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|Mycelex Troches

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CLOTRIMAZOLE (Oral)†

Some commonly used brand names are:

In the U.S.—

Mycelex Troches

† Not commercially available in Canada.

Description

Clotrimazole (kloe-TRIM-a-zole) lozenges are dissolved slowly in the mouth to prevent and treat thrush. Thrush, also called candidiasis or white mouth, is a fungus infection of the mouth and throat. This medicine may also be used for other problems as determined by your doctor.

Clotrimazole is available only with your doctor"s prescription, in the following dosage form:

Oral
Lozenges (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For clotrimazole, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to clotrimazole. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies have not been done in humans. Studies in mice, rats, and rabbits given very high doses have not shown that clotrimazole causes birth defects. However, studies in rats and mice given high doses have shown that clotrimazole lozenges may cause other harmful effects in the fetus.

Breast-feeding—It is not known whether clotrimazole passes into breast milk. However, only small amounts of clotrimazole are absorbed into the mother"s body. Clotrimazole has not been reported to cause problems in nursing babies.

Children—Although this medicine has not been shown to cause different side effects or problems in children than it does in adults, it should not be given to children under 3 years of age since they may be too young to use the lozenges safely.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of clotrimazole lozenges in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medicines—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 health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of clotrimazole. Make sure you tell your doctor if you have the following medical condition:

Liver disease—Your doctor may want to monitor your liver function while you are taking this medicine.

Proper Use of This Medicine

Clotrimazole lozenges should be held in the mouth and allowed to dissolve slowly and completely. This may take 15 to 30 minutes. Swallow saliva during this time. Do not chew the lozenges or swallow them whole .

Do not give clotrimazole lozenges to infants or children under 3 years of age. They may be too young to use the lozenges safely.

To help clear up your infection completely, it is very important that you keep using clotrimazole for the full time of treatment , even if your symptoms begin to clear up after a few days. Since fungus infections may be very slow to clear up, you may have to continue using this medicine every day for two weeks or more. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses .

Dosing—The dose of clotrimazole lozenges 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 clotrimazole lozenges. If your dose is different, do not change it unless your doctor tells you to do so.

For the treatment of thrush :
- Adults and children 3 years of age and older: Dissolve one 10-milligram lozenge slowly and completely in your mouth; this dose should be taken five times a day for at least fourteen days.
- Children up to 3 years of age: This medicine is not recommended in children under 3 years of age since they may be too young to use the lozenges safely.
For the prevention of thrush :
- Adults and children 3 years of age and older: Dissolve one 10-milligram lozenge slowly and completely in your mouth; this dose should be taken three times a day.
- Children up to 3 years of age: This medicine is not recommended in children under 3 years of age since they may be too young to use the lozenges safely.

Missed dose—If you miss a dose of this medicine, take 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—To store this medicine:

Keep out of the reach of children.
Store away from heat and direct light.
Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

If your symptoms do not improve within 1 week, or if they become worse, check with your doctor.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. The following side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of these effects continue or are bothersome:

More common

Abdominal or stomach cramping or pain; diarrhea; itching; nausea or vomiting; unpleasant mouth sensations

Note:

Some of the side effects, such as abdominal or stomach cramping or pain or diarrhea, usually occur only when the medicine is swallowed

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

Revised: 10/31/1999

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