and bilateral papilledema. Of approximately 850 patients treated with Halobetasol Propionate Ointment in clinical studies,
21% were 61 years and over and 6% were 71 years and over. No overall differences in safety or effectiveness
were observed between these patients and younger patients; and other reported clinical experience
has not identified differences in responses between the elderly and younger patients, but
greater sensitivity of some older individuals cannot be ruled out. In controlled clinical trials, the most frequent adverse events reported for Halobetasol Propionate
Ointment included stinging or burning in 1.6% of the patients. Less frequently reported adverse reactions
were pustulation, erythema, skin atrophy, leukoderma, acne, itching, secondary infection,
telangiectasia, urticaria, dry skin, miliaria, paresthesia, and rash.
The following additional local adverse reactions are reported infrequently with topical corticosteroids,
and they may occur more frequently with high potency corticosteroids, such as Halobetasol
Propionate Ointment. These reactions are listed in an approximate decreasing order of occurrence:
folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic
contact dermatitis, secondary infection, striae and miliaria.
Topically applied Halobetasol Propionate Ointment can be absorbed in sufficient amounts to produce
systemic effects (see PRECAUTIONS).
Apply a thin layer of Halobetasol Propionate Ointment to the affected skin once or twice daily, as
directed by your physician, and rub in gently and completely.
Halobetasol Propionate Ointment is a super-high potency topical corticosteroid; therefore, treatment
should be limited to two weeks, and amounts greater than 50 g/wk should not be used. As with
other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is
seen within 2 weeks, reassessment of diagnosis may be necessary.
Halobetasol Propionate Ointment should not be used with occlusive dressings. Halonate™ is supplied in the following:
(NDC 68712-042-01) one 50 g tube of Halobetasol Propionate Ointment 0.05% packaged with one
4 oz can of ammonium lactate mousse 12%
STORAGE: Store between 15°C and 30°C (59°F and 86°F).
Manufactured by:
G and W Laboratories, Inc.
South Plainfield, NJ  07080
Manufactured for:
JSJ Pharmaceuticals
Charleston, SC  29401
1-800-499-4468
www.jsjpharm.com


HALONATE PAC 
halobetasol   ointment Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68712-042 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HALOBETASOL PROPIONATE (HALOBETASOL ) HALOBETASOL PROPIONATE 0.5 mg  in 1 g Inactive Ingredients Ingredient Name Strength ALUMINUM STEARATE   YELLOW WAX   PENTAERYTHRITOL   PETROLATUM   PROPYLENE GLYCOL   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 68712-042-01 50 g In 1 TUBE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077721 05/01/2010
Labeler - JSJ Pharmaceuticals (615074866) Establishment Name Address ID/FEI Operations G and W Laboratories Inc. 001271188 manufacture Revised: 07/2010JSJ Pharmaceuticals
More Halobetasol Propionate Ointment resources Halobetasol Propionate Ointment Side Effects (in more detail) Halobetasol Propionate Ointment Use in Pregnancy & Breastfeeding Halobetasol Propionate Ointment Drug Interactions Halobetasol Propionate Ointment Support Group 14 Reviews for Halobetasol Propionate - Add your own review/rating Compare Halobetasol Propionate Ointment with other medications Atopic Dermatitis Dermatitis Eczema Psoriasis
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Halonate


halobetasol propionate
Dosage Form: ointment
Halonate (halobetasol Propionate ointmanet 0.05%) Description

Halonate Halobetasol Propionate Ointment, 0.05% contains halobetasol propionate, a synthetic corticosteroid for topical dermatological use. The corticosteroids constitute a class of primarily synthetic steroids used topically as an anti-inflammatory and anti-pruritic agent.  Chemically halobetasol propionate is 21-chloro-6?, 9-difluoro-11?,17-dihydroxy-16?-methylpregna-1, 4-diene-3-20-dione, 17-propionate, C25H31ClF2O5. It has the following structural formula:


Halobetasol propionate has the molecular weight of 485. It is a white crystalline powder insoluble in water.  Each gram of Halobetasol Propionate Ointment contains 0.5 mg/g of halobetasol propionate in a
base of aluminum stearate, beeswax, pentaerythritol cocoate, petrolatum, propylene glycol, sorbitan sesquioleate, and stearyl citrate.
Clinical Pharmacology Like other topical corticosteroids, halobetasol propionate has anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of the anti-inflammatory activity of the topical corticosteroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.
Human and animal studies indicate that less than 6% of the applied dose of halobetasol propionate enters the circulation within 96 hours following topical administration of the ointment. Studies performed with Halobetasol Propionate Ointment indicate that it is in the super-high range of potency as compared with other topical corticosteroids. Indications and Usage Halobetasol Propionate Ointment 0.05% is a superhigh potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in children under 12 years of age is not recommended.
As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Contraindications

Halobetasol Propionate Ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Precautions
General:  Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.
Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free-cortisol tests.  Patients receiving super potent corticosteroids should not be treated for more than 2 weeks at a time and only small areas should be treated at any one time due to the increased risk of HPA suppression.
Halobetasol Propionate Ointment produced HPA axis suppression when used in divided doses at 7 grams per day for one week in patients with psoriasis. These effects were reversible upon discontinuation of treatment.
If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (see PRECAUTIONS: Pediatric Use).
If irritation develops, Halobetasol Propionate Ointment should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing. If concomitant skin infections are present or develop, an appropriate antifungal or anti-bacterial agent should be used. If a favorable response does not occur promptly, use of Halobetasol Propionate Ointment should be discontinued until the infection has been adequately controlled.
Halobetasol Propionate Ointment should not be used in the treatment of rosacea or perioral dermatitis, and it should not be used on the face, groin,or in the axillae.
Information for Patients
Patients using topical corticosteroids should receive the following information and instructions:
1) The medication is to be used as directed by the physician. It is for external use only. Avoid contact
with the eyes.
2) The medication should not be used for any disorder other than that for which it was prescribed.
3) The treated skin area should not be bandaged, otherwise covered or wrapped, so as to be
occlusive unless directed by the physician.
4) Patients should report to their physician any signs of local adverse reactions.
Laboratory Tests The following tests may be helpful in evaluating patients for HPA axis suppression: ACTH-stimulation test; A.M. plasma cortisol test; Urinary freecortisol test. Carcinogenesis & Mutagenesis & Imprairment of Fertility Section

Long-term animal studies have not been performed to evaluate the carcinogenic potential of halobetasol propionate.

Positive mutagenicity effects were observed in two genotoxicity assays. Halobetasol propionate was positive in a Chinese hamster micronucleus test, and in a mouse lymphoma gene mutation assay in vitro.

Studies in the rat following oral administration at dose levels up to 50 ?g/kg/day indicated no impairment of fertility or general reproductive performance.

In other genotoxicity testing, halobetasol propionate was not found to be genotoxic in the Ames/Salmonella assay, in the sister chromatid exchange test in somatic cells of the Chinese hamster, in chromosome aberration studies of germinal and somatic cells of rodents, and in a mammalian spot test to determine point mutations.

