Product image of Itraconazol Germed (Itraconazole) supplied by GNH India

Itraconazol Germed

Active Ingredient:
Itraconazole
Origin:
EU

Itraconazol Germed (Itraconazole)

Itraconazole, the active ingredient in Itraconazol Germed, is an azole antifungal presented as an oral tablet for oral use. It treats a range of fungal infections including skin, nail and systemic mycoses in adult patients.

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

Manufacturer / TM Owner

Omnicals Pharma, Unipessoal Lda

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Indications & Clinical Uses

Itraconazole is used to treat fungal infections that affect the skin, nails and internal organs.

  • Dermatophytosis: eradicates dermatophyte fungi causing ringworm and related skin lesions.
  • Onychomycosis: clears fungal infection of the toenails and fingernails.
  • Blastomycosis: treats systemic infection caused by Blastomyces dermatitidis.
  • Histoplasmosis: combats disseminated disease due to Histoplasma capsulatum.
  • Aspergillosis: manages invasive disease caused by Aspergillus species.
  • Other systemic mycoses: effective against a broad spectrum of deep fungal infections.

How It Works

  • Itraconazole inhibits the fungal cytochrome P450 enzyme lanosterol 14α‑demethylase, preventing conversion of 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.

Side Effects

Common side effects are generally mild and may resolve without intervention.

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Headache: transient cranial discomfort.
  • Abdominal pain: intermittent discomfort in the abdomen.
  • Diarrhea: loose stools occurring occasionally.
  • Rash: mild skin erythema or itching.
  • Elevated liver enzymes: transient increase in hepatic transaminases.

Serious or Rare Side Effects

  • Hepatotoxicity: severe liver injury requiring monitoring.
  • Congestive heart failure: fluid retention and reduced cardiac function.
  • Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • Visual disturbances: blurred vision or photophobia.
  • Severe hypotension: sudden drop in blood pressure.
  • Anaphylaxis: rare systemic allergic reaction.

Precautions & Warnings

Before initiating therapy, consider the following precautions.

  • Liver function: assess baseline hepatic enzymes and monitor periodically.
  • Cardiac status: avoid in patients with existing heart failure.
  • Drug interactions: review concomitant medications for potential CYP3A4 interactions.
  • Pregnancy and lactation: use only if potential benefit outweighs risk, as safety data are limited.
  • Renal impairment: adjust dosing in severe renal dysfunction as advised by prescriber.
  • Store at ambient temperature: keep below 25 °C, retain in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Itraconazole has a notable interaction profile that requires careful management.

Major Interactions (Avoid)

  • Rifampin: induces CYP3A4, markedly reducing itraconazole exposure.
  • St. John’s wort: strong CYP3A4 inducer, decreases therapeutic levels.
  • Certain antiretrovirals (e.g., protease inhibitors): may cause toxic accumulation.
  • Ketoconazole: concurrent use increases risk of hepatotoxicity.
  • Certain statins (e.g., simvastatin, lovastatin): heightened risk of myopathy.

Moderate Interactions (Monitor Closely)

  • Warfarin: may enhance anticoagulant effect, monitor INR.
  • Phenytoin: may lower itraconazole concentrations.
  • Midazolam: increased sedation, adjust dose as needed.
  • Calcium channel blockers (e.g., verapamil): monitor for hypotension.
  • Digoxin: potential increase in serum levels, observe cardiac function.

Frequently Asked Questions

Itraconazol Germed contains itraconazole, which is prescribed for fungal infections such as dermatophytosis (ringworm), onychomycosis (nail fungus), blastomycosis, histoplasmosis, aspergillosis and other systemic mycoses. The drug targets the underlying fungus, helping to clear the infection in affected tissues.

Itraconazole blocks the fungal enzyme lanosterol 14α‑demethylase, a key step in ergosterol synthesis. By preventing ergosterol formation, the drug disrupts the fungal cell membrane, leading to increased permeability and inhibition of fungal growth and replication.

The specific dose of Itraconazol Germed 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. Patients should follow the exact regimen provided by their healthcare professional.

Safety data for itraconazole in pregnancy and lactation are limited, and the product is classified as pregnancy category unknown. It should only be used when the potential benefit justifies the potential risk to the fetus or infant, and the decision must be made by a qualified healthcare provider.

To place an order, 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 requirements) and necessary import documentation.

Itraconazole belongs to the azole class and offers broad‑spectrum activity against many dermatophytes and systemic fungi. Compared with older azoles like fluconazole, itraconazole has a wider spectrum that includes molds such as Aspergillus, but it may have a higher potential for drug‑drug interactions due to CYP3A4 inhibition.

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

Itraconazol Germed is taken orally, usually with food to improve absorption. The tablets should be swallowed whole with a full glass of water and not chewed or crushed, unless otherwise directed by a healthcare professional.

Serious risks include hepatotoxicity, congestive heart failure, severe skin reactions such as Stevens‑Johnson syndrome, visual disturbances, and rare cases of anaphylaxis. Patients should be monitored for signs of liver dysfunction, cardiac symptoms, and any unusual skin or visual changes.

Itraconazol Germed should be avoided in patients with known hypersensitivity to itraconazole or any azole antifungal, those with uncontrolled heart failure, and individuals taking contraindicated medications that strongly induce or inhibit CYP3A4 without appropriate monitoring.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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