Tioconazole

Generic name: tioconazole vaginal
Brand names: 1-Day, Vagistat-1
Dosage form: vaginal ointment w/applicator (6.5%)
Drug class: Vaginal anti-infectives

Medically reviewed by  A Ras MD.

What is tioconazole used for?

Tioconazole is a prescription medicine that is used to treat vaginal infections.

Tioconazole may be given to you for other reasons. Talk to your doctor.

Before taking tioconazole, tell your doctor:

• If you are allergic to tioconazole; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take tioconazole with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take tioconazole?

• Tell all of your health care providers that you take tioconazole. This includes your doctors, nurses, pharmacists, and dentists.
• If vaginal yeast infections happen often, talk with the doctor.
• If you have HIV infection, talk with your doctor.
• Do not use tioconazole if you have belly pain, fever, or bad-smelling vaginal discharge. Talk with your doctor.
• Protect clothing and fabrics from staining.
• Do not have vaginal sex while using tioconazole.
• Do not use tioconazole for itching caused by a health problem other than a vaginal yeast infection. Talk with the doctor.
• Condoms or diaphragms may not work to prevent pregnancy or stop the spread of diseases passed through sex while using tioconazole and for a period of time after you stop tioconazole. You will need to use some other kind of birth control for some time after the last dose. Be sure you know how long to do this.
• Do not douche or use other vaginal products like tampons while you are using tioconazole. You may need to avoid these things for some time after the last dose. If you have questions, talk with your doctor.
• This medicine may cause harm if swallowed. If tioconazole is swallowed, call a doctor or poison control center right away.
• Do not give tioconazole to a child younger than 12 years old without first checking with the doctor.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is tioconazole best taken?

Use tioconazole as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Use ointment vaginally.
• Keep out of your mouth, nose, and eyes (may burn).
• Use at bedtime.
• Wash your hands before and after use.
• Do not open until you are ready to use.
• Do not use the applicators more than 1 time.
• It may take 1 week to see the full effect.

What do I do if I miss a dose?

• Only 1 dose of tioconazole is needed. If you miss your dose, take it as soon as you think about it.

What are the side effects of tioconazole that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Stomach pain.
• Fever or chills.
• Upset stomach or throwing up.
• Bad-smelling vaginal discharge.

What are some other side effects of tioconazole?

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 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out tioconazole?

• Store at room temperature.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information

• 1-DOSE TREATMENT
• Tioconazole Ointment 6.5%
• VAGINAL ANTIFUNGAL
• EDUCATIONAL BROCHURE
• Please read this educational brochure completely before using this product.

USE: treats vaginal yeast infections

1 THIS PRODUCT CURES MOST RECURRENT VAGINAL YEAST INFECTIONS

IF THIS IS THE FIRST TIME YOU HAVE HAD VAGINAL ITCH AND DISCOMFORT, CONSULT YOUR DOCTOR. IF YOU HAVE HAD A DOCTOR DIAGNOSE A VAGINAL YEAST INFECTION BEFORE AND HAVE THE SAME SYMPTOMS NOW, USE THIS OINTMENT AS DIRECTED. THIS PRODUCT IS FOR THE TREATMENT OF RECURRENT VAGINAL YEAST INFECTIONS ONLY. IT DOES NOT TREAT OTHER INFECTIONS AND DOES NOT PREVENT PREGNANCY.

This product, a vaginal ointment that contains an antifungal medicine, works to cure most recurrent vaginal yeast infections by killing the overgrowth of yeast.

2 WHAT IS A VAGINAL YEAST INFECTION (CANDIDIASIS)?

A yeast infection is caused by an organism called Candida, which is a type of yeast. Healthy women usually have this yeast in the vagina. Either an overgrowth or rapid growth of this yeast can cause a vaginal yeast infection. The symptoms of a vaginal yeast infection can include any or all of the following:

• Vaginal itching – Itching can range from mild to intense
• Vaginal discharge – This discharge may be thick like paste or lumpy like cottage cheese
• Vaginal soreness, burning or irritation – The vagina can feel sore inside or there can be a burning sensation, particularly during vaginal intercourse.
• Rash or redness – Rash or redness may occur around the vagina (vulvar irritation).

NOTE: Vaginal discharge that is different from the above, for example, a yellow/green discharge or a discharge that smells “fishy” (foul-smelling), may indicate that you have something other than a yeast infection. If this is the case, you should consult your doctor before using this product.

3 WHAT ARE THE REASONS YOU GET VAGINAL YEAST INFECTIONS?

There are several conditions that can cause too much yeast to grow inside the vagina such as:

Hormonal changes – Changes in hormonal levels can occur during pregnancy, with the use of some birth control pills, and just before a woman’s menstrual period.

• Antibiotics – Because antibiotics can kill the normal bacteria in the vagina, yeast may grow very quickly.
• Diabetes – Diabetes can also make a woman more likely to get a vaginal yeast infection.
• Human Immunodeficiency Virus (HIV) – Various medical conditions can damage the body’s normal defenses against infection. One of the most serious of these conditions is infection with the human immunodeficiency virus (HIV -the virus that causes AIDS). Infection with HIV causes the body to be more susceptible to infections, including vaginal yeast infections. Women with HIV infection may have frequent vaginal yeast infections or, especially, vaginal yeast infections that do not clear up easily with proper treatment. If you may have been exposed to HIV and are experiencing either frequent recurring vaginal yeast infections or, especially, vaginal yeast infections that do not clear up easily with proper treatment, you should see your doctor promptly. If you wish further information on risk factors for HIV infection or on the relationship between recurrent or persistent vaginal yeast infections and HIV infection, please contact your doctor or the CDC National AIDS HOTLINE. The CDC phone numbers are: 1-800-232-4636 (English/Spanish), or 1-888-232-6348 (hearing impaired, TTY).