Pregnancy Teratogenic effects: Pregnancy Category C: Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.
Halobetasol propionate has been shown to be teratogenic in SPF rats and chinchilla-type rabbits when given systemically during gestation at doses of 0.04 to 0.1 mg/kg in rats and 0.01 mg/kg in rabbits. These doses are approximately 13, 33 and 3 times, respectively, the human topical dose of Halobetasol Propionate Ointment. Halobetasol propionate was embryotoxic in rabbits but not in rats.
Cleft palate was observed in both rats and rabbits. Omphalocele was seen in rats, but not in rabbits.
There are no adequate and well-controlled studies of the teratogenic potential of halobetasol propionate in pregnant women. Halobetasol Propionate Ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Halobetasol Propionate Ointment is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Halobetasol Propionate Ointment in pediatric patients have not been established and use in pediatric patients under 12 is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations
of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Geriatric Use Of approximately 850 patients treated with Halobetasol Propionate Ointment in clinical studies,
21% were 61 years and over and 6% were 71 years and over. No overall differences in safety or effectiveness
were observed between these patients and younger patients; and other reported clinical experience
has not identified differences in responses between the elderly and younger patients, but
greater sensitivity of some older individuals cannot be ruled out. Adverse Reactions In controlled clinical trials, the most frequent adverse events reported for Halobetasol Propionate Ointment included stinging or burning in 1.6% of the patients. Less frequently reported adverse reactions were pustulation, erythema, skin atrophy, leukoderma, acne, itching, secondary infection, telangiectasia, urticaria, dry skin, miliaria, paresthesia, and rash.
The following additional local adverse reactions are reported infrequently with topical corticosteroids, and they may occur more frequently with high potency corticosteroids, such as Halobetasol Propionate Ointment. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria. Overdosage
Topically applied Halobetasol Propionate Ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).
Dosage and Administration Apply a thin layer of Halobetasol Propionate Ointment to the affected skin once or twice daily, as directed by your physician, and rub in gently and completely.
Halobetasol Propionate Ointment is a super-high potency topical corticosteroid; therefore, treatment  should be limited to two weeks, and amounts greater than 50 g/wk should not be used. As with
other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
Halobetasol Propionate Ointment should not be used with occlusive dressings. How Supplied Halonate™ is supplied in the following:
(NDC 68712-042-01) one 50 g tube of halobetasol propionate ointment 0.05% packaged with one
4 oz can of ammonium lactate mousse 12%
STORAGE: Store between 15°C and 30°C (59°F and 86°F).
Manufactured by:
G and W Laboratories, Inc.
South Plainfield, NJ  07080
Manufactured for:
Innocutis Holdings LLC
Charleston, SC  29401
1-800-499-4468
www.innocutis.com


Halonate PAC 
halobetasol   ointment Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68712-042 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HALOBETASOL PROPIONATE (HALOBETASOL ) HALOBETASOL PROPIONATE 0.5 mg  in 1 g Inactive Ingredients Ingredient Name Strength ALUMINUM STEARATE   YELLOW WAX   PENTAERYTHRITOL   PETROLATUM   PROPYLENE GLYCOL   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 68712-042-01 50 g In 1 TUBE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077721 05/01/2010
Labeler - Innocutis Holdings LLC (071501252) Establishment Name Address ID/FEI Operations G &W Laboratories Inc. 001271188 manufacture Revised: 11/2011Innocutis Holdings LLC More Halonate resources Halonate Side Effects (in more detail) Halonate Use in Pregnancy & Breastfeeding Halonate Drug Interactions Halonate Support Group 0 Reviews for Halonate - Add your own review/rating Halonate Ointment MedFacts Consumer Leaflet (Wolters Kluwer) Ultravate Pack Ointment Concise Consumer Information (Cerner Multum) Compare Halonate with other medications Atopic Dermatitis Dermatitis Eczema Psoriasis
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CLARELUX cutaneous foam


CLARELUX 500 microgram/g cutaneous foam in pressurised container

(Clobetasol propionate)

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 your pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet:

1. What CLARELUX is and what it is used for
2. Before you use CLARELUX
3. How to use CLARELUX
4. Possible side effects
5. How to store CLARELUX
6. Further Information

What Clarelux Is And What It Is Used For

CLARELUX is a foam to be applied to the skin, containing 500 microgram/g clobetasol propionate as the active ingredient. Clobetasol propionate belongs to a group of medicines known as topical corticosteroids.

CLARELUX is one of the stronger corticosteroids and is used as a short-term treatment for scalp conditions, e.g. psoriasis of the scalp, which do not respond satisfactorily to weaker corticosteroids.

Before You Use Clarelux Do not use CLARELUX: If you are allergic to clobetasol propionate, to other corticosteroids or any of the other ingredients of CLARELUX If you suffer from burns and other skin condition such as rosacea, acne, skin inflammation around the mouth, itching (pruritus) around the anus or genitals, or have a skin infection On any area of your body or face, apart from your scalp. Take special care with CLARELUX

As with all topical corticosteroids, CLARELUX can be absorbed through the skin and can cause side effects- see Section 4 for all possible side effects. Due to this:

Long-term treatment with CLARELUX should be avoided. CLARELUX should not be applied to a large surface area. The treated areas should not be bandaged or covered unless directed by your doctor

When your skin condition is better or after a maximum duration treatment of two weeks, your doctor should modify or change your treatment.

Inform your doctor:

If your condition does not improve after 2 weeks of treatment. If an infection occurs, as this may require discontinuation of treatment with CLARELUX. If you have a problem with your liver. If you start to experience problems with your vision, as this type of medicine may increase the development of cataracts.

Children and adolescents: Treatment is not recommended in children and adolescents.

Driving and using machines: CLARELUX should not affect your ability to drive or operate machines.

Using other Medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.

Pregnancy and breast-feeding

Please inform your doctor if you are pregnant, planning to become pregnant, breast-feeding or planning to breast-feed. CLARELUX should not be used during pregnancy or breast-feeding unless advised by your doctor.

Important information about some of the ingredients in CLARELUX

CLARELUX contains propylene glycol, which may cause skin irritation. It also contains cetyl and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

How To Use Clarelux

WARNINGS:

The canister contains a pressurised, flammable liquid.

Do not use or store near a naked flame, source of ignition, any heat generating material or electrical device in use.

Do not smoke whilst using or holding this can.

Always use CLARELUX exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Use this medication only for the condition for which it was prescribed. CLARELUX must only be applied to the scalp and should not be swallowed.

Dispensing directly onto hands is not recommended, as the foam will begin to melt immediately upon contact with warm skin.

Apply CLARELUX to the affected area of the scalp twice a day, once in the morning and once at night, as follows:

1. Shake the can well.

2. Turn the can upside down and squirt a small amount (the size of a walnut) either directly onto the scalp, or into the cap of the can, onto a saucer or other cool surface and then onto the scalp.
Clarelux should always be applied thinly, so use as little as possible when covering the affected areas. The exact amount you need depends on the size of the affected area.
Do not apply to the eyelids and take care to avoid contact with eyes, nose, and mouth.
Do not squirt CLARELUX onto your hands, as the foam will begin to melt immediately upon contact with warm skin.

3. Move the hair away from the foam and gently massage into the scalp, until it disappears and is absorbed. Repeat if necessary, to treat the entire affected area.

Wash your hands after applying CLARELUX and discard any unused foam.

