No

Antifungal Agent, Parenteral; Antifungal Agent, Topical; Antifungal Agent, Vaginal

I.V.: Treatment of severe systemic fungal infections and fungal meningitis that are refractory to standard treatment

Topical: Treatment of vulvovaginal candidiasis and a variety of skin and mucous membrane fungal infections

C

Hypersensitivity to miconazole, fluconazole, ketoconazole, polyoxyl 35 castor oil, or any component; concomitant administration with cisapride

Administer I.V. with caution to patients with hepatic insufficiency; the safety of miconazole in patients <1 year of age has not been established; cardiorespiratory and anaphylaxis have occurred with excessively rapid administration

>10%:

Central nervous system: Fever, chills (10%)

Dermatologic: Rash, itching, pruritus (21%)

Gastrointestinal: Anorexia, diarrhea, nausea (18%), vomiting (7%)

Local: Pain at injection site

1% to 10%: Dermatologic: Rash (9%)

<1%: Flushing of face or skin, drowsiness, anemia, thrombocytopenia

Symptoms of overdose include nausea, vomiting, drowsiness

Following GI decontamination, supportive care only

CYP3A3/4 enzyme substrate; CYP2C enzyme inhibitor, CYP3A3/4 enzyme inhibitor (moderate), and CYP3A5-7 enzyme inhibitor

Increased risk of significant cardiotoxicity with concurrent administration of cisapride - concomitant administration is contraindicated (see interactions associated with ketoconazole)

Protect from heat; darkening of solution indicates deterioration; stability of parenteral admixture at room temperature (25°C): 2 days

Inhibits biosynthesis of ergosterol, damaging the fungal cell wall membrane, which increases permeability causing leaking of nutrients

Absorption: Negligible from topical dosage forms

Distribution: Appears to be widely distributed 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: In the liver

Half-life, multiphasic: Initial: 40 minutes; Secondary: 126 minutes; Terminal phase: 24 hours

Elimination: ~50% excreted in feces and <1% in urine as unchanged drug

Children:

<1 year: 15-30 mg/kg/day

1-12 years:

I.V.: 20-40 mg/kg/day divided every 8 hours (do not exceed 15 mg/kg/dose)

Topical: Apply twice daily for up to 1 month

Adults:

Topical: Apply twice daily for up to 1 month

I.T.: 20 mg every 1-2 days

I.V.: Initial: 200 mg, then 0.6-3.6 g/day divided every 8 hours for up to 20 weeks

Bladder candidal infections: 200 mg diluted solution instilled in the bladder

Vaginal: Insert contents of 1 applicator of vaginal cream (100 mg) or 100 mg suppository at bedtime for 7 days, or 200 mg suppository at bedtime for 3 days

Hemodialysis: Not dialyzable (0% to 5%)

protein

May cause drowsiness

None reported

No information available to require special precautions

No effects or complications reported

Take full course of therapy as directed; do not discontinue without consulting prescriber. Some infections may require long periods of therapy. Practice good hygiene measures to prevent reinfection.

Vaginal: Insert high in vagina. Refrain from intercourse during treatment.

If you are diabetic you should test serum glucose regularly at the same time of day. You may experience nausea and vomiting (small, frequent meals may help) or headache, dizziness (use caution when driving). Report unresolved headache, rash, burning, itching, anorexia, unusual fatigue, diarrhea, nausea, or vomiting. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Consult prescriber if breast-feeding.

Observe patient closely during first I.V. dose for allergic reactions

Cream:

Topical, as nitrate: 2% (15 g, 30 g, 56.7 g, 85 g)

Vaginal, as nitrate: 2% (45 g is equivalent to 7 doses)

Dual pack: Vaginal suppositories and external vulvar cream 2%

Injection: 1% [10 mg/mL] (20 mL)

Lotion, as nitrate: 2% (30 mL, 60 mL)

Powder, topical: 2% (45 g, 90 g, 113 g)

Spray, topical: 2% (105 mL)

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

Tincture: 2% with alcohol (7.39 mL, 29.57 mL)

Coulthard K, Martin J, and Matthews N, "Convulsions After Miconazole Overdose," Med J Aust, 1987, 146(1):57-8.

Fainstein V and Bodey GP, "Cardiorespiratory Toxicity Due to Miconazole," Ann Intern Med, 1980, 93:432-3.

Kanarek KS and Williams PR, "Toxicity of Intravenous Miconazole Overdosage in a Preterm Infant," Pediatr Infect Dis, 1986, 5(4):486-8.