Opizole B Cream

Betamethasone 0.05% + Clotrimazole 1% Topical
"0.5mg, 10mg/g"
Oman Pharmaceutical Products
Pack size 20g Collapsible Tube
Dispensing mode POM
Source OMAN
AgentMuscat Pharmaceutical Trading L.L.C.
Retail Price 11.00 AED

Indications

Opizole B Cream is used for: Inflammed tinea pedis, tinea cruris, tinea corporis.

Adult Dose

Adult: Topical: Apply twice daily. Recommended duration: Up to 2 wk (tinea corporis and tinea cruris) and 4 wk (tinea pedis). Max: 45 g/wk.

Child Dose

<17 years: Safety and efficacy not established

Renal Dose

Administration

Contra Indications

Hypersensitivity.

Precautions

Systemic absorption of betamethasone may result in suppression of the hypothalmic-pituitary-adrenal axis; prolonged or excessive use may increase systemic absorption of the drug. Monitor for signs of infection. Safety and efficacy have not been established in children <17 yr. Elderly. Pregnancy and lactation. Lactation: Excretion in milk unknown; use with caution

Pregnancy-Lactation

Pregnancy There are no available data on topical betamethasone dipropionate or clotrimazole use in pregnant women to identify drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; observational studies suggest an increased risk of low birth weight infants with use of potent or very potent topical corticosteroid during pregnancy Advise pregnant women that therapy may increase risk of having a low birth weight infant and to use drug on the smallest area of skin and for shortest duration possible Animal data In an animal reproduction study, betamethasone dipropionate caused malformations (ie, umbilical hernias, cephalocele, and cleft palate) in pregnant rabbits when given by intramuscular route during organogenesis The available data do not allow calculation of relevant comparisons between systemic exposure of clotrimazole and/or betamethasone dipropionate observed in animal studies to systemic exposure that would be expected in humans after topical use of drug Lactation Advise a woman to apply drug to smallest area of skin and for shortest duration possible while breastfeeding; advise breastfeeding women not to apply drug directly to nipple and areola to avoid direct infant exposure

Interactions

Adverse Effects

Side effects of Betamethasone 0.05% + Clotrimazole 1% Topical : 1-10% Dry skin (2%), Paresthesia (2%), Local burning (2%) <1% Edema, Rash, Skin atrophy, Secondary infection, Skin ulceration, Acneiform eruption, Bruising, Folliculitis, Striae Clotrimazole Erythema, Stinging, Blistering, Peeling, Edema, Pruritus, Urticaria, General skin irritation Betamethasone Burning, Itching, Irritation, Dryness, Folliculitis, Hypertrichosis, Acneiform eruptions, Hypopigmentation, Perioral dermatitis, Allergic contact dermatitis, Skin maceration, Skin atrophy, Striae, Miliaria, HPA suppression (with higher potency used >2 wk)

Mechanism of Action

Betamethasone dipropionate is a corticosteroid that prevents and reduce inflammation by depressing the migration of polymorphonuclear leukocytes and fibroblasts; reversing capillary permeability and lysosomal stabilisation at the cellular level. Clotrimazole is an antifungal agent that binds to phospholipids in the fungal cell membrane. It causes loss of essential intracellular components by altering cell wall permeability.

Note

Opizole B "0.5mg, 10mg/g" Cream manufactured by Oman Pharmaceutical Products. Its generic name is Betamethasone 0.05% + Clotrimazole 1% Topical. Opizole B is availble in United Arab Emirates. Farmaco UAE drug index information on Opizole B Cream is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

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