Do not use CLARELUX on your face. If some foam accidentally gets into your eyes, nose or mouth, rinse immediately with cold water. You may feel a stinging sensation. Contact your doctor, if the pain continues.

The treated areas should not be bandaged or covered unless directed by your doctor.

Do not wash or rinse the treated scalp areas immediately after applying CLARELUX.

Do not use more than 50g of CLARELUX foam per week.

Treatment should not be given for more than 2 weeks. After this period CLARELUX may be used occasionally if needed. Alternatively your doctor may prescribe a weaker steroid to control your condition.

If you use more CLARELUX than you should

If you use CLARELUX Foam in a larger quantity or for a long period of time without your doctor’s knowledge you should tell your doctor immediately.

If you forget to use CLARELUX, use it as soon as you remember, then continue as before. If you only remember at the time of your next dose, use a single dose and continue as before (do not apply a double dose to make up for the forgotten dose). If you miss several doses, tell your doctor.

If you stop using CLARELUX

Do not stop using CLARELUX suddenly as this may harm you. Your doctor may need to discontinue the treatment gradually and you may need regular check-ups.

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

Possible Side Effects

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

Stop using CLARELUX and contact your doctor immediately if hypersensitivity reactions occur, such as local irritation.

The side effects may include:

Common side effects (occurring in less than 1 in 10 people but more than 1 in 100):

Burning sensation Other skin reaction when applied to the skin

Very rare effects (occurring in less than 1 in 10,000 people):

Sensation of tingling or pricking Eye irritation Swollen veins Skin irritation and tenderness Skin tightness Itchy skin rash (contact dermatitis) Aggravated scaly skin rash (psoriasis aggravated) Redness at the application site Itching and sometimes with pain at the application site Presence of blood, protein and nitrogen in your urine may be detected by a doctor

Additional side effects may include:

Changes in hair growth (abnormal hair growth away from the application site and on unusual parts of the body ) Changes in skin colour Irritation of the hair follicules e.g. pain, heat and redness Mouth rashes Redness and eruptions on the face Delay in wound healing Effects on the eyes

Side effects caused by pronged use include:

White markings on skin (striae) and dilatation of the blood vessels of the skin As with other topical corticosteroids, when CLARELUX is used in large amounts and for a long period of time, this can lead to a disorder called Cushing’s syndrome which symptoms include a red, puffy and rounded face (called a moon face), high blood pressure, weight gain and changes in sugar levels in the blood and urine. Prolonged treatment with steroids may cause thinning of the skin.

In rare instances, treatment of psoriasis with corticosteroids (or on stopping treatment) may make the condition worse and a pustular form of the disease may occur. On stopping treatment with corticosteroids, sometimes, the scalp condition may return. Also pre-existing infections may worsen if CLARELUX is not used according to the instructions. If any of the 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 Clarelux The canister contains a pressurised, flammable liquid. Do not store near a naked flame, source of ignition, any heat generating material or electrical device in use. Do not expose to temperatures higher than 50?C or to direct sunlight. Do not pierce or burn the can even when empty. When you have finished your treatment, dispose of the can safely.

Keep out of the reach and sight of children.

Do not use CLARELUX after the expiry date which is stated on the can and the outer carton after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C. Do not refrigerate. Store upright.

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

Further Information What Clarelux Contains

1 g of CLARELUX contains 500 microgram of clobetasol propionate as active substance.

The other ingredients are: ethanol anhydrous, purified water, propylene glycol, cetyl alcohol, stearyl alcohol, polysorbate 60, citric acid anhydrous, potassium citrate and a propane/n-butane/isobutane propellant mixture.

What Clarelux Looks Like And Contents Of The Pack

CLARELUX is a cutaneous white foam. Each can of CLARELUX contains 50 or 100 grams.

Marketing Authorisation Holder : Pierre Fabre Dermatologie 45 place Abel Gance 92100 Boulogne France Manufacturer : Aerosol Service Italiana S.R.L. (ASI) Via del Maglio,6 23868 Valmadrera (LC) Italy

This medicinal product is authorised in the Member States of the EEA under the following names:

CLARELUX 500 microgram/g cutaneous foam in Austria, Belgium, Finland, Germany, Greece, Iceland, Ireland, Luxemburg, The Netherlands, Norway, Portugal, United-Kingdom and Spain.

OLUX 500 microgram/g cutaneous foam in Italy.

For any information on this product please contact:

Pierre Fabre Ltd Phone: + 44 (0)1962 874400

Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only).

Please be ready to give the following information:

United Kingdom: Clarelux PL20693/0004

Ireland: Clarelux PA1230/1/1

This is a service provided by the Royal National institute of the blind.

Clarelux is a trademark of Pierre Fabre Dermatologie.

Sold under Stiefel License - Patent n° GB 9504265

This leaflet was last approved in June 2008.


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Salicylic Acid Film-Forming Liquid


Pronunciation: SAL-i-SIL-ik AS-id
Generic Name: Salicylic Acid
Brand Name: Virasal
Salicylic Acid Film-Forming Liquid is used for:

Treating and removing common warts and plantar warts. It may also be used for other conditions as determined by your doctor.

Salicylic Acid Film-Forming Liquid is a topical salicylate. It works by causing the skin to swell, soften, and then slough or peel in areas where it is applied.

Do NOT use Salicylic Acid Film-Forming Liquid if: you are allergic to any ingredient in Salicylic Acid Film-Forming Liquid you have diabetes or poor blood circulation

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

Before using Salicylic Acid Film-Forming Liquid:

Some medical conditions may interact with Salicylic Acid Film-Forming Liquid. 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 had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to aspirin or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib) if you have liver or kidney problems, a skin infection, or skin irritation

Some MEDICINES MAY INTERACT with Salicylic Acid Film-Forming Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

Anticoagulants, (eg, heparin, warfarin), aspirin, methotrexate, or sulfonylureas (eg, glipizide) because the risk of side effects may be increased by Salicylic Acid Film-Forming Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Salicylic Acid Film-Forming Liquid 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 Salicylic Acid Film-Forming Liquid:

Use Salicylic Acid Film-Forming Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Soak the affected area in warm water for about 5 minutes. Remove any loosened skin by gently rubbing with a brush, washcloth, or emery board. Dry thoroughly. Using the brush applicator supplied with Salicylic Acid Film-Forming Liquid, apply Salicylic Acid Film-Forming Liquid to the entire wart surface. Be careful not to apply Salicylic Acid Film-Forming Liquid to the surrounding skin. If your doctor directs you to apply Salicylic Acid Film-Forming Liquid 2 times to the affected area, allow the first application to dry before applying the second application. Unless your hands are being treated, be sure to wash your hands after each application. If you miss a dose of Salicylic Acid Film-Forming Liquid, 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 Salicylic Acid Film-Forming Liquid.

