Mycelex (Clotrimazole)
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Mycelex (Clotrimazole)

MYCELEX®
(clotrimazole) TROCHE

FOR TOPICAL ORAL ADMINISTRATION

DRUG DESCRIPTION

Each Mycelex® Troche contains 10 mg clotrimazole [1 -(o-chloro-a,a-diphenylbenzyl) imidazole], a synthetic antifungal agent, for topical use in the mouth.

Structural Formula:

Mycelex® Troche (clotrimazole) structural formula illustration

Chemical Formula: C22H17CIN2

The troche dosage form is a large, slowly dissolving tablet (lozenge) containing 10 mg of clotrimazole dispersed in dextrose, microcrystalline cellulose, povidone, and magnesium stearate.

What are the possible side effects of clotrimazole (Mycelex Troche)?

Stop taking clotrimazole and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Side effects are not likely to occur with clotrimazole. Continue to take clotrimazole and talk to your doctor if you experience

  • nausea or stomach upset,
  • vomiting,
  • itching, or
  • an unpleasant sensation in the mouth.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or...

Read All Potential Side Effects and See Pictures of Mycelex »

What are the precautions when taking clotrimazole (Mycelex)?

Before taking clotrimazole lozenges, tell your doctor or pharmacist if you are allergic to clotrimazole; or to other azole antifungal drugs (e.g., ketoconazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Mycelex »

Last reviewed on RxList: 5/26/2011
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Mycelex® Troches are indicated for the local treatment of oropharyngeal candidiasis.The diagnosis should be confirmed by a KOH smear and/or culture prior to treatment.

Mycelex® Troches are also indicated prophylactically to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions that include chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation. There are no data from adequate and well-controlled trials to establish the safety and efficacy of this product for prophylactic use in patients immunocompromised by etiologies other than those listed in the previous sentence. (See DOSAGE AND ADMINISTRATION.)

DOSAGE AND ADMINISTRATION

Mycelex® Troches are administered only as a lozenge that must be slowly dissolved in the mouth. The recommended dose is one troche five times a day for fourteen consecutive days. Only limited data are available on the safety and effectiveness of the clotrimazole troche after prolonged administration; therefore, therapy should be limited to short term use, if possible.

For prophylaxis to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions that include chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation, the recommended dose is one troche three times daily for the duration of chemotherapy or until steroids are reduced to maintenance levels.

HOW SUPPLIED

Mycelex® Troches, white discoid, uncoated tablets are supplied in bottles of 70 and 140. Mycelex® Troches are also available for institutional use in foil packages of 70 tablets. Each tablet will be identified with the following: Mycelex 10.

  Strength NDC Code Tablet Identification
Bottles of 70: 10 mg NDC 17314-9400-1 MYCELEX 10
Bottles of 140: 10 mg NDC 17314-9400-3 MYCELEX 10
Unit Dose Package of 70: 10 mg NDC 17314-9400-2 MYCELEX 10

Store below 86°F (30°C).
Avoid freezing.

Manufactured by: Bayer Corporation West Haven, CT 06516. Distributed by ALZA Pharmaceuticals A Division of ALZA Corporation Mountain View, CA 94043

Last reviewed on RxList: 5/26/2011
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Abnormal liver function tests have been reported in patients treated with clotrimazole troches; elevated SGOT levels were reported in about 15% of patients in the clinical trials (See PRECAUTIONS section).

Nausea, vomiting, unpleasant mouth sensations and pruritus have also been reported with the use of the troche.

Drug Abuse And Dependence

No data available.

Read the Mycelex (clotrimazole) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 5/26/2011
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Mycelex® Troches are not indicated for the treatment of systemic mycoses including systemic candidiasis.

PRECAUTIONS

Abnormal liver function tests have been reported in patients treated with clotrimazole troches; elevated SGOT levels were reported in about 15% of patients in the clinical trials. In most cases the elevations were minimal and it was often impossible to distinguish effects of clotrimazole from those of other therapy and the underlying disease (malignancy in most cases). Periodic assessment of hepatic function is advisable particularly in patients with pre-existing hepatic impairment.

