Generic Name

Miconazole

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Classification

FDA Approved Indications

• Vaginal yeast infections (Monistat)
• Oral candidiasis (Oravig)

Mechanism of Action

Miconazole inhibits the synthesis of ergosterol, an essential component of fungal cell membranes, leading to increased membrane permeability and cell death.

Dosage and Administration

Adult: Vaginal dosage: 100 mg once at bedtime for 3, 6, or 7 days as prescribed. Oravig (oral): 50 mg once daily for 14 days.

Pediatric: Use approved age-specific formulations and dosing guidance.

Geriatric: No specific dosage adjustments required; monitor renal and hepatic function.

Renal Impairment: Use with caution; no specific dosage adjustment available.

Hepatic Impairment: Use with caution; no specific dosage adjustment available.

Pharmacokinetics

Absorption: Minimal systemic absorption when applied topically; well absorbed after oral administration.

Distribution: Widely distributed; crosses the blood-brain barrier to some extent.

Metabolism: Metabolized in the liver via the cytochrome P450 enzyme system.

Excretion: Primarily excreted in urine and feces.

Half Life: Approx. 2-8 hours, varies by formulation and route.

Contraindications

• Hypersensitivity to miconazole or other azole antifungals.

Precautions

• Use cautiously in hepatic impairment, as it is metabolized by the liver.
• Avoid in patients with known hypersensitivity to imidazoles.

Adverse Reactions - Common

• Local skin irritation, burning, or itching (Common)
• Vaginal discomfort or irritation (Common)

Adverse Reactions - Serious

• Allergic reactions including swelling, rash, difficulty breathing (Rare)
• Hepatotoxicity (very rare) (Rare)

Drug-Drug Interactions

• Warfarin: Increased bleeding risk.
• QT prolonging agents: Risk of cardiac arrhythmias.

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Patient/Family Teaching

• Use medication as directed, completing the full course.
• Report any signs of allergic reactions or adverse effects.
• Avoid applying topical medication in eyes, nose, or mouth unless directed.

Special Considerations

Black Box Warnings:

• None currently.

Genetic Factors: Consider genetic variations affecting metabolism if systemic use prolonged.

Lab Test Interference: May affect liver function tests.

Overdose Management

Signs/Symptoms: Nausea, vomiting, dizziness, headache, allergic reactions.

Treatment: Supportive care; no specific antidote. Seek medical attention.

Storage and Handling

Storage: Store at room temperature, away from moisture and heat.

Stability: Stable for the duration of the labeled expiration date.