Terazol 7

Avoid having sexual intercourse during treatment, unless your doctor says that you may.

Do not use a tampon, vaginal douche, or other vaginal products while you are using terconazole vaginal.

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.

It is not likely that other drugs you take orally or inject will have an effect on terconazole used in the vagina. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

• Altura Pharmaceuticals, Inc.

• Cheshire Pharm. Systems

• Compumed Pharmaceuticals, Inc.

• DispenseXpress, Inc.

• Dispensing Solutions, Inc.

• Janssen Pharmaceuticals, Inc.

• Ortho-McNeil-Janssen Pharmaceutical

• Pharma Pac (A Service Of H.J. Harkins Co., Inc.)

• Quality Care Pharmaceuticals

Terconazole is an antifungal medication that fights infections caused by fungus.

Terconazole vaginal (for use in the vagina) is used to treat vaginal Candida (yeast) infections.

Terconazole vaginal may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

It is not likely that other drugs you take orally or inject will have an effect on terconazole used in the vagina. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

This section provides information on the proper use of a number of products that contain terconazole. It may not be specific to Terazol 7. Please read with care.

Use this medicine exactly as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered.

This medicine should come with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

To use the vaginal cream:

• The vaginal cream comes in a tube. You will use an applicator to put the cream into your vagina.
• The applicator is an empty plastic tube called a barrel. There is a plunger on one end and an opening on the other end.
• Wash your hands before and after using this medicine.
• Remove the cap from the end of the tube. Screw the open end of the applicator onto the tube of cream.
• Squeeze the tube and fill the applicator until it is full or the plunger stops.
• Unscrew the applicator from the tube and replace the cap on the tube.
• To use the applicator: Lie on your back with your knees drawn up toward your chest. Hold the applicator by the open end of the barrel and gently insert it into the vagina as far as it will comfortably go. Slowly press the plunger of the applicator to release the cream into the vagina, and then gently remove it.
• After using, pull the plunger completely out of the applicator and wash both pieces with lukewarm, soapy water, and dry thoroughly.
• If the medicine comes with disposable applicators, use each applicator only once, and then throw it away.

To use the vaginal suppository:

• The oval-shaped suppositories may be inserted with or without an applicator.
• Wash your hands before and after using this medicine.
• If you are using it with an applicator, unwrap the tablet and place the flat end of the suppository into the open end of the applicator. Then, lie on your back with knees drawn up toward your chest. Gently insert the applicator high into the vagina and push the plunger to release the tablet. After using, pull the plunger completely out of the applicator and wash both pieces with lukewarm, soapy water and dry thoroughly. If the medicine comes with disposable applicators, use each applicator only once, and then throw it away.
• If you are inserting the tablet without an applicator, lie on your back with knees towards your chest, and place the suppository on the tip of your finger. Gently insert the suppository high into the vagina as far as it will comfortably go.

Avoid wearing tight jeans, nylon underwear, pantyhose and wet bathing suits which can cause yeast infection. Instead, wear looser pants or skirts, dry and clean cotton underwear, and stockings to avoid this problem.

This medicine may leak out of your vagina during the day. You may wear a sanitary pad to protect your clothing, but do not use a tampon. Keep using this medicine for the full time of treatment, even if your symptoms improve after the first few doses. Do not stop using the medicine if your menstrual period begins during your treatment time. Use sanitary pads rather than tampons.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For vaginal yeast infections:
  • For vaginal dosage form (cream):
    • Adults—One full applicator (5 grams) applied in the vagina once a day at bedtime for 3 or 7 consecutive days, as directed by your doctor.
    • Children—Use and dose must be determined by your doctor.
  • For vaginal dosage form (suppository):
    • Adults—One suppository inserted in the vagina once a day at bedtime for 3 consecutive days. Each suppository contains 80 milligrams (mg) of terconazole.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Burning feeling in the vagina

• Chills
• fever
• itching or irritation in the vagina

• Blistering, peeling, or loosening of the skin
• chills
• cough
• diarrhea
• difficulty with swallowing
• dizziness
• fast heartbeat
• fever
• general feeling of discomfort or illness
• headache
• hives or welts
• hoarseness
• irritation
• itching
• joint or muscle pain
• joint pain, stiffness or swelling
• loss of appetite
• muscle aches and pains
• nausea
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rash
• red skin lesions, often with a purple center
• red, irritated eyes
• redness of the skin
• runny nose
• shivering
• skin rash
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• sweating
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• trouble sleeping
• troubled breathing
• unusual tiredness or weakness
• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Cramps
• headache
• heavy bleeding
• pain

• Abdominal or stomach pain
• body pain

• Difficulty with moving
• lack or loss of strength
• muscle aching or cramping
• muscle pain or stiffness
• swollen joints

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

General:

Discontinue use and do not retreat with terconazole if sensitization, irritation, fever, chills or flu-like symptoms are reported during use.

