ARISTOBET

BETAMETHASONE VALERATE

Betamethasone oral dosage form is indicated for allergic and inflammatory disorders, Congenital adrenal hyperplasia, Skin disorders. Betamethasone cream or ointment is indicated for the treatment of eczema in children and adults, including atopic and discoid eczemas, prurigo nodularis, psoriasis (excluding widespread plaque psoriasis); neurodermatitis, including lichen simplex, lichen planus; seborrhoeic dermatitis; contact sensitivity reactions; discoid lupus erythematosus. Betamethasone Eye/Ear/Nasal Drops is indicated for short-term treatment of steroid responsive in inflammatory conditions of the eye after clinical exclusion of bacterial, viral or fungal infections. Non-infected inflammatory conditions of the ear or nose.

Corticosteroid

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.

Adult: A small quantity of Betamethasone cream or ointment should be applied and rubbed gently to the affected area 2 or 3 times daily until improvement occurs. Children: Courses should be limited to five days. Oral- Allergic and inflammatory disorders, Congenital adrenal hyperplasia: Adult: As betamethasone Na phosphate: 0.5-5 mg daily in divided doses, depending on the severity of the disease and clinical response. Recommended regimen: Short-term treatment: 2-3 mg daily for the first few days, then gradually decrease by 0.25 or 0.5 mg every 2-5 days, depending on response. Rheumatoid arthritis: 0.5-2 mg daily. Other conditions: 1.5-5 mg daily for 1-3 wk, then gradually reduce to Min effective dose. Child: Dose is proportional to adult dose (e.g. 1 yr 25% of adult dose; 7 yr 50% of adult dose; 12 yr75% of adult dose). Treatment is limited to the Min dosage for the shortest possible time. Eye/Ear/Nasal Drops: Adults and children- Eye: 1 or 2 drops to each affected eye every 1 or 2 hours until control is achieved, then the frequency may be reduced. Ear: 2 or 3 drops to each affected ear every 2 or 3 hours until control is achieved, then the frequency may be reduced. Nose: 2 or 3 drops instilled into each nostril 2 or 3 times daily.

Increased hyperglycaemia and hypokalaemia with thiazide diuretics. Increased incidence of peptic ulcer or GI bleeding with concurrent NSAIDs admin. Response to anticoagulants altered. Dose of antidiabetics and antihypertensives needs to be increased. Decreases serum concentration of salicylates and antimuscarinic agents. Potentially Fatal: Reduced efficacy with concurrent use of carbamazepine, phenytoin, primidone, barbiturates and rifampicin. Enhanced effect in women taking oestrogens or oral contraceptives

Betamethasone is contraindicated in patients with a history of hypersensitivity to any of the components of the preparation. Betamethasone Eye/Ear/Nasal Drops is contraindicated in Herpes simplex virus infection of the eye; known sensitivity or allergy to any ingredient; red eye due to unknown causes; viral or fungal infections in the treatment area; tuberculosis, glaucoma etc.

Common side effects are: problems with your vision; swelling, rapid weight gain, feeling short of breath; severe depression, unusual thoughts or behavior, seizure; bloody or tarry stools, coughing up blood; pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate); low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

There are no adequate and well controlled studies for pregnant woman. It should not be used extensively in pregnant woman. There is no information available whether it is secreted in the milk or not.

Long-term intensive topical use may lead to systemic effects

Uncontrolled diabetes, peptic ulcer, osteoporosis, psychosis, psychoneurosis, pregnancy and lactation. Congestive heart failure, hypertension, epilepsy, CRR elderly, regular monitoring of patients on long term therapy, withdraw gradually, glaucoma, hypothyroidism, cirrhosis, ocular herpes simplex, ulcerative colitis, infants and children.

Store below 258C. Topical: Store at 2-308C.