Each gram of Betamethasone cream for topical use contains:

active ingredient: betamethasone [as valerate] – 1 mg;

excipients: liquid paraffin, propylparaben, petrolatum white (vaseline), ethanol 96% (1.62%).

Glucocorticosteroid for topical use. ATC code – D07AC01.

Following topical application, Betamethasone produce anti-inflammatory, antipruritic, and vasoconstrictor actions. The activity of the drugs is thought to result at least in part from binding with a steroid receptor. Betamethasone decrease inflammation by stabilizing leukocyte lysosomal membranes, preventing release of destructive acid hydrolases from leukocytes; inhibiting macrophage accumulation in inflamed areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall permeability and edema formation; decreasing complement components; antagonizing histamine activity and release of kinin from substrates; reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation; and possibly by other mechanisms as yet unknown. Betamethasone have antimitotic activity on cutaneous fibroblasts and the epidermis.

Tachyphylaxis to the anti-inflammatory effects of the Betamethasone (as shown by vasoconstrictor assay) may occur with repeated application although the clinical importance of this effect is unknown. Following 3-times daily application to normal skin at the same site, diminished vasoconstrictor response may occur within 4–5 days. Withdrawal of the drug for 2–4 days restores response, although maximum vasoconstrictor response may be diminished; when application of the drug is reinstated, tachyphylaxis recurs.

Percutaneous penetration of Betamethasone varies among individual patients and can be increased by the use of occlusive dressings, by increasing the concentration of the corticosteroid, and by using different vehicles. Betamethasone apparently does not penetrate the dermis to a greater extent than does hydrocortisone. Following topical application of a Betamethasone to most areas of normal skin, only minimal amounts of the drug reach the dermis and subsequently the systemic circulation; however, absorption is markedly increased when the skin has lost its keratin layer and can be increased by inflammation and/or diseases of the epidermal barrier (e.g., psoriasis, eczema). The drug is absorbed to a greater degree from the scrotum, axilla, eyelid, face, and scalp than from the forearm, knee, elbow, palm, and sole. Even after washing the area being treated, prolonged absorption of the Betamethasone occurs, possibly because the drug is retained in the stratum corneum.

Betamethasone usually is metabolized in the liver and excreted by the kidneys.

Betamethasone crosses the placenta to varying degrees and may be distributed in small amounts into breast milk

Adminsitration

Betamethasone0.1% ointment is applied topically. Topical Betamethasone0.1% ointment usually is applied sparingly in thin films and are rubbed gently into the affected area 1–3 times daily.

Patients with lesions of the facial treatment should not exceed usage of Betamethasone more than 5 days.

However, once- or twice-daily administration of these preparations often is effective.

Use of Betamethasone ointment generally should not exceed 14 days.

Systemic Effects

In general, topical application of Betamethasone to the skin does not provoke clinical evidence of systemic absorption. However, adverse systemic corticosteroid effects may occur when the drugs are used on large areas of the body, for prolonged periods of time, with an occlusive dressing, and/or in infants and children. Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria have occurred in some patients receiving topical corticosteroids. Recovery of HPA-axis function is generally prompt and complete following discontinuance of the drug. In some patients, signs and symptoms of steroid withdrawal may occur, necessitating supplemental systemic corticosteroid therapy. Reversible HPA-axis suppression has occurred following topical dosages as low as 7 g of Betamethasone ointment (3.5 mg of Betamethasone) daily in patients with psoriasis.

Local Effects

Betamethasone may causes adverse dermatologic effects. Betamethasone should be used with caution on the face. Local adverse Betamethasone effects occur most frequently with occlusive dressings, especially with prolonged therapy, and may require discontinuing the occlusive dressing.

Betamethasone may causes atrophy of the epidermis, subcutaneous tissue, and dermal collagen and drying and cracking or tightening of the skin. Epidermal thinning, telangiectasia, increased fragility of cutaneous blood vessels, purpura, and atrophic striae may also occur. Other adverse dermatologic effects of Betamethasone include acne, acneiform eruption, vesiculation, irritation, pruritus, hypertrichosis, rosacea-like eruptions on the face, erythema, hyperesthesia, urticaria, perioral dermatitis, burning or stinging sensation, folliculitis, hypopigmentation, and alopecia. Skin ulceration has occurred in patients with impaired circulation who were treated with Betamethasone.

Adverse dermatologic effects of Betamethasone usually improve when the drug is discontinued but may persist for long periods; atrophic striae may be permanent. When prolonged (2 months or more) topical Betamethasone therapy is discontinued, pustular “rebound” may occur, especially on the face, perianal region, or genitals. Although improvement usually occurs spontaneously within a few weeks, some patients may require treatment with a systemic antibiotic (e.g., tetracycline) and a topical nonfluorinated corticosteroid (e.g., hydrocortisone) and/or sulfur.

In addition to the other adverse dermatologic effects of Betamethasone therapy, maceration of the skin and miliaria may occur, especially when occlusive dressings are used. Stripping of the epidermis and purpura have occurred with flurandrenolide tape dressings.

Topically applied Betamethasone are generally nonsensitizing, but allergic contact dermatitis may occur rarely. Allergic contact dermatitis associated with topical Betamethasone usually is diagnosed by observing a failure to heal rather than noting a clinical exacerbation as with most topical preparations that do not contain corticosteroids; such an observation should be corroborated with appropriate diagnostic patch testing.

Dermatologic infection may occur with topical Betamethasone therapy, particularly when an occlusive dressing is used. The anti-inflammatory activity of the drugs can also mask the manifestations of infection.

Should be decided the termination of breastfeeding when Betamethasone is applied during breast feeding.

Betamethasone is intended for external use only. Avoid contact with eyes, mouth, and nose. With the development of irritation and sensitization during the usage of Betamethasone the treatment should be canceled.Any adverse effects that may occur with systemic administration of glucocorticosteroids, including adrenal suppression may also occur during the topical usage.Systemic absorption of betamethasone topically will be higher if the treatment is carried out on large surfaces of the body or duing the usage of occlusive dressings.

Avoid applying of the preparation on injured skin or open wounds.During the prolonged usage in high doses may be systemic absorption and appearing of Cushing’s symptoms.During the long-term therapy the abolition of the preparation should be gradual.In case of infection presence should be assigned the appropriate therapy.

The use of Betamethasone should be with caution in case of violation peripheral circulation and diabetes.

General

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. Patients applying Betamethasone ointment to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. 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.

Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios.

If irritation develops, Betamethasone ointment should be discontinued and appropriate therapy instituted.

Pediatric Use

The use of the preparation is contraindicated for children up to 17 years, because the risk of systemic adverse effects associated with the administration of Betamethasone, is high.

None well documented.

Symptoms: prolonged use of high doses of corticosteroids may develop Cushing’s disease.

Treatment: symptomatic therapy. If necessary, can be performed correction of electrolyte imbalance. In the case of chronic overdose a gradual withdrawal of the preparation is recommended. It should intake sodium bicarbonate for alkalinity of urine and forcing diuresis.

White homogenous odorless cream.

15 g of ointment is filled into aluminum tubes (inside package).
The tubes are packed and inserted with the leaflet into cardboard boxes (outer package).

3 years. Do not use after the expiration date.

Store in a cool and dry place, out of the reach of children. Protect from light.

To be dispensed with prescription.