CLOBETASOL PROPIONATE shampoo

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)

Available from:

Padagis Israel Pharmaceuticals Ltd

INN (International Name):

CLOBETASOL PROPIONATE

Composition:

CLOBETASOL PROPIONATE 0.05 g in 100 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clobetasol Propionate Shampoo, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older. Treatment should be limited to 4 consecutive weeks. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week. Patients should be instructed to use Clobetasol Propionate Shampoo, 0.05% for the minimum time period necessary to achieve the desired results [see Dosage and Administration (2)] . Use in patients younger than 18 years of age is not recommended due to numerically high rates of hypothalamic-pituitary-adrenal (HPA) axis suppression [see Warnings and Precautions (5.1) andUse in Specific Populations (8.4)] . Clobetasol Propionate Shampoo, 0.05% should not be used on the face, groin or axillae. Avoid any contact of the drug product with the eyes and lips. In case of contact, rinse thoroughly with water all parts of the body that came in contact with the shampoo. None 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. 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. 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. 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. 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. Manufactured By Padagis Yeruham, Israel Distributed By Padagis, Allegan, MI 49010 • www.padagis.com Rev 06-22

Product summary:

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).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE SHAMPOO
PADAGIS ISRAEL PHARMACEUTICALS LTD
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOBETASOL
PROPIONATE SHAMPOO SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
CLOBETASOL PROPIONATE SHAMPOO.
CLOBETASOL PROPIONATE SHAMPOO, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1985
INDICATIONS AND USAGE
Clobetasol Propionate Shampoo, 0.05% is a corticosteroid indicated for
the treatment of moderate to
severe scalp psoriasis in subjects 18 years of age and older. (1)
Limitations of Use: (1)
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Shampoo, 0.05% (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Clobetasol propionate is a highly potent topical corticosteroid that
has been shown to suppress the
hypothalamic-pituitary-adrenal (HPA) axis at the lowest doses tested.
(5)
Cushing’s syndrome, hyperglycemia and unmasking of latent diabetes
mellitus can also result from
systemic absorption of topical corticosteroids. (5)
Systemic absorption may require periodic evaluation for HPA axis
suppression. Modify use if HPA axis
suppression develops. (5)
Children may be more susceptible to systemic toxicity from use of
topical corticosteroids. (5.1, 8.4) (5)
If irritation develops in the presence of dermatological infections,
the use of an appropriate antifungal or
antibacterial agent should be instituted. If a favorable response does
not occur promptly, use of Clobetasol
Propionate Shampoo, 0.05% should be discontinued until the infection
has been adequately controlled.
(5.3) (5)
Local adverse reactions with topical corticosteroids may occur more
frequently with the use of occlusive
dressings and higher potency corticosteroids, including clobetasol
propionate. These reactions include:
folliculitis, acneiform eruptions, hypopigmentation, perioral
dermatitis, allergic contact dermatitis,
secondary infection, striae and miliaria. (5.4) (5)
ADVERSE REACTIONS
The most common