Miconil

Approved Indications:

• Inflammatory dermatomycoses where fungal infection is accompanied by inflammation or pruritus, such as:
  • Tinea corporis (ringworm of the body)
  • Tinea cruris (jock itch)
  • Tinea pedis (athlete’s foot)
  • Cutaneous candidiasis
  • Intertrigo (especially in moist or occluded skin folds)
  • Eczema with secondary fungal infection
• Vulvovaginal candidiasis with inflammation or itching (for vaginal cream/suppository combinations)

Clinically Accepted Off-Label Uses:

• Angular cheilitis with mixed fungal and inflammatory components
• Atopic dermatitis or seborrheic dermatitis with secondary fungal infection
• Fungal otitis externa (in combination with other topical otic agents)

Formulations: Available as topical cream or ointment, vaginal cream, and sometimes lotion.

Topical (Cream/Ointment for Skin Use)

• Adults and Children (>2 years):
  • Apply a thin layer to the affected area twice daily (morning and evening)
  • Rub in gently until fully absorbed
  • Duration: Typically 7–14 days; do not exceed 2 weeks unless directed by a physician
  • Maximum area: Apply to limited surface areas only

Vaginal Cream (for Vaginal Candidiasis with Inflammation):

• Apply 5 grams intravaginally once daily at bedtime for 7 days, or as directed
• May also be applied externally to relieve vulvar itching

Pediatrics (<2 years):

• Use is not recommended without medical supervision

Elderly:

• No specific dose adjustment needed

Renal/Hepatic Impairment:

• No dose adjustment necessary (minimal systemic absorption)

This combination exerts dual action through its components:
Miconazole Nitrate inhibits ergosterol synthesis by interfering with the fungal cytochrome P450 14α-demethylase, disrupting the integrity of the fungal cell membrane and causing leakage of intracellular components, leading to fungistatic or fungicidal effects.
Hydrocortisone, a low-potency corticosteroid, binds to intracellular glucocorticoid receptors, modulating gene transcription to suppress inflammatory cytokine production, reduce vasodilation, decrease capillary permeability, and inhibit leukocyte infiltration. The combination provides antifungal action along with anti-inflammatory relief of itching, redness, and swelling.

Miconazole Nitrate (topical/vaginal use):

• Absorption: Minimal systemic absorption through intact skin (<1%)
• Metabolism: Hepatic, via non-CYP-specific oxidative pathways
• Excretion: Primarily in feces via biliary route
• Half-life: ~24 hours (if absorbed)

Hydrocortisone (topical):

• Absorption: Variable; increased through inflamed, broken, or occluded skin
• Distribution: Widely distributed; crosses cell membranes to act at intracellular glucocorticoid receptors
• Metabolism: Hepatic to inactive metabolites
• Excretion: Urine (as glucuronide and sulfate conjugates)

• Pregnancy:
  • FDA Category C
  • Use topical or vaginal preparations only if clearly needed
  • Avoid prolonged use, high doses, or application on large surface areas
• Lactation:
  • Generally safe with limited topical use
  • Avoid application to the breast area to prevent infant exposure
  • Systemic absorption of hydrocortisone from topical routes is low but not negligible

• Primary Class:
  • Antifungal + Corticosteroid Combination
• Subclasses:
  • Miconazole – Imidazole antifungal
  • Hydrocortisone – Low-potency glucocorticoid

• Known hypersensitivity to miconazole, hydrocortisone, other imidazoles, corticosteroids, or any component of the formulation
• Tuberculous or viral skin infections (e.g., herpes simplex, varicella)
• Rosacea or perioral dermatitis
• Use in the eyes, oral cavity, or for systemic fungal infections

• Occlusion and Prolonged Use:
  • Avoid use under occlusive dressings unless prescribed
  • May increase systemic absorption of hydrocortisone
• Skin Atrophy and Steroid Effects:
  • Long-term use may cause thinning of skin, striae, or telangiectasia
• Pediatric Use:
  • Increased risk of systemic corticosteroid absorption; use with caution
• Secondary Infection:
  • If irritation or superinfection occurs, discontinue use and evaluate
• Avoid Contact with Eyes:
  • May cause irritation or damage to the conjunctiva or cornea

Common (Local Effects)

• Burning, stinging, or irritation at application site
• Skin dryness, redness, or peeling
• Pruritus (itching) or tingling

Less Common

• Skin atrophy (with prolonged use)
• Telangiectasia, striae (stretch marks), or hypopigmentation
• Allergic contact dermatitis

Rare but Serious

• Systemic corticosteroid effects (especially in infants or under occlusion):
  • Adrenal suppression
  • Cushingoid features
  • Hyperglycemia

Onset: Typically within days; steroid-related effects may appear with prolonged use (>2 weeks)
Severity: Dose- and duration-dependent

• Warfarin:
  • Miconazole may enhance the anticoagulant effect of warfarin (even via topical use)
  • Monitor INR closely in patients on anticoagulants
• Immunosuppressants (e.g., cyclosporine, tacrolimus):
  • Hydrocortisone absorption may potentiate systemic corticosteroid effects
• CYP450 Interactions:
  • Miconazole inhibits CYP2C9 and CYP3A4, but systemic absorption is minimal
  • Use caution when applying over large areas or broken skin
• Alcohol & Food:
  • No known interaction for topical/vaginal routes

• Recent clinical practice guidelines continue to support use of topical antifungal-corticosteroid combinations for short-term therapy in mixed fungal-inflammatory conditions.
• Updated safety alerts emphasize limiting use to ≤2 weeks to avoid steroid-related side effects.
• NICE and WHO guidance recommend avoiding routine long-term use of combination antifungal-steroid products due to risk of skin thinning and fungal resistance.

• Topical and Vaginal Creams:
  • Store at 20°C to 25°C (68°F to 77°F)
  • Excursions permitted to 15°C–30°C
  • Protect from light and moisture
  • Keep container tightly closed after use
  • Do not freeze
• Handling Precautions:
  • Avoid contact with eyes and mucous membranes
  • Wash hands after application (unless treating hands)
  • Discard any unused product after 30 days of opening