Clotrimazole

Pronunciation

U.S. Brand Names

Cruex® Cream [OTC]; Gyne-Lotrimin® 3 [OTC]; Lotrimin® AF Athlete's Foot Cream [OTC]; Lotrimin® AF Athlete's Foot Solution [OTC]; Lotrimin® AF Jock Itch Cream [OTC]; Mycelex®; Mycelex®-7 [OTC]; Mycelex® Twin Pack [OTC]

Generic Available

Yes: Cream, solution, troche

Canadian Brand Names

Canesten® Topical; Canesten® Vaginal; Clotrimaderm; Trivagizole-3®

Use

Treatment of susceptible fungal infections, including oropharyngeal candidiasis, dermatophytoses, superficial mycoses, and cutaneous candidiasis, as well as vulvovaginal candidiasis; limited data suggest that clotrimazole troches may be effective for prophylaxis against oropharyngeal candidiasis in neutropenic patients

Use - Dental

Treatment of susceptible fungal infections, including oropharyngeal candidiasis; limited data suggests that the use of clotrimazole troches may be effective for prophylaxis against oropharyngeal candidiasis in neutropenic patients

Pregnancy Risk Factor

B (topical); C (troches)

Lactation

Excretion in breast milk unknown

Contraindications

Hypersensitivity to clotrimazole or any component of the formulation

Warnings/Precautions

Clotrimazole should not be used for treatment of systemic fungal infection; safety and effectiveness of clotrimazole lozenges (troches) in children <3 years of age have not been established; when using topical formulation, avoid contact with eyes

Adverse Reactions

Oral:

>10%: Hepatic: Abnormal liver function tests

1% to 10%:

Gastrointestinal: Nausea and vomiting may occur in patients on clotrimazole troches

Local: Mild burning, irritation, stinging to skin or vaginal area

Vaginal:

1% to 10%: Genitourinary: Vulvar/vaginal burning

<1% (Limited to important or life-threatening): Vulvar itching, soreness, edema, or discharge; polyuria; burning or itching of penis of sexual partner

Drug Interactions

Inhibits CYP1A2 (weak), 2A6 (weak), 2B6 (weak), 2C8/9 (weak), 2C19 (weak), 2D6 (weak), 2E1 (weak), 3A4 (moderate)

CYP3A4 substrates: Clotrimazole may increase the levels/effects of CYP3A4 substrates. Example substrates include benzodiazepines, calcium channel blockers, cyclosporine, mirtazapine, nateglinide, nefazodone, sildenafil (and other PDE-5 inhibitors), tacrolimus, and venlafaxine. Selected benzodiazepines (midazolam and triazolam), cisapride, ergot alkaloids, selected HMG-CoA reductase inhibitors (lovastatin and simvastatin), and pimozide are generally contraindicated with strong CYP3A4 inhibitors.

Mechanism of Action

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

Pharmacodynamics/Kinetics

Absorption: Topical: Negligible through intact skin

Time to peak, serum:

Oral topical (troche): Salivary levels occur within 3 hours following 30 minutes of dissolution time

Vaginal cream: High vaginal levels: 8-24 hours

Vaginal tablet: High vaginal levels: 1-2 days

Excretion: Feces (as metabolites)

Dosage

Children >3 years and Adults:

Oral:

Prophylaxis: 10 mg troche dissolved 3 times/day for the duration of chemotherapy or until steroids are reduced to maintenance levels

Treatment: 10 mg troche dissolved slowly 5 times/day for 14 consecutive days

Topical (cream, solution): Apply twice daily; if no improvement occurs after 4 weeks of therapy, re-evaluate diagnosis

Children >12 years and Adults:

Vaginal:

Cream:

1%: Insert 1 applicatorful vaginal cream daily (preferably at bedtime) for 7 consecutive days

2%: Insert 1 applicatorful vaginal cream daily (preferably at bedtime) for 3 consecutive days

Tablet: Insert 100 mg/day for 7 days or 500 mg single dose

Topical (cream, solution): Apply to affected area twice daily (morning and evening) for 7 consecutive days

Administration

Oral (troche): Allow to dissolve slowly over 15-30 minutes.

Topical: Avoid contact with eyes. For external use only. Apply sparingly. Protect hands with latex gloves. Do not use occlusive dressings.

Monitoring Parameters

Periodic liver function tests during oral therapy with clotrimazole troche

Patient Education

Oral (troche): Do not swallow oral medication whole; allow to dissolve slowly in mouth. You may experience nausea or vomiting (small, frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help). Report signs of opportunistic infection (eg, white plaques in mouth, fever, chills, perianal itching, vaginal itching or discharge, fatigue, unhealed wounds or sores).

