Nizoral (Ketoconazole)

$ 124.52$ 260.36

Category: Antifungal
Commercial name: Nizoral
Active ingredient: Ketoconazole
Production form: Pills
Available dosage: 200 mg

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Nizoral (Ketokonazol). Dosage, Side Effects, Interactions

NIZORAL is a synthetic broad spectrum antifungal available in white tablets, each containing 200 mg of ketoconazole base for oral administration. Inactive ingredients are colloidal silicon dioxide, cornstarch, lactose, magnesium stearate, microcrystalline cellulose and povidone. Ketoconazole is cis -1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxyl]phenyl ] piperazine

Ketoconazole is a white to slightly beige, odorless powder that is soluble in acids and has a molecular weight of 531.44.


NIZORAL tablets should only be used when other effective antifungal therapy is unavailable or not tolerated and the potential benefits outweigh the potential risks.

NIZORAL (ketoconazole) tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or are intolerant of other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. NIZORAL tablets should not be used in fungal meningitis as they penetrate poorly into the cerebrospinal fluid.



Before starting ketoconazole therapy, both laboratory and clinical documentation of the infection should be available. The usual duration of therapy for systemic infections is 6 months. Treatment should be continued until the active fungal infection has resolved.


The recommended starting dose of NIZORAL (ketoconazole) tablets is a daily administration of 200 mg (one tablet). If the clinical response is insufficient within the expected time, the dose of NIZORAL tablets can be increased to 400 mg (two tablets) once daily.


A single daily dose of 3.3 to 6.6 mg/kg has been used in a small number of children over the age of 2 years. NIZORAL tablets have not been studied in children under 2 years of age.


Because clinical trials are conducted under a wide variety of conditions, the adverse reaction rates observed in clinical trials of one drug cannot be directly compared to rates observed in clinical trials of another drug and may not reflect rates observed in practice.

The following side effects have been reported in clinical studies:

Immune system disorders: anaphylactoid reaction

Endocrine disorders: gynecomastia

Metabolism and nutrition disorders: alcohol intolerance, anorexia, hyperlipidemia, increased appetite

Mental disorders: insomnia, nervousness

Nervous system disorders: headache, dizziness, paresthesia, drowsiness

Eye disorders: photophobia

Vascular disorders: orthostatic hypotension

Respiratory, thoracic and mediastinal disorders: epistaxis

Gastrointestinal disorders: vomiting, diarrhea, nausea, constipation, abdominal pain, abdominal pain above, dry mouth, dysgeusia, dyspepsia, flatulence, tongue discoloration

Hepatobiliary disorders: hepatitis, jaundice, liver function abnormal

Skin and subcutaneous tissue disorders: erythema multiforme, rash, dermatitis, erythema, urticaria, pruritus, alopecia, xeroderma


Musculoskeletal and connective tissue disorders: myalgia

Reproductive System and Breast Disorders: Menstrual Disorder

General Disorders and Administrative Site Conditions: Asthenia, Fatigue, Flushing, Malaise, Peripheral Edema, Pyrexia, Chills Investigations: Platelet count decreased.

Post Marketing Experience

The following side effects have been identified during post-marketing use of Nizoral tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure.

The following side effects have been reported during post-marketing experience:


Blood and lymphatic system disorders: thrombocytopenia

Immune system disorders: allergic conditions including anaphylactic shock, anaphylactic reaction, angioneurotic edema

Endocrine disorders: adrenal insufficiency

Nervous system disorders: Reversible intracranial pressure increased (e.g. papilloedema, fontanelle bulging in infants).

Hepato-biliary disorders: serious hepatotoxicity including cholestatic hepatitis, biopsy-confirmed hepatic necrosis, cirrhosis, hepatic failure including cases leading to transplantation or death

Skin and subcutaneous tissue disorders: acute generalized exanthematous pustulosis, photosensitivity

Musculoskeletal and connective tissue disorders: Arthralgia

Reproductive system and breast disorders: erectile dysfunction; with doses higher than the recommended therapeutic dose of 200 or 400 mg daily, azoospermia.

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Additional information


200 mg


30, 60, 90, 120, 180


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