Label: CLOBETASOL PROPIONATE- clobetasol propionate ointment usp, 0.05% ointment

  • NDC Code(s): 21922-017-04, 21922-017-05, 21922-017-06, 21922-017-07
  • Packager: Encube Ethicals Private Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 19, 2019

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  • DESCRIPTION

    Clobetasol propionate ointment USP 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 (11β, 16β)-21-chloro-9-fluoro-11-hydroxy-16-methyt-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula:




    Structure 2


    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 ointment USP, 0.05% contains clobetasol propionate 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.




  • 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. 
    Studies performed with clobetasol propionate  ointment indicate that it is   in the super-high range of potency as compared with other topical corticosteroids.


  • INDICATIONS AND USAGE

    Clobetasol propionate ointment USP, 0.05%  is super-high potency corticosteroid formulations 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.

    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

    Clobetasol propionate ointment USP, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

  • PRECAUTIONS

    General:

    Clobetasol propionate ointment USP, 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.

    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 suppression.

    Clobetasol propionate ointment produced HPA axis suppression when used at doses as low as 2 g/day for 1 week in patients with eczema.
     
    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).

    If irritation develops, clobetasol propionate ointment 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 ointment should be discontinued until the infection has been adequately controlled.

    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.  

    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 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:

    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 ointment. 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 ointment. 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 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 either clobetasol propionate ointment is administered to a nursing woman.

    Pediatric Use:

    Safety and effectiveness of clobetasol propionate ointment in pediatric patients have not been established. Use in pediatric patients under 12 years of age 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:

    A limited number of patients at or above 65 years of age have been treated with clobetasol propionate ointment (n = 101) 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 clobetasol propionate ointment in geriatric patients is warranted.


  • ADVERSE REACTIONS

    In controlled clinical trials, the most frequent adverse events reported for clobetasol propionate ointment were burning sensation, irritation, and itching in 0.5% of treated patients. Less frequent adverse reactions were stinging, cracking, erythema, folliculitis, numbness of fingers, skin atrophy, and telangiectasia.

    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 have been reported with topical corticosteroids, 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, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria.

    To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.



  • OVERDOSAGE

    Topically applied clobetasol propionate ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).




  • DOSAGE AND ADMINISTRATION

    Apply a thin layer of clobetasol propionate ointment to the affected skin areas twice daily and rub in gently and completely. (See INDICATIONS AND USAGE.) 

    Clobetasol propionate ointment are super- high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks , and amounts greater than 50 g per 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 ointment should not be used with occlusive dressings.


    Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with clobetasol propionate ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

  • HOW SUPPLIED

    Clobetasol Propionate Ointment USP, 0.05% is supplied in:
    15 g tube (NDC 21922-017-04)
    30 g tube (NDC 21922-017-05)
    45 g tube (NDC 21922-017-06)
    60 g tube (NDC 21922-017-07) 
    Store at controlled room temperature 15°-30°C (59°-86°F). DO NOT REFRIGERATE.  

    Manufactured by:
    Encube Ethicals Pvt. Ltd.
    Plot No. C1, Madkaim Ind. Estate,
    Madkaim, Post: Mardol,
    Ponda, Goa - 403 404,
    India.

      

    Distributed by:

    Encube Ethicals Inc.

    200 Meredith Avenue,

    Suite 101A

    Durham, NC 27713

    USA

    Rev: 02

    September 2019


  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-15 G TUBE
    NDC 21922-017-04


    Clobetasol Propionate Ointment USP, 0.05%
    Rx only


    For dermatologic use only.
    Not for ophthalmic use.


    NET WT 15 grams

    tube-15g.jpg


    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-15 G CARTON
    NDC 21922-017-04


    Clobetasol Propionate Ointment USP, 0.05%

    Rx only


    For dermatologic use only.
    Not for ophthalmic use.


    NET WT 15 grams

    carton-15g.jpg




    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-30 G TUBE
    NDC 21922-017-05


    Clobetasol Propionate Ointment USP, 0.05%

    Rx only


    For dermatologic use only.
    Not for ophthalmic use.

    NET WT 30 grams
    tube-30g.jpg


    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-30  G CARTON
    NDC 21922-017-05

    Clobetasol Propionate Ointment USP, 0.05%
    Rx only

    For dermatologic use only.
    Not for ophthalmic use.

    NET WT 30 grams
    carton-30g.jpg

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-45  G TUBE
    NDC 21922-017-06


    Clobetasol Propionate Ointment USP, 0.05%
    Rx only


    For dermatologic use only.
    Not for ophthalmic use.

    NET WT 45 grams

    tube-45g.jpg

     
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-45  G CARTON
    NDC 21922-017-06

    Clobetasol Propionate Ointment USP, 0.05%
    Rx only

    For dermatologic use only.
    Not for ophthalmic use.


    NET WT 45 grams



    carton-45g.jpg

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-60 G TUBE
    NDC 21922-017-07


    Clobetasol Propionate Ointment USP, 0.05%
    Rx only


    For dermatologic use only.
    Not for ophthalmic use.

    NET WT 60 grams



    tube-60g.jpg


    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL- 60 G CARTON
    NDC 21922-017-07

    Clobetasol Propionate Ointment USP, 0.05%
    Rx only

    For dermatologic use only.
    Not for ophthalmic use.


    NET WT 60 grams


    carton-60g.jpg

      


  • INGREDIENTS AND APPEARANCE
    CLOBETASOL PROPIONATE 
    clobetasol propionate ointment usp, 0.05% ointment
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:21922-017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H) CLOBETASOL PROPIONATE0.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21922-017-041 in 1 CARTON11/18/2019
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:21922-017-051 in 1 CARTON11/18/2019
    230 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:21922-017-061 in 1 CARTON11/18/2019
    345 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:21922-017-071 in 1 CARTON11/18/2019
    460 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21129511/18/2019
    Labeler - Encube Ethicals Private Limited (915834105)
    Registrant - Encube Ethicals Private Limited (915834105)
    Establishment
    NameAddressID/FEIBusiness Operations
    Encube Ethicals Private Limited725076298ANALYSIS(21922-017) , LABEL(21922-017) , MANUFACTURE(21922-017) , PACK(21922-017) , PARTICLE SIZE REDUCTION(21922-017)