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Clotrimazole (Oral)

Medically reviewed by Drugs.com. Last updated on Sep 5, 2020.

Pronunciation

(kloe TRIM a zole)

Index Terms

  • Mycelex

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Troche, Mouth/Throat:

Generic: 10 mg

Pharmacologic Category

  • Antifungal Agent, Imidazole Derivative
  • Antifungal Agent, Oral Nonabsorbed

Pharmacology

Binds to phospholipids in the fungal cell membrane altering cell wall permeability resulting in loss of essential intracellular elements

Distribution

Oral: Inhibitory concentrations remain in the saliva for up to 3 hours after dissolution of the troche

Use: Labeled Indications

Oropharyngeal candidiasis (treatment): Local treatment of oropharyngeal candidiasis.

Oropharyngeal candidiasis (prophylaxis): To reduce the incidence of oropharyngeal candidiasis in immunocompromised patients undergoing chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation.

Contraindications

Hypersensitivity to clotrimazole or any component of the formulation

Documentation of allergenic cross-reactivity for antifungals is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity can not be ruled out with certainty.

Dosing: Adult

Oropharyngeal candidiasis, prophylaxis: Oral: 10 mg dissolved slowly 3 times daily for the duration of chemotherapy or until steroids are reduced to maintenance levels.

Oropharyngeal candidiasis, treatment (mild disease): Oral: 10 mg dissolved slowly 5 times daily for 7 to 14 consecutive days (AST-IDCOP [Aslam 2019]; HHS [OI adult 2020]; IDSA [Pappas 2016]).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Candidiasis, oropharyngeal; treatment: Children ≥3 years and Adolescents: Oral: 10 mg troche dissolved slowly 5 times daily for 14 consecutive days. Note: When used for initial treatment in patients with HIV, duration of therapy is 7 to 14 days (HHS [OI adult 2016]; HHS [OI pediatric 2016]).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Administration

Oral: Allow troche to dissolve slowly in the mouth. Dissolution is complete in approximately 30 minutes.

Storage

Store at 20°C to 25°C (68°F to 77°F). Avoid freezing.

Drug Interactions

Dofetilide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Dofetilide. Monitor therapy

Everolimus: Clotrimazole (Oral) may increase the serum concentration of Everolimus. Monitor therapy

Flibanserin: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Flibanserin. Monitor therapy

Lemborexant: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Lemborexant. Management: The maximum recommended dosage of lemborexant is 5 mg, no more than once per night, when coadministered with weak CYP3A4 inhibitors. Consider therapy modification

Lomitapide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Lomitapide. Management: Patients on lomitapide 5 mg/day may continue that dose. Patients taking lomitapide 10 mg/day or more should decrease the lomitapide dose by half. The lomitapide dose may then be titrated up to a max adult dose of 30 mg/day. Consider therapy modification

NiMODipine: CYP3A4 Inhibitors (Weak) may increase the serum concentration of NiMODipine. Monitor therapy

Pimozide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Pimozide. Avoid combination

Sirolimus: Clotrimazole (Oral) may increase the serum concentration of Sirolimus. Monitor therapy

Tacrolimus (Systemic): Clotrimazole (Oral) may increase the serum concentration of Tacrolimus (Systemic). Monitor therapy

Triazolam: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Triazolam. Management: Consider triazolam dose reduction in patients receiving concomitant weak CYP3A4 inhibitors. Consider therapy modification

Ubrogepant: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Ubrogepant. Management: In patients taking weak CYP3A4 inhibitors, the initial and second dose (given at least 2 hours later if needed) of ubrogepant should be limited to 50 mg. Consider therapy modification

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Hepatic: Abnormal liver function tests

Frequency not defined:

Dermatologic: Pruritus

Gastrointestinal: Nausea, vomiting

Warnings/Precautions

Concerns related to adverse effects:

• Hepatic effects: Abnormal LFTs have been reported, including abnormal aspartate aminotransferase (AST). Elevations are usually minimal. Monitor LFTs periodically, especially in patients with preexisting hepatic impairment.

Disease-related concerns:

• Hepatic impairment: Use with caution; abnormal LFTs have been reported. Elevations are usually minimal. Monitor LFTs periodically.

• Systemic fungal infection: Clotrimazole should not be used for treatment of systemic fungal infection.

Other warnings/precautions:

• Administration: Clotrimazole must be slowly dissolved in the mouth for maximum efficacy.

Monitoring Parameters

Consider KOH test or culture prior to treatment to confirm oropharyngeal candidiasis; periodic liver function tests during therapy.

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies.

Patient Education

What is this drug used for?

• It is used to treat or prevent fungal infections in the mouth.

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:

• Itching

• Nausea

• Vomiting

• Numbness or tingling in mouth

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:

• Liver problems like dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin.

• 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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.