Important safety information: Salicylic Acid Film-Forming Liquid is for external use only. Avoid getting Salicylic Acid Film-Forming Liquid in your eyes, nose, or mouth, or on the genitals. If contact with your eyes occurs, flush with water for 15 minutes. Do not inhale the vapors of Salicylic Acid Film-Forming Liquid. Do NOT use Salicylic Acid Film-Forming Liquid longer or more often than recommended by your doctor. Visible improvement will normally occur during the first or second week of treatment with Salicylic Acid Film-Forming Liquid. It may take 4 to 6 weeks before the wart is completely removed. Discuss any questions or concerns with your doctor. Be sure to apply Salicylic Acid Film-Forming Liquid only to the affected area and not to normal, healthy skin. Do not use Salicylic Acid Film-Forming Liquid on skin that is irritated, infected, or reddened. Do not use Salicylic Acid Film-Forming Liquid on open skin wounds, moles, birthmarks, genital warts, warts on the face, or warts growing hair. Do not use any other medicines or drying products on your skin unless your doctor instructs you otherwise. Salicylic Acid Film-Forming Liquid may interfere with certain lab test results. Make sure your doctor and lab personnel know you are using Salicylic Acid Film-Forming Liquid. Salicylic Acid Film-Forming Liquid is extremely flammable. Do not store or use Salicylic Acid Film-Forming Liquid near a fire or other open flame. Salicylic Acid Film-Forming Liquid may be harmful if swallowed. If you may have taken Salicylic Acid Film-Forming Liquid by mouth, contact your local poison control center or emergency room immediately. Salicylic Acid Film-Forming Liquid contains a salicylate, which has been linked to Reye syndrome. Do not use Salicylic Acid Film-Forming Liquid on children or teenagers during or after chickenpox, flu, or other viral infections without checking with your doctor or pharmacist. Caution is advised when using Salicylic Acid Film-Forming Liquid in CHILDREN; they may be more sensitive to its effects. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Salicylic Acid Film-Forming Liquid while you are pregnant. It is not known if Salicylic Acid Film-Forming Liquid is found in breast milk. If you are or will be breast-feeding while you are using Salicylic Acid Film-Forming Liquid, check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Salicylic Acid Film-Forming Liquid:

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:

Dry, peeling, red, or scaling 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); severe skin irritation.

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: Salicylic Acid side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; diarrhea; dizziness; loss of appetite; loss of hearing; mental disturbances; nausea; rapid or difficult breathing; ringing in the ears; seizures; sluggishness; vomiting; yellowing of the skin or eyes.

Proper storage of Salicylic Acid Film-Forming Liquid:

Store Salicylic Acid Film-Forming Liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Keep the bottle tightly capped when not in use. Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Keep Salicylic Acid Film-Forming Liquid out of the reach of children and away from pets.

General information: If you have any questions about Salicylic Acid Film-Forming Liquid, please talk with your doctor, pharmacist, or other health care provider. Salicylic Acid Film-Forming Liquid 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 Salicylic Acid Film-Forming Liquid. 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 Salicylic Acid resources Salicylic Acid Side Effects (in more detail) Salicylic Acid Use in Pregnancy & Breastfeeding Salicylic Acid Drug Interactions Salicylic Acid Support Group 1 Review for Salicylic Acid - Add your own review/rating Compare Salicylic Acid with other medications Acne Dermatological Disorders Warts
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Coal Tar/Salicylic Acid/Sulfur Shampoo


Pronunciation: kole tar/SAL-i-SIL-ik AS-id/SUL-fur
Generic Name: Coal Tar/Salicylic Acid/Sulfur
Brand Name: Examples include Ala-Seb-T and Pazol XS
Coal Tar/Salicylic Acid/Sulfur Shampoo is used for:

Relieving itching, flaking, irritation, redness, and scaling caused by dandruff, seborrheic dermatitis, and psoriasis of the scalp. It may also be used for other conditions as determined by your doctor.

Coal Tar/Salicylic Acid/Sulfur Shampoo is a topical coal tar, salicylate, and sulfur combination. It works by causing the skin to swell, soften, and then slough or peel in areas where it is applied.

Do NOT use Coal Tar/Salicylic Acid/Sulfur Shampoo if: you are allergic to any ingredient in Coal Tar/Salicylic Acid/Sulfur Shampoo you are using prescription medicine or other treatments for psoriasis (eg, ultraviolet radiation therapy), unless instructed by your doctor

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

Before using Coal Tar/Salicylic Acid/Sulfur Shampoo:

Some medical conditions may interact with Coal Tar/Salicylic Acid/Sulfur Shampoo. 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 had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to aspirin or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib) if you have liver or kidney problems, a skin infection, skin irritation, eczema, diabetes, or poor blood circulation

Some MEDICINES MAY INTERACT with Coal Tar/Salicylic Acid/Sulfur Shampoo. Because little, if any, of Coal Tar/Salicylic Acid/Sulfur Shampoo is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Coal Tar/Salicylic Acid/Sulfur Shampoo 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 Coal Tar/Salicylic Acid/Sulfur Shampoo:

Use Coal Tar/Salicylic Acid/Sulfur Shampoo as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Shake well before each use. Wet hair, apply generously, and massage onto wet scalp. Leave lather on your scalp for a full 5 minutes. Rinse well and repeat. Be sure to wash your hands after each use. If you miss a dose of Coal Tar/Salicylic Acid/Sulfur Shampoo, 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 Coal Tar/Salicylic Acid/Sulfur Shampoo.

Important safety information: Coal Tar/Salicylic Acid/Sulfur Shampoo is for external use only. Avoid getting Coal Tar/Salicylic Acid/Sulfur Shampoo in your eyes, nose, or mouth, or on the genitals. If contact with your eyes occurs, flush with water for 15 minutes. Do not inhale the vapors of Coal Tar/Salicylic Acid/Sulfur Shampoo. Coal Tar/Salicylic Acid/Sulfur Shampoo may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away. Overuse of topical products may worsen your condition. Do NOT use more than the recommended dose of Coal Tar/Salicylic Acid/Sulfur Shampoo. Do not use for longer than prescribed by your doctor or on the package label without checking with your doctor. If your condition does not get better after regular use of Coal Tar/Salicylic Acid/Sulfur Shampoo or if it gets worse, check with your doctor. Check with your doctor before use if you have a condition that covers a large area of the body. Be sure to apply Coal Tar/Salicylic Acid/Sulfur Shampoo only to the affected area and not to normal healthy skin. Do not use Coal Tar/Salicylic Acid/Sulfur Shampoo on skin that is irritated, infected, or reddened. Do not use Coal Tar/Salicylic Acid/Sulfur Shampoo on open skin wounds, moles, birthmarks, genital warts, warts on the face, or warts growing hair. Do not use any other medicines or drying products on your skin unless your doctor instructs you otherwise. Coal Tar/Salicylic Acid/Sulfur Shampoo may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Coal Tar/Salicylic Acid/Sulfur Shampoo. Use a sunscreen or protective clothing if you must be outside for a prolonged period. Coal Tar/Salicylic Acid/Sulfur Shampoo contains a salicylate, which has been linked to Reye syndrome. Do not use Coal Tar/Salicylic Acid/Sulfur Shampoo on children or teenagers during or after chickenpox, flu, or other viral infections without checking with your doctor or pharmacist. Coal Tar/Salicylic Acid/Sulfur Shampoo should not be used in CHILDREN younger than 2 years old unless your doctor tells you otherwise. PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Coal Tar/Salicylic Acid/Sulfur Shampoo during pregnancy. It is not known if Coal Tar/Salicylic Acid/Sulfur Shampoo is found in breast milk. Do not breast-feed while you are using Coal Tar/Salicylic Acid/Sulfur Shampoo. Possible side effects of Coal Tar/Salicylic Acid/Sulfur Shampoo:

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:

Dry, peeling, red, or scaling 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); severe irritation.

