Product image of Mycozal (Fluconazole) supplied by GNH India

Mycozal

Active Ingredient:
Fluconazole
Origin:
EU

Mycozal (Fluconazole)

Fluconazole, the active ingredient in Mycozal, is an azole antifungal presented as an oral dosage form for oral use. It treats a range of fungal infections including candidiasis, cryptococcal meningitis and systemic mycoses in both adults and children as prescribed.

GNH India supplies Mycozal as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Sapiens Pharmaceuticals Ltd

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Indications & Clinical Uses

Fluconazole is an azole antifungal used to treat infections caused by susceptible fungi.

  • Candidiasis: effective for oropharyngeal, esophageal and vaginal infections.
  • Cryptococcal meningitis: used for induction and maintenance therapy.
  • Systemic mycoses: treats disseminated infections such as blastomycosis and histoplasmosis.
  • Dermatophyte infections: manages skin and nail infections caused by dermatophytes.

How It Works

  • Fluconazole inhibits the fungal cytochrome P450 enzyme 14α‑demethylase, a key step in ergosterol synthesis. By blocking this pathway, the drug disrupts cell‑membrane integrity, leading to impaired fungal growth and eventual cell death. The selective inhibition of fungal enzymes over human counterparts provides its therapeutic antifungal activity.

Side Effects

Fluconazole may cause a variety of adverse reactions, ranging from mild to severe.

Common Side Effects

  • Nausea
  • Headache
  • Abdominal pain
  • Diarrhea
  • Rash
  • Elevated liver enzymes

Serious or Rare Side Effects

  • Severe hepatic injury
  • Stevens‑Johnson syndrome
  • Toxic epidermal necrolysis
  • Anaphylaxis
  • QT interval prolongation
  • Other severe skin reactions

Precautions & Warnings

Before initiating fluconazole therapy, clinicians should consider several safety measures.

  • Assess liver function: obtain baseline liver‑function tests.
  • Monitor renal function: adjust dose in severe renal impairment.
  • Review concomitant medications: avoid drugs that prolong QT or strongly inhibit CYP2C9/2C19.
  • Use caution in pregnancy: weigh potential risks against benefits.
  • Avoid in known hypersensitivity: discontinue if allergic reaction occurs.
  • Store at ambient temperature: keep in the original container, protect from moisture and light.

Avoid Interactions

Fluconazole interacts with several medicines; some combinations should be avoided while others require monitoring.

Major Interactions (Avoid)

  • Cisapride: risk of serious arrhythmia.
  • Terfenadine: may cause QT prolongation.
  • Potent CYP2C9 inhibitors (e.g., warfarin): increased anticoagulant effect.
  • Rifampin: reduces fluconazole plasma levels.
  • Azithromycin: heightened QT‑interval risk.

Moderate Interactions (Monitor Closely)

  • Oral contraceptives: possible reduction in efficacy.
  • Phenytoin: may lower fluconazole concentrations.
  • Carbamazepine: can decrease fluconazole exposure.
  • Statins (e.g., simvastatin): increased myopathy risk.
  • HIV protease inhibitors: may raise fluconazole levels.

Frequently Asked Questions

Mycozal, containing fluconazole, is prescribed for a variety of fungal infections such as oral, esophageal and vaginal candidiasis, cryptococcal meningitis, systemic mycoses like blastomycosis and histoplasmosis, and dermatophyte skin or nail infections. The specific indication depends on the infection type and the prescribing clinician’s assessment.

Fluconazole blocks the fungal enzyme 14α‑demethylase, which is essential for producing ergosterol, a key component of the fungal cell membrane. By inhibiting ergosterol synthesis, the drug compromises membrane integrity, halting fungal growth and leading to cell death while sparing most human cells.

The dosage of Mycozal is determined by the treating physician based on the infection type, severity, patient age, weight, renal and hepatic function, and other clinical factors. Only a qualified prescriber can set the appropriate regimen for each individual case.

Safety data for fluconazole in pregnancy and lactation are limited. It should only be used if the potential benefit justifies any possible risk to the fetus or infant. Women who are pregnant, planning pregnancy, or breastfeeding should discuss risks and alternatives with their healthcare provider.

To request Mycozal, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain needs) and required import documentation.

Compared with other azole antifungals, fluconazole offers excellent oral bioavailability and a relatively favorable safety profile, making it suitable for many outpatient infections. However, some fungal species may be resistant, and drugs like itraconazole or voriconazole may be preferred for certain deep‑tissue infections or resistant strains.

Mycozal should be stored at ambient temperature, below 25 °C, in its original packaging. Keep the product away from moisture, direct sunlight, and excessive heat to maintain potency throughout its shelf life.

Mycozal is taken orally, usually with or without food, as directed by the prescriber. The tablet or capsule should be swallowed whole with a glass of water. Patients should follow the exact schedule and duration prescribed to ensure effective treatment.

Serious adverse events, although rare, include severe liver injury, life‑threatening skin reactions such as Stevens‑Johnson syndrome or toxic epidermal necrolysis, anaphylaxis, and cardiac arrhythmias due to QT prolongation. Prompt medical attention is required if any of these symptoms develop.

Mycozal is contraindicated in individuals with a known hypersensitivity to fluconazole or any other azole antifungal. Patients with severe hepatic impairment or those taking medications that cause dangerous QT prolongation should avoid it unless a specialist determines that benefits outweigh risks.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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