TGP Pharma


Full Prescribing Info
Clotrimazole 1% w/w.
Pharmacology: Pharmacodynamics: Clotrimazole (Trimacort) 1% Cream is a broad-spectrum, antifungal agent that is used for the treatment of dermal infections caused various species of pathogenic dermatophytes, yeast and Malassezia furfur.
Pharmacokinetics: Clotrimazole cream containing C-labelled Clotrimazole was administered intravaginally to five women (four without gynecological disorders and one with Candida vulvovaginitis). A maximum serum level of 0.01 mg/mL was found between 10 and 30 hours after administration.
Studies of urinary excretion have shown that less than 0.5% dermally applied Clotrimazole cream appears in the urine over a five-day period of observation. Faecal excretion, the route by which most of the absorbed drug likely to be eliminated, has not been studied in humans.
It is used topically in superficial candidiasis and in skin infections pityriasis versicolor and dermatophytosis. Clotrimazole is also indicated in the treatment of vulvovaginal candidiasis.
Dosage/Direction for Use
Apply sparingly to the affected area and rub it gently, two to three times daily.
Duration of treatment: the following recommendations are made: Cutaneous candidiasis 2 weeks, Dermatomycoses 3-4 weeks, Onychia and Paronychia due to C. albicans 4-8 weeks or more.
Regular application of Clotrimazole cream is essential for successful treatment and whether or not a cure is confirmed mycologically, treatment should be continued for two weeks after clinical signs have disappeared.
Special Remarks: Attention to hygiene is important in the management of fungal diseases of the feet: After washing, the feet especially between toes, should be dried thoroughly. Clotrimazole cream may be useful in mycotic paronychia or onychia following removal of the nail. Clotrimazole cream may also be used in conjunction with Clotrimazole vaginal tablets in the management of Candida vulvovaginitis or infection of the peri-anal area, while application of the cream to the glans penis of the partner may help prevent reinfection of the female. It is suggested that treatment be timed so as to avoid the menstrual period and to be completed before the onset of menstruation.
Hypersensitivity to Clotrimazole or any of the ingredients in this medicine.
Special Precautions
General: If irritation or sensitivity develops with use of Clotrimazole, treatment should be discontinued and appropriate therapy instituted.
For Patients: The patient should be advised to use this medication for the full treatment time even though the symptoms may have improved. Notify the physician if there is no improvement after 4 weeks of treatment. Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, oozing) indicative of possible sensitization.
Avoid sources of infection or reinfection.
Adverse Reactions
Clotrimazole cream is generally well tolerated after local application. The following have been reported infrequently: erythema, stinging, blistering, peeling, oedema, pruritus, urticaria and general irritation.
Caution For Usage
Store at temperatures not exceeding 30°C.
ATC Classification
D01AC01 - clotrimazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.
Cream 1% x 20 g.
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