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: Coal Tar/Salicylic Acid/Sulfur side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; diarrhea; dizziness; loss of appetite; loss of hearing; mental disturbances; nausea; rapid or difficult breathing; ringing in the ears; seizures; sluggishness; vomiting; yellowing of the skin or eyes.

Proper storage of Coal Tar/Salicylic Acid/Sulfur Shampoo:

Store Coal Tar/Salicylic Acid/Sulfur Shampoo at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Keep Coal Tar/Salicylic Acid/Sulfur Shampoo out of the reach of children and away from pets.

General information: If you have any questions about Coal Tar/Salicylic Acid/Sulfur Shampoo, please talk with your doctor, pharmacist, or other health care provider. Coal Tar/Salicylic Acid/Sulfur Shampoo 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 Coal Tar/Salicylic Acid/Sulfur Shampoo. 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 Coal Tar/Salicylic Acid/Sulfur resources Coal Tar/Salicylic Acid/Sulfur Side Effects (in more detail) Coal Tar/Salicylic Acid/Sulfur Use in Pregnancy & Breastfeeding Coal Tar/Salicylic Acid/Sulfur Drug Interactions Coal Tar/Salicylic Acid/Sulfur Support Group 0 Reviews · Be the first to review/rate this drug
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Clear Up Prep



Dosage Form: gel
Drug Facts ACTIVE INGREDIENT

Salicylic Acid 2% w/w.

INACTIVE INGREDIENTS

WATER • SORBITOL • ETHOXYDIGLYCOL • GLYCOLIC ACID • METHYL GLUCETH-20 • SODIUM CITRATE • GLYCERIN • LACTIC ACID • SODIUM HYDROXIDE • CELLULOSE GUM • XANTHAN GUM • ETHYLHEXYLGLYCERIN • PROPYLENE GLYCOL • PHENOXYETHANOL • CITRUS MEDICA LIMONUM (LEMON) FRUIT EXTRACT • HEDERA HELIX (IVY) EXTRACT • SAPONARIA OFFICINALIS EXTRACT •
ARCTIUM LAPPA ROOT EXTRACT • SALVIA OFFICINALIS (SAGE) LEAF EXTRACT •

DIRCETIONS

Cover the eyes with cotton pads soaked in Blue Water. With the fingertips, apply evenly to the face and neck Clear Up Prep Lotion, making sure to avoid the lips.

Application: 2-3 minutes | Pause: 7-8 minutes

WARNINGS

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image of carton label
image of tube 5ml label

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Keep out of reach of children.

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Clear Up Prep 
salicylic acid  gel Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 62499-395 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 2 g  in 100 g Inactive Ingredients Ingredient Name Strength WATER   SORBITOL   DIETHYLENE GLYCOL MONOETHYL ETHER   GLYCOLIC ACID   METHYL GLUCETH-20   SODIUM CITRATE   GLYCERIN   LACTIC ACID   SODIUM HYDROXIDE   PROPYLENE GLYCOL   PHENOXYETHANOL   CARBOXYMETHYLCELLULOSE SODIUM   XANTHAN GUM   ETHYLHEXYLGLYCERIN   LEMON OIL   SAPONARIA OFFICINALIS ROOT   ARCTIUM LAPPA ROOT   SAGE OIL   Product Characteristics Color blue (dark bleu) Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 62499-395-11 1 TUBE In 1 CARTON contains a TUBE (62499-395-10) 1 62499-395-10 5 g In 1 TUBE This package is contained within the CARTON (62499-395-11)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 07/01/2010
Labeler - Laboratoire Dr. Renaud (202501565) Revised: 07/2010Laboratoire Dr. Renaud
More Clear Up Prep resources Clear Up Prep Side Effects (in more detail) Clear Up Prep Use in Pregnancy & Breastfeeding Clear Up Prep Drug Interactions Clear Up Prep Support Group 1 Review for Clear Up Prep - Add your own review/rating Compare Clear Up Prep with other medications Acne Dermatological Disorders Warts
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Keratoconjunctivitis Medications


Definition of Keratoconjunctivitis: Inflammation of the cornea and conjunctiva.

Drugs associated with Keratoconjunctivitis

The following drugs and medications are in some way related to, or used in the treatment of Keratoconjunctivitis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.


Drug List: Ak-Cide Ak-Neo-Dex Ak-Poly-Bac Ak-Trol Alomide Blephamide-Suspension Blephamide-S-O-P-Ointment Cetapred Cortisporin-Ophthalmic-Suspension-Drops-Suspension Cortomycin-Suspension Crolom-Ophthalmic Dexacidin Dexacine Dexasporin Fml-S-Suspension Fml-S-Liquifilm Isopto-Cetapred Maxitrol-Drops Methadex Metimyd Neo-Decadron Neo-Decadron-Ocumeter Neo-Dex Neo-Dexair Neo-Poly-Dex Neocidin-Ophthalmic-Ointment Neocin-Ointment Neosporin-Ophthalmic-Ointment Npd-Ophthalmic-Ointment Ocu-Lone-C Ocu-Spore-B Ocu-Trol Ocutricin Opticrom-Ophthalmic Poly-Pred-Drops Poly-Dex-Drops Polycin-B-Ointment Polysporin-Ophthalmic Polytracin-Ophthalmic Pred-G Pred-G-S-O-P Vasocidin-Drops Voltaren-Drops
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Josamina


Josamina may be available in the countries listed below.

Ingredient matches for Josamina Josamycin

Josamycin propionate (a derivative of Josamycin) is reported as an ingredient of Josamina in the following countries:

Spain

International Drug Name Search


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Aphthous Stomatitis, Recurrent Medications


Drugs associated with Aphthous Stomatitis, Recurrent

The following drugs and medications are in some way related to, or used in the treatment of Aphthous Stomatitis, Recurrent. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.


