Registered Tanzania · TMDA

KENIZA

ketokonazole 2 %w/w

TAN 24 HM 0506 Cream Ketoconazole 2%w/w

What it does

Ketoconazole is an antifungal medication used to treat fungal infections on the skin and in the body.

Commonly used for: fungal skin infections, dandruff, ringworm (tinea), systemic fungal infections

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
TAN 24 HM 0506
Registration date
2024-12-17
Expiry date
2029-12-16
Status
Registered/Compliant
Active ingredient
ketokonazole 2 %w/w
Dosage form
Cream
Strength
Ketoconazole 2%w/w
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Uniza Lifecare
Applicant / LTR
UNIZA LIFECARE PVT LTD
Country of origin
INDIA
Manufacturer location
Kadi - Detroj Rd, Balasar, Gujarat 384440, India

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:41:56 · updated 2026-09-17 03:00:43

Disclaimer: This information is sourced from Tanzania Medicines and Medical Devices Authority (Tanzania). Always consult a qualified healthcare professional before using any medication.

About this medicine

Ketoconazole is an antifungal medication used to treat fungal infections on the skin and in the body.

What it treats

  • fungal skin infections
  • dandruff
  • ringworm (tinea)
  • systemic fungal infections

How it works

Ketoconazole works by stopping the growth of fungi, helping to eliminate the infection.

Who it's for

Ketoconazole is for people who have fungal infections affecting their skin or other areas of the body.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: ketokonazole

Ketoconazole is an antifungal agent belonging to the imidazole class, primarily used in the treatment of fungal infections. It works by inhibiting the synthesis of ergosterol, an essential component of fungal cell membranes, leading to cell death. Ketoconazole is effective against a range of dermatophyte infections, candidiasis, and certain systemic fungal infections.

Indications

  • Dermatophyte infections
  • Candidiasis
  • Systemic fungal infections
  • Tinea (ringworm)
  • Seborrheic dermatitis
  • Histoplasmosis

Dosage

Children: Refer to the BNF for Children for appropriate dosing in paediatric populations.

Adults: Refer to the BNF for specific dosing guidance, as doses may vary based on the indication and severity of infection.

Mechanism of action

Ketoconazole exerts its antifungal effects by inhibiting the enzyme 14-alpha-demethylase, which is involved in the biosynthesis of ergosterol. This inhibition disrupts cell membrane integrity and function, ultimately resulting in fungal cell death. Additionally, ketoconazole shows anti-inflammatory properties by inhibiting certain steroidogenic enzymes.

Pharmacodynamics

The pharmacodynamics of ketoconazole involve its action against a broad spectrum of fungi, including dermatophytes and yeasts. The drug's efficacy is influenced by factors such as the organism's susceptibility, the site of infection, and the concentration of the drug at the site. Ketoconazole also has some activity against certain protozoa and leishmaniasis.

Pharmacokinetics

Ketoconazole is well-absorbed from the gastrointestinal tract, with maximum plasma concentrations occurring within 1 to 2 hours post-administration. It is highly protein-bound, primarily to albumin, and has a large volume of distribution. The drug undergoes extensive hepatic metabolism, with CYP450 enzymes playing a significant role. Its elimination half-life ranges from 2 to 8 hours, and it is primarily excreted in feces, with a small percentage excreted in urine.

Contra-indications

  • Hypersensitivity to ketoconazole or any component of the formulation
  • Concurrent use with certain medications such as astemizole, terfenadine, and cisapride due to the risk of serious cardiac arrhythmias
  • Liver disease or history of liver dysfunction associated with ketoconazole

Adverse effects

  • Nausea
  • Vomiting
  • Abdominal pain
  • Headache
  • Dizziness
  • Rash
  • Hepatotoxicity
  • Gynecomastia
  • Hormonal imbalances

Interactions

  • May increase plasma concentrations of drugs metabolized by CYP3A4 such as certain benzodiazepines, statins, and antihistamines
  • Concurrent use with drugs that prolong the QT interval may increase the risk of arrhythmias
  • May reduce the effectiveness of certain contraceptive methods

Precautions

  • Use with caution in patients with a history of liver disease
  • Monitor liver function tests periodically during treatment
  • Caution in patients with a history of cardiac arrhythmias
  • Not recommended for use in pregnancy unless the benefits outweigh the risks

Pregnancy

Ketoconazole is classified as pregnancy category C. It should only be used if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

It is not known whether ketoconazole is excreted in human milk. Caution is advised when administering to nursing mothers.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

  • Tablets
  • Cream
  • Shampoo
  • Topical solution

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.