Clobetasol Shampoo

• Tell all of your health care providers that you take clobetasol shampoo. This includes your doctors, nurses, pharmacists, and dentists.
• Talk with your doctor before you use other drugs or products on your skin.
• Do not put on cuts, scrapes, or damaged skin.
• Do not use longer than you have been told by the doctor.
• This medicine may cause harm if swallowed. If this medicine is swallowed, call a doctor or poison control center right away.
• Use with care in children. Talk with the doctor.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• Some products are not approved for use in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using clobetasol shampoo while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Use as you have been told, even if your signs get better.
• Do not take clobetasol shampoo by mouth. Use on your scalp and hair only. Keep out of your mouth, nose, ears, and eyes (may burn).
• Do not put on the face, underarms, or the groin area. Do not put on skin that is thinning.
• Wash your hands before and after use.
• To use on the scalp, part your hair. Put a thin layer on the affected skin. Put on a dry scalp. Rub in gently. Leave on the scalp for 15 minutes.
• Do not cover head while shampoo is on hair.
• After 15 minutes, wet the hair with water and lather.
• Rinse well.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses or extra doses.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store at room temperature. Do not refrigerate or freeze.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about clobetasol shampoo, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about clobetasol shampoo. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using clobetasol shampoo.

Review Date: October 4, 2017

Pregnancy

Teratogenic effects:

Pregnancy Category C.

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

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 is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and the mouse.

Clobetasol propionate has greater teratogenic potential than steroids that are less potent.

The effect of clobetasol propionate on pregnancy outcome and development of offspring was studied in the rat. Clobetasol propionate was administered subcutaneously to female rats twice daily (0, 12.5, 25, and 50 μg/kg/day) from day 7 of presumed gestation through day 25 of lactation or day 24 presumed gestation for those rats that did not deliver a litter. The maternal no-observed-effect-level (NOEL) for clobetasol propionate was less than 12.5 μg/kg/day due to reduced body weight gain and feed consumption during the gestation period. The reproductive NOEL in the dams was 25 μg/kg/day (ratio of animal dose to proposed human dose of 0.07 on a mg/m2/day basis) based on prolonged delivery at a higher dose level. The no-observed-adverse-effect-level (NOAEL) for viability and growth in the offspring was 12.5 μg/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m2/day basis) based on incidence of stillbirths, reductions in pup body weights on days 1 and 7 of lactation, increased pup mortality, increases in the incidence of umbilical hernia, and increases in the incidence of pups with cysts on the kidney at higher dose levels during the preweaning period. The weights of the epididymides and testes were significantly reduced at higher dosages. Despite these changes, there were no effects on the mating and fertility of the offspring.

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 shampoo, 0.05% is administered to a nursing woman.

Pediatric Use

Use of clobetasol propionate shampoo, 0.05% in patients under 18 years old is not recommended due to potential for HPA axis suppression [see Warnings and Precautions (5.1)]

The effect of clobetasol propionate shampoo, 0.05% on HPA axis suppression was evaluated in one trial in adolescents 12 to 17 years of age with moderate to severe scalp psoriasis with involvement of at least 25% of the scalp. In this trial, 5 of 12 evaluable subjects developed suppression of their HPA axis following 4 weeks of treatment with clobetasol propionate shampoo, 0.05%, applied once daily for 15 minutes to a dry scalp before lathering and rinsing. Only 1 of the 5 subjects who had suppression was tested for recovery of HPA axis, and this subject recovered after 2 weeks.

No studies have been performed in patients under the age of 12. 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 and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. Therefore, use is not recommended in patients under the age of 18.

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

Clinical studies of clobetasol propionate shampoo, 0.05% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. In general, dose selection for an elderly patient should be made with caution, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Topically applied, Clobetasol Propionate Shampoo, 0.05% can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1)]

Clobetasol Propionate Shampoo, 0.05% is a translucent, colorless viscous liquid, supplied in 4 fl. oz. (118 mL) bottles. NDC 45802-961-26

Storage:

Keep bottle tightly closed. Store at USP controlled room temperature 68° to 77°F (20° - 25°C), with excursions permitted between 59° and 86°F (15° - 30°C).

