Topibet CL - Ointment Betamethasone 0.1% + Clotrimazole 1% Topical - 0.1%+1% 1 10gm tube(s) / 10gm tube Eskayef Pharmaceuticals Ltd. Introduction: Topibet CL is a combination medicine. It is used to treat various types of skin infections usually the fungal type of skin infections. It minimizes symptoms of inflammation such as redness, swelling, and itching. It also acts against the infection-causing microorganisms. Topibet CL is only meant for external use and should be used as advised by your doctor. A thin layer of the medicine should be applied only to the affected areas of the skin with clean and dry hands. If it gets into your eyes, nose, mouth, or vagina rinse with water. It may take several days to weeks... Uses of Topibet CL: Skin infections Side effects of Topibet CL: Application site reactions (burning, irritation, itching and redness)Thinning of skinSkin peeling How to use Topibet CL: This medicine is for external use only. Use it in the dose and duration as advised by your doctor. Check the label for directions before use. Clean and dry the affected area and apply the cream. Wash your hands after applying, unless hands are the affected area. How Topibet CL works: Topibet CL is a combination of two medicines: Betamethasone and Clotrimazole which treat skin infections. Betamethasone is a steroid which blocks the production of certain chemical messengers (prostaglandins) that make the skin red, swollen and itchy. Clotrimazole is an antifungal which stops the growth of fungi on the skin by preventing them from forming their own protective covering. Indication: Tinea pedis, tinea cruris, tinea corporis, ringworm, athlete's foot, jock itch. Adult Dose: Tinea Pedis, Tinea Cruris, & Tinea Corporis Apply to infected area q12hr for 2 weeks for tinea cruris and tinea corporis; 4 weeks for tinea pedis Allergic or Inflammatory Diseases Apply to affected area in the morning and evening Child Dose: <17 years: Safety and efficacy not established Contraindication: Patients who are sensitive to clotrimazole, betamethasone dipropionate, other corticosteroids or imidazoles, or to any ingredient in these preparations. Mode of Action: Betamethasone is a corticosteroid with mainly glucocorticoid activity. It prevents and controls inflammation by controlling the rate of protein synthesis, depressing the migration of polymorphonuclear leukocytes and fibroblasts, and reversing capillary permeability and lysosomal stabilisation. Clotrimazole is an antifungal agent that binds to phospholipids in the fungal cell membrane. It causes loss of essential intracellular components by altering cell wall permeability. Precaution: Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Conditions which augment systemic absorption include use over large surface areas, prolonged use, and use under occlusive dressings. 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 corticosteroid. Pediatric patients may be more susceptible to systemic toxicity... Side Effect: 1-10% Dry skin (2%),Paresthesia (2%),Local burning (2%) 2 wk) Pregnancy Category Note: Pregnancy There are no available data on topical betamethasone dipropionate or clotrimazole use in pregnant women to identify drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; observational studies suggest an increased risk of low birthweight infants with use of potent or very potent topical corticosteroid during pregnancy Advise pregnant women that therapy may increase risk of having a low birthweight infant and to use drug on the smallest area of skin and for shortest duration possible Animal data In an animal reproduction study, betamethasone dipropionate caused malformations (ie, umbilical hernias, cephalocele, and cleft palate)...