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Betamethasone cream

Betamethasone cream

 

Composition

Betamethasone 17-Valerate

equivalent to Betamethasone  0.1%w/w

Pharmacology
Topical corticosteroids, such as betamethasone valerate, are effective in the treatment of corticosteroid-responsive dermatoses primarily because of anti-inflammatory, anti-pruritic and vasoconstrictive actions.

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

Once absorbed through the skin topical corticosteroids are handled through pharmacokinetic pathway similar to systemically administered asteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolised primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Indications
It is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, eg psoriasis and allergic and inflammatory dermatitis.

Side-effects / Adverse reactions
The following local adverse reactions have been reported with topical dermatological corticosteroids especially under occlusive dressings: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria. Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia and glucosuria in some patients.

Precautions / Warnings
Patients receiving a large dose of a potent topical steroid applied to a large surface area or prolonged use or under an occlusive dressings should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. 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 steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

If irritation or sensitization develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

In the presence of dermatological infections, an appropriate anti-fungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infections has been adequately controlled. This preparation is for external use only. Avoid introduction of the cream into the eye. If a reaction suggesting sensitivity or chemical irritation should occur, use of this medication should be discontinued.

Use In Pregnancy and Lactation
Topical corticosteroids should be used during pregnancy only If the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

It is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in breast milk.

Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are prescribed for nursing woman.

Use in Children
Paediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. HPA axis suppression, Cushing's syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestation of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

Contraindications
It is contraindicated in patients who are hypersensitive to betamethasone valerate, or to other corticosteroids, or to any ingredients in this preparation.

Dosage
A thin film of the cream is applied to the effected skin area one to three times a day. Dosage once or twice a day is often effective.

Symptoms and treatment for overdosage and antidotes:
Excessive prolonged use of topical corticosteroids can suppress pituitary-adrenal function resulting in secondary adrenal insufficiency.

Appropriate symptomatic treatment is indicated. Acute hypercorticoid symptoms are virtually reversible. Treat electrolyte imbalance, if necessary. In cases of chronic toxicity, slow withdrawal of steroids is advised.

Storage conditions:
Store at or below 25C.

Shelf-life: 3 years.

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