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CLOTRIMADERM VAGINAL 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: Clotrimaderm Vaginal 6 (clotrimazole) is indicated for the 6-day treatment of vaginal candidiasis. Clotrimaderm Vaginal 3 (clotrimazole) is indicated for the 3-day treatment of vaginal candidiasis. 1.1 Pediatrics Pediatrics (>12 years of age): Based on the data submitted and reviewed by Health Canada, the safety and…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations ............................................................................................................... 2 Recommended Dose and Dosage Adjustment..........................................................................
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1 Special Populations ................................................................................................................... 1 Adverse Reaction Overview ......................................................................................................
2 Clinical Trial Adverse Reactions................................................................................................. 4 Drug-Drug Interactions ..............................................................................................................
1 Mechanism of Action ................................................................................................................ 3 Pharmacokinetics ......................................................................................................................
16 PATIENT MEDICATION INFORMATION ............................................................................................. 17 Clotrimaderm Vaginal 6 (Clotrimazole 1% Cream) Page 4 of 26 Clotrimaderm Vaginal 3 (Clotrimazole 2% Cream) PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Clotrimaderm Vaginal 6 (clotrimazole) is indicated for the 6-day treatment of vaginal candidiasis.
Clotrimaderm Vaginal 3 (clotrimazole) is indicated for the 3-day treatment of vaginal candidiasis. 1 Pediatrics Pediatrics (>12 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of Clotrimazole in pediatric patients (>12 years of age) has been established.
Therefore, Health Canada has authorized an indication for pediatric (>12 years of age) use. 2 CONTRAINDICATIONS Clotrimazole is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any on-medicinal ingredient, or component of the container.
1 Dosing Considerations • Vaginal Candidiasis may be accompanied by irritation in the vaginal area. Therefore, concomitant local treatment with Clotrimaderm vaginal creams, applied to the irritated vaginal area and as far as the anal region twice a day is advisable.
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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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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Clotrimaderm vaginal creams applied on the glans penis may prevent re-infection by the partner. • The cream should be inserted deep intravaginally by means of the applicator (See 7 WARNINGS AND PRECAUTIONS). The plunger should then be depressed slowly.
• General hygienic measures such as twice daily tub baths and avoidance of tight underclothing are important in vaginal infections. 2 Recommended Dose and Dosage Adjustment • Clotrimaderm Vaginal 6 The recommended daily dose is ONE full applicator intravaginally for SIX consecutive days, preferably at bedtime.
• Clotrimaderm Vaginal 3 The recommended daily dose is ONE full applicator intravaginally for THREE consecutive days, preferably at bedtime. Clotrimaderm Vaginal 6 (Clotrimazole 1% Cream) Page 5 of 26 Clotrimaderm Vaginal 3 (Clotrimazole 2% Cream) 5 OVERDOSAGE For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1- 844-764-7669).
6 DOSAGE FORMS, STRENGTH, COMPOSITION AND PACKAGING Table – Dosage Forms, Strengths, Composition and Packaging Brand name Route of Administration Dosage Form/ Strength/Composition Non-medicinal Ingredients Clotrimaderm Vaginal 6 Vaginal Vaginal cream / 1% / clotrimazole benzyl alcohol, cetyl esters wax, cetostearyl alcohol, 2- octyl dodecanol, sorbitan monostearate, polysorbate 60, water.
Clotrimaderm vaginal 3 Vaginal Vaginal cream / 2% / clotrimazole benzyl alcohol, cetyl esters wax, cetostearyl alcohol, 2- octyl dodecanol, sorbitan monostearate, polysorbate 60, water. Clotrimaderm Vaginal 6 is supplied in a 50 g tube of 1% vaginal cream in a carton containing 6 disposable plastic applicators and patient instructions.
50 g of Clotrimazole Vaginal Cream 1% is sufficient for 6 intravaginal applications with additional cream for extravaginal use if required. Clotrimaderm Vaginal 3 is supplied in a 25 g tube of 2% vaginal cream in a carton containing 3 disposable plastic applicators and patient instructions.
25 g of Clotrimazole Vaginal Cream 2% is sufficient for 3 intravaginal applications with additional cream for extravaginal use if required. 7 WARNINGS AND PRECAUTIONS Ge ne ral Patients should seek medical advice if they have frequent vaginal infections or if their yeast infection returns in less than 2 months.
Treatment during the menstrual period should not be performed. The treatment should be finished before the onset of menstruation. Clotrimaderm Vaginal 6 (Clotrimazole 1% Cream) Page 6 of 26 Clotrimaderm Vaginal 3 (Clotrimazole 2% Cream) Immune Patients should seek medical advice if they have underlying immunodeficiency disease (such as HIV-AIDS).
Ophthalmologic Clotrimaderm vaginal creams are not for ophthalmic use. Renal Patients should seek medical advice if they suffer from diabetes mellitus.
Reproductive Health:
Female and Male Potential • Fertility No human […]