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Clotrimazole (Oral)

Pronunciation

Pronunciation

(kloe TRIM a zole)

Index Terms

  • Mycelex

Dosage Forms

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

Lozenge, Mouth/Throat:

Generic: 10 mg (70 ea, 140 ea)

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): Oral: 10 mg dissolved slowly 5 times daily for 14 consecutive days. Note: When used for initial treatment in patients with HIV-1, duration of therapy is 7 to 14 days (DHHS [adult] 2014; DHHS [pediatric] 2013).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Oropharyngeal candidiasis (treatment): Children ≥3 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

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

Amodiaquine: CYP2C8 Inhibitors may increase the serum concentration of Amodiaquine. Avoid combination

ARIPiprazole: CYP3A4 Inhibitors (Weak) may increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole pharmacologic effects. Aripiprazole dose adjustments may or may not be required based on concomitant therapy and/or indication. Consult full interaction monograph for specific recommendations. Monitor therapy

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

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

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

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

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

TiZANidine: CYP1A2 Inhibitors (Weak) may increase the serum concentration of TiZANidine. Management: Avoid these combinations when possible. If combined use cannot be avoided, initiate tizanidine at an adult dose of 2 mg and increase in 2-4 mg increments based on patient response. Monitor for increased effects of tizanidine, including adverse reactions. Consider therapy modification

Adverse Reactions

>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.

Concurrent drug therapy related concerns:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

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

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patients may experience itching, nausea, vomiting, or numbness or tingling in mouth. Have patient report immediately to prescriber signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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