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Bio-Clo

Quick Overview

Our aim is to reach out to the globe within shortest possible time frame.  


To promote this objective, not only we distribute and market our Dermatology  range of products globally through our distribution channels but we also undertake ‘contract manufacturing’& ‘formulation development ’of our wide range of generic products such Bio-Clo which contains Clobetasol Propionate BP 0.05% w/w.


 


 

Bioclo Cream

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Details

Clobetasol Propionate BP... 0.05% w/w

Cream base q.s.

CHEMISTRY: 21-Chloro-9-fluoro-11p-hydroxy-16p-methy1-3, 20-dioxopregna-1, 4-dien-17-y1 propionate.

CATEGORY: Glucocorticoid.

PHARMACOLOGY

PHARMACODYNAMICS:

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.

PHARMACOKINETICS:

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

INDICATIONS:

Clobetasol propionate is the treatment of more resistant dermatoses such as psoriasis (excluding widespread plaque psoriasis), recalcitrant eczemas, lichen planes, discoid lupus erythematous, and other skin conditions which do not respond satisfactorily to less active steroids.

DOSAGE AND ADMINISTRATION:

Apply a thin layer of clobetasol propionate cream to the affected skin areas twice daily and rub in gently and completely.

Treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used.

If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Clobetasol propionate cream should not be used with occlusive dressings.

USE IN CHILDREN

Use in pediatric patients under 12 years of age is not recommended.

CONTRAINDICATIONS

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

PRECAUTIONS AND WARNINGS:

General

Clobetasol propionate cream should not be used in the treatment of rosacea or perioral dermatitis and should not be used on the face, groin or axillae.

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

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

If irritation develops, clobetasol propionate cream should be discontinued and appropriate therapy instituted.

INTERACTIONS  None reported.

PREGNANCY AND LACTATION

Pregnancy

Teratogenic Effects

Pregnancy Category C

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

Nursing Mothers

Many drugs are excreted in human milk; caution should be exercised when clobetasol propionate cream is administered to a nursing woman.

Pediatric Use

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

Geriatric Use

Based on available data, no adjustment of dosage of clobetasol propionate cream in geriatric patients is warranted.

ADVERSE DRUG REACTIONS:

The most frequent adverse reactions reported for clobetasol propionate cream were burning and slinging sensation. Less frequent adverse reactions were itching, skin atrophy, and cracking and fissuring of the skin.

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

OVERDOSAGE:

Topically applied clobetasol propionate cream can be absorbed in sufficient amounts to produce systemic effects.

PRESENTATION: 15 g Collapsible Alu Tube

STORAGE: Store in a dry place below 30°C

 Keep out of reach of children.

 

 

 
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