Since patients must be instructed to allow each troche to dissolve slowly in the mouth in order to achieve maximum effect of the medication, they must be of such an age and physical and/or mental condition to comprehend such instructions.

Carcinogenesis

An 18 month dosing study with clotrimazole in rats has not revealed any carcinogenic effect.

Usage in Pregnancy

Pregnancy Category C: Clotrimazole has been shown to be embryotoxic in rats and mice when given in doses 100 times the adult human dose (in mg/kg), possibly secondary to maternal toxicity. The drug was not teratogenic in mice, rabbits, and rats when given in doses up to 200, 180, and 100 times the human dose.

Clotrimazole given orally to mice from nine weeks before mating through weaning at a dose 120 times the human dose was associated with impairment of mating, decreased number of viable young, and decreased survival to weaning. No effects were observed at 60 times the human dose. When the drug was given to rats during a similar time period at 50 times the human dose, there was a slight decrease in the number of pups per litter and decreased pup viability.

There are no adequate and well controlled studies in pregnant women. Clotrimazole troches should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pediatric Use

Safety and effectiveness of clotrimazole in children below the age of 3 years have not been established; therefore, its use in such patients is not recommended.

The safety and efficacy of the prophylactic use of clotrimazole troches in children have not been established.

Geriatric Use

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

Last reviewed on RxList: 5/26/2011
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No data available.

CONTRAINDICATIONS

Mycelex® Troches are contraindicated in patients who are hypersensitive to any of its components.

Last reviewed on RxList: 5/26/2011
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Clotrimazole is a broad-spectrum antifungal agent that inhibits the growth of pathogenic yeasts by altering the permeability of cell membranes. The action of clotrimazole is fungistatic at concentrations of drug up to 20 mcg/mL and may be fungicidal in vitro against Candida albicans and other species of the genus Candida at higher concentrations. No single-step or multiple-step resistance to clotrimazole has developed during successive passages of Candida albicans in the laboratory; however, individual organism tolerance has been observed during successive passages in the laboratory. Such in vitro tolerance has resolved once the organism has been removed from the antifungal environment.

After oral administration of a 10 mg clotrimazole troche to healthy volunteers, concentrations sufficient to inhibit most species of Candida persist in saliva for up to three hours following the approximately 30 minutes needed for a troche to dissolve. The long term persistence of drug in saliva appears to be related to the slow release of clotrimazole from the oral mucosa to which the drug is apparently bound. Repetitive dosing at three hour intervals maintains salivary levels above the minimum inhibitory concentrations of most strains of Candida; however, the relationship between in vitro susceptibility of pathogenic fungi to clotrimazole and prophylaxis or cure of infections in humans has not been established. In another study, the mean serum concentrations were 4.98 ± 3.7 and 3.23 ± 1.4 nanograms/mL of clotrimazole at 30 and 60 minutes, respectively, after administration as a troche.

Last reviewed on RxList: 5/26/2011
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 5/26/2011
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 5/26/2011
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Mycelex Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

CLOTRIMAZOLE LOZENGE - MUCOUS MEMBRANE (ORAL)

(kloe-TRIM-a-zole)

COMMON BRAND NAME(S): Mycelex

USES: Clotrimazole lozenge is only approved for the treatment of fungal infections of the mouth or throat. It may also be used to prevent these infections in patients receiving treatments that may weaken the body's immune system (e.g., chemotherapy). Clotrimazole is known as an azole antifungal agent. It works by stopping the growth of fungus.

HOW TO USE: Use this medication orally by placing it in your mouth and allowing it to slowly dissolve over 15-30 minutes. Do not chew or swallow the lozenge whole. Do not eat or drink while this medication is in your mouth. If your child cannot safely use this tablet, consult your doctor or pharmacist for advice.