Drug List: Ala-Cort Ala-Scalp-Hp Anucort-Hc-Cream-Ointment-Suppository Anumed-Hc-Cream-Ointment-Suppository Aphthasol Aquanil-Hc Beta-Hc Caldecort Cetacort Cortaid Cortaid-Intensive-Therapy Cortaid-Maximum-Strength Cortaid-With-Aloe Cortalo-With-Aloe Corticaine Cortizone-For-Kids Cortizone-10-Cream Cortizone-10-Anal-Itch-Cream-Cream-Ointment-Suppository Cortizone-10-Intensive-Healing-Formula Cortizone-10-Plus Cortizone-5 Cotacort Dermarest-Dricort Dermarest-Eczema-Medicated Dermarest-Plus-Anti-Itch Dermtex-Hc Genasone-Aloe Gly-Cort Gynecort-Maximum-Strength Hemorrhoidal-Hc-Cream-Ointment-Suppository Hemril-30-Cream-Ointment-Suppository Hemril-Hc-Uniserts-Cream-Ointment-Suppository Hycort Hydrocortisone-1-In-Absorbase Hydrocortisone-With-Aloe-Cream Hytone-Cream Instacort-Gel Itch-X-Foam Lacticare-Hc Locoid-Cream Locoid-Lipocream Massengill-Medicated-Soft-Cloth Md-Hydrocortisone Neutrogena-T-Scalp Nucort-With-Aloe Nutracort-Lotion Nuzon Pandel Pediaderm-Hc-Lotion Procto-Kit-1-Cream-Ointment-Suppository Procto-Kit-2-5-Cream-Ointment-Suppository Procto-Pak-1-Cream-Ointment-Suppository Proctocare-Hc-Cream Proctocort-Cream-Ointment-Suppository Proctocream-Hc-Cream-Ointment-Suppository Proctosert-Hc-Cream-Ointment-Suppository Proctosol-Hc-Cream-Ointment-Suppository Proctozone-Hc-Cream-Ointment-Suppository Proctozone-H-Cream-Ointment-Suppository Recort-Plus Rectasol-Hc-Cream-Ointment-Suppository Rederm Sarnol-Hc Scalacort Scalpcort Scalpicin-Gel Texacort U-Cort Westcort-Cream
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Sentry HC Dermasphere Medicated Shampoo



Dosage Form: FOR ANIMAL USE ONLY
Medicated Shampoo For Dogs Indications and Usage for Sentry HC Dermasphere Medicated Shampoo Sentry HC Dermasphere Medicated Shampoo For Dogs is an antiseborrheic shampoo that aids in the removal of scales, crust, and excessive skin oil associated with seborrhea and other non-specific skin conditions.  Combines the proven benefits of oatmeal, sulfur and salicylic acid.  Contains Dermaspheres, a micro encapsulation technology that holds key ingredients in miscroscopic spheres and improves th effectiveness of the shampoo.
SIGNS:  Recommended for dogs with oily skin and coat.
Specially formulated for seborrhea and other skin conditions
Medicated Dermaspheres attach to skin and coat and release over time
Aids in the removal of scales, crust and excessive skin oil
DIRECTIONS FOR USE Shake well before use.  Wet the hair coat with warm water.  Apply a thin line of shampoo from the base of the neck to the base of the tail.  Massage the shampoo into wet hair coat.  Rinse and repeat.  May be used two to three times a week.  Discontinue use and consult a veterinarian if undue skin irritation develops or increases, or if the condition persists or recurs, as symptoms may be indicative of an underlying serious condition.
CAUTION For Animal Use Only.  FOR EXTERNAL USE ONLY.  Avoid contact with eyes or mucous membranes.  In case of contact, flush eyes with water and seek medical attention if irritation persists. KEEP OUT OF REACH OF CHILDREN
Warnings Wash hands after use.  In case if accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. ACTIVE INGREDIENTS Salicylic Acid 2%, Solubilized Sulfur 2%. OTHER INGREDIENTS Water, Sodium Lauryl Sulfate, Lauramide DEA, Glycerin, Colloidal Oatmeal, Dermaspheres, Magnesium Aluminum Silicate, Sodium Hydroxide, Fragrance, Hydroxypropyl Cellulosa, FD and C Blue #1.  May also contain sodium chloride and/or sodium hydroxide. How is Sentry HC Dermasphere Medicated Shampoo Supplied Net 12 fl oz (354 mL)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Distributed by:  Sergeant's Pet Care Products, Inc., Omaha NE 68130
Made in USA
PATENTED DERMASPHERE TECHNOLOGY
Patent #6,277,404
Sentry HC Dermasphere Medicated Shampoo FOR DOGS 
salicylic acid, solubilized sulfur  lotion/shampoo Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 21091-074 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 7.08 mL  in 354 mL SULFUR (SULFUR) SULFUR 7.08 mL  in 354 mL Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color blue (Aqua Blue) Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 21091-074-12 354 mL In 1 BOTTLE, PUMP None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/19/2008
Labeler - Sergeant's Pet Care Products, Inc. (876995171) Revised: 04/2010Sergeant's Pet Care Products, Inc.

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Fluticasone Ointment



Dosage Form: ointment
FLUTICASONE PROPIONATE OINTMENT 0.005%

Rx only

For Dermatologic Use Only—Not for Ophthalmic Use

Fluticasone Ointment Description

Fluticasone Propionate Ointment, 0.005% contains fluticasone propionate [(6?,11?,16?,17?) - 6,9, - difluoro - 11 - hydroxy - 16 - methyl - 3 - oxo - 17 - (1 - oxopropoxy)androsta - 1,4 - diene - 17 - carbothioic acid, S-(fluoromethyl) ester], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.

Chemically, fluticasone propionate is C25H31F3O5S. It has the following structural formula:

Fluticasone propionate has a molecular weight of 500.6. It is a white to off-white powder and is insoluble in water.

Each gram of Fluticasone Propionate Ointment, 0.005% contains fluticasone propionate 0.05 mg in a base of liquid paraffin, microcrystalline wax, propylene glycol, and sorbitan sesquioleate.

Fluticasone Ointment - Clinical Pharmacology

Like other topical corticosteroids, fluticasone propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Fluticasone propionate is lipophilic and has a strong affinity for the glucocorticoid receptor. It has weak affinity for the progesterone receptor, and virtually no affinity for the mineralocorticoid, estrogen, or androgen receptors. The therapeutic potency of glucocorticoids is related to the half-life of the glucocorticoid-receptor complex. The half-life of the fluticasone propionate-glucocorticoid receptor complex is approximately 10 hours.

Studies performed with Fluticasone Propionate Ointment, 0.005% indicate that it is in the medium range of potency as compared with other topical corticosteroids.

Pharmacokinetics Absorption

The activity of Fluticasone Propionate Ointment, 0.005% is due to the parent drug, fluticasone propionate. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusive dressing enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. In a study of 6 healthy volunteers applying 25 g of fluticasone propionate ointment 0.005% twice daily to the trunk and legs for up to 5 days under occlusion, plasma levels of fluticasone ranged from 0.08 to 0.22 ng/mL.

In an animal study using radiolabeled 0.05% fluticasone propionate cream and ointment preparations, rats received a topical dose of 1 g/kg for a 24-hour period. Total recovery of radioactivity was approximately 80% at the end of 7 days. The majority of the dose (73%) was recovered from the surface of the application site. Less than 1% of the dose was recovered in the skin at the application site. Approximately 5% of the dose was absorbed systemically through the skin. Absorption from the skin continued for the duration of the study (7 days), indicating a long retention time at the application site.

Distribution

Following intravenous administration of 1 mg of fluticasone propionate in healthy volunteers, the initial disposition phase for fluticasone propionate was rapid and consistent with its high lipid solubility and tissue binding. The apparent volume of distribution averaged 4.2 L/kg (range, 2.3-16.7 L/kg). The percentage of fluticasone propionate bound to human plasma proteins averaged 91%. Fluticasone propionate is weakly and reversibly bound to erythrocytes. Fluticasone propionate is not significantly bound to human transcortin.