See FDA-approved patient labeling (Patient Information)

Information for Patients

Inform the patient using topical corticosteroids to adhere to the following instructions:

• This medication is to be used as directed by the physician and should not be used longer than the prescribed time period. • Clobetasol Propionate Shampoo, 0.05% is for external use only. It should not be used on the face, underarms or groin areas. Avoid contact with the eyes and lips. • This medication should not be used for any disorder other than that for which it was prescribed. • The scalp area should not be covered while the medication is on the scalp (e.g., shower cap, bathing cap) so as to be occlusive unless directed by the physician. • Patients should report any signs of local or systemic adverse reactions to their physician. • As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, contact the physician. • Patients should wash their hands after applying the medication. • Patients should inform their physician(s) that they are using Clobetasol Propionate Shampoo, 0.05% if surgery is contemplated. • Do not use other corticosteroid-containing products while using Clobetasol Propionate Shampoo, 0.05%. • Patients should not use more than 50 g (50 mL or 1.75 fl. oz.) per week of Clobetasol Propionate Shampoo, 0.05%.

Made in Israel

Manufactured By Perrigo

Yeruham, Israel

Distributed By

Perrigo®

Allegan, MI 49010 • www.perrigo.com

Rev 11-15

: 6A900 RC J1

Patient Information

Clobetasol Propionate Shampoo, 0.05%

Important: For use on the scalp only. Do not get Clobetasol Propionate Shampoo, 0.05% near or in your eyes, mouth or vagina.

Read the Patient Information that comes with Clobetasol Propionate Shampoo, 0.05% before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is Clobetasol Propionate Shampoo, 0.05%?

• Clobetasol Propionate Shampoo, 0.05% is a prescription corticosteroid medicine used to treat adults with moderate to severe forms of scalp psoriasis. Clobetasol Propionate Shampoo, 0.05% is for use on the scalp only (topical). • Clobetasol Propionate Shampoo, 0.05% should be used for the shortest amount of time needed to treat your scalp psoriasis. • You should not use Clobetasol Propionate Shampoo, 0.05% for longer than 4 weeks in a row. • You should not use more than 50 mL (1.75 fluid ounces) of Clobetasol Propionate Shampoo, 0.05% in one week.

You should not use Clobetasol Propionate Shampoo, 0.05%:

• on your face, underarms (armpits) or groin areas. Avoid getting Clobetasol Propionate Shampoo, 0.05% in your eyes or on your lips.   Clobetasol Propionate Shampoo, 0.05% should not be used in children under 18 years of age.

What should I tell my doctor before using Clobetasol Propionate Shampoo, 0.05%?

Before you use Clobetasol Propionate Shampoo, 0.05%, tell your doctor if you:

• have a scalp infection. You may need medicine to treat the scalp infection before you use Clobetasol Propionate Shampoo, 0.05%. • have any open sores or cuts on your scalp • plan to have surgery • have acne vulgaris, rosacea, or a rash around your mouth (perioral dermatitis) • have any other medical conditions • are pregnant or plan to become pregnant. It is not known if Clobetasol Propionate Shampoo, 0.05% can harm your unborn baby. • are breast-feeding or plan to breast-feed. It is not known if Clobetasol Propionate Shampoo, 0.05% passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use Clobetasol Propionate Shampoo, 0.05%.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids. You should not use other products that contain corticosteroids while you are using Clobetasol Propionate Shampoo, 0.05%. Ask your doctor or pharmacist if you are not sure.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist if you get a new medicine.

How should I use Clobetasol Propionate Shampoo, 0.05%?

• Use Clobetasol Propionate Shampoo, 0.05% exactly as your doctor tells you to use it. • Your doctor should tell you how much Clobetasol Propionate Shampoo, 0.05% to use and where to apply it. • Clobetasol Propionate Shampoo, 0.05% is for use on your scalp only (topical). • Apply Clobetasol Propionate Shampoo, 0.05% on affected areas of your scalp one time each day. • Use only enough Clobetasol Propionate Shampoo, 0.05% to cover the affected areas of your scalp. • Do not use Clobetasol Propionate Shampoo, 0.05% on your face, groin, or underarms. Avoid getting Clobetasol Propionate Shampoo, 0.05% in your eyes or on your lips. • Do not wet your hair before using Clobetasol Propionate Shampoo, 0.05%. • If Clobetasol Propionate Shampoo, 0.05% gets on any part of your body other than your scalp, rinse the area well with water. • You should not bandage or cover your head with a shower cap, bathing cap, or a towel, while Clobetasol Propionate Shampoo, 0.05% is on your scalp, unless your doctor tells you to. • Tell your doctor if your scalp condition is not getting better after 4 weeks of using Clobetasol Propionate Shampoo, 0.05%. You should not use Clobetasol Propionate Shampoo, 0.05% for more than 4 weeks unless your doctor tells you to.

