Mycelex

Name: Mycelex

Is clotrimazole safe to take if I'm pregnant or breastfeeding?

: Clotrimazole is very poorly absorbed into the blood and the body after application to the skin or the vagina. Studies in women in their second or third trimesters of pregnancy have demonstrated no ill effects. No data is available in pregnant women during their first trimester. Rats given large amounts of clotrimazole via the vagina have demonstrated no ill effects. The oral troche has not been adequately evaluated in pregnant women.

It is not known if clotrimazole is secreted in breast milk.

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.

What is clotrimazole (mycelex troche)?

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.

Mycelex Drug Class

Mycelex is part of the drug classes:

  • Antiinfectives and antiseptics for local oral treatment

  • Imidazole and triazole derivatives

  • Imidazole derivatives

Uses of Mycelex

  • It is used to treat fungal infections of the skin.
  • It may be given to you for other reasons. Talk with the doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad irritation where Mycelex is used.

What are some other side effects of Mycelex?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Irritation where this medicine is used.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Mycelex - 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.

Overdosage

No data available.

Drug Abuse and Dependence

No data available.

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