In the pharmaceutical industry, Ketoconazole 200 mg is a broad-spectrum imidazole antifungal agent. As a pharmacist, I classify this as a secondary systemic option; while it was once a frontline treatment, it is now primarily reserved for specific fungal infections when other therapies (like Fluconazole or Itraconazole) are not available or tolerated, due to its potent effect on the cytochrome P450 enzyme system.

Primary Clinical Uses

• Systemic Mycoses: Treatment of serious fungal infections such as Blastomycosis, Coccidioidomycosis, Histoplasmosis, and Paracoccidioidomycosis.

• Severe Cutaneous Infections: Used for extensive tinea infections (ringworm, athlete’s foot) or recalcitrant cases of Pityriasis versicolor that do not respond to topical creams or other oral antifungals.

• Chronic Mucocutaneous Candidiasis: Indicated for severe yeast infections of the skin and mucous membranes.

• Cushing’s Syndrome (Off-label): In specialized endocrinology, it is used to inhibit the production of cortisol in the adrenal glands.

Mechanism of Action: Sterol Synthesis Inhibition

Ketoconazole works by disrupting the structural integrity of the fungal cell membrane.

Enzyme Inhibition: It inhibits the fungal enzyme lanosterol 14-$\alpha$-demethylase.

Ergosterol Depletion: This enzyme is essential for converting lanosterol into ergosterol, which is the fungal equivalent of cholesterol.

Lysis: Without ergosterol, the fungal cell membrane becomes “leaky” and fragile, leading to the death of the fungal cell.

The Manufacturer’s Perspective: Formulation & Export

From a manufacturing and global trade standpoint, Ketoconazole 200 mg is a technically sensitive product:

• Acid-Dependent Absorption: Ketoconazole requires an acidic stomach environment for optimal dissolution. As a WHO-GMP manufacturer, we advise that the tablets should not be taken with antacids or $H_2$-blockers, as this can lead to therapeutic failure.

• Hepatotoxicity & Safety Monitoring: Due to the risk of liver injury, as a firm owner, you must ensure your Product Information Leaflets (PIL) and dossiers emphasize the need for liver function tests (LFTs) before and during treatment.

• Stability for Global Trade: Ketoconazole is relatively stable but sensitive to high humidity. We utilize Alu-Alu or high-grade PVC/PVDC blister packaging to ensure a 36-month shelf life for export to Zone IVb regions (Africa, SE Asia, and Latin America).

• B2B & Dossier Support: We provide comprehensive CTD/eCTD Dossiers to support our B2B partners in international registration against the innovator (Nizoral).