Metabolism

No metabolites of fluticasone propionate were detected in an in vitro study of radiolabeled fluticasone propionate incubated in a human skin homogenate. The total blood clearance of systemically absorbed fluticasone propionate averages 1093 mL/min (range, 618-1702 mL/min) after a 1 mg intravenous dose, with renal clearance accounting for less than 0.02% of the total. Fluticasone propionate is metabolized in the liver by cytochrome P450 3A4-mediated hydrolysis of the 5-fluoromethyl carbothioate grouping. This transformation occurs in 1 metabolic step to produce the inactive 17-?-carboxylic acid metabolite, the only known metabolite detected in man. This metabolite has approximately 2000 times less affinity than the parent drug for the glucocorticoid receptor of human lung cytosol in vitro and negligible pharmacological activity in animal studies. Other metabolites detected in vitro using cultured human hepatoma cells have not been detected in man.

Excretion

Following an intravenous dose of 1 mg in healthy volunteers, fluticasone propionate showed polyexponential kinetics and had an average terminal half-life of 7.2 hours (range, 3.2-11.2 hours).

Indications and Usage for Fluticasone Ointment

Fluticasone Propionate Ointment, 0.005% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adult patients.

Contraindications

Fluticasone Propionate Ointment, 0.005% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

Precautions General

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal from treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (see PRECAUTIONS - Pediatric Use).

Fluticasone Propionate Ointment, 0.005% may cause local cutaneous adverse reactions (see ).

If irritation develops, Fluticasone Propionate Ointment, 0.005% should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing. If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Fluticasone Propionate Ointment, 0.005% should be discontinued until the infection has been adequately controlled.

Fluticasone Propionate Ointment, 0.005% should not be used in the presence of preexisting skin atrophy and should not be used where infection is present at the treatment site. Fluticasone Propionate Ointment, 0.005% should not be used in the treatment of rosacea and perioral dermatitis.

Information for Patients

Patients using topical corticosteroids should receive the following information and instructions:

This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. This medication should not be used for any disorder other than that for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician. Patients should report to their physician any signs of local adverse reactions. This medication should not be used on the face, underarms, or groin areas unless directed by a physician. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician. Laboratory Tests

The following tests may be helpful in evaluating patients for HPA axis suppression:

ACTH stimulation test

A.M. plasma cortisol test

Urinary free cortisol test

A concentrated fluticasone propionate ointment, 0.05% (10 times that of the marketed Fluticasone Propionate Ointment, 0.005%) suppressed 24-hour urinary free cortisol levels in 2 of 6 patients when used at a dose of 30 g/day for a week in patients with psoriasis or atopic eczema. No suppression of A.M. plasma cortisol was observed. In a second study of the same concentrated formulation of fluticasone propionate ointment, 0.005%, depression of A.M. plasma cortisol levels was noted in 2 of 8 normal volunteers when applied at doses of 50 g/day for 21 days. Morning plasma levels returned to normal levels within 4 days upon discontinuation of fluticasone propionate. In this study, there was no corresponding decrease in 24-hour urinary free cortisol levels.

In a study of 35 pediatric patients treated with fluticasone propionate ointment, 0.005% for atopic dermatitis over at least 35% of body surface area, subnormal adrenal function was observed with cosyntropin stimulation testing at the end of 3 to 4 weeks of treatment in 4 patients who had normal testing prior to treatment. It is not known if these patients had recovery of adrenal function because follow-up testing was not performed (see PRECAUTIONS - Pediatric Use and ADVERSE REACTIONS. Adrenal suppression was indicated by either a ? 5 mcg/dL pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol ? 18 mcg/dL, and/or an increase of < 7 mcg/dL from the baseline cortisol level.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Two 18-month studies were performed in mice to evaluate the carcinogenic potential of fluticasone propionate when given topically (as an 0.05% ointment) and orally. No evidence of carcinogenicity was found in either study.

Fluticasone propionate was not mutagenic in the standard Ames test, E. coli fluctuation test, S. cerevisiae gene conversion test, or Chinese Hamster ovarian cell assay. It was not clastogenic in mouse micronucleus or cultured human lymphocyte tests.

In a fertility and general reproductive performance study in rats, fluticasone propionate administered subcutaneously to females at up to 50 mcg/kg per day and to males at up to 100 mcg/kg per day (later reduced to 50 mcg/kg per day) had no effect upon mating performance or fertility. These doses are approximately 150 and 300 times, respectively, the human systemic exposure following use of the recommended human topical dose of Fluticasone Propionate Ointment, 0.005%, assuming human percutaneous absorption of approximately 3% and the use in a 70-kg person of 15 g/day.

Pregnancy Teratogenic Effects Pregnancy Category C

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Teratology studies in the mouse demonstrated fluticasone propionate to be teratogenic (cleft palate) when administered subcutaneously in doses of 45 mcg/kg per day and 150 mcg/kg per day. This dose is approximately 140 and 450 times, respectively, the human topical dose of Fluticasone Propionate Ointment, 0.005%. There are no adequate and well-controlled studies in pregnant women. Fluticasone Propionate Ointment, 0.005% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Fluticasone Propionate Ointment, 0.005% is administered to a nursing woman.

Pediatric Use

Use of Fluticasone Propionate Ointment, 0.005% in pediatric patients is not recommended. In a study of 35 pediatric patients treated with fluticasone propionate ointment 0.005% for atopic dermatitis over at least 35% of body surface area, subnormal adrenal function was observed with cosyntropin stimulation testing at the end of 3 to 4 weeks of treatment in 4 patients who had normal testing prior to treatment. It is not known if these patients had recovery of adrenal function because follow-up testing was not performed (see PRECAUTIONS - Pediatric Use and ADVERSE REACTIONS). The decreased responsiveness to cosyntropin testing was not correlated to age of patient, amount of fluticasone propionate ointment used, or serum levels of fluticasone propionate. Plasma fluticasone propionate were not performed in a six-month old patient who demonstrated an abnormal response to cosyntropin stimulation testing. Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface to body weight ratio. HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Geriatric Use

A limited number of patients above 65 years of age (n = 203) have been treated with Fluticasone Propionate Ointment, 0.005% in US and non-US clinical trials. While the number of patients is too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this population were similar to those reported by younger patients. Based on available data, no adjustment of dosage of Fluticasone Propionate Ointment, 0.005% in geriatric patients is warranted.

Adverse Reactions

In controlled clinical trials, the total incidence of adverse reactions associated with the use of Fluticasone Propionate Ointment, 0.005% was approximately 4%. These adverse reactions were usually mild, self-limiting, and consisted primarily of pruritus, burning, hypertrichosis, increased erythema, hives, irritation, and lightheadedness. Each of these events occurred individually in less than 1% of patients. In a study of 35 pediatric patients treated with fluticasone propionate ointment 0.005% for atopic dermatitis over at least 35% of body surface area, subnormal adrenal function was observed with cosyntropin stimulation testing at the end of 3 to 4 weeks of treatment in 4 patients who had normal testing prior to treatment. It is not known if these patients had recovery of adrenal function because follow-up testing was not performed (see PRECAUTIONS - Pediatric Use and ADVERSE REACTIONS). Telangiectasia on the face was noted in one patient on the eighth day of a four week treatment period. Facial use was discontinued and the telangiectasia resolved.

