Description
B Trac 200 – Itraconazole 200mg Prescription Antifungal Medication
B Trac 200 is a prescription antifungal medication containing Itraconazole 200mg, used for the treatment of various fungal infections under medical supervision.
COMPOSITION:
Each Film Coated Tablet Contains:
• Itraconazole IP – 200 mg
MECHANISM OF ACTION:
Itraconazole is a triazole antifungal agent that works by inhibiting the cytochrome P450-dependent synthesis of ergosterol, an essential component of fungal cell membranes. This disruption leads to increased cellular permeability and ultimately inhibits fungal cell growth.
THERAPEUTIC INDICATIONS:
• Aspergillosis (pulmonary and extrapulmonary)
• Blastomycosis (pulmonary and extrapulmonary)
• Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, nonmeningeal histoplasmosis
• Onychomycosis (fungal infections of the toenails and fingernails)
• Oral and esophageal candidiasis
• Pityriasis versicolor
• Dermatophytosis
• Vulvovaginal candidiasis
• Systemic fungal infections in immunocompromised patients
DOSAGE AND ADMINISTRATION:
Dosage varies depending on the type and severity of infection. Common regimens include:
• Systemic fungal infections: 200mg once or twice daily
• Onychomycosis: Pulse therapy – 200mg twice daily for one week, repeated after a 3-week interval
• Oropharyngeal candidiasis: 100-200mg once daily
Dose and duration should be determined by a qualified healthcare professional based on individual patient needs.
CONTRAINDICATIONS:
• Hypersensitivity to Itraconazole or any excipients
• Concomitant use with certain medications (see drug interactions)
• Ventricular dysfunction, heart failure, or history of heart failure (except for life-threatening infections)
• Pregnancy (teratogenic effects documented)
WARNINGS AND PRECAUTIONS:
• Hepatotoxicity: Monitor liver function tests before and during treatment
• Cardiac effects: May cause or exacerbate congestive heart failure
• Drug interactions: Strong CYP3A4 inhibitor – numerous clinically significant interactions
• Absorption: Take with food for optimal absorption
• Renal/hepatic impairment: Use with caution; dose adjustment may be required
• Neuropathy: Discontinue if peripheral neuropathy develops
• Hearing loss: Monitor for hearing impairment during treatment
DRUG INTERACTIONS:
Itraconazole has significant drug interactions due to CYP3A4 inhibition. Contraindicated with: certain statins, ergot alkaloids, triazolam, oral midazolam, nisoldipine, felodipine, pimozide, quinidine, dofetilide, methadone, disopyramide, dronedarone, and ranolazine. Consult healthcare provider for complete interaction list.
ADVERSE EFFECTS:
Common: Nausea, vomiting, diarrhea, abdominal pain, headache, rash, elevated liver enzymes
Serious: Hepatotoxicity, cardiac failure, Stevens-Johnson syndrome, hypokalemia, adrenal insufficiency
PREGNANCY AND LACTATION:
• Pregnancy Category C: Contraindicated except for life-threatening situations
• Lactation: Excreted in breast milk; breastfeeding not recommended
STORAGE:
Store at room temperature (15-30°C), protected from light and moisture. Keep out of reach of children.
REGULATORY INFORMATION:
Manufactured following strict pharmaceutical standards. Each ingredient meets Indian Pharmacopoeia (IP) specifications. Prescription only medicine – to be sold only on the prescription of a registered medical practitioner.
IMPORTANT NOTICE:
This medication should only be used under medical supervision. Do not self-medicate. Complete the full course of treatment as prescribed. Consult your healthcare provider before use, especially if you have liver disease, heart problems, or are taking other medications.
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