Clotrimazole


Full Generic Medicine Info
Dosage/Direction for Use

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
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.

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.
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. 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
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
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.
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 epidermis (topical).
Metabolism: Metabolised in the liver to inactive compounds.
Excretion: Via faeces and urine.
Storage
Oral: Store between 20-25°C. Otic/Aural: Store between 20-25°C. Topical/Cutaneous: Store between 20-25°C. Vaginal: Store between 20-25°C.
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 CIMSAsia.com
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