betamethasone + clotrimazole




R. Oasis
Full Prescribing Info
Betamethasone valerate, Clotrimazole.
Each 100 g contains: Betamethasone valerate eq. to Betamethasone 0.1 g (0.1% w/w) and Clotrimazole 1 g (1% w/w).
Pharmacology: 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 messenger RNA (mRNA) and subsequent protein synthesis of various inhibitory enzymes responsible for the anti-inflammatory effects include inhibition of early processes eg, edema, fibrin deposition, capillary dilatation, movement of phagocytes into the area and phagocytic activities. Later processes eg, capillary production, collagen deposition and keloid formation also are inhibited by corticosteroids. The overall actions of topical corticosteroids are catabolic.
Factors that increase the clinical efficacy and potential for adverse effects of topical corticosteroids include enhancement of pharmacologic activity of the compound by altering molecular structure, increasing stratum corneum penetration of the compound and increasing bioavailability of the compound from the vehicle.
The pharmacologic activity of corticosteroids is increased by several changes in molecular structure.
Addition of 9-α-fluorine atom increases the anti-inflammatory glucocorticoid activity, but simultaneously increases undesired mineralocorticoid activity. Mineralocorticoid activity is diminished by addition of a 16-hydroxy group with longer side chains eg, acetonide, propionate or valerate increase lipophilicity and subsequently stratum corneum penetration.
Pharmacokinetics: Absorption: Absorbed systemically across the stratum corneum. Stratum corneum penetration is primarily enhanced by increasing skin hydration and/or temperature or by changes in molecular structure of the compound. Hydrating the skin with occlusive dressings eg, plastic wrap, a tight-fitting diaper or 1 covered with plastic pants, plastic tape or dermatological patches can increase corticosteroid penetration by up to 10-fold. Absorption of topical corticosteroids has been greatly increased by altering the product vehicle or the drug substance itself. Vehicles containing substances that solubilize the corticosteroid enhance absorption.
Increasing the concentration of the drug increases skin penetration but may also increase wastage of the drug.
Decreasing drug particle size has been shown to increase topical bioavailability. Increased percutaneous absorption of corticosteroids also occurs when the skin mucosa is abraded or inflamed, when body temperature is elevated with prolonged use or with extensive use. There is some systemic absorption of topical corticosteroids through the oral mucosa; absorption increases with increased potency and prolonged use.
Biotransformation: Primarily in the skin; once absorbed systemically in the liver. Corticosteroids that contain substituted 17-hydroxyl groups or that are fluorinated are resistant to local metabolism in the skin. Repeated application results in a cumulative depot effect in the skin, which may lead to a prolonged duration of action, increased side effects and increased systemic absorption.
Indicated as a secondary agent in the topical treatment of tinea corporis (ringworm of the body), tinea cruris (jock itch; ringworm of the groin) and tinea pedis (athlete's foot; ringworm of the foot).
Dosage/Direction for Use
Adults and Adolescents: Tinea Corporis or Tinea Cruris: Apply to the affected skin and surrounding areas, 2 times daily, morning and evening for 2 weeks.
Tinea Pedis: Apply to the affected skin and surrounding areas, 2 times daily morning and evening for 4 weeks.
Children ≥12 years: Same as adult and adolescent dose.
Infants & Children up to 12 years: Safety and efficacy have not been established.
Administration: Topical.
Risk-benefit should be considered when the following medical problems exist: Allergy to corticosteroids.
Infection at treatment site (may be exacerbated if no appropriate antimicrobial agent is used concurrently).
Skin atrophy, pre-existing (may be exacerbated due to atrophigenic properties of corticosteroids).
Special Precautions
Carcinogenicity: Long-term animal studies to determine the carcinogenicity of topical corticosteroids have not been done.
Mutagenicity: Betamethasone was found to be genotoxic in the in vitro human peripheral blood lymphocyte chromosome aberration assay with metabolic activation and in the in vivo mouse bone marrow micronucleus assay.
