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CLOTRIMADERM TOPICAL 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.
General As with all topical agents, skin sensitization may result. Use of Clotrimaderm Topical and Clotrimaderm Topical Solution 1% USP should be discontinued should such reactions occur, and appropriate therapy instituted. Clotrimaderm Topical and Clotrimaderm Topical Solution 1% USP are not suitable for treating fungal infections of the nail or scalp.
Occlusive dressings should not be applied over Clotrimaderm Topical and Clotrimaderm Topical Solution 1% USP unless directed by a physician. It is noted that diapers would not be considered occlusive dressings because of frequent changes and airings, normal hygiene practices and the use of newer more breathable and absorbent diapers.
ClotrimadermTopical and Clotrimaderm Topical Solution 1% USP are not for ophthalmic use. Effects on Fertility No human studies of the effects of clotrimazole on fertility have been performed; however, animal studies have not demonstrated any effects of the drug on fertility.
Special Populations Pregnant Women:
There are limited amounts of data from the use of clotrimazole in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see ‘Reproduction and Teratology’). Although the topical application of clotrimazole has resulted in very low serum and tissue levels, the use of Clotrimaderm Topical and Clotrimaderm Topical Solution USP 1% by pregnant women is not recommended unless it is on the advice of a physician.
Clotrimaderm Topical and Clotrimaderm Topical Solution 1% USP should not be used in the first trimester or if you are trying to get pregnant unless the physician considers it essential to the welfare of the patient.
Nursing Women:
Available pharmacodynamic/toxicological studies in animals have shown excretion of clotrim az o le /m e ta b oli te s in milk. Breastfeeding should be discontinued during treatment with clotrim a z ole. Although the topical application of clotrimazole has resulted in very low serum and tissue levels, the use of Clotrimaderm Topical and Clotrimaderm Topical Solution 1% USP by lactating women is not recommended unless it is on the advice of a physician.
ADVERSE REACTIONS Adverse Drug Reaction Overview Experimental, therapeutic, and large scale clinical studies have shown clotrimazole to be well tolerated after topical application. Immune system disorders: anaphylactic reactions, angioedema, hypersensitivity Vascular disorders: hypotension, syncope Clotrimaderm Topical and Clotrimaderm Topical Solution 1% USP Product Monograph Page 5 of 18 Respiratory, thoracic and mediastinal disorders: dyspnea Skin and subcutaneous tissue disorders: blisters, dermatitis contact, erythema, paraesthesia, skin exfoliation, pruritis, rash, urticaria, stinging/burning sensation General disorders and administration site conditions: application site irritation, application site reaction, edema, pain Out of a total of 184 patients treated with the 1% cream, irritation was reported in 12 and soreness in 1 patient; therapy was discontinued in 3 patients.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Clotrimazole in Canada.
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In comparison, 1 case of increased inflammation and pruritus and 1 case of folliculitis was reported in the 54 patients treated with the vehicle control.
Other Formulations:
Drying effect, maculopapular rash and increased sweating have been reported with use of clotrimazole topical solution in a clinical trial. DOSAGE AND ADMINISTRATION 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 Clotrimaderm Topical and Clotrimaderm Topical Solution 1 % USP , 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 Clotrimaderm Topical CHILDREN (for the treatment of diaper rash): Thinly apply and gently massage sufficient Clotrimaderm Topical 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. Clotrimaderm Topical and Clotrimaderm Topical Solution 1% USP ADULTS (for the treatment of jock itch, athletes foot and ringworm): Thinly apply and gently massage sufficient Clotrimaderm into the affected and surrounding skin areas twice daily, in Clotrimaderm Topical and Clotrimaderm Topical Solution 1% USP Product Monograph Page 6 of 18 the morning and evening.
For the treatment to be completely successful Clotrimaderm 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 Clotrimazole acts primarily by damaging the permeability barrier in the cell membrane of fungi.
Clotrimazole 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 […]