Vagistat-1

DRUG DESCRIPTION

Tioconazole, 1-[2-{(2-chloro-3-thienyl)methoxy}-2(2,4-dichlorophenyl)ethyl]1,H-imidazole, is a topical antifungal agent. Its chemical formula is C16H13Cl3N2OS with a molecular weight of 387.7.

VAGISTAT-1 (tioconazole 6.5%) is formulated in a base of white, soft paraffin and aluminum magnesium silicate with butylated hydroxyanisole (BHA) added as a preservative. Each applicator-full of VAGISTAT-1 (tioconazole) provides approximately 4.6 grams of ointment containing 300 mg of tioconazole.

What are the possible side effects of tioconazole vaginal (Monistat-1, Vagistat-1)?

Stop using tioconazole vaginal and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

Other, less serious side effects may be more likely to occur. These include burning, itching, irritation of the skin, and an increased need to urinate.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may...

Read All Potential Side Effects and See Pictures of Vagistat-1

What are the precautions when taking tioconazole (Vagistat-1)?

See also Uses section.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungal agents (such as clotrimazole, fluconazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

If you have any of the following health problems, consult your doctor or pharmacist before using this medication: diabetes, immune system problems (such as HIV-AIDs), frequent vaginal yeast infections (more than 3 in 6 months or 4 in 1 year).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Ask...

Read All Potential Precautions of Vagistat-1


Vagistat-1 Consumer (continued)

SIDE EFFECTS: Headache or vaginal/urethral burning/itching/pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

If your doctor has prescribed this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Uses section.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungal agents (such as clotrimazole, fluconazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

If you have any of the following health problems, consult your doctor or pharmacist before using this medication: diabetes, immune system problems (such as HIV-AIDs), frequent vaginal yeast infections (more than 3 in 6 months or 4 in 1 year).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Ask your doctor whether you can have sexual intercourse while using this product. This product may weaken rubber products (such as latex condoms, diaphragms, cervical caps) and lead to failure. This can result in pregnancy. Therefore, do not use these products during treatment with this medication and for 3 days after treatment is over. Consult your doctor about other forms of barrier protection/birth control (such as polyurethane condoms) during this time.

Do not use this medication for self-treatment if you are pregnant. During pregnancy, this medication should be used only when clearly needed. If you are pregnant, follow your doctor's instructions on how to use the applicator to insert this medication. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Vagistat-1 Patient Information Including Side Effects

Brand Names: Monistat-1, Vagistat-1

Generic Name: tioconazole vaginal (Pronunciation: tee oh CON a zole)

  • What is tioconazole vaginal (Vagistat-1)?
  • What are the possible side effects of tioconazole vaginal (Vagistat-1)?
  • What is the most important information I should know about tioconazole vaginal (Vagistat-1)?
  • What should I discuss with my healthcare provider before using tioconazole vaginal (Vagistat-1)?
  • How should I use tioconazole vaginal (Vagistat-1)?
  • What happens if I miss a dose (Vagistat-1)?
  • What happens if I overdose (Vagistat-1)?
  • What should I avoid while using tioconazole vaginal (Vagistat-1)?
  • What other drugs will affect tioconazole vaginal (Vagistat-1)?
  • Where can I get more information?

What is tioconazole vaginal (Vagistat-1)?

Tioconazole is an antifungal medication. It prevents fungus from growing.

Tioconazole vaginal is used to treat vaginal candida (yeast) infections.

Tioconazole vaginal may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of tioconazole vaginal (Vagistat-1)?

Stop using tioconazole vaginal and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

Other, less serious side effects may be more likely to occur. These include burning, itching, irritation of the skin, and an increased need to urinate.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about tioconazole vaginal (Vagistat-1)?

Use this medication for the full amount of time prescribed by your doctor or recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

Avoid wearing tight-fitting, synthetic clothing (e.g., panty hose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Avoid getting this medication in the eyes, nose, or mouth.

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