Terazol 3, Terazol 7

TERAZOL® 7 (terconazole) Vaginal Cream 0.4% is available in 45g (NDC 50458-535-01) tubes with an ORTHO Measured-Dose Applicator. Store at Controlled Room Temperature 15–30°C (59–86°F).

TERAZOL® 3 (terconazole) Vaginal Cream 0.8% is available in 20g (NDC 50458-536-01) tubes with an ORTHO Measured-Dose Applicator. Store at Controlled Room Temperature 15–30°C (59–86°F).

TERAZOL® 3 (terconazole) Vaginal Suppositories 80 mg are available as 2.5g, elliptically-shaped white to off-white suppositories in packages of three (NDC 50458-531-01) with a vaginal applicator. Store at Controlled Room Temperature 15–30°C (59–86°F).

Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674 (for the Vaginal Cream) Jubilant HollisterStier General Partnership, Kirkland, Quebec, Canada H9H 4J4 (for the Vaginal Cream and Vaginal Suppositories). Manufactured for: Janssen Pharmaceuticals, Inc. Titusville, New Jersey 08560

TERAZOL® 7 VAGINAL CREAM 0.4%
(terconazole)

TERAZOL® 3 VAGINAL CREAM 0.8%
(terconazole)

PATIENT INSTRUCTIONS

Filling the applicator:

Remove the cap from the tube.

Use the pointed tip on the top of the cap to puncture the seal on the tube.

Screw the applicator onto the tube.

Squeeze the tube from the bottom and fill the applicator until the plunger stops.

Unscrew the applicator from the tube.

Using the applicator:

1. Lie on your back with your knees drawn up toward your chest.

Holding the applicator by the ribbed end of the barrel, insert the filled applicator into the vagina as far as it will comfortably go.

Slowly press the plunger of the applicator to release the cream into the vagina.

Remove the applicator from the vagina.

Apply one applicatorful each night for as many days at bedtime, as directed by your doctor.

Cleaning the applicator: (Does not apply to sample applicators, which are for one time use only)

After each use, you should thoroughly clean the applicator by following the procedure below:

1. Pull the plunger out of the barrel.

Wash the pieces with lukewarm, soapy water, and dry them thoroughly.

Put the applicator back together by gently pushing the plunger into the barrel as far as it will go.

NOTE: Store the cream at Controlled Room Temperature 15–30°C (59–86°F). See end flap for lot number and expiration date.

TERAZOL® 3 VAGINAL SUPPOSITORIES 80mg
(terconazole)

Three oval suppositories, for use inside the vagina only.

Designed to be inserted into the vagina.

HOW TO USE:

Place one suppository into the vagina each night at bedtime, for 3 nights, as directed by your doctor. The TERAZOL Suppository is self-lubricating and may be inserted with or without the applicator.

A. Insertion with the applicator

1. Filling the applicator

Break off suppository from the plastic strip.

Pull the plastic completely apart at the notched end.

Place the flat end of the suppository into the open end of the applicator as shown. You are now ready to insert the suppository into the vagina.

2. Using the applicator

Lie on your back with your knees drawn up toward your chest.

Holding the applicator by the ribbed end of the barrel, gently insert it into the vagina as far as it will comfortably go.

Press the plunger to release the suppository into the vagina.

Remove the applicator from the vagina.

3. Cleaning the applicator (Does not apply to sample applicators, which are for one time use only)

After each use, you should thoroughly clean the applicator by following the procedure below:

Pull the plunger out of the barrel.

Wash both pieces with lukewarm, soapy water, and dry them thoroughly.

Put the applicator back together by gently pushing the plunger into the barrel as far as it will go.

B. Insertion without the applicator

Lie on your back with your knees drawn up toward your chest.

Place the suppository on the tip of your finger as shown.

Insert the suppository gently into the vagina as far as it will comfortably go. NOTE: Store the suppositories at Controlled Room Temperature 15–30°C (59–86°F). See end flap for lot number and expiration date.

A WORD ABOUT YEAST INFECTIONS

Why do yeast infections occur?

Yeast infections are caused by an organism called Candida (KAN di duh). It may be present in small and harmless amounts in the mouth, digestive tract, and vagina. Sometimes the natural balance of the vagina becomes upset. This may lead to rapid growth of Candida, which results in a yeast infection. Symptoms of a yeast infection include itching, burning, redness, and an abnormal discharge.

Your doctor can make the diagnosis of a yeast infection by evaluating your symptoms and looking at a sample of the discharge under the microscope.

How can I prevent yeast infections?

Certain factors may increase your chance of developing a yeast infection. These factors don't actually cause the problem, but they may create a situation that allows the yeast to grow rapidly.

Clothing: Tight jeans, nylon underwear, pantyhose, and wet bathing suits can hold in heat and moisture (two conditions in which yeast organisms thrive). Looser pants or skirts, 100% cotton underwear, and stockings may help avoid this problem.

Diet: Cutting down on sweets, milk products, and artificial sweeteners may reduce the risk of yeast infections.

Antibiotics: Antibiotics work by eliminating disease-causing organisms. While they are helpful in curing other problems, antibiotics may lead to an overgrowth of Candida in the vagina.

Pregnancy: Hormonal changes in the body during pregnancy encourage the growth of yeast. This is a very common time for an infection to occur. Until the baby is born, it may be hard to completely eliminate yeast infections. If you believe you are pregnant, tell your doctor.

Menstruation: Sometimes monthly changes in hormone levels may lead to yeast infections.

Diabetes: In addition to heat and moisture, yeast thrives on sugar. Because diabetics often have sugar in their urine, their vaginas are rich in this substance. Careful control of diabetes may help prevent yeast infection.

Controlling these factors can help eliminate yeast infections and may prevent them from coming back.

Some other helpful tips:

1. For best results, be sure to use the medication as prescribed by your doctor, even if you feel better quickly.

Avoid sexual intercourse, if your doctor advises you to do so. The suppository formulation (not the cream) may damage the diaphragm. Therefore, use of the diaphragm during therapy with the suppository is not recommended. Consult your physician.

If your partner has any penile itching, redness, or discomfort, he should consult his physician and mention that you are being treated for a yeast infection.

You can use the medication even if you are having your menstrual period. However, you should not use tampons because they may absorb the medication. Instead, use external pads or napkins until you have finished your medication. You may also wish to wear a sanitary napkin if the vaginal medication leaks.

Dry the genital area thoroughly after showering, bathing, or swimming. Change out of a wet bathing suit or damp exercise clothes as soon as possible. A dry environment is less likely to encourage the growth of yeast.

Wipe from front to rear (away from the vagina) after a bowel movement.

Don't douche unless your doctor specifically tells you to do so. Douching may disturb the vaginal balance.

Don't scratch if you can help it. Scratching can cause more irritation and spread the infection.

Discuss with your physician any medication you are already taking. Certain types of medication can make your vagina more susceptible to infection.

Eat nutritious meals to promote your general health.

• Yeast Infection (in Women and Men)