Registered Malawi · PMRA

KETAZOL 2%W/W CREAM

KETACONAZOLE

PMPB/PL503/25 CREAM

What it does

Ketoconazole is an antifungal medicine that helps treat infections caused by fungi.

Commonly used for: fungal infections of the skin (like athlete's foot), fungal infections of the nails, fungal infections in the mouth or throat (oral thrush)

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

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Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

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Sourcing - Kenya only

Registration & product details

Registration no.
PMPB/PL503/25
Registration date
27/11/2020
Expiry date
31/03/2025
Status
Registered
Active ingredient
KETACONAZOLE
Dosage form
CREAM
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Applicant / LTR
-
Country of origin
-

Source: Pharmacy and Medicines Regulatory Authority · fetched 2026-04-21 17:37:45 · updated 2026-09-19 04:30:23

Disclaimer: This information is sourced from Pharmacy and Medicines Regulatory Authority (Malawi). Always consult a qualified healthcare professional before using any medication.

About this medicine

Ketoconazole is an antifungal medicine that helps treat infections caused by fungi.

What it treats

  • fungal infections of the skin (like athlete's foot)
  • fungal infections of the nails
  • fungal infections in the mouth or throat (oral thrush)

How it works

It works by stopping the growth of fungi, helping to clear up the infection.

Who it's for

Ketoconazole is for adults and children with certain fungal infections.

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

Clinical monograph: ketaconazole

Ketoconazole is an antifungal agent belonging to the imidazole class. It is primarily used to treat various fungal infections by inhibiting the synthesis of ergosterol, an essential component of fungal cell membranes. Ketoconazole has a broad spectrum of activity against dermatophytes, yeasts, and certain systemic fungi. Additionally, it has anti-androgenic effects, which can be beneficial in specific conditions such as Cushing's syndrome.

Indications

  • Candidiasis
  • Dermatophyte infections
  • Tinea corporis
  • Tinea pedis
  • Seborrheic dermatitis
  • Cushing's syndrome

Dosage

Children: Refer to specific guidelines and recommendations for appropriate dosing.

Adults: Refer to specific guidelines and recommendations for appropriate dosing.

Mechanism of action

Ketoconazole works by inhibiting the enzyme lanosterol 14α-demethylase, which is crucial for the conversion of lanosterol to ergosterol. This inhibition disrupts the fungal cell membrane integrity, leading to cell death. Ketoconazole also affects the synthesis of steroid hormones in humans by inhibiting steroidogenic enzymes, which is the basis for its use in conditions like Cushing's syndrome.

Pharmacodynamics

Ketoconazole exhibits fungistatic activity against a wide range of fungi. The drug's effectiveness is influenced by factors such as pH and concentration. At higher concentrations, ketoconazole can exert fungicidal effects. Its anti-androgenic properties arise from its ability to inhibit steroidogenesis, which can lead to decreased levels of testosterone and cortisol in the body.

Pharmacokinetics

Ketoconazole is well absorbed from the gastrointestinal tract, with absorption significantly enhanced in acidic environments. It is extensively metabolized in the liver, with a half-life of approximately 2 to 8 hours. The drug is primarily excreted in bile as metabolites, with minimal unchanged drug excreted in urine. Ketoconazole has a high volume of distribution, indicating extensive tissue binding.

Contra-indications

  • Hypersensitivity to ketoconazole or any excipients
  • Concomitant use with terfenadine, astemizole, or cisapride
  • Liver disease
  • Adrenal insufficiency

Adverse effects

  • Nausea
  • Vomiting
  • Abdominal pain
  • Headache
  • Rash
  • Itching
  • Hepatotoxicity
  • Gynecomastia
  • Decreased libido
  • QT interval prolongation

Interactions

  • Increased plasma concentrations of drugs metabolized by CYP3A4
  • Potentially increased effects of warfarin and other anticoagulants
  • Concomitant use with drugs that prolong the QT interval may increase the risk of arrhythmias

Precautions

  • Use with caution in patients with liver disease or history of liver dysfunction
  • Monitor liver function tests during treatment
  • Assess risk of adrenal insufficiency in patients on long-term therapy
  • Patients should be advised to report any signs of liver dysfunction, such as jaundice or unusual fatigue

Pregnancy

Ketoconazole is classified as Category C. Use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Ketoconazole is excreted in breast milk. Caution should be exercised when administering to nursing mothers.

Storage

Store in a cool, dry place, away from light. Do not store above 25°C.

Formulations

  • Oral tablets
  • Topical cream
  • Topical shampoo

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