Each gram cream contains: Betamethasone valerate equivalent to 1 mg betamethasone (0.1 % w /w).
Excipients/Inactive Ingredients: Methyl paraben 0.25 mg and Propyl paraben 0.15 mg as preservatives.
Pharmacology: Pharmacodynamics: Mode or Mechanisms of Action: Betamethasone diffuses across cell membranes and complexes with specific cytoplasmic receptors. These complexes then enter the cell nucleus, bind to DNA (chromatin), and stimulate transcription of messenger RNA (mRNA) and subsequent protein synthesis of various enzymes thought to be ultimately responsible for anti-inflammatory effects of topical application of adrenocorticoids.
Pharmacokinetics: Absorption: Absorbed systemically. Occlusion, use over extensive areas, or prolonged used increases absorption of topical dosage forms.
Rectal absorption is increased if intestinal mucosa is inflamed.
Metabolism: Mostly in skin, fluorinated compounds more slowly metabolised in the skin and thus tend to be systemically absorbed to a greater extent.
Half-life: Unbound hydrocortisone-Approximately 2 hours.
Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses e.g., psoriasis, eczemas, pruritus, contact dermatitis, neurodermatitis, lichen planus.
Usual adult dose: Topical, one to three times a day.
Usual paediatric dose: Topical, once a day.
Symptoms and treatment for overdose and antidote(s): Therapeutic efficacy depends on drug release from the vehicle, solubilization of the drug at the skin surface, and its subsequent percutaneous absorption through the outer barrier layer of the epidermis (stratum corneum) so that it can reach the site of action in the living epidermis and / or the dermis.
Factors influencing product selection include skin hydration, site, severity, age, and whether the lesion is moist or dry as well as potency and strength of the product and the method of application.
Occlusion, whether by oleaginous ointment, by a thin film of polythene, or by tape, promotes increased hydration of the stratum corneum and increased absorption.
Excessive prolonged use of topical corticosteroids can result in suppression of pituitary - adrenal function resulting in secondary adrenal insufficiency which is usually reversible. In such cases appropriate symptomatic, supportive treatment is indicated. Gradual withdrawal of the preparation may be necessary.
Viral diseases, bacterial & fungal skin infections, acne, rosacea & perioral dermatitis. Hypersensitivity to the preparation and propylene glycol. Contraindicated in infants under 1 year old.
Avoid extensive or prolonged use in pregnancy and children below 4 years. Avoid contact with eyes.
Long-term continuous topical therapy should be avoided where possible, particularly in infants and children, as adrenal suppression can occur even without occlusion.
The face, more than other areas of the body, may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids. If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as glaucoma might result. If used in childhood or on the face, courses should be limited if possible to five days and occlusion should not be used.
Appropriate antimicrobial therapy should be used whenever treating inflammatory lesion which have become infected. Any spread of infection requires withdrawal of the topical corticosteroid therapy and systemic administration of Antimicrobial agents. Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and so the skin should be cleansed before a fresh dressing is applied.
Use in Children: Since adrenal suppression and growth retardation due to the systemic absorption of topical adrenocorticoids, have been documented in children, special care must be exercised in using these agents in the paediatric patient, especially when extensive areas are treated or if an occlusive dressing is used. It is recommended that only low-potency topical corticoids that are not fluorinated and that have a free 17- hydroxyl group be used in children unless there is a very specific indication for one of the other topical corticoids. As a general rule, paediatric therapy continuing for longer than 2 weeks and consisting of doses in excess of one daily application (with intermediates or high potency corticoids) or two daily applications (with low potency corticoids) should be evaluated carefully by the physician. This is especially important if medication is applied to more than 5 to 10 % of body surface or if an occlusive dressing is used. A tight-fitting diaper or one covered with plastic pants may constitute an occlusive dressing.
Use in Pregnancy & Lactation: Although studies in humans have not been done, risk-benefit must be considered since studies in animals have shown that adrenocorticoids, when used in large amounts for prolonged periods of time are systemically absorbed and may cause foetal abnormalities (FDA Pregnancy Category C).
Pregnancy and Lactation: Although studies in humans have not been done, risk-benefit must be considered since studies in animals have shown that adrenocorticoids, when used in large amounts for prolonged periods of time are systemically absorbed and may cause foetal abnormalities (FDA Pregnancy Category C).
Local atrophic changes (prolonged & intensive treatment). Skin collagen loss. Hypercorticism. Itching, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral & allergic contact dermatitis, skin maceration, secondary infection, striae and miliaria.
Do not use in or around the eye.
Store below 30°C.
Protect from light and freezing.
Shelf-Life: 3 years.
D07AC01 - betamethasone ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases.
Cream 0.1% w/w (a smooth, soft, homogenous, white colour) x 15 g.