See the “Instructions for Use” at the end of the Patient Information for detailed information about the right way to use Clobetasol Propionate Shampoo, 0.05%.

What are the possible side effects of Clobetasol Propionate Shampoo, 0.05%?

Clobetasol Propionate Shampoo, 0.05% can pass through your skin. Too much Clobetasol Propionate Shampoo, 0.05% passing through your skin can cause your adrenal glands to stop working. Your doctor may do blood tests to check how well your adrenal glands are working.

The most common side effects of Clobetasol Propionate Shampoo, 0.05% include:

• burning or stinging at the site of application • itching • swelling • inflamed hair follicle • acne • dry, itchy and reddened skin • hair loss • rash or hives • thinning of the skin • widening of small blood vessels in the skin

If you go to another doctor for illness, injury or surgery, tell that doctor that you are using Clobetasol Propionate Shampoo, 0.05%.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Clobetasol Propionate Shampoo, 0.05%. For more information, ask your doctor or pharmacist.

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

You may also report side effects to Perrigo at 1-866-634-9120

How should I store Clobetasol Propionate Shampoo, 0.05%?

• Store Clobetasol Propionate Shampoo, 0.05% at room temperature between 68°F to 77°F (20°C to 25°C). • Keep the Clobetasol Propionate Shampoo, 0.05% bottle tightly closed.

Keep Clobetasol Propionate Shampoo, 0.05% and all medicines out of the reach of children.

General information about Clobetasol Propionate Shampoo, 0.05%

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Clobetasol Propionate Shampoo, 0.05% for a condition for which it was not prescribed. Do not give Clobetasol Propionate Shampoo, 0.05% to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Clobetasol Propionate Shampoo, 0.05%. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Clobetasol Propionate Shampoo, 0.05% that is written for health professionals.

What are the ingredients in Clobetasol Propionate Shampoo, 0.05%?

Active ingredient: clobetasol propionate

Inactive ingredients (shampoo base): alcohol, coco-betaine, hydrochloric acid, polyquaternium-10, purified water, and sodium laureth sulfate.

Instructions for Use

Clobetasol Propionate Shampoo, 0.05%

Important: For use on the scalp only. Do not get Clobetasol Propionate Shampoo, 0.05% near or in your eyes, mouth or vagina.

Read the Instructions for Use that comes with Clobetasol Propionate Shampoo, 0.05% before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

How to apply Clobetasol Propionate Shampoo, 0.05% to your scalp:

Your hair should be dry when you apply Clobetasol Propionate Shampoo, 0.05% to your scalp.

Do not get Clobetasol Propionate Shampoo, 0.05% on your face, in your eyes or on your lips. If Clobetasol Propionate Shampoo, 0.05%does get on these areas, rinse well with water.

Step 1: To apply Clobetasol Propionate Shampoo, 0.05% to your scalp, part your hair at the area where it is to be applied.

Step 2: Hold the bottle of Clobetasol Propionate Shampoo, 0.05% over the affected area. Gently squeeze the bottle and apply a small amount of shampoo to the affected area.

Step 3: Gently rub Clobetasol Propionate Shampoo, 0.05% into the affected area so that only the affected area is covered with a thin, even layer of Clobetasol Propionate Shampoo, 0.05%.

Step 4: Repeat Steps 1 through 3 to apply Clobetasol Propionate Shampoo, 0.05% to other affected areas on your scalp as instructed by your doctor.

Step 5: Wash your hands after applying Clobetasol Propionate Shampoo, 0.05%.

Step 6: Leave Clobetasol Propionate Shampoo, 0.05% on your scalp for 15 minutes. You should not bandage or cover your head with a shower cap, bathing cap, or a towel while Clobetasol PropionateShampoo, 0.05% is on your scalp, unless your doctor tells you to.

Step 7: After 15 minutes have passed, wet your hair with water. Lather and rinse your hair and scalp completely. Rinse any other parts of your body that come into contact with Clobetasol Propionate Shampoo, 0.05%, such as your hands, face, neck and shoulders.

No other shampoo is needed, but you may wash your hair with a non-medicated shampoo after using Clobetasol Propionate Shampoo, 0.05%.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Made in Israel

Manufactured By Perrigo

Yeruham, Israel

Distributed By

Perrigo®

Allegan, MI 49010 • www.perrigo.com

Rev 11-15

: 6A900 RC J1