Clotrimazole


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Oropharyngeal candidiasis As 10 mg loz: Treatment: Dissolve 1 loz slowly in the mouth 5 times/day for 14 days. As prophylaxis for immunocompromised patients undergoing chemotherapy, radiotherapy, or steroid therapy: 1 loz tid for the duration of chemotherapy or until steroids are reduced to maintenance levels. Vaginal Vulvovaginal candidiasis As pessary: Insert 100 mg/day for 6 days, or 200 mg/day for 3 days, or 500 mg as a single dose. As 10% cream: Insert 5g (1 applicator-full) intravaginally as a single dose. All doses are inserted as high as possible intravaginally, preferably at night, using the applicator provided. Treatment may be repeated once if necessary and should be finished before onset of menstruation. As 1% or 2% cream: Apply thinly bid or tid, onto the external anogenital area, for at least 2 weeks (candida infections). Topical/Cutaneous Candidal balanitis As 1% or 2% cream: Apply bid or tid onto male sexual partner’s genital organ, for up to 2 weeks. Skin fungal infections As 1% cream, lotion, solution: Apply thinly onto the affected area(s) bid or tid. Continue treatment for at least 4 weeks (dermatophyte infections) or at least 2 weeks (candida infections). Otic/Aural Fungal otitis externa As 1% solution: Instill 2-3 drops onto affected ear(s) bid or tid for at least 2 weeks to prevent relapse.
Dosage Details
Oral
Oropharyngeal candidiasis
Adult: As 10 mg loz: Treatment: Dissolve 1 loz slowly in the mouth 5 times daily for 14 days. As prophylaxis for immunocompromised patients undergoing chemotherapy, radiotherapy, or steroid therapy: 1 loz tid for the duration of chemotherapy or until steroids are reduced to maintenance levels.
Child: ≥3 years As 10 mg loz: Treatment: Same as adult dose.

Otic/Aural
Fungal otitis externa
Adult: As 1% solution: Instill 2-3 drops onto affected ear(s) bid or tid for at least 2 weeks to prevent relapse.

Topical/Cutaneous
Candidal balanitis
Adult: As 1% or 2% cream: Apply bid or tid onto male sexual partner’s genital organ, for up to 2 weeks.

Topical/Cutaneous
Skin fungal infections
Adult: As 1% cream, lotion, solution: Apply thinly onto the affected area(s) bid or tid. Continue treatment for at least 4 weeks (dermatophyte infections) or at least 2 weeks (candida infections).

Vaginal
Vulvovaginal candidiasis
Adult: As pessary: Insert 100 mg daily for 6 days, or 200 mg daily for 3 days, or 500 mg as a single dose. As 10% cream: Insert 5 g (1 applicator-full) intravaginally as a single dose. All doses are inserted as high as possible intravaginally, preferably at night, using the applicator provided. Treatment may be repeated once if necessary and should be finished before onset of menstruation. As 1% or 2% cream: Apply thinly bid or tid, onto the external anogenital area, for at least 2 weeks (candida infections).
Child: >16 years As pessary: Insert 100 mg daily for 6 days or 200 mg daily for 3 days. As 10% cream: Same as adult dose. All doses are inserted as high as possible intravaginally, preferably at night, using the applicator provided. Treatment may be repeated once if necessary and should be finished before onset of menstruation.
Contraindications
Hypersensitivity.
Special Precautions
Vaginal: Patient who have had >2 infections of candidal vaginitis for the past 6 months, history of STD or exposure to partner with STD, irregular or abnormal bleeding, vaginal ulcers, diarrhoea, dysuria or lower abdominal pain, fever or chills. Not indicated for systemic fungal infection (oral). Hepatic impairment. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Abnormal LFTs, including elevated AST levels; increased skin irritation (e.g. redness, itching, burning, blistering, swelling, oozing).
Gastrointestinal disorders: Nausea, vomiting, unpleasant mouth sensation, abdominal pain.
General disorders and administration site conditions: Application site reactions (e.g. peeling/exfoliation, stinging sensation, pain, discomfort).
Immune system disorders: Allergic reaction.
Nervous system disorders: Paraesthesia.
Reproductive system and breast disorders: Vulvovaginal burning, vaginal discharge, pruritus vulvae, vulvar pain and swelling, genital peeling, pelvic pain, vaginal haemorrhage.
Skin and subcutaneous tissue disorders: Rash, urticaria, pruritus.
Vascular disorders: Syncope, hypotension.
Topical/Vag: B; Mouth/Throat: C
Patient Counseling Information
Vaginal: May damage and decrease the effectiveness of latex contraceptives (e.g. condoms, diaphragms); use alternative contraceptive measures. Avoid use of tampons, intravaginal douches, spermicides, or other vaginal products. Topical: Avoid use of occlusive wrappings or dressings; contact with eyes and mucous membranes.
MonitoringParameters
Monitor LFTs periodically during therapy; consider KOH test or culture prior to treatment to confirm oropharyngeal candidiasis. Monitor for severe skin irritation (e.g. redness, itching, burning, blistering, swelling, oozing).
Overdosage
Symptoms: Dizziness, nausea or vomiting. Management: Perform gastric lavage only if life-threatening amount has been ingested, symptoms become apparent and if the airway can be adequately protected.
Drug Interactions
May diminish therapeutic effects of progesterone. May increase the serum concentrations of sirolimus, tacrolimus, aripiprazole, dofetilide, lomitapide, neratinib, nimodipine, pimozide.
Action
Description: Clotrimazole is an imidazole antifungal that exerts its antimicrobial activity by binding to phospholipids in the cell membrane and altering cell wall permeability, thereby causing a loss in essential intracellular elements.
Pharmacokinetics:
Absorption: Well absorbed from the gastrointestinal tract. Minimally absorbed from the skin and vagina. Time to peak plasma concentration: Approx 24 hours (vaginal cream).
Distribution: Inhibitory concentration in saliva for up to 3 hours (loz); penetrates the epidermis (topical).
Metabolism: Metabolised in the liver to inactive compounds.
Excretion: Via faeces and urine.
Chemical Structure

Click on icon to see table/diagram/image
Storage
Store between 20-25°C.
ATC Classification
G01AF02 - clotrimazole ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of gynecological infections.
A01AB18 - clotrimazole ; Belongs to the class of local antiinfective and antiseptic preparations. Used in the treatment of diseases of the mouth.
D01AC01 - clotrimazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.
Disclaimer: This information is independently developed by MIMS based on Clotrimazole from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
  • Candazole Solution
  • Candid Mouth Paint
  • Lotremin
  • Pharmaniaga Clotrimazole
  • Taraten
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in