4 WARNINGS

For vaginal use only

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor

Ask a doctor before use if you have

• vaginal itching and discomfort for the first time
• lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition.
• vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
• been exposed to the human immunodeficiency virus (HIV) that causes AIDS

When using this product

• do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted disease (STDs).

• do not have vaginal intercourse
• mild increase in vaginal burning, itching or irritation may occur
• if you do not get complete relief ask a doctor before using another product

Stop use and ask a doctor if

• symptoms do not get better after 3 days
• symptoms last more than 7 days
• you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

5 WHEN CAN YOU EXPECT SYMPTOM RELIEF?

While this product is a 1-dose treatment, most women do not experience complete relief of their symptoms in just 1 day. Most women experience some improvement within 1 day and complete relief of symptoms within 7 days.

If your symptoms do not improve in 3 days or if you still have symptoms after 7 days, consult your doctor. Your doctor may recommend other treatment, or you may have a condition other than a yeast infection.

If your symptoms return within 2 months or if you think you have been exposed to the human immunodeficiency virus (HIV) that causes AIDS, consult your doctor immediately. Recurring yeast infections may be a sign of pregnancy or a serious condition, such as AIDS or diabetes.

6 HOW TO USE TIOCONAZOLE OINTMENT 6.5%

This product comes in a pre-filled, single-dose applicator.

Directions for use:

Read the full directions printed below and on the printed packet carefully before using.

• Bedtime is the best time to apply this product.
• Open the printed packet just before use.
• Remove the applicator and plunger from the printed packet. The applicator is pre-filled with vaginal ointment.
• While firmly holding the purple-capped end of the applicator, push the tip of the plunger into the base of applicator. Fig. 1

REMOVE PURPLE CAPfrom the top of the applicator using a pull-twist action. Fig. 2

Lie on your back with your knees bent. Gently insert applicator into the vagina as far as it will go comfortably. Fig. 3

Push the plunger into the applicator until it will go no farther. Withdraw the applicator and plunger and dispose of it in the wastebasket. Do not flush. Fig. 4

DO NOT USE TAMPONS while using this medicine. Use sanitary napkins instead.

7 ADVERSE REACTIONS (SIDE EFFECTS)

A temporary increase in vaginal burning, itching and/or irritation may be experienced upon insertion of this ointment. These reactions, in addition to vaginal swelling or redness; difficulty or burning on urination; headache; abdominal pain/cramping and upper respiratory infection have been reported with the use of this product. If you experience any of these, consult your doctor.

8 COMMON QUESTIONS ABOUT VAGINAL YEAST INFECTIONS AND TIOCONAZOLE OINTMENT 6.5%

Q. Should I use this product while I have my period?

You should use this product while menstruating but you should not use tampons following application. Use sanitary napkins instead.

Q. Can I have sex while using this product?

It is generally recommended not to have vaginal intercourse the first few nights after treatment with this product.

Q. Can I use a condom or diaphragm while using this product?

No. This product contains petrolatum which may damage the latex from which condoms and diaphragms are made and may cause them to fail. This may reduce their effectiveness in preventing sexually transmitted diseases and pregnancy. You should wait 3 days after treatment to resume using condoms or your diaphragm.

Q. Does my partner need to be treated?

Yeast infections occur less frequently in men than in women. However, if your partner has any of the following symptoms: itching, redness or discomfort in the genital area, he should see a doctor and mention that you are treating a vaginal yeast infection.

Q. Can I use feminine hygiene products (such as douche) while I have a vaginal yeast infection?

It is best not to use any vaginal preparations while you have a yeast infection including douches, feminine hygiene sprays, contraceptive foams, inserts, or jellies.

9 FOR BEST RESULTS

• • Wear cotton underwear and loose-fitting clothes – Yeast grow in warm, moist environments. Wearing loose-fitting, cotton clothes helps create a cooler environment, which makes it more difficult for yeast to grow.
  • Change out of a wet bathing suit quickly – Dampness is more likely to encourage the growth of yeast.
  • Use proper hygiene – Wipe from front to rear (away from vagina) after a bowel movement or urination.
  • Discuss with your doctor any medication you are now taking – Certain types of medication can make your vagina more prone to infection.If you have any other questions or concerns about vaginal yeast infections or of a medical nature, don’t hesitate to consult your doctor.

    If you have questions or comments about this product, call our toll-free number 1-800-719-9260.

Label

• 1-Dose Treatment
• Vaginal Ointment
• Compare to the active ingredient in Monistat® 1
• 1-Dose Treatment with 1 Pre-Filled Ointment Applicator
• Educational Brochure Enclosed
• TIOCONAZOLE 1
• Tioconazole Ointment (6.5%)
• Vaginal Antifungal
• CURES Most Vaginal YEAST INFECTIONS
• 1 Pre-Filled Applicator
• Odorless Formula
• OUR PHARMACISTS RECOMMEND
• NET WT. 4.6 g (0.16 OZ) APPLICATOR

SRC: NLM .