Terazol 3

Terazol 3 and suppositories are used to treat vaginal fungal or yeast infections. This medicine works by killing the fungus or yeast and preventing its growth.

This medicine is available only with your doctor's prescription. This product is available in the following dosage forms:

• Cream
• Suppository

Before using Terazol 3, you must know all about the risks and complications associated with it. This is a decision you and your doctor will make.

For this medicine, the following should be considered:

Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric Population: Appropriate studies have not been performed on the relationship of age to the effects of terconazole in the pediatric population. Safety and efficacy have not been established.

Geriatric Population: Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of terconazole in the elderly.

Pregnancy: All Trimesters: Category C: Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding: There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions: Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. 

Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions: Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper usage of Terazol 3 requires strict adherence to your doctor’s orders. 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 a 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 into 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.

Before using Terazol 3, there are some precautions you must take. It is important that your doctor checks your progress after treatment.

This is to make sure that the infection is cleared up completely, and to allow your doctor to check for any unwanted effects. If your symptoms do not improve or if they become worse, check with your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. 

Call your doctor right away if you have a blistering, peeling, or red skin rash, itching, sores or ulcers on the mouth or lips, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Check with your doctor right away if you have a fever, chills, irritation, or flu-like symptoms after using this medicine.

Terconazole suppositories should not be used together with vaginal contraceptive diaphragms that contain certain rubber or latex products.

As with many medications, there are several potential side effects associated with Terazol 3. 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:

More common:

• Burning feeling in the vagina

Less common:

• Chills
• fever
• itching or irritation in the vagina

Incidence not known:

• Blistering, peeling or loosening of the skin
• chills
• cough
• diarrhea
• the difficulty with swallowing
• dizziness
• fast heartbeat
• fever
• the 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:

More common:

• Cramps
• headache
• heavy bleeding
• pain

Less common:

• Abdominal or stomach pain
• body pain

Incidence not known:

• 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.