Besone - Ointment Betamethasone valerate 0.01% Topical - 0.01% 1 5gm tube(s) / 5gm tube Pharmadesh Laboratories Ltd. Indication: Lichen planus, Psoriasis, Eczema, Contact dermatitis, Systemic lupus erythematosus, Lichen simplex, Prurigo nodularis, Plaque psoriasis. Administration: Topical Administration Use medium to very high potency for less than 2 weeks to reduce local and systemic side effects Use low potency for chronic therapy Avoid medium to very high potency on face, folds, and groin, because use in these areas can increase steroid absorption Use lower potency for children (ie, increased BSA/kg, therefore increased systemic absorption) Adult Dose: As valerate: Apply sparingly 2-3 times daily. Cream for moist & ointment for dry surface. Contraindication: Hypersensitivity; systemic fungal or acute infections. 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. Precaution: Uncontrolled diabetes, peptic ulcer, osteoporosis, psychosis, psychoneurosis, pregnancy and lactation. Congestive heart failure, hypertension, epilepsy, CRF, elderly, regular monitoring of patients on long term therapy, withdraw gradually, glaucoma, hypothyroidism, cirrhosis, ocular herpes simplex, ulcerative colitis, infants and children. Lactation: It is not known whether topical corticosteroid use could result in sufficient systemic absorption to produce detectable quantities in human milk; use with caution. Side Effect: Dermal atrophy, local irritation, folliculitis, hypertrichosis, burning, dry skin, pigmentation changes. Pregnancy Category Note: Pregnancy There are no available data on ointment use in pregnant women to identify a 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 the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy; advise pregnant women that the ointment may increase risk of having a low birthweight infant and to use it on the smallest area of skin and for the shortest duration possible Animal data In animal reproduction studies, increased malformations, including umbilical hernias, cephalocele,...