The following additional local adverse reactions have been reported infrequently with topical corticosteroids, including fluticasone propionate, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. Also, there are reports of the development of pustular psoriasis from chronic plaque psoriasis following reduction or discontinuation of potent topical corticosteroid products.

Overdosage

Topically applied Fluticasone Propionate Ointment, 0.005% can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

Fluticasone Ointment Dosage and Administration

Apply a thin film of Fluticasone Propionate Ointment, 0.005% to the affected skin areas twice daily. Rub in gently.

Fluticasone Propionate Ointment, 0.005% should not be used with occlusive dressings.

Geriatric Use

In studies where geriatric patients (65 years of age or older, see ) have been treated with Fluticasone Propionate Ointment, 0.005%, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

How is Fluticasone Ointment Supplied

Fluticasone Propionate Ointment, 0.005% is available as follows:

15 g tube (NDC 45802-221-35)

30 g tube (NDC 45802-221-11)

60 g tube (NDC 45802-221-37)

STORAGE

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

DISTRIBUTED BY PERRIGO®

ALLEGAN, MI 49010

Rev. 07/09

0A300 RC J4

Principal Display Panel - 15 g Carton

Fluticasone Propionate Ointment, 0.005%

For Dermatologic Use Only - Not for Ophthalmic Use

Rx Only

Fluticasone Propionate Ointment, 0.005% Carton Image

Principal Display Panel - 15 g Tube

Fluticasone Propionate Ointment, 0.005%

For Dermatologic Use Only - Not for Ophthalmic Use

Rx Only

Fluticasone Propionate Ointment, 0.005% Tube Image


FLUTICASONE PROPIONATE 
fluticasone propionate  ointment Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 45802-221 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLUTICASONE PROPIONATE (FLUTICASONE) FLUTICASONE PROPIONATE 0.05 mg  in 1 g Inactive Ingredients Ingredient Name Strength MINERAL OIL   MICROCRYSTALLINE WAX   PROPYLENE GLYCOL   SORBITAN   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 45802-221-35 1 TUBE In 1 CARTON contains a TUBE 1 15 g In 1 TUBE This package is contained within the CARTON (45802-221-35) 2 45802-221-11 1 TUBE In 1 CARTON contains a TUBE 2 30 g In 1 TUBE This package is contained within the CARTON (45802-221-11) 3 45802-221-37 1 TUBE In 1 CARTON contains a TUBE 3 60 g In 1 TUBE This package is contained within the CARTON (45802-221-37)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076668 07/09/2007
Labeler - Perrigo New York Inc (078846912) Revised: 07/2011Perrigo New York Inc More Fluticasone Ointment resources Fluticasone Ointment Use in Pregnancy & Breastfeeding Fluticasone Ointment Drug Interactions Fluticasone Ointment Support Group 5 Reviews for Fluticasone - Add your own review/rating Compare Fluticasone Ointment with other medications Atopic Dermatitis Dermatologic Lesion Lichen Sclerosus
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Brolene Eye Ointment


Brolene 0.15% w/w Eye Ointment

dibropropamidine isetionate

Is this leaflet hard to see or read?

Phone 01483 505515 for help

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription.

However, you still need to use Brolene Eye Ointment carefully to get the best results from it.

Keep this leaflet. You may need to read it again Ask your pharmacist if you need more information or advice You must contact a doctor if your symptoms worsen or do not improve after 2 days If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist In this leaflet: 1. What Brolene Eye Ointment is and what it is used for 2. Before you use Brolene Eye Ointment 3. How to use Brolene Eye Ointment 4. Possible side effects 5. How to store Brolene Eye Ointment 6. Further information What Brolene Eye Ointment is and what it is used for

Brolene Eye Ointment contains a medicine called dibrompropamidine isetionate. This belongs to a group of medicines called disinfectants and antifungals. It works by stopping the growth of bacteria, allowing your body to fight off the infection.

It is used for minor infections of the eye or eyelid.

Signs include sore, red or inflamed eyes, stickiness or a crust on the eyelids.

Before you use Brolene Eye Ointment Do not use this medicine and tell your doctor or pharmacist if: You are allergic (hypersensitive) to dibrompropamidine isetionate or any of the other ingredients of Brolene Eye Ointment (listed in Section 6 below)

Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat, tongue and worsening of redness, itching or swelling of the eye or eyelid

Do not use this medicine if this applies to you. If you are not sure, talk to your doctor or pharmacist before using Brolene Eye Ointment.

Take special care with Brolene Eye Ointment

Check with your doctor or pharmacist before taking your medicine if:

You wear contact lenses. You should not wear contact lenses while using the ointment.

If you are not sure, talk to your doctor or pharmacist before using Brolene Eye Ointment.

Pregnancy and breast-feeding

Talk to your doctor before using this medicine if you are pregnant, might become pregnant, or think you may be pregnant.

If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking or using any medicine.

Driving and using machines

You may have blurred eyesight straight after using this medicine. If this happens, do not drive or use any tools or machines until you can see clearly.

Important information about some of the ingredients of Brolene Eye Ointment

Brolene Eye Ointment contains lanolin. This may cause local skin reactions (e.g. contact dermatitis).

How to use Brolene Eye Ointment

Always use Brolene Eye Ointment exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

How to use this medicine Wash your hands Remove the cap from the tube Tilt your head back Squeeze 1cm of the ointment inside the lower lid without touching your eye with the tube Close your eye Wipe away any excess ointment with a clean tissue Always put the cap back on the tube as soon as you have used it How much to use Apply the ointment in the affected eye once or twice each day Use for at least 2 days If your symptoms worsen or do not improve after 2 days, talk to your doctor or pharmacist If you forget to use Brolene Eye Ointment

If you forget a dose, use your Ointment as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not use a double dose to make up for a forgotten dose.

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

Possible side effects

Like all medicines, Brolene Eye Ointment can cause side effects, although not everybody gets them.

Stop using Brolene Eye Ointment and see a doctor if: You get any kind of skin problem, such as a rash or itching around your eyes or they become more red

Talk to your doctor or pharmacist if you get any of the side effects or if you notice any side effects not listed in this leaflet.

How to store Brolene Eye Ointment

Keep this medicine in a safe place where children cannot see or reach it.

Do not use Brolene Eye Ointment after the expiry date which is stated on the tube and carton. The expiry date refers to the last day of that month.

Store below 25?C.

Brolene Eye Ointment is sterile when you buy it, so you must not keep it for more than four weeks after opening the container.

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

Further information What Brolene Eye Ointment contains The ointment contains 0.15%w/w of the active substance, dibrompropamidine isetionate The other ingredients are soft yellow paraffin, liquid paraffin, anhydrous lanolin, phenylethanol and water for injections What Brolene Eye Ointment looks like and contents of the pack

Brolene Eye Ointment is yellow to pale golden brown, smooth and almost translucent. It is supplied in 5g aluminium collapsible tubes fitted with a screw capped nozzle and a polythene cap.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sanofi-aventis One Onslow Street Guildford Surrey GU1 4YS UK Tel:01483 505515 Fax:01483 535432 email:uk-medicalinformation@sanofi-aventis.com

Manufacturer

Patheon UK Limited Covingham Swindon Wiltshire SN3 5BZ

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in 08/2007

© Sanofi-aventis, 2007

BNE 90270


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