Nyoxep (Ketoconazole)

Ketoconazole is an azole antifungal that interferes with fungal cell membrane synthesis, making it useful for several dermatologic and systemic mycotic conditions.

• Seborrheic dermatitis: reduces scaling and inflammation on the scalp and face.
• Tinea corporis (ringworm): clears skin lesions caused by dermatophytes.
• Onychomycosis: improves nail appearance by eradicating fungal infection.
• Candidiasis (systemic): used as part of combination therapy for serious Candida infections.
• Histoplasmosis: contributes to treatment of this systemic fungal disease.

• Ketoconazole inhibits the fungal cytochrome P450 enzyme lanosterol 14α‑demethylase, blocking the conversion of lanosterol to ergosterol. This disruption impairs fungal cell membrane integrity, leading to increased permeability and ultimately cell death. The drug’s activity is selective for fungal enzymes, providing a therapeutic window between human and fungal cells.

Ketoconazole may cause a range of adverse reactions, from mild to severe, depending on the formulation and patient factors.

Common Side Effects

• Nausea and vomiting: mild gastrointestinal upset.
• Abdominal pain: discomfort in the stomach area.
• Headache: mild to moderate head pain.
• Elevated liver enzymes: mild, transient increase in hepatic markers.
• Rash: mild skin irritation or redness.
• Pruritus: itching without rash.

Serious or Rare Side Effects

• Hepatotoxicity: significant liver injury, potentially leading to jaundice.
• Adrenal insufficiency: suppression of cortisol production.
• Severe allergic reaction: anaphylaxis or angioedema.
• QT prolongation: cardiac rhythm disturbance.
• Thrombocytopenia: reduced platelet count.
• Stevens‑Johnson syndrome: severe skin and mucous membrane disorder.

Ketoconazole should be used with careful clinical assessment and monitoring, especially in patients with pre‑existing conditions.

• Liver function monitoring: perform baseline and periodic liver enzyme tests.
• Drug interaction review: assess concomitant medications for CYP3A4 interactions.\n- Pregnancy and lactation: avoid unless benefits outweigh risks.
• Renal impairment: adjust use in severe kidney disease.
• Avoid in patients with known hypersensitivity to azole antifungals.
• Store at below 25°C: keep in the original container, protect from moisture and direct sunlight.

Ketoconazole interacts with several medicines through inhibition of cytochrome P450 enzymes, requiring attention to avoid adverse events.

Major Interactions (Avoid)

• Simvastatin: increased risk of myopathy and rhabdomyolysis.
• Midazolam: enhanced sedation and respiratory depression.
• Cis‑cis‑dichlorodiamine platinum (Cisplatin): heightened nephrotoxicity.

Moderate Interactions (Monitor Closely)

• Warfarin: potential alteration of INR values.
• Oral contraceptives: reduced efficacy, risk of unintended pregnancy.
• Phenytoin: decreased ketoconazole levels, reduced antifungal effect.