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Clotrimazole (oral): Drug information

Clotrimazole (oral): Drug information
(For additional information see "Clotrimazole (oral): Patient drug information" and see "Clotrimazole (oral): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Pharmacologic Category
  • Antifungal Agent, Imidazole Derivative;
  • Antifungal Agent, Oral Nonabsorbed
Dosing: Adult
Candidiasis

Candidiasis:

Oropharyngeal, mild disease, treatment: Oral: 10 mg dissolved slowly 5 times daily for 7 to 14 days (Ref).

Oropharyngeal, chronic suppression for recurrent infection:

Note: Suppressive therapy is usually unnecessary; however, if given, some experts prefer a systemic azole (eg, fluconazole) (Ref).

Oral: 10 mg dissolved slowly 3 times daily for the duration of immunosuppression (eg, chemotherapy or high-dose steroids).

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

Dosing: Kidney Impairment: Adult

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

Dosing: Hepatic Impairment: Adult

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

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Clotrimazole (oral): Pediatric drug information")

Candidiasis, oropharyngeal; treatment

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 (Ref).

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

Dosing: Kidney Impairment: Pediatric

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

Dosing: Hepatic Impairment: Pediatric

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

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

Contraindications

Hypersensitivity to clotrimazole or any component of the formulation

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.

Dosage Forms: US

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

Troche, Mouth/Throat:

Generic: 10 mg

Generic Equivalent Available: US

Yes

Pricing: US

Troche (Clotrimazole Mouth/Throat)

10 mg (per each): $1.43 - $3.44

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

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

Administration: Pediatric

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

Use: Labeled Indications

Oropharyngeal candidiasis, mild disease, treatment: Local treatment of oropharyngeal candidiasis.

Oropharyngeal candidiasis, chronic suppression for recurrent infection: 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.

Medication Safety Issues
Sound-alike/look-alike issues:

Clotrimazole may be confused with co-trimoxazole

Mycelex may be confused with Myoflex

International issues:

Cloderm: Brand name for clotrimazole [Germany], but also brand name for alclomethasone [Indonesia]; clobetasol [China, India, Malaysia, Singapore, Thailand]; clocortolone [U.S., Canada]

Canesten [multiple international markets] may be confused with Canesten Bifonazol Comp brand name for bifonazole/urea [Austria]; Canesten Extra brand name for bifonazole [China, Germany]; Canesten Extra Nagelset brand name for bifonazole/urea [Denmark]; Canesten Fluconazole brand name for fluconazole [New Zealand]; Canesten Oasis brand name for sodium citrate [Great Britain]; Canesten Once Daily brand name for bifonazole [Australia]; Canesten Oral brand name for fluconazole [United Kingdom]; Cenestin brand name for estrogens (conjugated A/synthetic) [U.S., Canada]

Mycelex: Brand name for clotrimazole [U.S.] may be confused with Mucolex brand name for bromhexine [Malaysia]; carbocisteine [Thailand]

Metabolism/Transport Effects

Inhibits CYP3A4 (weak)

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

ALPRAZolam: CYP3A4 Inhibitors (Weak) may increase the serum concentration of ALPRAZolam. Risk C: Monitor therapy

CarBAMazepine: CYP3A4 Inhibitors (Weak) may increase the serum concentration of CarBAMazepine. Risk C: Monitor therapy

CycloSPORINE (Systemic): CYP3A4 Inhibitors (Weak) may increase the serum concentration of CycloSPORINE (Systemic). Risk C: Monitor therapy

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

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

Finerenone: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Finerenone. Risk C: Monitor therapy

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

Ixabepilone: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Ixabepilone. Risk C: 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. Risk D: 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. Risk D: Consider therapy modification

Lonafarnib: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Lonafarnib. Management: Avoid concurrent use of lonafarnib with weak CYP3A4 inhibitors. If concurrent use is unavoidable, reduce the lonafarnib dose to or continue at a dose of 115 mg/square meter. Monitor for evidence of arrhythmia, syncope, palpitations, or similar effects. Risk D: Consider therapy modification

Methysergide: Clotrimazole (Oral) may increase the serum concentration of Methysergide. Risk X: Avoid combination

Midazolam: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Midazolam. Risk C: Monitor therapy

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

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

Simvastatin: CYP3A4 Inhibitors (Weak) may increase serum concentrations of the active metabolite(s) of Simvastatin. CYP3A4 Inhibitors (Weak) may increase the serum concentration of Simvastatin. Risk C: Monitor therapy

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

Sirolimus (Protein Bound): CYP3A4 Inhibitors (Weak) may increase the serum concentration of Sirolimus (Protein Bound). Management: Reduce the dose of protein bound sirolimus to 56 mg/m2 when used concomitantly with a weak CYP3A4 inhibitor. Risk D: Consider therapy modification

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

Triazolam: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Triazolam. Risk C: Monitor therapy

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. Risk D: Consider therapy modification

Pregnancy Considerations

Clotrimazole troches are an alternative treatment for oropharyngeal candidiasis in non-pregnant patients. However, local topical treatment of oropharyngeal candidiasis is preferred during pregnancy (HHS [OI adult] 2020).

Breastfeeding Considerations

It is not known if clotrimazole is present in breast milk following oral (troche) administration.

Monitoring Parameters

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

Mechanism of Action

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

Pharmacokinetics (Adult Data Unless Noted)

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

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (IL) Israel: Oralten;
  • (IN) India: Clenorush troche | Clogen | Cloral | Clotrivin troche | Oraloz;
  • (JP) Japan: Empecid;
  • (KE) Kenya: Orush troche;
  • (PR) Puerto Rico: Mycelex troche;
  • (TH) Thailand: Cada | Canazol | Candinox | Fungiderm | Tricloda
  1. Aslam S, Rotstein C; AST Infectious Disease Community of Practice. Candida infections in solid organ transplantation: guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019;33(9):e13623. doi:10.1111/ctr.13623 [PubMed 31155770]
  2. Candidiasis (Mucocutaneous). In: US Department of Health and Human Services (HHS) Panel on Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/Adult_OI.pdf. Updated May 26, 2020. Accessed June 16, 2021.
  3. Clotrimazole troche [prescribing information]. Columbus, OH: Roxane Laboratories; August 2014.
  4. Clotrimazole lozenge [prescribing information]. Minneapolis, MN: Perrigo; March 2012.
  5. Clotrimazole Troche lozenges (clotrimazole oral) [prescribing information]. Eatontown, NJ: West-Ward Pharmaceuticals Corp; April 2016.
  6. Duhm B, Medenwald H, Puetter J, et al. The pharmacokinetics of clotrimazole 14C. Postgrad Med J. 1974;50(Suppl 1):13-16. [PubMed 4467160]
  7. Kauffman CA. Oropharyngeal candidiasis in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com. Accessed June 17, 2021.
  8. Pappas PG, Kauffman CA, Andes DR, et al. Clinical practice guideline for the management of candidiasis: 2016 update by the Infectious Diseases Society of America. Clin Infect Dis. 2016;62(4):e1-e50. doi:10.1093/cid/civ933 [PubMed 26679628]
  9. US Department of Health and Human Services (HHS) Panel on Opportunistic Infections in HIV-Exposed and HIV-Infected Children. Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Exposed and HIV-Infected Children. Department of Health and Human Services. November 2013. Available at http://aidsinfo.nih.gov/contentfiles/lvguidelines/oi_guidelines_pediatrics.pdf.
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