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Fluconazole Tablets

Fluconazole Tablets

Fluconazole Tablets IP 150 mg
Each uncoated tablet contains Fluconazole IP 150 mg; excipients q.s.

Nuflucon-200 — Fluconazole Tablets IP 200 mg
Each uncoated tablet contains Fluconazole IP 200 mg.

Usage: Prevention and treatment of selected susceptible fungal and yeast infections.

Category: Antifungal Drugs

Therapeutic Category: Antifungal

SKU: Fluconazole Tablets

Categories: Pharmaceutical Exporter India, Pharmaceutical Formulations India, WHO GMP Certified Formulations

Product Information

Fluconazole Tablets is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.

For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.

Description

Fluconazole Tablets (150 mg / 200 mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)
Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. manufactures Fluconazole Tablets in India. Fluconazole is a triazole antifungal used for susceptible yeast and fungal infections. Treatment choice depends on the organism, infection site, severity, local resistance patterns and patient factors. The compositions provided for this product are uncoated Fluconazole IP tablets in 150 mg and 200 mg strengths.

2. Product Specifications

ParameterSpecification
Product NameFluconazole Tablets
Active IngredientFluconazole IP
Specified Strengths150 mg and 200 mg
150 mg CompositionEach uncoated tablet contains Fluconazole IP 150 mg; excipients q.s.
200 mg CompositionNuflucon-200: each uncoated tablet contains Fluconazole IP 200 mg
Other strengths referenced50 mg and 100 mg — not confirmed in supplied compositions
Dosage FormUncoated tablets (specified products)
Pharmacopoeial StandardIP (specified products)
CAS Number86386-73-4
Therapeutic ClassTriazole antifungal
Packaging and Shelf LifeAs per approved product specifications and stability data

3. Manufacturing Technology

Manufacture of oral fluconazole tablets requires controlled blending, compression and appropriate in-process checks to support dose uniformity and tablet performance. Suitable disintegrants and manufacturing processes are selected according to the registered formulation. Packaging configuration, including single-tablet or multi-tablet packs, is determined by the approved market presentation. No specific manufacturing process or disintegration time is asserted without batch documentation.

4. Quality Assurance

Finished-product testing may include identification, assay, dissolution, dosage uniformity, related substances and stability according to the applicable IP monograph and registered specifications. Exact acceptance criteria and shelf life must be supported by product-specific quality records.

5. Pharmacology and Clinical Use

Fluconazole inhibits fungal lanosterol 14-alpha-demethylase, interfering with ergosterol synthesis and fungal membrane function. Depending on local approval and susceptibility, uses include selected Candida infections and certain cryptococcal infections. Cryptococcal meningitis requires specialist-directed combination and/or staged treatment; fluconazole alone is not an appropriate universal initial regimen. Resistance and species-specific susceptibility can limit effectiveness.

6. Export and Regulatory Support

Product-specific registration dossiers, certificates of analysis and regulatory documents may be available on request, subject to the approved formulation and destination-market requirements. Supply to a country does not imply local marketing authorization.

7. Frequently Asked Questions

Who manufactures Fluconazole Tablets?
Healthy Life Pharma Pvt. Ltd., India.

Is this Diflucan?
Diflucan is a brand containing fluconazole. A claim of bioequivalence to a reference product requires appropriate product-specific evidence.

Can one 150 mg tablet treat vaginal yeast infection?
A single 150 mg oral dose is an established regimen for uncomplicated vulvovaginal candidiasis in certain nonpregnant adults, but not all symptoms or infections are suitable for this approach.

Is oral fluconazole recommended during pregnancy?
Oral fluconazole is generally avoided for vulvovaginal candidiasis during pregnancy; guidelines commonly recommend a seven-day course of topical azole therapy instead. A clinician should assess any systemic infection individually.

8. Dosage and Administration

Fluconazole dose and duration vary substantially by indication, organism, severity, kidney function and patient characteristics. The 150 mg and 200 mg tablets are not interchangeable for all conditions. Renal dose adjustments may be required for repeated dosing. Take according to the approved label and prescriber instructions; tablets may generally be taken with or without food.

9. Side Effects and Precautions

  • Common effects: Nausea, abdominal discomfort, diarrhoea and headache.
  • Liver: Rare serious hepatic injury is possible; seek medical assessment for jaundice, dark urine or persistent vomiting.
  • Heart rhythm: QT prolongation can occur, particularly with interacting drugs or electrolyte abnormalities.
  • Drug interactions: Fluconazole inhibits certain CYP enzymes and can interact with anticoagulants, some statins, antiepileptics and other medicines.
  • Skin reactions: Rare severe skin reactions require urgent care.
  • Pregnancy: Discuss pregnancy or pregnancy planning with a clinician before oral use.

10. Storage Instructions

Store according to the approved pack label, protected from excessive heat and moisture. Keep the original container closed and out of reach of children.