Product image of Itraconazole/Kleva (Itraconazole) supplied by GNH India

Itraconazole/Kleva

Active Ingredient:
Itraconazole
Origin:
EU

Itraconazole/Kleva (Itraconazole)

Itraconazole, the active ingredient in Itraconazole/Kleva, is a triazole antifungal presented as an oral formulation for systemic and topical fungal infections. It is used to treat a range of mycotic diseases in adult patients, including skin, nail and deep organ infections caused by susceptible fungi. The drug is administered under medical supervision and requires appropriate diagnostic confirmation.

GNH India supplies Itraconazole/Kleva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. Our distribution network ensures reliable access to quality‑assured products across multiple regions.

Manufacturer / TM Owner

Kleva Pharmaceuticals

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Indications & Clinical Uses

Itraconazole is indicated for a variety of fungal infections affecting the skin, nails and internal organs.

  • Dermatophyte infections: effective in treating skin infections caused by dermatophyte fungi.
  • Onychomycosis: clears fungal nail disease and promotes regrowth of healthy nail tissue.
  • Blastomycosis: used to eradicate systemic Blastomyces dermatitidis infection.
  • Histoplasmosis: treats disseminated Histoplasma capsulatum disease.
  • Coccidioidomycosis: manages pulmonary and extrapulmonary Coccidioides infection.
  • Aspergillosis: employed in therapy of invasive Aspergillus species infections.

How It Works

  • Itraconazole inhibits the fungal cytochrome P450 enzyme lanosterol 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. The selective inhibition of the fungal pathway provides antifungal activity while sparing human cells.

Side Effects

Adverse reactions may occur with itraconazole therapy.

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Headache: transient cranial discomfort.
  • Abdominal pain: intermittent discomfort in the upper abdomen.
  • Rash: mild skin erythema or pruritus.

Serious or Rare Side Effects

  • Hepatotoxicity: elevated liver enzymes or hepatitis.
  • Severe allergic reactions: anaphylaxis, angioedema, or Stevens‑Johnson syndrome.
  • Cardiac failure: new or worsening congestive heart failure, especially in patients with pre‑existing cardiac disease.

Precautions & Warnings

Before initiating therapy, several safety considerations are recommended.

  • Liver function monitoring: assess hepatic enzymes before and during treatment.
  • Drug interactions: review concomitant medications for CYP3A4 substrates or inhibitors.
  • Cardiac assessment: avoid use in patients with known heart failure.
  • Pregnancy and lactation: prescribe only when benefits outweigh potential risks.
  • Store at ambient temperature: keep in the original container, protect from moisture and light.

Avoid Interactions

Itraconazole has a notable interaction profile that requires careful management.

Major Interactions (Avoid)

  • Rifampin: strong enzyme inducer that markedly reduces itraconazole plasma levels.
  • Ketoconazole: additive hepatotoxic potential when combined.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inhibitors (e.g., erythromycin): may increase itraconazole exposure, requiring dose adjustment.
  • Statins (e.g., simvastatin): increased risk of myopathy; consider alternative lipid‑lowering agents or dose modification.

Frequently Asked Questions

Itraconazole/Kleva is prescribed for a range of fungal infections, including dermatophyte skin infections, onychomycosis (fungal nail disease), and systemic mycoses such as blastomycosis, histoplasmosis, coccidioidomycosis, and invasive aspergillosis. The drug targets susceptible fungi and is used in adult patients when a confirmed fungal diagnosis is present.

Itraconazole blocks the fungal enzyme lanosterol 14α‑demethylase, which is essential for converting lanosterol to ergosterol, a critical component of the fungal cell membrane. Inhibiting this step disrupts membrane integrity, leading to impaired fungal growth and eventual cell death, while sparing human cells because the target enzyme is fungal‑specific.

The dosage of Itraconazole/Kleva is determined by the prescribing clinician based on the specific infection, severity, patient weight, renal and hepatic function, and other individual factors. Healthcare professionals follow established guidelines and adjust the regimen as needed; patients should follow the prescriber’s instructions precisely.

Safety data for itraconazole in pregnancy and lactation are limited, and the drug is generally classified as contraindicated unless the potential benefit justifies the risk. Women who are pregnant, planning pregnancy, or breastfeeding should discuss alternatives and risk assessment with their healthcare provider before starting therapy.

To request Itraconazole/Kleva, visit the product page on gnhindia.com, enter the desired quantity, and submit the enquiry form. 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 triazole class and offers broader spectrum activity against dermatophytes and many systemic fungi compared with fluconazole, which is less effective for certain molds and dimorphic fungi. Itraconazole also has a longer half‑life, allowing once‑daily dosing for many indications, but it carries a higher potential for drug‑drug interactions due to CYP3A4 inhibition.

Store Itraconazole/Kleva at ambient temperature, preferably below 25 °C. Keep the product in its original packaging, protect it from moisture, excessive heat, and direct sunlight. Do not refrigerate or freeze the tablets or capsules, as this could affect their stability and efficacy.

Itraconazole/Kleva is taken orally, usually with food or a full glass of water to enhance absorption. The exact administration instructions, such as whether to take it with a high‑fat meal, depend on the formulation and the prescriber’s guidance. Patients should swallow tablets or capsules whole and avoid crushing them unless directed otherwise.

Serious adverse events include hepatotoxicity, which may present as elevated liver enzymes or hepatitis, and severe allergic reactions such as anaphylaxis or Stevens‑Johnson syndrome. Cardiac failure can also occur, particularly in patients with pre‑existing heart disease. Prompt medical attention is required if any signs of liver injury, severe rash, or breathing difficulties develop.

Itraconazole/Kleva is contraindicated in patients with known hypersensitivity to itraconazole or any triazole antifungal. It should also be avoided in individuals with uncontrolled congestive heart failure, severe liver impairment, or those taking medications that strongly induce CYP3A4 (e.g., rifampin) without appropriate dose adjustments. Clinicians must evaluate each patient’s medical history before prescribing.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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