Composition:

Each 100g topical solution contains 0.064g Betamethasone Dipropionate (equivalent to 0.05g Betamethasone base).

Mechanism of Action:

Betamethasone-dipro has anti-inflammatory, anti-pruritic, and vasoconstrictive actions.

Pharmacokinetics:

When administered topically, particularly under occlusive dressings or when the skin is broken, sufficient corticosteroid may be absorbed to give systemic effects.

Corticosteroids are extensively bound to plasma proteins.

Only unbound corticosteroid have pharmacological effects or are metabolized.

They are metabolized mainly in the liver, also in the kidneys, and are excreted in the urine.

Indications:

Betamethasone Dipropionate is active topically for Suppression of skin diseases in which inflammation , eg. eczema, atopic dermatitis, dermatitis herpetiformis, contact dermatitis, dermatitis venenata, seborrhoeic dermatitis, neurodermatitis, psoriasis and intertrigo.

Contraindications:

Hypersensitivity to betamethasone dipropionate, other corticosteroids, or any component in this product. Topical corticosteroids are contraindicated in most viral infections of the skin, such as varicella, and Herpes simplex, also tuberculosis and acne rosacea.

Warnings and precautions:

• Discontinue use if irritation or sensitivity develops.
• Special care must be taken when giving to paediatric patients as systemic absorption can occur in topical administration causing growth retardation.
• Caution is advised if the medication is to be applied to extensive surface area or under occlusive dressing.
• Not suitable for ophthalmic use. Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma, or rare diseases such as central serous chorioretinopathy (CSCR) that reported after use of systemic and topical corticosteroids

Side Effects:

• Adverse reactions reported with betamethasone-dipro include: burning, itching, irritation, dryness folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
• Systemic adverse reactions, such as vision blurred, have also been reported with the use of topical corticosteroids.
• Large doses of corticosteroids may produce symptoms typical of hyperactivity of the adrenal cortex, with moon face, sometimes with hirsutism, buffalo hump, flushing, sometimes leading to a fully developed Cushing's syndrome.

Dosage and administration:

Wash and dry affected area. Apply Bethamethasone-Dipro Topical Solution sparingly to the affected areas once or twice daily

Overdosage:

Corticosteroids applied to the skin can be absorbed in sufficient quantity to produce a systemic effect such as hypothalamic-pituary-adrenal axis suppression, manifestations of Cushing's syndrome, hyperglycaemia and glucosuria.

  If HPA axis suppression is noted, the drug should be withdrawn, the frequency of application reduced, or a less potent steroid substituted.

Using during pregnancy or lacation:

Safety of its use during pregnancy and lactation has not been established. Thus it should be used only if the potential benefit justifies the potential risk to the foetus or nursing infant.