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BETAMETHASONE (as VALERATE)-HAKIM |
| :: Anti-inflammatory, Steroidal (topical) :: |
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Top. cream 0.1% |
Top. ointment 0.1% |
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Pharmacologic category
Anti –inflammatory , Steroidal (topical)
Mechanism of action
Corticosteroids diffuse across cell membranes and complex with specific cytoplasmic receptors . These complexes then enter the cell nucleus , bind to DNA (chromatin) and stimulate transcription of mRNA and subsequent protein synthesis of various inhibitory enzymes responsible for the anti – inflammatory effects of topical corticosteroids . These anti – inflammatory effects include inhibition of early processes such as edema , fibrin deposition , capillary dilatation , movement of phagocytes into the area , and phagocytic activities. Later processes , such as capillary production , collagen deposition , and keloid formation also are inhibited by corticosteroids . The overal actions of topical corticosteroids are catabolic.
Indications
Topical Betamethasone is indicated to provide symptomatic relief of inflammation and/or pruritus associated with acute and chronic corticosteroid – responsive disorders including: atopic dermatitis, contact dermatitis , nummular dermatitis , seborrheic dermatitis ( facial and intertriginous) , intertrigo , lichen planus , discoid lupus erythematosus , sunburn , anogenital pruritus , psoriasis , inflammatory phase of xerosis , alopecia areata , granuloma annulare , pemphigoid , pemphigus , pityriasis rosea , and sarcoidosis.
Side/Adverse effects
Allergic contact dermatitis ; Folliculitis ; Furunculosis ; Pustules ; Pyoderma or vesiculation ; Hyperesthesia ; Numbness in fingers ; Purpura ; Skin atrophy ; Secondary skin infection ; Telangiectasia ; Mild and transient burning , dryness , irritation , itching , or redness of skin ; Mild and transient increased redness or scaling of skin lesions ; Minor and transient skin rash ; Mild and temporary stinging . Percutaneous absorption of topical corticosteroids has resulted in systemic side effects including acneiform eruptions , Cushing’s syndrome , perioral dermatitis , ecchymosis , edema , gastric ulcer , hirsutism or hypertrichosis , hypertension , hypokalemic syndrome , hypopigmentation or other changes in skin pigmentation , aggravation of infection , miliaria rubra , protein depletion , skin laceration , skin maceration , striae , subcutaneous tissue atrophy , unusual loss of hair (especially on the scalp).
Contraindications
hypersensitivity to betamethasone or any component of the formulation
Warnings / Precautions
Risk – benefit should be considered when the following medical problems exist : Infection at treatment site and pre – existing skin atrophy . Do not use occlusive dressings on weeping or exudative lesions and general caution with occlusive dressings should be observed . Discontinue if skin irritation or contact dermatitis should occur . Do not use in patients with decreased skin circulation.
Pregnancy
Topical corticosteroids , especially the more potent ones , should not be used extensively , in large amounts , or for protracted periods in pregnant patients or in patients who are planning to become pregnant . Adequate and well – controlled studies in humans have not been done.
Breast–Feeding
It is not known whether topical betamethasone are distributed into breast milk . However , problems in humans have not been documented . Topical betamethasone should not be applied to the breasts prior to nursing.
Monitoring Parameters
Periodic monitoring of adrenal function assessment , including blood or urine cortisol concentration or ACTH stimulation test , may be advisable during and following use if factors that increase percutaneous absorption are present and treatment is prolonged.
Administration and dosage
- Usual adult dose: Apply thin film to the skin , one to three times a day.
- Usual pediatric dose: Apply thin film to the skin , once a day.
How Supplied
- Betamethasone valerate, cream 0.1 %
- Betamethasone valerate, Ointment 0.1%
Storage
Store below 30°C (86°F). Protect from freezing.
References
- USP DI, 2004
- Up To Date, Vol. 13.1 (2005)
- Martindale, The Complete Drug Reference, 33 rd edition 2002
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