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MICOCORT CREAM 30G
- Sku : I-030861
Key features
MICOCORT CREAM 30G is a topical prescription cream containing miconazole nitrate 2% and hydrocortisone 1%. Miconazole inhibits fungal ergosterol synthesis to disrupt the fungal cell membrane, while hydrocortisone, a low‑potency corticosteroid, reduces inflammatory mediator production to relieve erythema, pruritus and edema. It is used for the topical treatment of inflamed superficial fungal skin infections due to dermatophytes or Candida, including inflamed tinea pedis, cruris, corporis and cutaneous candidiasis. Available as a 30 g cream.- Brand: MICOCORT
- Active Ingredient: MICONAZOLE NITRATE 2%, HYDROCORTISONE 1%
- Strength: 2,1%
- Dosage Form: Cream
- Pack Size: 30 g
- Route: Topical
- Prescription Status: Prescription
- Therapeutic Class: Dermatological
- Pharmacological Group: Antifungals (Topical)
- Drug Class: Topical Antifungal (Imidazole) + Mild Topical Corticosteroid Combination
- Manufacturer: DEEF PHARMACEUTICAL INDUSTRIES
- Country of Origin: Saudi Arabia
- SFDA Registration No.: 42-539-10
- Shelf Life: 24 months
- Storage: store below 25°c
- Skin Condition: Fungal
- Steroid Potency: Mild
Indications
Approved Uses
Topical treatment of inflammatory superficial fungal skin infections due to dermatophytes or Candida where a mild corticosteroid is indicated (e.g., inflamed tinea pedis/cruris/corporis and cutaneous candidiasis).
Off-Label Uses
Intertrigo with suspected/confirmed fungal component and significant inflammation (short-term), then step down to antifungal-only therapy.
Dosage & Administration
Dosing by Condition
Inflamed tinea/cutaneous candidiasis: apply a thin layer twice daily; limit the hydrocortisone-containing combination to short courses (generally 7-14 days), then continue with an antifungal-only product if ongoing antifungal therapy is needed (often total 2-4 weeks depending on site, e.g., longer for tinea pedis).
Initial Dose
Apply a thin layer to the affected and surrounding skin twice daily
Maintenance Dose
Not applicable for long-term maintenance. Use should be short-term.
Maximum Dose
Apply a thin layer twice daily; limit to the smallest area and shortest duration (typically ≤2 weeks unless prescriber advises), and avoid prolonged use, large surface areas, or occlusion.
Children's Dosage
Not recommended in children under 2 years. In children over 2 years, use with caution, apply sparingly, and avoid prolonged use due to higher risk of systemic corticosteroid absorption.
Dose Adjustment Notes
No renal/hepatic dose adjustment; use the smallest amount for the shortest duration, avoid occlusion and large surface areas, and use extra caution in children/elderly or on thin-skin areas due to increased corticosteroid absorption/atrophy risk.
How to Take
Clean and dry the affected area; apply a thin layer to the affected skin (and a small surrounding margin) and rub in gently. Wash hands after application (and before application if hands are contaminated); avoid contact with eyes/mucous membranes and do not apply to broken skin unless directed.
Side Effects
Common Side Effects
Application-site burning/stinging, irritation, pruritus, erythema; less commonly contact dermatitis or skin dryness.
Side Effect Frequency
Most common: local application-site reactions (burning/stinging, irritation, pruritus, erythema); less common/uncommon: contact dermatitis, rash/urticaria; rare with prolonged/extensive/occlusive use (especially in children): corticosteroid effects such as skin atrophy/striae/hypopigmentation and potential HPA-axis suppression; serious immediate hypersensitivity (e.g., angioedema/anaphylaxis) is very rare/unknown frequency.
Safety & Warnings
Contraindications
Hypersensitivity to miconazole, hydrocortisone, other imidazoles, or excipients; viral skin infections (e.g., herpes simplex, varicella/zoster); tuberculous skin lesions; acne vulgaris; rosacea; perioral dermatitis; not for ophthalmic use.
Warnings & Precautions
For external use only; avoid eyes and ophthalmic use; avoid use on large areas, broken skin, mucosa, or under occlusion; limit duration (typically ≤2 weeks unless directed) and avoid prolonged facial use; discontinue if irritation/sensitization occurs; monitor for steroid adverse effects (atrophy, striae, HPA suppression-higher risk in children); consider INR monitoring if on warfarin.
Age Restriction
Avoid use in children <2 years unless specifically prescribed; use with extra caution in children due to higher systemic corticosteroid absorption risk.
