Registered Kenya · PPB

PHYTOROL TABLETS

KETCONAZOLE USP

12176 200 MG

What it does

Ketoconazole is an antifungal medication used to treat infections caused by fungi.

Commonly used for: fungal skin infections, fungal infections of the nails, candidiasis (thrush)

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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.
12176
Registration date
-
Expiry date
-
Status
Registered
Active ingredient
KETCONAZOLE USP
Dosage form
200 MG
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Micro Labs
Applicant / LTR
-
Country of origin
FOREIGN
Manufacturer location
31, Race Course Rd, Madhava Nagar, Gandhi Nagar, Bengaluru, Karnataka 560001, India

Source: Pharmacy and Poisons Board · fetched 2026-01-28 21:13:29 · updated 2026-07-20 08:56:39

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Ketoconazole is an antifungal medication used to treat infections caused by fungi.

What it treats

  • fungal skin infections
  • fungal infections of the nails
  • candidiasis (thrush)

How it works

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

Who it's for

Ketoconazole is for adults and children who have certain fungal infections.

Cautions

  • • Not suitable for people with liver problems.
  • • Should be used with caution in those who are pregnant or breastfeeding.

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

Clinical monograph: ketconazole

Ketoconazole is an antifungal medication that belongs to the imidazole class of antifungals. It is primarily used to treat various fungal infections by inhibiting the synthesis of ergosterol, a key component of fungal cell membranes. Ketoconazole can be administered orally or topically and is effective against a range of fungal pathogens, including dermatophytes and yeasts.

Indications

  • Dermatophytosis
  • Candidiasis
  • Tinea infections
  • Seborrheic dermatitis
  • Histoplasmosis
  • Coccidioidomycosis

Dosage

Children: Refer to the BNF for Children for specific dosing information.

Adults: Refer to the BNF for specific dosing information.

Mechanism of action

Ketoconazole exerts its antifungal effects by inhibiting the enzyme lanosterol 14-alpha-demethylase, which is involved in the biosynthesis of ergosterol. By disrupting ergosterol production, ketoconazole alters the fungal cell membrane's integrity and function, leading to cell death.

Pharmacodynamics

The pharmacodynamics of ketoconazole involve its ability to inhibit fungal growth and reproduction. The drug has fungistatic activity at lower concentrations and can be fungicidal at higher doses. Its effectiveness can be influenced by factors such as pH, with increased absorption in acidic environments enhancing its antifungal activity.

Pharmacokinetics

Ketoconazole is well absorbed from the gastrointestinal tract, with its absorption significantly enhanced by acidic pH. It undergoes extensive hepatic metabolism and has a half-life of approximately 2 to 8 hours. The drug is primarily excreted in the feces, with only a small percentage eliminated unchanged in the urine. Ketoconazole has a high volume of distribution, indicating extensive tissue binding.

Contra-indications

  • Hypersensitivity to ketoconazole or any of its components
  • Concomitant use with certain medications that prolong the QT interval
  • Liver disease or significant hepatic impairment

Adverse effects

  • Nausea
  • Vomiting
  • Abdominal pain
  • Diarrhea
  • Headache
  • Dizziness
  • Rash
  • Hepatotoxicity
  • Hormonal effects such as gynecomastia or menstrual irregularities

Interactions

  • Increased risk of hepatotoxicity when used with other hepatotoxic drugs
  • May interact with drugs that affect hepatic enzymes, leading to altered metabolism of ketoconazole or the interacting drug
  • Concomitant use with drugs that prolong the QT interval can increase the risk of serious heart rhythm abnormalities

Precautions

  • Use with caution in patients with a history of liver disease
  • Monitor liver function tests during treatment
  • Assess for signs of adrenal insufficiency, especially with long-term use
  • Consider potential drug interactions before initiating therapy

Pregnancy

Ketoconazole is classified as a Category C drug. 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 should be exercised when administering to breastfeeding women.

Storage

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

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.