Product Description
Clotidal MAX 500 mg vaginal tablet is a pharmaceutical product for local intravaginal use in the treatment of fungal infections of the vagina and external female genitalia caused by organisms sensitive to clotrimazole (usually Candida species).
Ingredients
Active substance: Clotrimazole – 1 vaginal tablet contains 500 mg.
Excipients: Monohydrate lactose, adipic acid, sodium bicarbonate, magnesium stearate, colloidal anhydrous silica, sodium lauryl sulfate, potato starch, corn starch.
Dosage and Administration
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Adults and adolescents aged 16 years and older: Insert one vaginal tablet deeply into the vagina once daily at bedtime.
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Ensure a moist vaginal environment for complete dissolution of the tablet. Undissolved portions may exit the vagina; to avoid this, insert the tablet as deeply as possible before lying down.
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Do not use Clotidal MAX during menstruation; complete treatment prior to menstrual bleeding.
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Sexual partners should also undergo local treatment if symptoms (e.g., itching, inflammation) are present.
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Duration of treatment: Single-dose, intravaginal application.
Special populations:
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Adolescents aged 12–15 years: Use only under medical supervision after the first menstruation. Dose is the same as for adults.
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Children under 12 years: Safety and efficacy have not been established.
Pharmacological Action
Clotrimazole inhibits ergosterol synthesis in fungal cells, causing structural and functional disruption of the cell membrane, increasing permeability, and ultimately leading to fungal cell death.
Indications
Local treatment of:
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Vaginal and vulvar infections caused by Candida species (vulvovaginal candidiasis).
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Fungal balanitis (infection of the glans penis) in male sexual partners.
Contraindications
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Hypersensitivity to clotrimazole or any excipient.
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Not recommended during menstruation.
Adverse Effects
Adverse reactions may occur, but not everyone will experience them. Frequency of observed side effects:
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Common (>1/100): Burning sensation.
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Uncommon (>1/1,000): Abdominal pain, itching, redness, and/or irritation of genital area.
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Rare (>1/10,000): Allergic reactions, swelling, skin rash, vaginal bleeding.
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Frequency unknown: Peeling in the genital area, discomfort, pelvic pain.
Seek medical attention immediately in case of hypersensitivity symptoms, e.g., fainting, hypotension, breathing difficulties, swelling, or hives.
Warnings and Precautions
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Read the package leaflet before use. Consult a physician or pharmacist if in doubt.
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Clotrimazole applied to genital areas may reduce the effectiveness of latex contraceptives (condoms, diaphragms). Use additional contraception during treatment.
Use with Other Medicines
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Inform your doctor or pharmacist about any current or recent medications.
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Clotrimazole may interact with tacrolimus or sirolimus.
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Single-dose 500 mg application is unlikely to cause significant drug interactions.
Pregnancy and Lactation
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Pregnancy: Avoid use during the first trimester.
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Breastfeeding: Not recommended; breastfeeding should be discontinued during treatment.
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Consult your doctor before use if pregnant or breastfeeding.
Pediatric Use
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Adolescents ≥16 years: Same dosing as adults.
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Adolescents 12–15 years: Only under medical supervision.
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Children <12 years: Safety and efficacy not established.