Topical: Avoid contact with eyes. Wash hands before applying or wear gloves. Apply thin film to affected area. May apply porous dressing. Report persistent burning, swelling, itching, worsening of condition, or lack of response to therapy.

Vaginal: Wash hands before using. Insert full applicator into vagina gently and expel cream, or insert tablet into vagina, at bedtime. Wash applicator with soap and water following use. Remain lying down for 30 minutes following administration. Avoid intercourse during therapy (sexual partner may experience penile burning or itching). Report adverse reactions (eg, vulvar itching, frequent urination), worsening of condition, or lack of response to therapy. Contact prescriber if symptoms do not improve within 3 days or you do not feel well within 7 days. Do not use tampons until therapy is complete. Contact prescriber immediately if you experience abdominal pain, fever, or foul-smelling discharge.

Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Consult prescriber if breast-feeding.

Dental Health: Effects on Dental Treatment

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Mental Health: Effects on Mental Status

None reported

Mental Health: Effects on Psychiatric Treatment

None reported

Oncology: Emetic Potential

Very low (<10%)

Dosage Forms

Combination pack (Mycelex®-7): Vaginal tablet 100 mg (7s) and vaginal cream 1% (7 g)

Cream, topical: 1% (15 g, 30 g, 45 g)

Cruex®: 1% (15 g)

Lotrimin® AF Athlete's Foot: 1% (12 g, 24 g)

Lotrimin® AF Jock Itch: 1% (12 g)

Cream, vaginal: 2% (21 g)

Mycelex®-7: 1% (45 g)

Solution, topical: 1% (10 mL, 30 mL)

Lotrimin® AF Athlete's Foot: 1% (10 mL)

Tablet, vaginal (Gyne-Lotrimin® 3): 200 mg (3s)

Troche (Mycelex®): 10 mg

References

Duhm B, Medenwald H, Puetter J, et al, "The Pharmacokinetics of Clotrimazole 14C," Postgrad Med J , 1974, 50(Suppl 1):13-6.

Hughes D and Kriedman T, "Treatment of Vulvovaginal Candidiasis With a 500 mg Vaginal Tablet of Clotrimazole," Clin Ther , 1984, 6(5):662-8.

