Concise Prescribing Info
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.
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. Patient Counselling 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. Monitoring Parameters 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).
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.
ROUTE(S) : Topical / Vag: B
ROUTE(S) : Mouth/Throat: C
Drug Interactions
May diminish therapeutic effects of progesterone. May increase the serum concentrations of sirolimus, tacrolimus, aripiprazole, dofetilide, lomitapide, neratinib, nimodipine, pimozide.
ATC Classification
D01AC01 - clotrimazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.
A01AB18 - clotrimazole ; Belongs to the class of local antiinfective and antiseptic preparations. Used in the treatment of diseases of the mouth.
G01AF02 - clotrimazole ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of gynecological infections.
Disclaimer: This information is independently developed by CIMS 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 CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS 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 © 2021 CIMS. All rights reserved. Powered by
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