Nizral

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Remaining narrow indications

Nizral (ketoconazole 200 mg, Cipla) in oral form is now used only when other antifungal agents are not tolerated or are contraindicated, or in specific indications where it remains evidence-based:

• Endemic mycoses — blastomycosis, paracoccidioidomycosis, histoplasmosis, chromoblastomycosis — where amphotericin B or itraconazole have failed or are not available.
• Cushing’s syndrome — second-line cortisol-lowering agent (off-label, hospital-initiated, monitored).
• Recalcitrant pityriasis versicolor that has failed topical and oral fluconazole / itraconazole.

Dose & monitoring

Monitoring is non-negotiable:

• Baseline LFTs, then every 2 weeks for first 2 months, then monthly.
• Discontinue immediately if AST/ALT > 3× ULN OR jaundice, dark urine, or persistent nausea.
• Baseline ECG; repeat if QT-prolonging drugs co-prescribed.
• For Cushing’s use: morning cortisol, urinary free cortisol, and ACTH stim if symptoms suggestive of adrenal insufficiency.

Как се приема

Take with a meal — gastric acid is required for capsule dissolution and absorption. Avoid concurrent PPIs / H2-blockers / antacids unless separated by ≥ 2 hours.

Как работи

Ketoconazole inhibits fungal CYP51 (lanosterol 14-α-demethylase) — the same target as fluconazole and itraconazole. It is less selective than the newer triazoles, also inhibiting human steroidogenesis enzymes (CYP17, CYP11B1, CYP11B2) — the basis both for Cushing’s use and for adrenal insufficiency as a side effect.

Странични ефекти

Взаимодействия с лекарства

Ketoconazole is among the most potent CYP3A4 inhibitors known — it raises levels of any drug metabolised by CYP3A4. Selected major interactions:

Противопоказания

• Acute or chronic liver disease.
• Concurrent QT-prolonging drugs above.
• Concurrent simvastatin / atorvastatin / lovastatin / triazolam / midazolam (oral) / ergot alkaloids.
• Бременност и кърмене.
• Hypersensitivity to azoles.

Често задавани въпроси

Why is oral ketoconazole ‘restricted’?

FDA, EMA, MHRA, and Health Canada concluded between 2013 and 2014 that fatal hepatotoxicity made oral ketoconazole unsuitable for routine fungal infections when safer alternatives exist (fluconazole, itraconazole, terbinafine). Topical ketoconazole shampoo / cream is unaffected — it is poorly absorbed.

Should I be on this for athlete’s foot or thrush?

Almost certainly not. Standard care for vaginal candidiasis is fluconazole 150 mg single dose; for tinea pedis a 4-week topical antifungal or oral terbinafine; for oral thrush fluconazole or itraconazole oral solution. Discuss switching with your clinician.

Is topical ketoconazole still safe?

Yes — ketoconazole shampoo (for seborrhoeic dermatitis, dandruff) and cream / lotion (for tinea, candidiasis, pityriasis versicolor) are not affected by these regulatory restrictions. Topical absorption is minimal.

What does ketoconazole do to my hormones?

It inhibits adrenal cortisol synthesis (this is why it’s used off-label for Cushing’s) and testicular testosterone synthesis. Chronic high-dose oral therapy can cause adrenal insufficiency, gynaecomastia in men, oligospermia, loss of libido, and menstrual irregularity in women.

What are the symptoms of liver damage?

Yellowing of skin or eyes, dark urine, pale stools, persistent nausea, right-upper-quadrant pain, severe fatigue, confusion. Stop the drug immediately and seek medical advice. Hepatotoxicity can be sudden and fatal — early recognition matters.

What if I have already finished a short course of ketoconazole?

If you completed a short course (e.g. 1–2 weeks for blastomycosis or refractory pityriasis versicolor) without symptoms, you are unlikely to develop delayed hepatotoxicity now. If you have any symptoms (jaundice, dark urine), seek medical advice. Future fungal infections — discuss safer alternatives.

Why is ketoconazole sometimes still used for Cushing’s syndrome?

Because it inhibits adrenal cortisol synthesis. In Cushing’s, this is the desired effect — to lower an excess. Specialist endocrinology supervision; metyrapone, mifepristone, osilodrostat, or bilateral adrenalectomy are alternatives.

Can ketoconazole be used in cancer (prostate, etc.)?

Historically used at high doses (1200 mg/day) to suppress testicular and adrenal androgen synthesis in advanced prostate cancer. Now largely replaced by abiraterone, enzalutamide, etc. Not first-line oncology therapy.

Is Nizral the same as Nizoral?

Yes — Nizoral is the original Janssen brand of ketoconazole. Nizral is the same active ingredient, manufactured by Cipla under WHO-GMP. The regulatory restrictions apply equally to all brands of oral ketoconazole.

What antifungal should I be on instead?

Depends on the infection. Vaginal candidiasis → fluconazole 150 mg single dose. Oral thrush → fluconazole 100 mg/day × 7 days. Tinea pedis / cruris → topical terbinafine cream × 1–4 weeks. Onychomycosis → oral terbinafine 250 mg/day × 6 weeks (fingernails) or 12 weeks (toenails). Pityriasis versicolor → topical ketoconazole shampoo or oral fluconazole.

Съхранение

Store tablets at 15–25 °C, away from moisture and light. Do not use after expiry. Keep out of reach of children.

Други противогъбични лекарства, които може да ви интересуват

Oral ketoconazole is no longer first-line for routine fungal infections. Listed below are recommended alternatives for the common indications.

• Zocon (флуконазол 150 mg) — Oral first-line for Candida — safer than oral ketoconazole.
• Zimig (terbinafine 250 mg) — First-line oral for dermatophyte nail / scalp / extensive skin.
• Sporanox (itraconazole 100 mg) — For non-dermatophyte moulds, dimorphic mycoses, mixed Candida.
• Keto Cream (ketoconazole 2%) — Topical ketoconazole — safe even though oral is restricted.
• Clocip (клотримазол 1% крем) — Topical broad-spectrum antifungal.

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