Product image of Mycosyst (Fluconazole) supplied by GNH India

Mycosyst

Active Ingredient:
Fluconazole
Origin:
EU

Mycosyst (Fluconazole)

Fluconazole, the active ingredient in Mycosyst, is an azole antifungal presented as an oral dosage form for systemic use. It treats a range of fungal infections, including candidiasis, cryptococcal meningitis and other systemic mycoses, in adult and pediatric patients as prescribed by a healthcare professional.

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

Manufacturer / TM Owner

Gedeon Richter Polska Sp. Z. O.O.

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Indications & Clinical Uses

Fluconazole acts on a broad spectrum of fungal pathogens, making Mycosyst suitable for several serious infections.

  • Candidiasis: effective for oral, esophageal, vaginal and systemic infections caused by Candida species.
  • Cryptococcal meningitis: used in induction and consolidation therapy for central nervous system infection.
  • Systemic fungal infections: treats invasive infections such as blastomycosis, histoplasmosis and coccidioidomycosis when other agents are unsuitable.

How It Works

  • Fluconazole inhibits the fungal cytochrome P450 enzyme 14α‑demethylase, a key step in ergosterol synthesis. By blocking this enzyme, the drug disrupts the formation of ergosterol, an essential component of the fungal cell membrane, leading to increased membrane permeability and ultimately fungal cell death or growth inhibition.

Side Effects

Fluconazole may cause a range of adverse reactions, most of which are mild and reversible.

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Headache: transient cranial discomfort.
  • Abdominal pain: cramping or discomfort in the abdomen.
  • Diarrhea: loose stools.
  • Rash: skin redness or itching.
  • Elevated liver enzymes: mild hepatic enzyme changes.

Serious or Rare Side Effects

  • Hepatotoxicity: severe liver injury requiring monitoring.
  • Stevens‑Johnson syndrome or toxic epidermal necrolysis: severe skin reactions.
  • Anaphylaxis: rare but life‑threatening allergic response.
  • QT interval prolongation: potential cardiac rhythm disturbance.
  • Severe neutropenia: marked reduction in white blood cells.
  • Hepatic failure: rare but critical liver dysfunction.

Precautions & Warnings

Before initiating therapy with Mycosyst, consider the following safety measures.

  • Assess liver function: obtain baseline liver enzymes and monitor periodically.
  • Review concomitant medications: identify potential drug‑drug interactions.
  • Evaluate renal function: dose adjustment may be needed in severe impairment.
  • Pregnancy and lactation: use only if benefits outweigh potential risks, as data are limited.
  • Known hypersensitivity: avoid in patients with documented allergy to fluconazole or other azoles.
  • Store at ambient temperature: keep in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Fluconazole can alter the plasma concentrations of several co‑administered drugs.

Major Interactions (Avoid)

  • Rifampin: induces metabolism, markedly reducing fluconazole exposure.
  • Terbinafine: combined use increases risk of hepatotoxicity.
  • Certain azole combinations: additive toxicity may occur.

Moderate Interactions (Monitor Closely)

  • Warfarin: fluconazole may increase INR, requiring dose adjustment.
  • Phenytoin: may decrease fluconazole levels, reducing efficacy.
  • Oral contraceptives: possible reduction in contraceptive effectiveness.
  • Cyclosporine or tacrolimus: may increase levels, necessitating monitoring.
  • Statins (e.g., simvastatin): increased risk of myopathy, monitor for muscle symptoms.

Frequently Asked Questions

Mycosyst, containing fluconazole, is prescribed for infections caused by susceptible fungi, including various forms of candidiasis, cryptococcal meningitis, and other systemic fungal infections such as blastomycosis, histoplasmosis and coccidioidomycosis when indicated by a healthcare professional.

Fluconazole inhibits the fungal enzyme 14α‑demethylase, which is essential for converting lanosterol to ergosterol. This disruption impairs the synthesis of ergosterol, a critical component of the fungal cell membrane, leading to increased membrane permeability and inhibition of fungal growth or death.

The dosage of Mycosyst is determined by the prescribing clinician based on the specific infection, severity, patient age, weight, renal and hepatic function, and other individual factors. Patients should follow the exact regimen provided by their healthcare provider.

Safety data for fluconazole in pregnancy are limited, and the drug is classified as pregnancy category unknown. It should be used only if the potential benefit justifies the potential risk to the fetus. Breastfeeding mothers should consult their physician, as fluconazole is excreted in breast milk.

To place an order, submit an enquiry on the Mycosyst 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 and any necessary import documentation.

Mycosyst (fluconazole) belongs to the azole class and offers oral administration with good bioavailability, making it convenient for many infections. Compared with other azoles, it has a relatively favorable safety profile and fewer drug‑interaction concerns than some newer agents, though selection depends on the pathogen, infection site and patient-specific factors.

Store Mycosyst at ambient temperature, below 25 °C. Keep the tablets in the original packaging, protect them from moisture, heat and direct sunlight to maintain potency and stability throughout the shelf life.

Mycosyst is taken orally, usually with a glass of water. The tablet should be swallowed whole and not chewed or crushed unless specifically instructed by a healthcare professional. Dosing frequency and duration are set by the prescriber based on the infection being treated.

Serious adverse events, though rare, include severe liver injury (hepatotoxicity), life‑threatening skin reactions such as Stevens‑Johnson syndrome or toxic epidermal necrolysis, anaphylactic reactions, and cardiac QT interval prolongation. Patients should seek immediate medical attention if they experience symptoms such as jaundice, rash, fever, or palpitations.

Mycosyst should be avoided in individuals with known hypersensitivity to fluconazole or other azole antifungals. Caution is advised for patients with severe liver disease, significant renal impairment, or those taking medications that have major interactions with fluconazole. The prescribing clinician will assess suitability for each patient.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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