tioconazole (OTC)

Brand and Other Names:Vagistat 1
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

vaginal ointment

  • 6.5%

Vaginal Candidiasis

Insert 1 applicatorful (5 g of 6.5% ointment) intravaginally qHS once

Safety & efficacy not established

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Adverse Effects

Frequency Not Defined

Vulvovaginal burning, vaginitis, pruritus

Headache

Abdominal cramping

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Warnings

Contraindications

Hypersensitivity

Self treatment not recommended for pregnant patients, diabetic patients or patients <12 years

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: not known whether distributed into milk, manufacturer recommends women discontinue breastfeeding while receiving drug

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Antifungal ointment inhibits P450 system which reduces synthesis of fungal ergosterol

Pharmacokinetics

Peak Plasma: 18 ng/mL in 2-24 hr

Onset of action: 24 hr (symptom improvement); 7 days (complete relief)

Metabolism: Glucuronidation of the imidazole ring

Distribution: Vaginal fluid (24-72 hr)

Excretion: Urine and feces

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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.