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 |
| Agent | Muscat 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.