Clotrimazole (mucous membrane, oral route)


    Brand Name

    US Brand Name

    Mycelex Troche


    Description

    Clotrimazole 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.

    This product is available in the following dosage forms:

    • Lozenge/Troche

    Before Using

    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 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

    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.

    Geriatric

    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.

    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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Bedaquiline
    • Dihydroergotamine
    • Doxorubicin
    • Doxorubicin Hydrochloride Liposome
    • Ergoloid Mesylates
    • Ergonovine
    • Ergotamine
    • Lisuride
    • Metergoline
    • Methylergonovine
    • Methysergide
    • Nicergoline
    • Tacrolimus

    Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Trimetrexate

    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.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    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

    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 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 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. Do not double doses.

    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.


    Precautions

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


    Side Effects

    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.

    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

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

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

    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.






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