Betol 0.05%+0.005% is a Product of the Generic Betamethasone + Calcipotriol

What Is Betol 0.05%+0.005% Indications and Uses?

Betol 0.05%+0.005% (Betamethasone + Calcipotriol) topical ointment is indicated for the topical treatment of plaque-type psoriasis vulgaris amenable to topical therapy. Betol topical suspension is indicated for the topical treatment of plaque psoriasis of the scalp and body.

Pharmacology (Source, Chemical and Physical Composition) Of Betol 0.05%+0.005%

Betol 0.05%+0.005% (Betamethasone + Calcipotriol) Dipropionate is a potent topically-active corticosteroid producing prompt, marked and prolonged anti-inflammatory, antipruritic, vasoconstrictive and immunosuppressive properties, without curing the underlying condition. These effects can be enhanced under occlusive conditions due to increased penetration of stratum corneum (by approximately a factor of 10). Calcipotriol is a non-steroidal antipsoriatic agent, derived from vitamin D. Calcipotriol exhibits a vitamin D-like effect by competing for the 1,25(OH) 2 D 3 receptor. Calcipotriol is as potent as 1,25(OH) 2 D 3 , the naturally occurring active form of vitamin D, in regulating cell proliferation and cell differentiation, but much less active than 1,25(OH) 2 D 3 in its effect on calcium metabolism. Calcipotriol induces differentiation and suppresses proliferation (without any evidence of a cytotoxic effect) of keratinocytes, thus reversing the abnormal keratinocyte changes in psoriasis. The therapeutic goal envisaged with Calcipotriol is thus a normalization of epidermal growth.

Dosage And Administration of Betol 0.05%+0.005%

Topical Ointment : This Ointment is indicated for topical use only. The phototoxic effects have not been studied in psoriasis patients. All psoriasis-affected areas treated with this Ointment should be, where possible, protected from direct sunlight and UV-light with items of clothing. Adults : This ointment should be applied topically to the affected area once daily. The maximum daily dose should not exceed 15 gm. The maximum recommended weekly dose of ointment is 100 gm/week. The treated area should not be more than 30% of the body surface. The use of this ointment should be intermittent for up to one year under close medical supervision. Treatment should be limited to four week periods with Calcipotriol used alone for one month between periods of use of this ointment as needed. Children : This ointment is not recommended for use in children and adolescents below the age of 18 years. Topical Suspension : Apply required quantity of spray of Topical Suspension once daily to the affected areas and gently rub in using the tips of the fingers. Treatment may be continued for up to 8 weeks. Treatment may be discontinued earlier, if symptoms are cleared. The maximum weekly dose should not exceed 100 gm. Shake before use. This Topical Suspension is not for oral, ophthalmic or intravaginal use.

Drug Interactions of Betol 0.05%+0.005%

Additive adverse effects when used with other steroids.

Side Effects of Betol 0.05%+0.005%

The most common adverse reactions are folliculitis and burning sensation of skin.

Precautions And Warnings for Betol 0.05%+0.005%

Hypercalcemia and hypercalciuria have been reported. If either occurs, discontinue until parameters of calcium metabolism normalize. Topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome and unmask latent diabetes. Rate of adrenal suppression increased with treatment duration. Systemic absorption may require evaluation for HPA axis suppression. Modify use if HPA axis suppression develops. Potent corticosteroids, use on large areas, prolonged use or occlusive use may increase systemic absorption. Local adverse reactions may include atrophy, striae, irritation, acne form eruptions, hypopigmentation, and allergic contact dermatitis and may be more likely with occlusive use or more potent corticosteroids. Use is not recommended on face, axillae, groin or where atrophy is present. Children may be more susceptible to systemic toxicity when treated with topical corticosteroids.

Use During Pregnancy and Lactation

There are no adequate and well-controlled studies in pregnant women. Ointment or suspension should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topically administered calcipotriene or corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Calcipotriol and Betol 0.05%+0.005% (Betamethasone + Calcipotriol) ointment or suspension is administered to a nursing woman.

Therapeutic Class

Betamethasone & Combined preparations

Storage Conditions of It

Store in a cool (below 25ºC) & dry place & protect from light. Do not refrigerate. Keep out of the reach of children. Pack Image: Betol 0.05%+0.005% Ointment Thanks for using MedEx! How would you rate your experience so far?