Tioconazole, Vaginal

________________________________________________________________________

KEY POINTS

• This medicine is used in the vagina to treat fungus and yeast infections. Use it exactly as directed.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: antifungal

Generic and brand names: tioconazole, vaginal; Vagistat 1 (There may be other brand names for this medicine.)

What is this medicine used for?

This medicine is used in the vagina to treat fungus and yeast infections.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, contact your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• HIV/AIDS
• Vaginal itching or discomfort that has returned within 2 months after receiving treatment

Do not use this medicine if this is your first vaginal yeast infection. Also, tell your healthcare provider if you have vaginal infections often.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Check the label on the medicine for directions about your specific dose. Use this medicine exactly as directed by your healthcare provider. If you have a nonprescription product, follow the directions on the package.

Check with your healthcare provider before using this medicine in girls under age 12.

Wash your hands before and after using this medicine. Use the applicator to put the correct amount of medicine into your vagina. Lie on your back with your knees bent. Hold the full applicator in 1 hand. Put the applicator into your vagina (like you would a tampon) as far as you can. Slowly press the plunger until it stops. Withdraw the applicator and dispose of it in the trash. The medicine will be left behind in the vagina.

While using this medicine, wear a sanitary napkin to protect your clothing. Use the medicine at bedtime.

If you do not understand how to use this medicine, ask your healthcare provider or pharmacist to explain.

This medicine is a 1-dose treatment.

What if I overdose?

An acute overdose of this medicine is not likely to cause life-threatening symptoms. If you think that you or anyone else may have taken too much of this medicine, call the poison control center at 800-222-1222.

What should I watch out for?

If your condition does not improve in 3 days or if it gets worse, contact your healthcare provider.

Do not use this medicine if you have: vaginal itching and discomfort for the first time, abdominal pain, shoulder or back pain, fever higher than 100°F, or 37.8°C, chills, nausea, vomiting, diarrhea, or foul smelling discharge. You may have a more serious condition, and should contact your healthcare provider.

Do not use this medicine for other vaginal infections unless your healthcare provider approves.

The ointment base used in this medicine may interact with rubber or latex in products such as condoms and vaginal diaphragms. Do not use condoms and diaphragms within 72 hours of using this medicine. Ask your healthcare provider if you can have vaginal intercourse while using this product.

Do not use tampons while using this medicine. Use sanitary pads. Do not use any other vaginal products, such as douches or spermicides, while using this medicine.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Burning or itching that continues or gets worse; severe belly pain, shoulder or back pain; fever; chills; nausea, vomiting, or diarrhea; foul-smelling vaginal discharge; vaginal swelling or redness; trouble urinating or painful urinating; stomach pain or cramping; trouble breathing.

Other: Temporary burning or itching, dry vagina, minor vaginal pain, vaginal discharge; headache.

What products might interact with this medicine?

No significant drug interactions have been reported. Do not use other medicines in the vagina unless your healthcare provider approves.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.