Each ml of Betacid lotion contains:

active ingredients: betamethasone [as dipropionate] – 0.5 mg, salicylic acid – 20 mg;

excipients: sodium hydroxide, disodium EDTA, hydroxypropylcellulose, ethanol 96%, water purified.

Dermatological drug; D07XC01.

Betacid contains combinations of salicylic acid, а keratolytic agent, and betamethasone, a corticosteroid, for dermatologic use.

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.

Salicylic acid has a potent keratolytic action and a slight antiseptic action when applied topically to the skin. In low concentrations, the drug has keratoplastic activity (correction of abnormal keratinization) and in higher concentrations (i.e., 1% or higher, depending on the vehicle), the drug has keratolytic activity (causes peeling of skin). Salicylic acid softens and destroys the stratum corneum by increasing endogenous hydration (water concentration), probably because of decreased pH, which causes the cornified epithelium (horny layer) of the skin to swell, soften, and then desquamate. Necrosis of normal skin has been associated with overuse of the drug. At high concentrations (e.g., 20%), Salicylic acid has a caustic effect. Moisture is essential for Salicylic acid to exert its action on the skin and for maceration and desquamation of epidermal tissue to occur. The drug has weak antifungal and antibacterial activity. When combined, Salicylic acid and sulfur may produce a synergistic keratolytic effect.

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.

Betacid is indicated for the relief of the inflammatory manifestations of hyperkeratotic and dry corticosteroid-responsive dermatoses such as: psoriasis, atopic dermatitis, neurodermatitis (lichen simplex chronicus), lichen planus, eczema (including nummular eczema, hand eczema, eczematous dermatitis), dyshidrosis (pompholyx), seborrheic dermatitis of the scalp, ichthyosis vulgaris and other ichthyotic conditions.

Adminsitration

A thin film of Betacidshould be applied to cover completely the affected area.

Apply a few drops of Betacidlotion to the affected areas and massage gently and thoroughly into the scalp or skin.

The usual frequency of application is twice daily, in the morning and at night. For some patients, adequate maintenance therapy may be achieved with less frequent application.

Dosage should be limited to 5 days.

Betacid preparations are generally well tolerated and side effects are rare.

Continuous application without interruption may result in local atrophy of the skin, striae and superficial vascular dilation, particularly on the face.

Adverse reactions that have been reported with the use of topical corticosteroids include: burning, itching, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis.

The following may occur more frequently with the use of occlusive dressings: maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

Salicylic acid preparations may cause dermatitis.

Symptoms: excessive or prolonged use of topical corticosteroids can suppress pituitary-adrenal function, resulting in secondary adrenal insufficiency and produce manifestations of hypercorticism, including Cushing’s disease.

Excessive or prolonged use of topical preparations containing salicylic acid may cause symptoms of salicylism.

Treatment: appropriate symptomatic treatment is indicated. Acute hypercorticoid symptoms are usually reversible. Treat electrolyte imbalance, if necessary. In case of chronic toxicity, slow withdrawal of corticosteroids is advised.

Treatment of salicylism is symptomatic treatment is indicated. Measured should be taken to rid the body rapidly of salicylate. Administer oral sodium bicarbonate to alkalinize the urine and force diuresis.

Contact with mouth, eyes, and other mucous membranes should be avoided; if contact with the eyes occurs, the affected eyes should be rinsed thoroughly with water. It should also be used with care on the extremities of patients with impaired peripheral circulation or diabetes; caution has also been suggested for the use of caustic preparations in patients with significant peripheral neuropathy.

Do not cover treated area with dressings or use tight-fitting diapers, plastic pants, or underwear over treated area.

If irritation or sensitization occurs following topical application of Betacid, the drug should be discontinued. Use of Betacid in the treatment of diaper dermatitis is not recommended.

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 Betacid 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, Betacid should be discontinued and appropriate therapy instituted.

Pediatric Use

• Betacid contraindicated for children to 17 years of age due to risk of development of systemic adverse effects, associated with betamethasone.

Geriatric Use

• Adverse effects reporting for Betacid in patients aged 65 and above includes reports of skin atrophy and extremely rare reports of skin ulceration. Caution should be exercised with the use of these corticosteroid containing topical products on thinning skin.

Pregnancy

• Betacid should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. The drug should not be used on extensive areas, in large amounts, or for prolonged periods in pregnant women.

Lactation

• Betacid should be used with caution in nursing women.

• Hypersensitivity to corticosteroids.
• Betacid should not be used with occlusive dressings.
• Betacid contraindicated for children to 17 years of age.
• Betacid contraindicated in tuberculous lesions of the skin.
• Betacid should not be used in fungal skin infections without suitable concomitant anti-infective therapy.

None well documented.

White to yellowish white odorless ointment (Betacid, ointment).
A transparent, colorless and odorless liquid (Betacid, lotion).

30 ml of lotion is filled into amber glass bottles (inside package).
The bottles are packed and inserted with the leaflet into cardboard boxes (outer package).

3 years.

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