DAKTACORT CREAM 15G @

Indications

Approved Uses

Inflammatory tinea pedis, tinea cruris, tinea corporis with significant inflammation, cutaneous candidiasis with inflammation, seborrheic dermatitis with secondary fungal infection, intertrigo with fungal component

Dosage & Administration

Dosing by Condition

For inflamed fungal skin infections: Apply a thin layer to the affected and surrounding area twice daily. Continue for up to 7 days. If inflammation subsides, treatment can be continued with an antifungal-only cream.

Initial Dose

Apply a thin layer to the affected and surrounding skin twice daily

Maintenance Dose

Apply twice daily until clinical cure, typically 2-4 weeks

Maximum Dose

Apply a thin layer 2 times daily; do not use longer than 7 days without medical review (and avoid prolonged use on large areas/under occlusion).

Dose Adjustment Notes

No systemic dose adjustment required for topical use. Avoid prolonged application to large body surface areas, occluded areas, or skin folds to minimize systemic absorption of hydrocortisone.

How to Take

Clean and dry the affected area before application. Apply a thin layer of cream to the affected skin and a small surrounding area. Gently rub in. Apply twice daily. Wash hands after application unless hands are the treated area. Avoid contact with eyes and mucous membranes.

Side Effects

Common Side Effects

Local burning or stinging sensation, pruritus at application site, erythema, skin irritation, contact dermatitis

Side Effect Frequency

Common: local application-site reactions such as burning/stinging, irritation, pruritus, erythema. Uncommon/with prolonged or extensive use: corticosteroid-related effects (skin thinning/atrophy, striae, telangiectasia, hypopigmentation), secondary infection, and very rarely systemic effects (e.g., HPA-axis suppression) especially with occlusion/large areas. Rare/unknown frequency: hypersensitivity reactions; visual disturbance (e.g., blurred vision) has been reported with topical corticosteroids.

Safety & Warnings

Contraindications

Hypersensitivity to miconazole, hydrocortisone, or excipients; viral skin infections (e.g., herpes simplex, varicella); tuberculous skin lesions; acne/rosacea/perioral dermatitis; use in/around the eyes (ophthalmic use).

Warnings & Precautions

Avoid eyes/mucosa and do not use ophthalmically; avoid occlusion unless directed; limit duration (review if >7 days) and avoid prolonged use on face/flexures/large areas; stop if irritation/sensitization occurs and reassess if infection worsens; use extra caution in children; monitor INR if on warfarin/coumarins; visual disturbance warrants evaluation.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Warfarin/other coumarin anticoagulants (possible INR increase-monitor); latex condoms/diaphragms may be damaged if applied to genital area; other systemic interactions (e.g., phenytoin, oral hypoglycemics) are unlikely with typical topical use but may be relevant with extensive/prolonged application.

Food Interaction

No restriction

Alcohol Interaction

Safe

Special Populations

Pregnancy

Caution

Breastfeeding

Caution

Elderly

Standard adult dosing; use with caution on fragile or atrophic skin common in elderly patients to minimize risk of skin atrophy

Kidney Impairment

No dose adjustment needed (topical use).

Liver Impairment

No dose adjustment needed (topical use).

Storage & Patient Advice

Missed Dose

Apply as soon as remembered; if close to the time of the next application, skip the missed dose and resume the regular schedule. Do not double the amount applied.

Overdose

Topical overdose is unlikely; excessive/prolonged use may cause local irritation/skin atrophy and systemic corticosteroid effects (e.g., adrenal suppression); accidental ingestion usually causes GI upset-seek medical advice and provide supportive care.

Patient Counseling

Apply a thin layer to the affected area 1-2 times daily (as prescribed) and rub in gently; use the shortest duration needed-typically up to 7 days for inflamed fungal infection, and do not continue beyond 7 days or use large areas/occlusion without medical review. Avoid eyes, mouth, and mucous membranes; do not apply to broken skin or the face/groin/axillae unless specifically directed. Wash hands before and after application. Stop and seek advice if irritation/worsening occurs or if no improvement within 7 days. This is a prescription-only topical cream. Store in a refrigerator at 2-8°C (per SFDA). If using in the genital area, be aware the cream may reduce the effectiveness of latex condoms/diaphragms during treatment.

Monitoring Requirements

Monitor INR closely if patient is on warfarin. Monitor for signs of HPA axis suppression with prolonged use over large areas. No routine blood monitoring required for standard short-term use.

Pharmacology

Mechanism of Action

Miconazole nitrate disrupts fungal cell membrane synthesis by inhibiting ergosterol biosynthesis via CYP51 (lanosterol 14α-demethylase), causing membrane permeability changes and fungal cell death. Hydrocortisone is a mild corticosteroid that binds glucocorticoid receptors, suppressing inflammatory mediators (prostaglandins, histamine, cytokines) to reduce erythema, pruritus, and edema.

Onset of Action

Anti-inflammatory effect: within 24-48 hours. Antifungal effect: clinical improvement typically within 1-2 weeks

Duration of Effect

Topical effect maintained with twice-daily application; antifungal effect requires completion of full treatment course

Metabolism

Miconazole (if systemically absorbed): extensively metabolized in the liver, including via CYP3A4 (and other CYPs). Hydrocortisone (if systemically absorbed): primarily hepatic metabolism to inactive metabolites (then conjugation).

Product Information

Available Dosage Forms

Cream

Composition per Dose

Each gram of cream: Miconazole nitrate 20 mg (2%) + Hydrocortisone 10 mg (1%)

OTC Alternatives

Clotrimazole 1% cream (antifungal only, OTC) for non-inflamed fungal infections; miconazole 2% cream (antifungal only, OTC) for non-inflamed fungal infections

Skin Condition

Fungal

Steroid Potency

Mild

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