Antifungals work best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals.

If you are using this medication to treat an oral fungal infection, take it usually five times daily or as directed by your doctor. If you have trouble swallowing or have pain while swallowing, consult your doctor. Other medications may be necessary.

Continue to use this medication until the full-prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may allow fungus to continue to grow, which may result in a relapse of the infection. Inform your doctor if your condition persists or worsens.

If you are using this medication to prevent an oral fungal infection, take it usually three times daily or as directed by your doctor. Continue to use it for the full number of days prescribed.

Disclaimer

Mycelex Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, mild itching, or an unpleasant sensation in the mouth may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Mycelex (clotrimazole) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking clotrimazole lozenges, tell your doctor or pharmacist if you are allergic to clotrimazole; or to other azole antifungal drugs (e.g., ketoconazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Mycelex Consumer (continued)

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: certain medications for diabetes (sulfonylureas such as glipizide, glyburide), rifamycins (e.g., rifampin), tacrolimus.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in those cases.

Laboratory and/or medical tests (e.g., liver function tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature below 86 degrees F (30 degrees C) away from heat and moisture. Do not freeze. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised May 2010. Copyright(c) 2010 First Databank, Inc.

Mycelex Patient Information Including Side Effects

Brand Names: Mycelex Troche

Generic Name: clotrimazole (Pronunciation: kloe TRIM a zole)

What is clotrimazole (Mycelex)?

Clotrimazole is an antifungal medication. It is like an antibiotic but is used to treat yeast (fungal) infections.

Oral clotrimazole is used to treat and prevent yeast infections of the mouth and throat.

Clotrimazole may also be used for purposes other than those listed in this medication guide.

Clotrimazole 10 mg-ROX

round, white, imprinted with 54 552

What are the possible side effects of clotrimazole (Mycelex)?

Stop taking clotrimazole and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Side effects are not likely to occur with clotrimazole. Continue to take clotrimazole and talk to your doctor if you experience

  • nausea or stomach upset,
  • vomiting,
  • itching, or
  • an unpleasant sensation in the mouth.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the Mycelex (clotrimazole) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about clotrimazole (Mycelex)?

Take all of the clotrimazole that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated.

Side Effects Centers

Mycelex Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking clotrimazole (Mycelex)?

Before taking this medication, tell your doctor if you have liver disease. You may not be able to take clotrimazole, or you may need a lower dose or special monitoring during treatment.

Clotrimazole is not absorbed through your stomach. It will not treat fungal infections in any part of your body other than your mouth and throat. Talk to your doctor if you have another type of fungal infection such as athlete's foot, jock itch, ringworm, or a vaginal yeast infection.

Oral clotrimazole is in the FDA pregnancy category C. This means that it is not known whether clotrimazole will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant.

It is not known whether clotrimazole will harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

The safety and effectiveness of clotrimazole have not been established for children younger than 3 years of age.

How should I take clotrimazole (Mycelex)?

Take clotrimazole exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

The troches should be allowed to dissolve slowly in your mouth. Suck on one troche at a time until it is completely dissolved, usually 30 minutes.

Do not chew or swallow the troches whole.

The troches are usually used five times a day. Follow your doctor's instructions.

Store clotrimazole at room temperature away from moisture and heat.

Side Effects Centers

Mycelex Patient Information including If I Miss a Dose

What happens if I miss a dose (Mycelex)?

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose (Mycelex)?

Seek emergency medical attention.

Symptoms of a clotrimazole overdose are unknown.

What should I avoid while taking clotrimazole (Mycelex)?

There are no restrictions on foods, beverages, or activities during treatment with clotrimazole unless your doctor directs otherwise.

What other drugs will affect clotrimazole (Mycelex)?

Since clotrimazole is not absorbed by your body, drug interactions are not expected. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines.

Where can I get more information?

Your pharmacist has additional information about clotrimazole written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.09. Revision date: 12/15/2010.

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Side Effects Centers

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