BETAZOL CREAM 30G

Indications

Approved Uses

Topical treatment of inflammatory superficial fungal skin infections due to dermatophytes/yeasts (e.g., tinea pedis, tinea cruris, tinea corporis) where concomitant corticosteroid therapy is warranted.

Dosage & Administration

Dosing by Condition

Apply a thin layer twice daily; typical maximum durations: tinea cruris/corporis up to 2 weeks and tinea pedis up to 4 weeks; reassess if no improvement and avoid prolonged continuous use.

Initial Dose

Apply a thin layer to the affected skin and surrounding area twice daily (morning and evening)

Maintenance Dose

Apply twice daily until clinical resolution, typically 2-4 weeks depending on indication

Maximum Dose

Apply a thin layer twice daily; limit duration-generally up to 2 weeks for tinea corporis/cruris and up to 4 weeks for tinea pedis; avoid large areas/occlusion to reduce systemic corticosteroid absorption

Children's Dosage

Not recommended for children under 12 years due to higher risk of systemic corticosteroid absorption relative to body surface area

Dose Adjustment Notes

No renal/hepatic dose adjustment is required for topical use; use the smallest effective amount for the shortest duration and avoid large areas/occlusion to minimize systemic corticosteroid absorption.

How to Take

Clean and dry the affected area; apply a thin layer to the affected skin (and a small margin of surrounding skin) and rub in gently; wash hands after application (unless treating hands); typically apply twice daily as directed.

Side Effects

Common Side Effects

Application-site burning, stinging, itching, irritation, erythema/redness, and dryness; with corticosteroid component, possible folliculitis and skin atrophy/striae with prolonged or occlusive use.

Safety & Warnings

Contraindications

Hypersensitivity to miconazole, betamethasone, or excipients; viral skin infections (e.g., herpes simplex, varicella); tuberculous or syphilitic skin lesions

Warnings & Precautions

External use only; avoid eyes/mucosa; avoid occlusive dressings unless directed; use the smallest amount for the shortest duration and avoid large areas to reduce systemic steroid effects; avoid prolonged use on face/groin/axilla; stop if irritation/sensitization occurs; monitor for secondary infection; caution in diabetes due to possible hyperglycemia

Age Restriction

Not recommended under 12 years.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Interactions are uncommon but possible: warfarin (increased INR/bleeding risk) with topical miconazole especially if used on large/occluded areas; additive systemic corticosteroid effects with other corticosteroids (including systemic) if significant absorption occurs

Food Interaction

No food interactions (topical product).

Alcohol Interaction

Safe

Special Populations

Pregnancy

Caution

Breastfeeding

Caution

Children

Not recommended for children under 12 years due to higher risk of systemic corticosteroid absorption relative to body surface area

Elderly

Standard adult dosing; use with caution due to increased risk of skin atrophy with corticosteroid use in elderly patients with thinner skin

Kidney Impairment

No dose adjustment needed

Storage & Patient Advice

Missed Dose

Apply when remembered; if it is near the time of the next application, skip the missed dose and resume the regular schedule; do not apply extra to make up for a missed dose.

Stopping the Medicine

Complete the prescribed course; do not use longer than prescribed; if used for an extended period or on large areas, taper/step-down may be needed rather than abrupt cessation

Patient Counseling

Apply a thin layer to affected skin as prescribed (commonly twice daily) and rub in gently; external use only-avoid eyes/mouth and avoid use on face and intertriginous areas (groin/axilla) unless specifically directed; do not occlude (no tight dressings) unless instructed; use the shortest effective duration-generally reassess if no improvement within 1-2 weeks and avoid prolonged use (typically not >2-4 weeks) due to steroid adverse effects; stop and seek medical advice if worsening, significant irritation, signs of skin atrophy/striae, or if extensive use/occlusion is occurring; inform clinician if using warfarin/other anticoagulants because miconazole can increase anticoagulant effect if systemically absorbed.

Monitoring Requirements

No routine labs for short courses on small areas; monitor clinically for local adverse effects (irritation, atrophy/striae, secondary infection) and for systemic corticosteroid effects (e.g., hyperglycemia, HPA-axis suppression) if used on large areas, under occlusion, in children, or for prolonged durations.

Pharmacology

Mechanism of Action

Miconazole inhibits fungal 14-α-demethylase, reducing ergosterol synthesis and disrupting fungal cell membranes; betamethasone dipropionate activates glucocorticoid receptors to suppress inflammatory mediators, reducing erythema, pruritus, and edema.

Half-Life

Not well-defined for topical use because systemic absorption is variable and usually minimal; any half-life values apply only to the absorbed fraction and are not clinically reliable for routine topical dosing.

Bioavailability

Systemic absorption is generally low from intact skin but can increase with inflammation/broken skin, large surface area, prolonged use, or occlusion (more relevant for the corticosteroid component).

Metabolism

If absorbed: miconazole undergoes hepatic metabolism (notably via CYP pathways including CYP3A4) and can inhibit CYP enzymes; betamethasone dipropionate is hydrolyzed in skin to active metabolites and then further metabolized hepatically.

Protein Binding

Protein binding is not clinically relevant for routine topical use due to minimal systemic exposure; if systemically absorbed, miconazole is highly protein bound (~90%+) and corticosteroids (including betamethasone) are moderately to highly protein bound.

Product Information

Available Dosage Forms

Cream (30 g).

Composition per Dose

Each 1g of cream contains: 20mg Miconazole Nitrate (2% w/w) and 0.5mg Betamethasone as Dipropionate (0.05% w/w)

OTC Alternatives

OTC alternatives are single-agent topical antifungals (e.g., miconazole 2% cream, clotrimazole 1% cream, terbinafine 1% cream) for uncomplicated tinea/cutaneous candidiasis; the fixed combination miconazole 2% + betamethasone dipropionate 0.05% is prescription-only and should not be substituted with OTC steroid-containing combinations.

Skin Condition

Fungal

Steroid Potency

Potent

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