Product image of Oronazol (Ketoconazole) supplied by GNH India

Oronazol

Active Ingredient:
Ketoconazole
Origin:
EU

Oronazol (Ketoconazole)

Ketoconazole, the active ingredient in Oronazol, is an antifungal presented as an oral dosage form for systemic use. It treats fungal infections of the skin, nails and mucous membranes in adult patients.
GNH India supplies Oronazol as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and pharmacies worldwide.

Manufacturer / TM Owner

Stada D.O.O.

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Indications & Clinical Uses

Ketoconazole is an azole antifungal that targets fungal infections of the skin and mucous membranes.

  • Dermatophyte infections: reduces fungal growth on skin and nails, improving lesions.
  • Seborrheic dermatitis: alleviates scaling, redness and itching of affected areas.
  • Pityriasis versicolor: clears pigmentary changes caused by Malassezia species.
  • Candidiasis: treats oral and esophageal candidiasis, relieving discomfort and infection.

How It Works

  • Ketoconazole inhibits the fungal enzyme lanosterol 14α‑demethylase, a cytochrome P450 isoform essential for ergosterol synthesis. By blocking ergosterol production, the drug disrupts fungal cell membrane integrity, leading to impaired growth and cell death of susceptible yeasts and dermatophytes.

Side Effects

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

Common Side Effects

  • Nausea: occasional stomach upset after oral intake.
  • Abdominal pain: mild discomfort in the gastrointestinal tract.
  • Headache: transient cranial pain.
  • Rash: skin redness or itching.

Serious or Rare Side Effects

  • Hepatotoxicity: elevated liver enzymes or liver injury requiring monitoring.
  • Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • Adrenal insufficiency: suppression of steroid synthesis with prolonged use.

Precautions & Warnings

Ketoconazole should be used with careful clinical oversight.

  • Liver function monitoring: assess baseline and periodic liver enzymes.
  • Drug interactions: review concomitant medications, especially CYP3A4 substrates and inhibitors.
  • Pregnancy: avoid unless benefits outweigh potential fetal risk.
  • Breastfeeding: contraindicated due to excretion in milk.
  • Renal impairment: use with caution and adjust if necessary.
  • Store at ambient temperature: keep in original container, protect from moisture.

Avoid Interactions

Ketoconazole can alter the plasma levels of several co‑administered drugs.

Major Interactions (Avoid)

  • CYP3A4 inhibitors (e.g., clarithromycin, itraconazole): may increase ketoconazole concentrations and toxicity.
  • CYP3A4 inducers (e.g., rifampicin, phenytoin): may reduce antifungal efficacy.

Moderate Interactions (Monitor Closely)

  • Warfarin: ketoconazole may potentiate anticoagulant effect, requiring INR monitoring.
  • Statins: increased risk of myopathy when combined with certain statins.
  • Oral contraceptives: reduced hormonal effectiveness, consider alternative contraception.

Frequently Asked Questions

Oronazol contains ketoconazole, an azole antifungal indicated for treating dermatophyte skin infections, seborrheic dermatitis, pityriasis versicolor and oral or esophageal candidiasis. It works by eliminating the fungal organisms responsible for these conditions, helping to clear lesions, reduce itching and restore normal skin or mucosal appearance.

Ketoconazole blocks the fungal enzyme lanosterol 14α‑demethylase, a key step in ergosterol synthesis. Without ergosterol, the fungal cell membrane becomes unstable, inhibiting growth and leading to cell death. This mechanism is effective against a broad range of yeasts and dermatophytes.

The dosage of Oronazol is determined by the prescribing clinician based on the specific infection, patient age, weight and renal or hepatic function. Physicians tailor the regimen to achieve optimal therapeutic effect while minimizing risk, and patients should follow the prescribed instructions exactly.

Ketoconazole is generally contraindicated during pregnancy and lactation because of potential teratogenic effects and drug transfer into breast milk. It should only be used if the expected benefit justifies the possible risk to the fetus or infant, and alternative therapies are preferred when possible.

To order Oronazol, 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 needs) and required import documentation.

Ketoconazole offers a broad spectrum against dermatophytes and yeasts, similar to other azoles such as clotrimazole or fluconazole. Compared with topical agents, oral ketoconazole provides systemic coverage for extensive or resistant infections, but it carries a higher risk of hepatic and endocrine side effects, requiring careful monitoring.

Oronazol should be stored at ambient temperature, below 25 °C, in its original packaging to protect it from moisture and light. Keep the product out of reach of children and avoid storing it in bathrooms or other humid environments.

Oronazol is taken orally, usually with a full glass of water. It may be recommended to ingest the medication with food to reduce gastrointestinal irritation, but patients should follow the specific instructions provided by their healthcare professional.

The most serious adverse effects of ketoconazole include hepatotoxicity, which can manifest as elevated liver enzymes or severe liver injury, and rare but severe skin reactions such as Stevens‑Johnson syndrome. Long‑term use may also suppress adrenal steroid synthesis, leading to adrenal insufficiency.

Oronazol is contraindicated in patients with known hypersensitivity to ketoconazole or other azole antifungals, those with pre‑existing severe liver disease, pregnant or breastfeeding women, and individuals taking medications that strongly interact via the CYP3A4 pathway without appropriate monitoring.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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