Active Pharmaceutical Ingredients

Molecular Formula: C13H12F2N6O

Molecular Weight: 306.271

CAS No.: 86386-73-4

It is a fluorotriazole antifungal drug with a broad-spectrum antifungal effect. Its antibacterial spectrum is similar to that of ketoconazole, and its antibacterial activity is stronger than that of ketoconazole.

Description

It is a white or almost white crystal or crystalline powder, hygroscopic, slightly peculiar and bitter. It is easily soluble in glacial acetic acid, methanol or ethanol, hardly soluble in water, and hardly soluble in ether.

Application

It is a fluorotriazole antifungal drug with a broad-spectrum antifungal effect. Its antibacterial spectrum is similar to that of ketoconazole, and its antibacterial activity is stronger than that of ketoconazole. Fluconazole has strong antibacterial activity against Candida albicans, Large and Small Spores, Cryptococcus neoformans, Epidermophytes and Histoplasma capsulatus.

It is clinically mainly used for vaginal candidiasis, thrush, atrophic oral candidiasis, fungal meningitis, pulmonary fungal infections, abdominal infections, urinary tract infections and skin fungal infections.

Packing

25Kg per drum

Storage：

Preserve in tight containers in a dry place.

Shelf Life :

24 months from date of production when stored in good condition.

Minimum Order

One package.

Item	Content
Chemical Information	– Molecular Formula: C₁₃H₁₂F₂N₆O<br>- Molecular Weight: 306.27
Appearance	White or almost white, crystalline powder; hygroscopic. Soluble in methanol, sparingly soluble in water.
Indications	– Candidiasis: Treatment of oropharyngeal, esophageal, and disseminated candidiasis.<br>- Cryptococcosis: Treatment of cryptococcal meningitis.<br>- Other Fungal Infections: Used for other susceptible fungal infections as indicated by susceptibility testing.
Mechanism of Action	Fluconazole inhibits the enzyme lanosterol 14α-demethylase, which is essential for the synthesis of ergosterol in fungal cell membranes. This disruption leads to fungal cell death.
Specifications	– Purity: Meets USP 40 requirements for purity and related substances.<br>- Assay: 98.0%–102.0% of C₁₃H₁₂F₂N₆O on the dried basis.<br>- Impurities: Complies with USP 40 limits.
Storage Conditions	Store in a tightly closed container at controlled room temperature (20°C–25°C). Protect from moisture.
Packaging	Available in bulk packaging, typically in 25Kg drums.
Pharmacopoeia Standard	Complies with United States Pharmacopeia (USP) 40 standards.
Adverse Reactions	– Common: Nausea, headache, rash, dizziness.<br>- Serious: Hepatotoxicity (elevated liver enzymes, jaundice), allergic reactions (anaphylaxis, Stevens-Johnson syndrome).
Dosage and Administration	– Disseminated Candidiasis: Initial dose 400 mg, followed by 200 mg once daily.<br>- Esophageal Candidiasis: Initial dose 200 mg, followed by 100 mg once daily.<br>- Cryptococcal Meningitis: 400 mg once daily.
Precautions	– Liver Function Monitoring: Regular liver function tests are recommended, especially for long-term use.<br>- Pregnancy and Breastfeeding: Use with caution; benefits should outweigh potential risks.<br>- Drug Interactions: Inform your doctor about other medications to avoid interactions.

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