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 injection solution for intravenous use. It treats systemic fungal infections such as candidemia, invasive candidiasis, cryptococcal meningitis, and esophageal candidiasis in adult patients.

GNH India supplies Mycozal as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide. The product complies with European Union quality standards and is distributed under strict Good Distribution Practice to ensure potency and safety across global markets.

Manufacturer / TM Owner

Sapiens Pharmaceuticals Ltd

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Indications & Clinical Uses

Mycozal (fluconazole) is used to treat systemic fungal infections within the azole antifungal class.

  • Candidemia: eradicates bloodstream Candida species, reducing mortality in adult patients.
  • Invasive candidiasis: clears deep‑tissue Candida infections, including organ involvement.
  • Cryptococcal meningitis: penetrates the central nervous system to treat Cryptococcus neoformans meningitis.
  • Esophageal candidiasis: resolves mucosal Candida infection causing painful swallowing.

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 the fungal cell membrane, leading to increased membrane permeability and inhibition of fungal growth. This mechanism results in fungistatic activity against most Candida species and fungicidal effects at higher concentrations.

Side Effects

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

Common Side Effects

  • Nausea: mild gastrointestinal upset occurring in many patients.
  • Headache: transient cranial discomfort reported during therapy.
  • Abdominal pain: discomfort or cramping in the stomach region.
  • Rash: skin erythema or mild itching.
  • Elevated liver enzymes: transient increase in hepatic transaminases.
  • Fever: low‑grade temperature elevation without infection.

Serious or Rare Side Effects

  • Hepatotoxicity: severe liver injury requiring discontinuation.
  • Anaphylaxis: rapid, life‑threatening allergic reaction.
  • Stevens‑Johnson syndrome: severe skin and mucous membrane detachment.
  • Cardiac arrhythmia: QT prolongation leading to irregular heart rhythm.
  • Severe neutropenia: marked reduction in white blood cells.
  • Hepatic failure: acute liver failure with jaundice and coagulopathy.

Precautions & Warnings

Prior to initiating Mycozal, clinicians should evaluate several safety considerations to minimise risk.

  • Renal impairment: adjust dosing and monitor renal function closely.
  • Hepatic impairment: use with caution and observe liver enzyme trends.
  • Concomitant QT‑prolonging drugs: avoid or monitor cardiac rhythm.
  • Pregnancy: safety category unknown; weigh potential benefits against risks.
  • Pediatric use: limited data; prescribe only when clearly indicated.
  • Drug interactions: review concomitant medications for potential CYP interactions.
  • Store at 2‑8 °C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Fluconazole interacts with several medicines through cytochrome P450 inhibition or induction, requiring careful management.

Major Interactions (Avoid)

  • Warfarin: increased anticoagulant effect leading to bleeding risk.
  • Cisapride or terfenadine: heightened risk of life‑threatening QT prolongation.
  • Certain statins (e.g., simvastatin): elevated plasma levels causing myopathy.

Moderate Interactions (Monitor Closely)

  • Rifampin: induces metabolism, reducing fluconazole efficacy.
  • Phenytoin or carbamazepine: may lower fluconazole concentrations.
  • Oral hypoglycemics (e.g., sulfonylureas): enhanced hypoglycaemic effect.

Frequently Asked Questions

Mycozal is the brand name for an intravenous fluconazole injection indicated for the treatment of systemic fungal infections such as candidemia, invasive candidiasis, cryptococcal meningitis and esophageal candidiasis in adult patients.

Fluconazole blocks the fungal cytochrome P450 enzyme 14α‑demethylase, preventing ergosterol synthesis. This disrupts the fungal cell membrane, leading to inhibited growth and, at higher concentrations, fungal cell death.

The dose of Mycozal is determined by the prescribing clinician based on the type and severity of the infection, patient weight, renal and hepatic function, and other individual factors. No standard dose is provided here.

Fluconazole’s pregnancy category is unknown, and safety data are limited. It should be used only if the potential benefit justifies the potential risk to the fetus. Breastfeeding mothers should consult a healthcare professional before use.

To order 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 cold‑chain where required) and necessary import documentation.

Mycozal (fluconazole) belongs to the azole class and offers broad activity against Candida species and Cryptococcus. Compared with echinocandins, it is administered intravenously with a simpler dosing schedule but may have more drug‑interaction potential. Itraconazole provides similar coverage but is less commonly used intravenously.

Mycozal should be stored at 2‑8 °C in a refrigerator, protected from light, and must not be frozen or shaken. Keep the vial in its original packaging until use to maintain stability.

Mycozal is given as an intravenous infusion. The powder is reconstituted with the appropriate diluent, then diluted in compatible IV fluid and infused over the time period prescribed by the clinician, usually ranging from 30 minutes to several hours.

Serious risks include hepatotoxicity, severe allergic reactions such as anaphylaxis, Stevens‑Johnson syndrome, QT‑prolongation leading to cardiac arrhythmias, and profound neutropenia. Patients should be monitored for signs of liver dysfunction, skin reactions and cardiac abnormalities.

Mycozal is contraindicated in patients with known hypersensitivity to fluconazole or other azole antifungals. Caution is advised in individuals with severe liver disease, uncontrolled cardiac arrhythmias, or those taking medications that have major interactions with fluconazole.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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