Contents

Miconazole nitrate

Indication

For the treatment of myoctic infections of the skin and nails and superinfections due to Gram-positive bacteria.

Dosage / Direction For Use

Route of administration: Cutaneous use.Recommended dosage: For all ages: Fungal infections of the skin: Apply some cream to the lesions two times daily. Rub the cream into the skin with the finger until it has fully penetrated. The duration of therapy varies from 2 to 6 weeks depending on the localisation and the severity of the lesion. Treatment should be continued at least one week after disappearance of all signs and symptoms.Nail infections: Apply the cream once or twice daily to the lesions. Treatment should be prolonged for 10 days after all lesions have disappeared to prevent relapse.

Overdosage

Symptoms: Cutaneous use: Excessive use can result in skin irritation, which usually disappears after discontinuation of therapy.Treatment: Miconazole cream is intended for cutaneous use, not for oral use. If accidental ingestion of large quantities of the product occurs, use appropriate supportive care.

Administration

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Contraindication

Hypersensitivity to the active substance(s), other imidazole derivatives.

Special Precaution

Miconazole cream must not come into contact with the mucosa of the eyes.Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with miconazole cream and with other miconazole topical formulations. If a reaction suggesting hypersensitivity or irritation should occur, the treatment should be discontinued.Benzoic acid (E210) is mildly irritant to the skin, eyes and mucous membranes.Butylated hydroxyanisole (E320) may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.

Adverse Reactions

The adverse drug reactions are ranked by frequency, using the following convention: Very common ≥1/10; Common ≥1/100 and <1/10; Uncommon ≥1/1,000 and <1/100; Rare ≥1/10,000 and <1/1,000; Very rare <1/10,000, including isolated reports.Adverse reactions reported in clinical trials and post-marketing experience: See table.

Drug Interaction

Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after topical application, clinically relevant interactions are rare. However, in patients on oral anticoagulants, such as warfarin, caution should be exercised and anticoagulant effect should be monitored.

Storage

Store at temperatures not exceeding 30°C.

Description

Each g contains: Miconazole nitrate 20 mg.

Action

Pharmacotherapeutic classification: Antifungals for dermatological/topical use; imidazole derivative.Pharmacology: Pharmacodynamics: Miconazole nitrate is an imidazole antifungal agent and may act by interfering with the permeability of the fungal cell membrane. It possesses a wide antifungal spectrum and has some antibacterial activity.Pharmacokinetics: Absorption: There is little absorption through skin or mucous membranes when miconazole nitrate is applied topically.Distribution: Absorbed miconazole is bound to plasma proteins (88.2%) and red blood cells (10.6%).Metabolism and Excretion: The small amount of miconazole that is absorbed is eliminated predominantly in faeces as both unchanged drug and metabolites.