Use in children: Children and adolescents have a large skin surface area to the body weight ratio and less developed, thinner skin, which may result in absorption of greater amounts of topical corticosteroids compared with older patients. Absorption also is greater in premature infants than in full term newborns, due to inadequate development of the stratum corneum. Adrenal suppression, Cushing's syndrome, intracranial hypertension and growth retardation due to the systemic absorption of topical corticosteroids have been documented in children. Therefore, special care must be exercised when these agents are used in children and growing adolescents, especially if factors that increase absorption are involved. It is recommended that only low-potency, unfluorinated topical corticosteroids that have a free 17-hydroxyl group be used in children or growing adolescents unless there is a demonstrated need for one of the other topical corticosteroids. Generally, pediatric therapy continuing for longer than 2 weeks and consisting of doses in excess of 1 daily application (with medium- or high-potency corticosteroids) or 2 daily applications (with low-potency corticosteroids) should be evaluated carefully by the physician. This is especially important if medication is applied to >5-10% of the 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 the elderly: Although appropriate studies with topical corticosteroids have not been performed in the geriatric population, geriatrics-specific problems are not expected to limit the usefulness of topical corticosteroids in the elderly. However, elderly patients may be more likely to have preexisting skin atrophy secondary to aging. Purpura and skin lacerations that may raise the skin and SC tissue from deep fascia may be more likely to occur with the use of topical corticosteroids in geriatric patients. Therefore, topical corticosteroids should be used infrequently, for brief periods or under close medical supervision in patients with evidence of preexisting skin atrophy. Use of lower potency topical corticosteroids also may be necessary in some patients.
Use In Pregnancy & Lactation
Use in 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. Studies in animals have shown that topical corticosteroids are systemically absorbed and may cause fetal abnormalities, especially when used in large amounts, with occlusive dressings, for prolonged periods of time, or if the more potent agents are used. A dose-related increase in fetal resorptions was observed in rabbits and mice given betamethasone dipropionate IM. This effect was not observed in rats. Teratogenic effects (umbilical hernia, cephalocele, cleft palate) were observed in rabbits when betamethasone dipropionate was administered IM.
Use in lactation: It is not known whether topical corticosteroids are distributed into breast milk. However, problems in humans have not been documented. Topical corticosteroids should not be applied to the breasts prior to nursing.
Adverse Reactions
Those Indicating Need for Medical Attention: Incidence Less Frequent or Rare: Allergic contact dermatitis (burning and itching of skin; apparent chronic therapeutic failure). May also be caused by vehicle ingredients; folliculitis, furunculosis, pustules, pyoderma, or vesiculation (painful, red or itchy, pus-containing blisters in hair follicles), more frequent with occlusion or use of ointments in intertriginous areas; hyperesthesia (increased skin sensitivity); numbness in fingers; purpura (blood-containing blisters on skin); skin atrophy (thinning of skin with easy bruising, especially when used on facial or intertriginous area); skin infection, secondary - more frequent with occlusion; stripping of epidermal layer- for tape dosage forms; telangiectasis (raises, dark red, wart-like spots on skin, especially when used on the face).
Rare Incidence: With prolonged use or other factors that increase absorption. Acneiform eruptions (acne or oily skin, especially when used on the face); cataracts, posterior subcapsular (gradual blurring or loss of vision)- reported with use of systemic corticosteroids; caution is advised with use of high- and very high-potency topical corticosteroids in periorbital area; Cushing's syndrome (backache; filling or rounding out of the face; irritability; menstrual irregularities; mental depressions; in men, unusual decrease in sexual desire or ability; unusual tiredness or weakness); dermatitis, perioral (irritation of skin around mouth); ecchymosis (unusual bruising); edema (increased blood pressure; rapid weight; swelling of feet or lower legs); gastric ulcer (loss of appetite; nausea; stomach bloating, burning, cramping, or pain; vomiting; weight loss); secondary glaucoma (eye pain; gradual decrease in vision; nausea; vomiting)- with use of high- and very high-potency topical corticosteroids in peritoneal area; hirsutism or hypertrichosis (unusual increase in hair growth, especially on the face); hypertension; hypokalemia syndrome (irregular heartbeat; loss of appetite; muscle cramps or pain; nausea; severe weakness of extremities and trunk; vomiting); hypopigmentation (lightened skin color); or other changes in skin pigmentation; aggravation of infection; miliaria rubra (burning and itching of skin with pinhead-sized red blisters); protein depletion (muscle weakness); skin laceration (tearing of skin); skin maceration (softening of skin); striae (reddish purple lines on arms, face, legs, trunk or groin); SC tissue atrophy; unusual loss of hair especially on the scalp.
Those indicating need for medical attention only if they continue or are bothersome: Less Frequent or Rare Incidence: Burning, dryness, irritation, itching or redness of skin, mild and transient; increased redness or scaling of skin lesions, mild and transient; skin rash, minor and transient.
Those Not Indicating Need for Medical Attention Only if They Continue or are Bothersome: Stinging, mild and temporary when foam, gel, lotion, solution or aerosol form of medication is applied.
Store at temperature not more than 30°C.
MIMS Class
Topical Anti-Infectives with Corticosteroids
ATC Classification
D07BC01 - betamethasone and antiseptics ; Belongs to the class of potent (group III) corticosteroids, in combination with antiseptics. Used in the treatment of dermatological diseases.
Cream 15 g.
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