Zole Ointment

Side Effects of Zole Ointment

Nausea, vomiting, febrile reactions, rash, drowsiness, diarrhoea, anorexia and flushing, hepatitis. Local irritation and sensitisation, contact dermatitis. Potentially Fatal: IV: Anaphylactic reaction and cardiac arrest.

Drug Interactions

Increased toxicity reported with carbamazepine. Miconazole acts as an inhibitor of CYP3A4 and CYP2D6 and may, therefore, interact with a large number of drugs e.g. statins, HIV protease inhibitors, ciclosporin, tacrolimus, sildenafil, quinidine, pimozide. Potentially Fatal: Potentiates anticoagulant effect of warfarin. Increased risk of cardiotoxicity with cisapride, astemizole or terfenadine.

Contraindications

Hypersensitivity; hepatic impairment (oral gel). Porphyria.

Mechanism of Action

Miconazole inhibits ergosterol biosynthesis thus damaging fungal cell wall membrane and increases its permeability, allowing leakage of nutrients. Absorption: Incomplete from the GI tract (oral); minimal (topical). Metabolism: Hepatic; converted to inactive metabolites. Excretion: 10-20% of an oral dose will be excreted in urine (as metabolites), 50% of an oral dose is excreted as unchanged drug in the faeces. Elimination half-life: 40 minutes (initial), 126 minutes (secondary), 24 hr (terminal).

Special Precautions

For external use only; discontinue if sensitization or irritation occurs. Pregnancy and lactation.

How to Use

Take orally with food and water, as directed by your physician.

How to Store

Keep in a cool, dry place away from sunlight and moisture.

Safety Concerns

• Alcohol: Avoid during treatment.
• Breastfeeding: Not recommended.
• Pregnancy: Contraindicated.
• Liver/Kidney: Use with caution.

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