Pronunciation:

(mi KON a zole)

U.S. Brand Names:

Synonyms:

Generic Available:

Canadian Brand Names:

Use:

Pregnancy Risk Factor:

Lactation:

Contraindications:

Warnings/Precautions:

Adverse Reactions:

Topical: Allergic contact dermatitis, burning, maceration

Vaginal: Abdominal cramps, burning, irritation, itching

Drug Interactions:

Note: The majority of reported drug interactions were observed following intravenous miconazole administration. Although systemic absorption following topical and/or vaginal administration is low, potential interactions due to CYP isoenzyme inhibition may occur (rarely). This may be particularly true in situations where topical absorption may be increased (eg, inflamed tissue).

Amphotericin B: Antifungal effects of both agents may be decreased

Cisapride: Risk of cardiotoxicity may be increased due to effect on metabolism; concurrent administration is contraindicated

CYP1A2 substrates: Miconazole may increase the levels/effects of CYP1A2 substrates. Example substrates include aminophylline, fluvoxamine, mexiletine, mirtazapine, ropinirole, theophylline, and trifluoperazine.

CYP2A6 substrates: Miconazole may increase the levels/effects of CYP2A6 substrates. Example substrates include dexmedetomidine and ifosfamide.

CYP2C8/9 substrates: Miconazole may increase the levels/effects of CYP2C8/9 substrates. Example substrates include amiodarone, fluoxetine, glimepiride, glipizide, nateglinide, phenytoin, pioglitazone, rosiglitazone, sertraline, and warfarin.

CYP2C19 substrates: Miconazole may increase the levels/effects of CYP2C19 substrates. Example substrates include citalopram, diazepam, methsuximide, phenytoin, propranolol, and sertraline.

CYP2D6 substrates: Miconazole may increase the levels/effects of CYP2D6 substrates. Example substrates include amphetamines, selected beta-blockers, dextromethorphan, fluoxetine, lidocaine, mirtazapine, nefazodone, paroxetine, risperidone, ritonavir, thioridazine, tricyclic antidepressants, and venlafaxine.

CYP2D6 prodrug substrates: Miconazole may decrease the levels/effects of CYP2D6 prodrug substrates. Example prodrug substrates include codeine, hydrocodone, oxycodone, and tramadol.

CYP2E1 substrates: Miconazole may increase the levels/effects of CYP2E1 substrates. Example substrates include inhalational anesthetics, theophylline, and trimethadione.

CYP3A4 inducers: CYP3A4 inducers may decrease the levels/effects of miconazole. Example inducers include aminoglutethimide, carbamazepine, nafcillin, nevirapine, phenobarbital, phenytoin, and rifamycins.

CYP3A4 substrates: Miconazole may increase the levels/effects of CYP3A4 substrates. Example substrates include benzodiazepines, calcium channel blockers, mirtazapine, nateglinide, nefazodone, tacrolimus, and venlafaxine. Selected benzodiazepines (midazolam and triazolam), cisapride, ergot alkaloids, selected HMG-CoA reductase inhibitors (lovastatin and simvastatin), and pimozide are generally contraindicated with strong CYP3A4 inhibitors.

Phenytoin: Serum concentration may be increased by miconazole

Sulfonylureas: Hypoglycemic effects may be increased

Warfarin: An increased anticoagulant effect may occur with coadministration, including reports associated with short-term (3-day) intravaginal miconazole therapy

Ethanol/Nutrition/Herb Interactions:

Mechanism of Action:

Pharmacodynamics/Kinetics:

Absorption: Topical: Negligible

Distribution: Widely to body tissues; penetrates well into inflamed joints, vitreous humor of eye, and peritoneal cavity, but poorly into saliva and sputum; crosses blood-brain barrier but only to a small extent

Protein binding: 91% to 93%

Metabolism: Hepatic

Half-life elimination: Multiphasic: Initial: 40 minutes; Secondary: 126 minutes; Terminal: 24 hours

Excretion: Feces (~50%); urine (<1% as unchanged drug)

Dosage:

Topical: Children and Adults: Note: Not for OTC use in children <2 years:

