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Miconazole information from DrugsUpdate  

See Available Brands of Miconazole in India

P - Caution when used during pregnancy
L - Caution when used during lactation

Miconazole is an imidazole antifungal agent, developed by Janssen Pharmaceutica, and commonly applied topically (to the skin) or mucus membranes to cure fungal infections. It works by inhibiting the synthesis of ergosterol, a critical component of fungal cell membranes. It can also be used against certain species of Leishmania protozoa (which are a type of unicellular parasite), as these also contain ergosterol in their cell membranes. In addition to its antifungal and antiparasitic actions, it also has some limited antibacterial properties. It is marketed in various formulations under various brand names (see below).

Miconazole is also used in Ektachrome film developing (along with surfactants such as Photo-Flo) in the final rinse of the Kodak E-6 process and similar Fuji CR-56 process, replacing formaldehyde. Fuji Hunt also includes miconazole as a final rinse additive in their formulation of the process C-41RA rapid access color negative developing process.

Pharmacodynamics

Pharmacokinetics

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 hours (terminal).

Miconazole Indications / Miconazole Uses

Information Not Available

Miconazole Adverse Reactions / Miconazole Side Effects

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.

Precautions

Discontinue drug if sensitization or irritation is reported during use. The base contained in the suppository formulation may interact with certain latex products, such as that used in vaginal contraceptive diaphragms. Concurrent use is not recommended. Miconazole Nitrate Vaginal Cream USP, 2% may be considered for use under these conditions.

Special Precautions

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

Other 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.

Other Interactions

Information Not Available

Dosage

Vaginal
Vaginal candidiasis
Adult: 100 mg (as pessary or 5 g of 2% cream) inserted at night for 7-14 days. Alternatively, 100 mg bid for 7 days; 200 or 400 mg (as pessaries) daily for 3 days or 1200 mg (as pessary) as a single dose.

Topical/Cutaneous

Skin fungal infections
Adult: Apply 2% cream once daily.
Child: Apply 2% cream once daily.

Mouth/Throat

Intestinal or oropharyngeal candidiasis
Adult: As oral gel containing 20 mg/g (24 mg/ml): 5-10 ml after food 4 times a day. Retain near oral lesions before swallowing. Continue treatment until 48 hours after lesions have healed. For treatment of oral lesions, apply directly onto the lesions 4 times a day for 5-7 days. Continue treatment until 48 hours after lesions have healed.
Child: As oral gel containing 20 mg/g: 1 month-2 years: 2.5 ml bid. 2-6 years: 5 ml bid. >6 years: 5 ml 4 times a day. Retain near oral lesions before swallowing. Continue treatment until 48 hours after lesions have healed.

Food(before/after)

Information Not Available

List of Contraindications

Miconazole and Pregnancy

Caution when used during pregnancy

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Miconazole and Lactation

Caution when used during lactation

Miconazole and Children

Safety and efficacy in children younger than 1 year of age not studied sufficiently.

Miconazole and Geriatic

Information Not Available

Miconazole and Other Contraindications

Hypersensitivity; hepatic impairment (oral gel). Porphyria.

Storage

Information Not Available

Lab interference

Information Not Available

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