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 tablet for systemic use. It treats a range of fungal infections, including candidiasis, cryptococcal meningitis, and dermatophyte infections, and is prescribed for adult, pediatric and immunocompromised patients as appropriate.

GNH India supplies Mycozal as a licensed, GDP‑compliant international pharmaceutical product, adhering to EU quality standards. The company provides the medicine to hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide, supporting global antifungal therapy programs through validated supply chains.

Manufacturer / TM Owner

Sapiens Pharmaceuticals Ltd

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Indications & Clinical Uses

Fluconazole is an azole antifungal indicated for several systemic and superficial fungal infections.

  • Candidiasis: Effective in treating oral, esophageal and vaginal candidiasis by eradicating susceptible Candida species.
  • Cryptococcal meningitis: Used as part of induction therapy to clear Cryptococcus neoformans from the central nervous system.
  • Dermatophyte infections: Controls skin and nail infections caused by Trichophyton, Microsporum and Epidermophyton species.
  • Systemic fungal infections: Provides therapy for disseminated infections such as candidemia and other invasive mycoses.

How It Works

  • Fluconazole inhibits the fungal cytochrome P450 enzyme 14α‑demethylase, a key step in ergosterol biosynthesis. By blocking conversion of lanosterol to ergosterol, the drug disrupts the fungal cell membrane, increasing permeability and leading to growth inhibition and cell death. Its high affinity for the enzyme and low affinity for human P450 isoforms underlies its selective antifungal activity. The inhibition is dose‑dependent and results in fungistatic effects at standard therapeutic concentrations.

Side Effects

Fluconazole may cause a range of adverse reactions, varying from mild to serious.

Common Side Effects

  • Nausea: mild stomach upset.
  • Headache: transient headache.
  • Diarrhea: loose stools.

Serious or Rare Side Effects

  • Hepatotoxicity: elevated liver enzymes or rare liver injury.
  • Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • Cardiac arrhythmia: QT prolongation leading to irregular heart rhythm.

Precautions & Warnings

When prescribing fluconazole, clinicians should consider several precautionary measures to ensure safe use.

  • Assess liver function: obtain baseline hepatic enzymes before initiating therapy.
  • Review concomitant medications: avoid drugs that strongly inhibit CYP2C9, CYP2C19 or CYP3A4.
  • Monitor renal function: dose adjustment may be needed in severe renal impairment.
  • Pregnancy and lactation: use only if benefits outweigh potential risks.
  • Avoid in patients with known hypersensitivity to azole antifungals.
  • Store at ambient temperature: keep below 25 °C in the original container, protected from moisture.

Avoid Interactions

Fluconazole interacts with several medicines through cytochrome P450 pathways, requiring careful management.

Major Interactions (Avoid)

  • CYP3A4 substrates such as certain statins (e.g., simvastatin) – risk of severe toxicity.
  • Warfarin – increased anticoagulant effect, may require INR monitoring.
  • Phenytoin – reduced phenytoin levels, risking loss of seizure control.

Moderate Interactions (Monitor Closely)

  • Oral hypoglycemics (e.g., sulfonylureas) – may enhance hypoglycemia.
  • Benzodiazepines metabolized by CYP3A4 – possible increased sedation.
  • Rifampin – may decrease fluconazole concentrations, reducing efficacy.

Frequently Asked Questions

Mycozal contains fluconazole, an azole antifungal indicated for a range of fungal infections. It is commonly prescribed for oral, esophageal and vaginal candidiasis, for cryptococcal meningitis, for dermatophyte infections of the skin and nails, and for systemic infections such as candidemia and other invasive mycoses. The specific indication depends on the patient’s diagnosis and the prescriber’s assessment.

Fluconazole inhibits the fungal enzyme 14α‑demethylase, a cytochrome P450 isoform that converts lanosterol to ergosterol, an essential component of the fungal cell membrane. By blocking this step, ergosterol synthesis is reduced, leading to defective membrane formation, increased permeability, and ultimately inhibition of fungal growth or cell death. Its selective affinity for the fungal enzyme provides antifungal activity with limited impact on human cells.

The dosage of Mycozal is determined by the prescribing clinician based on the infection being treated, the patient’s age, weight, renal and hepatic function, and any concomitant medications. Fluconazole dosing regimens vary widely, ranging from a single oral dose for uncomplicated candidiasis to daily doses for several weeks in systemic infections. Patients should follow the exact instructions provided by their healthcare professional.

Fluconazole is classified as a pregnancy‑category drug where safety depends on the dose and duration of therapy. Short courses for uncomplicated candidiasis are sometimes considered acceptable, while higher or prolonged doses may pose risks to the fetus. Breastfeeding mothers should discuss potential exposure with their physician, as fluconazole can be excreted in breast milk. The prescriber will weigh benefits against possible risks before recommending use.

To request Mycozal, visit the product page on gnhindia.com and submit an enquiry specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, and will ask for trade or institutional credentials to verify eligibility. After verification, the sales team provides pricing, availability, shipping details—including any temperature‑controlled handling if needed—and assists with import documentation.

Fluconazole, the active ingredient in Mycozal, belongs to the azole class and is distinguished by its oral bioavailability, relatively long half‑life, and activity against many Candida species and Cryptococcus. Compared with polyenes such as amphotericin B, fluconazole is less nephrotoxic and can be administered orally, but it has a narrower spectrum against molds. Clinicians select Mycozal when the infecting organism is known to be fluconazole‑susceptible and when oral therapy is preferred.

Mycozal should be stored at ambient temperature, preferably below 25 °C (77 °F). Keep the tablets in the original packaging to protect them from moisture and light, and store them out of reach of children. Do not refrigerate or freeze the product, as temperature extremes may affect tablet integrity.

Mycozal is taken orally, usually with a glass of water. The tablet can be swallowed whole and does not require food for absorption, although taking it with food may reduce gastrointestinal upset in some patients. The exact frequency and duration are prescribed by the treating physician based on the infection type and severity.

The most serious adverse reactions to fluconazole include hepatotoxicity, which may present as elevated liver enzymes or, rarely, severe liver injury; severe cutaneous reactions such as Stevens‑Johnson syndrome or toxic epidermal necrolysis; and cardiac effects like QT‑interval prolongation that can lead to arrhythmias. Patients should be monitored for signs of liver dysfunction, skin rash, or cardiac symptoms, and therapy should be discontinued if serious events occur.

Mycozal is contraindicated in individuals with a known hypersensitivity to fluconazole or other azole antifungals. Caution is also advised for patients with significant liver disease, uncontrolled cardiac arrhythmias, or those taking medications that strongly interact with fluconazole’s metabolic pathway. Pregnant women requiring high‑dose or prolonged therapy should avoid use unless the benefits clearly outweigh the risks.

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GNH India Pharmaceuticals Limited

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Last updated:

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