Beclomethasone 0.025% cream

(i) ROUTE OF ADMINISTRATION

Topical

DOSAGE AND ADMINISTRATION

The effective action of corticosteroids is not more than 68 hours when applied locally. There is usually a need for three applications per day in acute cases. In resolving chronic dermatoses, a single application is adequate because the Health 2000 Beclomethasone 0.025% cream contains a potent corticosteroid, the thinnest application possible should be used. When improvement is seen the intervals between applications may be extended and eventually stopped.

(ii) THERAPEUTIC / DIAGNOSTIC CLAIMS

Health 2000 Beclomethasone 0.025% cream is indicated for the local treatment of eczema, dermatitis and psoriasis, neuro-dermatoses including lichen simplex, lichen planus, and discoid lupus erythematosus.

(iii) DESCRIPTION OF DOSAGE FORM

Beclomethasone dipropionate is a corticosteroid with potent topical action. It has marked vasoconstrictor and antiinflammatory activity. When applied to the skin it has been shown to be therapeutically active without causing suppression of the hypothalamicpituitaryadrenal axis.

(iv) CONTRAINDICATIONS

Hypersensitivity to the preparations. These preparations are contraindicated in the presence of tuberculosis of the skin, chickenpox, vaccinia, herpes virus infections and also for the treatment of varicose ulcers.

Warnings and Precautions

PREGNANCY
There is inadequate evidence of safety in pregnancy.

OTHERS
Long term continuous therapy should be avoided, especially in infants and children, as adrenal suppression can occur even without occlusion.
Bacterial infection is encouraged by the warm and moist conditions induced by occlusive dressings and so the skin should be cleansed, before a fresh dressing is applied.

Interaction
No drug interactions have been described with beclomethasone dipropionate.

(v) SIDE EFFECTS

Local side effects may include skin atrophy, striae and telangiectasia. While these preparations are generally well tolerated, percutaneous absorption following prolonged application over a large surface area can cause Cushingoid changes and adrenal suppression.
Should such systemic effects arise, topical treatment should be discontinued. If adrenal function is impaired, the patient will need to be protected from any harmful effects of stress with oral corticosteroid preparations until normal adrenal function is established.

(vi) TOXIC EFFECTS

MUTAGENICITY
Studies have not been performed to date to evaluate the mutagenic potential of beclomethasone dipropionate.
CARCINOGENICITY
No evidence of carcinogenicity was observed when rats were given the drug for 95 weeks ( 13 weeks by oral inhalation [ up to 0.4 mg/kg daily ] and 82 weeks by combined oral and inhalation routes [ up to 2.4 mg/kg daily, about 40 times the maximum recommended human intranasal dosage on a mg/m2 basis] ).
TERATOGENICITY
Glucocorticoids are known teratogens in rodent species and beclomethasone dipropionate is no exception. Teratology studies were done in rats, mice, and rabbits treated with subcutaneous beclomethasone dipropionate. Beclomethasone dipropionate was found to produce fetal resorption, cleft palate, agnathia, microstomia, absence of tongue, delayed ossification, and partial agenesis of the thymus." "The use of beclomethasone dipropionate in pregnant women, nursing mothers, or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother, embryo, or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for hypoadrenalism."