Tinea pedis and tinea corporis: Apply twice daily for 4 weeks

Tinea cruris: Apply twice daily for 2 weeks

Vaginal: Adults: Vulvovaginal candidiasis:

Cream, 2%: Insert 1 applicatorful at bedtime for 7 days

Cream, 4%: Insert 1 applicatorful at bedtime for 3 days

Suppository, 100 mg: Insert 1 suppository at bedtime for 7 days

Suppository, 200 mg: Insert 1 suppository at bedtime for 3 days

Suppository, 1200 mg: Insert 1 suppository (a one-time dose); may be used at bedtime or during the day

Note: Many products are available as a combination pack, with a suppository for vaginal instillation and cream to relieve external symptoms. External cream may be used twice daily, as needed, for up to 7 days.

Patient Education:

Topical: Wash and dry area before applying medication; apply thinly. Do not get in or near eyes. Not for OTC use in children <2 years of age.

Vaginal: Consult with healthcare provider if using for a vaginal yeast infection for the first time. Insert high in vagina. Refrain from intercourse during treatment. Condoms and diaphragms may not be effective during therapy. Do not use tampons, douches, spermicides, or other vaginal products during treatment. Deodorant-free pads or panty shields may be used to protect clothing during use.

Dental Health: Effects on Dental Treatment:

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

Mental Health: Effects on Mental Status:

Mental Health: Effects on Psychiatric Treatment:

Dosage Forms:

Combination products: Miconazole nitrate vaginal suppository 200 mg (3s) and miconazole nitrate external cream 2%; Miconazole nitrate vaginal suppository 100 mg (7s) and miconazole nitrate external cream 2%

Monistat® 1 Combination Pack: Miconazole nitrate vaginal insert 1200 mg (1) and miconazole external cream 2% (5 g) [Note: Do not confuse with 1-Day™ (formerly Monistat® 1) which contains tioconazole]

Monistat® 3 Combination Pack: Miconazole nitrate vaginal suppository 200 mg (3s) and miconazole nitrate external cream 2%

Monistat® 3 Cream Combination Pack: Miconazole nitrate vaginal cream 4% and miconazole nitrate external cream 2%

Monistat® 7 Combination Pack:

Miconazole nitrate vaginal suppository 100 mg (7s) and miconazole nitrate external cream 2%

Miconazole nitrate vaginal cream 2% (7 prefilled applicators) and miconazole nitrate external cream 2%

Cream, topical, as nitrate: 2% (15 g, 30 g, 45 g)

Baza® Antifungal: 2% (4 g, 57 g, 142 g) [zinc oxide based formula]

Carrington Antifungal: 2% (150 g)

Micaderm®: 2% (30 g)

Micatin®: 2% (15 g)

Micro-Guard®, Mitrazol™: 2% (60 g)

Monistat-Derm®: 2% (15 g, 30 g, 85 g)

Triple Care® Antifungal: 2% (60 g, 98 g)

Cream, vaginal, as nitrate [prefilled or with single refillable applicator]: 2% (45 g)

Femizol-M™: 2% (47 g)

Monistat® 3: 4% (15 g, 25 g)

Monistat® 7: 2% (45 g)

Liquid, spray, as nitrate (Micatin®): 2% (90 mL, 105 mL)

Lotion, powder, as nitrate (Zeasorb®-AF): 2% (56 g) [contains alcohol 70%]

Ointment, topical, as nitrate: (Aloe Vesta® 2-n-1 Antifungal): 2% (60 g, 150 g)

Powder, topical, as nitrate:

Lotrimin® AF, Micatin®, Micro-Guard®: 2% (90 g)

Mitrazol™: 2% (30 g)

Zeasorb®-AF: 2% (70 g)

Powder spray, topical, as nitrate (Lotrimin® AF): 2% (100 g)

Suppository, vaginal, as nitrate: 100 mg (7s); 200 mg (3s)

Monistat® 3: 200 mg (3s)

Monistat® 7: 100 mg (7s)

Tincture, topical, as nitrate (Fungoid®): 2% (30 mL, 473 mL) [contains isopropyl alcohol 30%]

International Brand Names: