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tioconazole (OTC)Brand and Other Names:Vagistat 1

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

vaginal ointment

  • 6.5%
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Vaginal Candidiasis

Prefilled vaginal applicator (5 g of 6.5% ointment) applied intravaginally qHS

Safety & efficacy not established

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Adverse Effects

1-10%

Vulvovaginal burning, vaginitis, pruritus (5-6%)

Headache (5%)

Infection (3%)

Abdominal pain (2%)

Dysuria, nocturia, pharyngitis, and rhinitis (<2%)

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Warnings

Contraindications

Hypersensitivity

Self Tx not recommended for pregnant pts, diabetic pts or pts <12 yo

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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

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

Metabolism: glucuronidation of the imidazole ring

Excretion

Urine as metabolites: 25-27%

Feces as unchanged drug: 59%

Mechanism of Action

Antifungal ointment inhibits P450 system which reduces synthesis of fungal ergosterol

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