The base contained in the suppository formulation may interact with certain rubber or latex products, such as those used in vaginal contraceptive diaphragms; therefore concurrent use is not recommended.

Laboratory Tests:

If there is lack of response to terconazole, appropriate microbiologic studies (standard KOH smear and/or cultures) should be repeated to confirm the diagnosis and rule out other pathogens.

Drug Interactions:

The therapeutic effect of these products is not affected by oral contraceptive usage.

The levels of estradiol (E2) and progesterone did not differ significantly when 0.8% terconazole vaginal cream was administered to healthy female volunteers established on a low dose oral contraceptive.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Studies to determine the carcinogenic potential of terconazole have not been performed.

Terconazole was not mutagenic when tested in vitro for induction of microbial point mutations (Ames test), or for inducing cellular transformation, or in vivo for chromosome breaks (micronucleus test) or dominant lethal mutations in mouse germ cells.

No impairment of fertility occurred when female rats were administered terconazole orally up to 40 mg/kg/day for a three month period.

Pregnancy:

Pregnancy Category C.

There was no evidence of teratogenicity when terconazole was administered orally up to 40 mg/kg/day (25x the recommended intravaginal human dose of the suppository formulation, 50x the recommended intravaginal human dose of the 0.8% vaginal cream formulation, and 100x the intravaginal human dose of the 0.4% vaginal cream formulation) in rats, or 20 mg/kg/day in rabbits, or subcutaneously up to 20 mg/kg/day in rats.

Dosages at or below 10 mg/kg/day produced no embryotoxicity; however, there was a delay in fetal ossification at 10 mg/kg/day in rats. There was some evidence of embryotoxicity in rabbits and rats at 20–40 mg/kg. In rats, this was reflected as a decrease in litter size and number of viable young and reduced fetal weight. There was also delay in ossification and an increased incidence of skeletal variants.

The no-effect dose of 10 mg/kg/day resulted in a mean peak plasma level of terconazole in pregnant rats of 0.176 mcg/mL which exceeds by 44 times the mean peak plasma level (0.004 mcg/mL) seen in normal subjects after intravaginal administration of terconazole 0.4% vaginal cream, by 30 times the mean peak plasma level (0.006 mcg/mL) seen in normal subjects after intravaginal administration of terconazole 0.8% vaginal cream, and by 17 times the mean peak plasma level (0.010 mcg/mL) seen in normal subjects after intravaginal administration of terconazole 80 mg vaginal suppository. This safety assessment does not account for possible exposure of the fetus through direct transfer to terconazole from the irritated vagina by diffusion across amniotic membranes.

Since terconazole is absorbed from the human vagina, it should not be used in the first trimester of pregnancy unless the physician considers it essential to the welfare of the patient.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Animal studies have shown that rat offspring exposed via the milk of treated (40 mg/kg/orally) dams showed decreased survival during the first few post-partum days, but overall pup weight and weight gain were comparable to or greater than controls throughout lactation. Because many drugs are excreted in human milk, and because of the potential for adverse reaction in nursing infants from terconazole, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use:

Safety and efficacy in children have not been established.

Geriatric Use:

Clinical studies of TERAZOL® did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

TERAZOL® 7 (terconazole) Vaginal Cream 0.4% is available in 45g (NDC 0062-5350-01) 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 0062-5356-01) 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 0062-5351-01) with a vaginal applicator. Store at Controlled Room Temperature 15–30°C (59–86°F).

*Trademark

Manufactured by:

• Janssen Ortho, LLC, Manati, Puerto Rico 00674 (for the Vaginal Cream)
• Draxis Specialty Pharmaceuticals Inc., Kirkland, Quebec, Canada H9H 4J4 (for the Vaginal Cream and Vaginal Suppositories)

Manufactured for:

Ortho Women's Health & Urology, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Raritan, New Jersey 08869

NDC 0062-5351-01

TERAZOL® 3
(terconazole)
VAGINAL SUPPOSITORIES 80mg
With Applicator

Each suppository contains terconazole 80 mg compounded with
triglycerides derived from coconut and/or palm kernel oil (a base
of hydrogenated vegetable oils) and butylated hydroxyanisole.

Rx only.

Prescribing information enclosed.
Store at 15-30°C (59-86°F).
See end panel for lot number and expiration date.
Keep out of reach of children.

3 suppositories with vaginal applicator.

Manufactured by:
DRAXIS Specialty Pharmaceuticals Inc.
Kirkland, Quebec, Canada
H9H 4J4

ORTHO WOMEN'S HEALTH & UROLOGY™
DIVISION OF ORTHO-MCNEIL-JANSSEN PHARMACEUTICALS, INC.

Manufactured for:
Ortho Women's Health & Urology,
Division of Ortho-McNeil-Janssen
Pharmaceuticals, Inc.
Raritan, New Jersey 08869