Vagistat-1

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

Contraindications

Hypersensitivity

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

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.

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

Vagistat-1 is part of the drug classes:

• Imidazole and triazole derivatives

• Imidazole derivatives

Avoid wearing tight-fitting, synthetic clothing such as nylon underwear or panty hose that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until your infection is healed.

Do not use a tampon, vaginal douche, spermicide, or other vaginal products while you are using tioconazole vaginal. Do not have vaginal intercourse during treatment.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Vaginal irritation.
• Itching.
• Burning.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Applies to tioconazole topical: vaginal ointment w/applicator

Local

Local side effects have been commonly reported. These have involved the genitourinary area (occurring in up to 7% of treated patients), and have included burning, itching, and, less commonly, pain, irritation, and dryness.[Ref]

Hypersensitivity

Hypersensitivity side effects have included contact dermatitis in patients using a topical nail solution (not available in the US). Most patients had been using the product for several weeks when dermatitis developed. Cross-sensitivity to other imidazoles has been reported.[Ref]

Some side effects of Vagistat-1 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.