Driving Warning
Safe
Drug Interactions
Drug Interactions
Warfarin/other oral anticoagulants: potential increased anticoagulant effect (monitor INR); latex condoms/diaphragms may be weakened by some topical azole formulations-advise alternative contraception during use.
Interaction Severity
MAJOR: Warfarin/other coumarin anticoagulants (potential INR increase/bleeding risk, even with topical miconazole in some cases).
Food Interaction
No restriction
Alcohol Interaction
Safe
Special Populations
Pregnancy
Caution
Breastfeeding
Caution
Children
Not recommended in children under 2 years. In children over 2 years, use with caution, apply sparingly, and avoid prolonged use due to higher risk of systemic corticosteroid absorption.
Elderly
Standard adult dosing; use with caution on fragile or atrophic skin common in elderly patients
Kidney Impairment
No adjustment needed
Liver Impairment
No adjustment needed
Storage & Patient Advice
Storage Conditions
Store below 25°C. Keep tube tightly closed. Do not freeze.
Missed Dose
Apply when remembered; if it is close to the next scheduled application, skip the missed dose and resume the regular schedule-do not apply extra to make up.
Stopping the Medicine
May stop when the prescribed course is completed and symptoms have resolved; if used for prolonged periods or on large areas/under occlusion, taper rather than abrupt cessation to reduce rebound/withdrawal risk.
Overdose
Topical overdose is unlikely; excessive/prolonged use may cause local irritation and systemic corticosteroid effects (e.g., HPA-axis suppression). If ingested, manage supportively and seek medical advice/poison center guidance.
Patient Counseling
Apply a thin layer to clean, dry skin (usually twice daily) and use only for the prescribed short course (generally 7-14 days for the steroid-containing combination); if antifungal treatment must continue, switch to antifungal-only to complete the course (often 2-4 weeks depending on site). Avoid eyes/mouth and occlusive dressings; do not use on face/groin/skin folds longer than directed; stop and seek advice if worsening, severe irritation, or no improvement. If taking warfarin, inform the prescriber and monitor for bleeding/INR changes. Store below 25°C.
Monitoring Requirements
Routine lab monitoring is not required for short courses; assess clinical response and local tolerability, and if used beyond short-term/over large areas/under occlusion (or in children), monitor for corticosteroid adverse effects (skin atrophy; rare HPA-axis suppression). If on warfarin, monitor INR more closely after starting/stopping.
Pharmacology
Mechanism of Action
Miconazole inhibits ergosterol synthesis (via fungal lanosterol 14-α-demethylase), disrupting the fungal cell membrane; hydrocortisone is a low-potency corticosteroid that activates glucocorticoid receptors to reduce inflammatory mediator production, decreasing erythema/pruritus/edema.
Onset of Action
Anti-inflammatory symptom relief may begin within 1-3 days; antifungal clinical improvement typically becomes evident over several days, with mycologic cure requiring a full course (often weeks depending on site).
Duration of Effect
No fixed single-dose duration is established; typical regimens require once- to twice-daily application, most commonly twice daily, to maintain local effect.
Half-Life
Not clinically meaningful for the topical product due to minimal systemic absorption; if systemically absorbed, hydrocortisone has a short plasma half-life of approximately 1.5-2 hours (miconazole systemic half-life is not well characterized for topical exposure).
Bioavailability
Topical miconazole: minimal systemic absorption, typically <1% on intact skin; topical hydrocortisone: variable percutaneous absorption, generally low (~1-3% on intact skin) but increases with inflammation, occlusion, large surface area, prolonged use, or in children.
Metabolism
Miconazole (absorbed fraction): hepatic metabolism (primarily CYP-mediated, including CYP3A4); hydrocortisone (absorbed fraction): metabolized mainly in the liver (and to some extent in peripheral tissues) via reduction and conjugation.
Excretion
Miconazole (systemically absorbed fraction): predominantly excreted via feces/biliary route with minor renal excretion; hydrocortisone (systemically absorbed fraction): metabolites excreted mainly in urine (renal).
Protein Binding
Miconazole: highly protein bound (~91-93%); hydrocortisone: >90% bound in plasma (primarily to corticosteroid-binding globulin and albumin).
Product Information
Available Dosage Forms
Cream (30 g tube).
Composition per Dose
Each 1 gram of cream contains: 20mg Miconazole Nitrate and 10mg Hydrocortisone.
Generic Availability
Yes
OTC Alternatives
For non-severe/non-inflamed fungal infections: OTC topical antifungal alone (e.g., clotrimazole 1% or miconazole 2%). If inflammation/itch is significant, a short separate course of OTC hydrocortisone 1% may be used with an antifungal (where permitted), but avoid prolonged combination use.
Skin Condition
Fungal
Steroid Potency
Mild
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