International Brand Names

Abtrim® (GB); Adco-Clotrimazol® (ZA); Aflorix® (AR); Agisten® (IL); Aknecolor® (CH, CZ); Altenal® (MX); Antifungol® (DE, LU, RO, RU); Apocanda® (DE); A-Por® (ZA); Arnela 500® (CL); Arnela® (CL); Axasol® (CL); Azutrimazol® (DE); Baby Agisten® (IL); Benzoderm myco® (DE); Caginal® (TH); Canadine® (TH); Canalba® (ZA); Canazol Lozenge® (TH); Canazol® (TH); Candazol® (DE); Candazole® (SG); Candibene® (AT, CZ, HU, RU); Candiden® (GB); Candid® (PT, RU, TH); Candid-V3® (TH); Candimon® (MX); Candinox® (TH); Candizole® (ZA); Canesten 1® (CL, SG, SI, TH); Canesten® (AT, AU, BG, BR, CH, CL, CO, CY, CZ, DE, DK, EC, EG, ES, FI, GB, HK, HR, HU, ID, IE, IT, JO, KW, LB, NL, NO, PL, PT, RO, RU, SE, SG, SI, TH, TR, YU, ZA); Canestene® (BE, LU); Canesten Once® (GB); Canesten® Topical (CA); Canesten® Vaginal (CA); Canex® (ZA); Canifug® (CZ, DE, HU, SI); Canison® (RU); Cestop® (CL); Chemists' Own Clozole Vaginal Cream® (AU); Chingazol® (TH); Clandistan® (RO); Clocreme® (NZ); Cloderm® (DE); Clofeme Pessaries® (AU); Clogen Kit® (DO); Clomatin® (DO); Clomazen® (BR); Clomazol® (EC); Clonea® (AU); Clonitia® (ID); Closcript® (ZA); Clotricin Vaginal® (TH); Clotri-Denk® (DE); Clotrigalen® (DE); Clotri-Hemopharm® (DE); Clotrihexal® (NZ); Clotrimaderm (CA, IL, NZ); CLotrimazol 1A Pharma® (DE); Clotrimazol-Akri® (RU); Clotrimazol AL® (CZ, DE, HU); Clotrimazol Bayvit® (ES); Clotrimazol® (BG, BR, CL, CR, CZ, EC, PL, RO, RU); Clotrimazol-Cophar® (CH); Clotrimazol Denver® (AR); Clotrimazole® (GB, IL, RU); Clotrimazole-Teva® (IL); Clotrimazol Genericon® (AT); Clotrimazol HelvePharm® (CH); Clotrimazol Heumann® (DE); Clotrimazol L.CH.® (CL); Clotrimazol Lindo® (DE); Clotrimazol MK® (CO, CR, GT, HN, SV); Clotrimazol Sandoz® (DE); Clotrimazolum® (CZ, PL); Clotrimazol Vagin Bayvit® (ES); clotrimazol von ct® (DE); Clotrim® (BD); Clotrimin® (CL); Clotrimix® (BR); Clotrizole® (BD); Clozole® (HK); Clozol® (TR); Comat® (TH); Corisol® (CH); Cotren® (SG, TH); Cotrisan® (CL); Covospor® (ZA); Cremolum® (DE); Cristan® (SG); Cst-Pose® (TH); Cutamycon® (DO, EC, HN, PA, SV); cutistad® (DE); Defungo® (TH); Derma Fung® (DO); Dermobene® (BR); Desfungil® (CL); durafungol® (DE); Efasit® (DE); Empecid® (AR); Empecid Gyno® (AR); Epicort® (CO); Fungicon® (TH); Fungiderm® (DE, ID, TH); Fungidermo® (ES); Fungin® (BD); Fungizid-ratiopharm® (CZ, DE, LU); Fungizol® (BD); Fungosten® (TR); Fungotox® (CH); Funzal® (CL); Gilt® (DE); Gine Canesten® (ES); Gino-Canesten® (BR); Gino Clotrimix® (BR); Gino-Lotremine® (PT); Ginolotrimin® (CO); Gromazol® (CH); Gynebo® (TH); Gyne-Lotremin® (HK, ID, SG); Gyne Lotrim® (RO); Gyno Canesten® (BG); Gyno-Canesten® (CH); Gyno-Canestene® (BE); Gyno Canesten® (EC); Gyno-Canesten® (IT); Gyno Canesten® (LU); Gyno-Canesten® (RO, TR); Gyno-Trimaze® (ZA); Hexal Clofeme® (AU); Holfungin® (DE); Hongal® (AR); Ikolan® (AR); Imazol® (CZ, TR); Imidil® (IN, RU); Jenamazol® (CZ, DE, RU); KadeFungin® (DE); Kanesol® (ID); Kanezin® (TH); Kansen® (YU); Kinasten® (BR); Klamacin® (TH); Klotrimazol NM Pharma® (SE); Klotrimazol® (NO); Konifungil® (CL); Konifungil Ginecologico® (CL); Kranos® (ID); Laboterol® (CL); Livomonil® (AR); Lotremin® (HK, ID, SG); Lotrimin® (CO, MX); Lotrim® (RO); Manomazole® (TH); Medaspor® (ZA); Med-Clotrimazol® (RO); Medifungol® (AR); Medisten® (ID); Medizol® (CO); Micofix C® (CO); Micomazol® (AR); Micomisan® (ZA); Micosep DEO® (AR); Micotrizol® (BR); Mycoban® (ZA); Mycocid® (IN); Mycofug® (DE); Myco-Hermal® (CN, IL, SG); Mycohexal 1® (ZA); Mycoril® (CY, SG); Mycozole® (TH); Myko Cordes® (AT, DE); Mykofungin® (DE); Mykohaug® (DE); Neosten® (BD); Nestic® (TH); Normospor® (ZA); Novacetol® (CL); Oralten Troche® (IL); Pan-Fungex® (PT); Panmicol® (AR); Pedikurol® (AT); Plimycol® (HR, PL); Sastid Anti-Fungal® (SG); SD-Hermal® (DE); Sinersul® (HR); Stiemazol® (ZA); Surfaz® (IN); Taraten® (TH); Telugren® (CL); Tinaderm Extra Preparations® (AU); Tinatrim® (BD); Trimadan® (ID); Trimaze® (ZA); Trimazole® (BD); Trivagizole-3® (CA); Undex® (CH); Uromykol® (DE); Vagiclot® (HN); Vamazole® (TH); Vanesten® (SG); Warimazol® (CR, DO, HN, PA, SV); Xeraspor® (ZA)

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