Clobetasol Propionate (Clobetasol Propionate)

Trade Name : Clobetasol Propionate

Alembic Pharmaceuticals, Inc.

OINTMENT

Strength 0.5 mg/g

CLOBETASOL PROPIONATE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Clobetasol Propionate (Clobetasol Propionate) which is also known as Clobetasol Propionate and Manufactured by Alembic Pharmaceuticals, Inc.. It is available in strength of 0.5 mg/g per ml. Read more

Clobetasol Propionate (Clobetasol Propionate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Clobetasol Propionate Ointment USP, 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.
Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water. Chemically, it is 21-chloro-9-fluoro-11u03b2,17-dihydroxy-16u03b2-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula:
Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.

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 An n n 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 An n n .n nn
Pharmacokinetics:
Studies performed with clobetasol propionate ointment indicate that this is in the super-high range of potency as compared with other topical corticosteroids.

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 per 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.

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

General:
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 grams per 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 n n n ).n nn
If irritation develops, clobetasol propionate should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing n n n 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 should be discontinued until the infection has been adequately controlled.n nn
Information for Patients:
Laboratory Tests:
ACTH stimulation test
A.M. plasma cortisol test
Urinary free cortisol test.
Carcinogenesis, Mutagenesis, Impairment of Fertility: n- Saccharomyces cerevisiae n- E. coli
Pregnancy: n- Teratogenic Effectsn- 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 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
Pediatric Use: Safety and effectiveness of clobetasol propionate ointment in pediatric patients have not been established. Use in children 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 (see PRECAUTIONS).
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:

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 Alembic Pharmaceuticals, Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or n n n n

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

Apply a thin layer of clobetasol propionate ointment to the affected skin areas twice daily and rub in gently and completely. (See n n n )n nn
Clobetasol propionate ointment is super-high potency topical corticosteroids; therefore, n n n n
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:

Clobetasol Propionate Ointment USP, 0.05% is supplied in tamper-evident tubes as follows:
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) excursions permitted between 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F). [see USP Controlled Room Temperature].
Manufactured for:
Alembic Pharmaceuticals, Inc.
750 Route 202,
Bridgewater,
NJ 08807, USA
Manufactured by:
Encube Ethicals Pvt. Ltd.
Madkaim, Ponda,
Goa, India u2013 403404
Mfg. License No.: 361
Revised Date: 10/2019

NDC
Alembic Pharmaceuticals, Inc.
Clobetasol Propionate Ointment USP, 0.05%
Rx only
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE.
NET WT 15 grams

NDC
Alembic Pharmaceuticals, Inc.
Clobetasol Propionate Ointment USP, 0.05%
Rx only
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE.
NET WT 15 grams

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Clobetasol Propionate (Clobetasol Propionate)

Trade Name : Clobetasol Propionate

OINTMENT

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Clobetasol Propionate (Clobetasol Propionate)

Trade Name : Clobetasol Propionate

OINTMENT

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

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