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CANESTEN is a brand name for Clotrimazole, supplied as a cream. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..................................................................................... 3 CONTRAINDICATIONS .......................................................................................................... 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations Clinical improvement with relief of pruritus, usually occurs within the first week of treatment. The symptoms of jock itch, ringworm and diaper rash usually resolve within 2-4 weeks. Athlete's foot may require at least four (4) weeks.
In mycoses of the foot, treatment should be continued - even when it has led to rapid subjective improvement - for about 2 weeks after all symptoms have disappeared so that relapses may be prevented. If the signs and symptoms of the infection have not been resolved after four weeks of treatment with CANESTEN®, a physician should be consulted.
If a cure is not mycologically confirmed, treatment should, as a rule, be continued for 2 weeks after all clinical symptoms have disappeared. Candida infections are generally treated for only 2 weeks. Added hygienic measures are of special importance in the management of the often refractory fungal diseases of the foot.
After washing, the feet - particularly between the toes - should be dried thoroughly to avoid trapped moisture. Well-fitting, ventilated shoes and cotton or wool socks are recommended to ensure a successful treatment outcome and to help prevent a recurrence.
Recommended Dose and Dosage Adjustment Skin Infections CHILDREN (for the treatment of diaper rash): Thinly apply and gently massage sufficient CANESTEN® 1% Topical Cream onto the affected and surrounding skin areas twice daily at a diaper change (in the morning and evening).
Do not use for more than 14 days. If symptoms worsen or there is no improvement after 2 weeks, consult a physician.
ADULTS (for the treatment of jock itch, athletes foot and ringworm):
Thinly apply and gently massage sufficient CANESTEN® 1% Topical Cream into the affected and surrounding skin areas twice daily, in the morning and evening. For the treatment to be completely successful CANESTEN® 1% Topical Cream should be applied regularly and in sufficient quantities.
OVERDOSAGE For management of a suspected drug overdose, contact your regional Poison Control Centre. ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action CANESTEN® acts primarily by damaging the permeability barrier in the cell membrane of fungi.
CANESTEN® brings about inhibition of ergosterol biosynthesis, an essential constituent of fungal cell membranes. If ergosterol synthesis is completely or partially inhibited, the cell is no longer able to construct an intact cell membrane.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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This leads to death of the fungus. Exposure of Candida albicans to clotrimazole causes leakage of intracellular phosphorus compounds into the ambient medium with a concomitant breakdown of cellular nucleic acids and potassium efflux.
The onset of these events is rapid and extensive after exposure of the organism CANESTEN® 1% TOPICAL CREAM (Clotrimazole, Bayer Std) Page 6 of 15 to the drug, and causes a time-dependent and concentration-dependent inhibition of fungal growth.
Pharmacokinetics Metabolism studies performed after oral or intravenous administration have shown that in most species studied, levels of Clotrimazole in tissue and serum are low. The majority of the drug is excreted as metabolites in the feces, with small amounts excreted in the urine.
Human studies indicate slow excretion following oral administration of 14C-labelled Clotrimazole (greater than 6 days). After intraperitoneal and subcutaneous administration, very low levels have been observed in the urine. Sitka reported levels of about 1% of the quantity of Clotrimazole in the 24-hour urine in newborns and premature infants.
The absorption and organ distribution of the drug is very poor when administered parenterally. The pharmacokinetics of topically applied Clotrimazole in human subjects have been evaluated by Duhm et al. who reported on the penetration of radioactive Clotrimazole 1% cream and 1% solution into intact and acutely inflamed skin.
1 μg/cm3 in the subcutis. 8 g of the cream. Sitka et al. 7 μg/mL in school children. 2 μg/mL after 24 hours; this level dropped faster to the zero point after 12 hours in older children. In animal experiments; Clotrimazole exerts an in vitro and in vivo, dose-dependent stimulating effect on certain microsomal enzyme systems which is approximately equal to that of phenobarbital in its inductive potential.
However, this stimulating effect subsides rapidly when treatment is discontinued. The enzyme-inductive effect of Clotrimazole has been found to be intact in adrenalectomized animals. Results of twenty-two mycologically controlled double-blind, one mycologically controlled single blind, and four mycologically controlled open studies show that 1% solution and cream (CANESTEN®) are effective in the treatment of tinea cruris, tinea corporis, tinea pedis, tinea versicolor and cutaneous candidiasis.
5% and 0%, respectively, for the vehicle control (total of 238 patients). STORAGE AND STABILITY Store between 15 ºC -30ºC. DOSAGE FORMS, COMPOSITION AND PACKAGING CANESTEN® 1% Topical Cream is supplied in 15 g and 30 g tubes in cartons.
Composition:
CANESTEN® 1% Topical Cream contains 10 mg/g of clotrimazole in a vanishing cream base of benzyl alcohol, cetostearyl alcohol, cetyl esters wax, octyldodecanol, polysorbate 60, sorbitan monostearate and water.
CANESTEN® 1% TOPICAL CREAM (Clotrimazole, Bayer Std) Page 7 of 15 PART II:
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