Medicine Information

Ketotab

Name: Ketotab
Brand: Ketotab
Rating: 4.5 (117 reviews)

Tablet200 mgAntifungalATC: J02AB02

Generic Name

Ketoconazole

Manufacturer

Square Pharmaceuticals Ltd.

Country

Bangladesh

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Price Details

Current market pricing information

Variant	Unit Price	Strip Price
ketotab 200 mg tablet	৳ 9.00	৳ 90.00

Description

Overview of the medicine

Ketoconazole is an antifungal medication used to treat various fungal infections. Ketotab 200 mg tablet contains Ketoconazole as its active ingredient and is used for systemic fungal infections when other treatments are not tolerated or effective, particularly due to its potential for hepatotoxicity.

Uses & Indications

Treatment of serious systemic fungal infections (e.g., blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis) in patients who have failed or are intolerant to other therapies.

Mucocutaneous candidiasis (chronic) when other treatments are ineffective.

Prophylaxis of fungal infections in immunocompromised patients (limited use due to toxicity).

Dosage

Adults

Usually 200 mg once daily. In severe infections or if no improvement, dose may be increased to 400 mg once daily.

Elderly

No specific dose adjustments required, but monitor for adverse effects due to potential for decreased hepatic function.

Renal_impairment

No dose adjustment is usually required as excretion is primarily via bile. However, caution is advised in severe renal impairment.

How to Take

Take orally with a meal to improve absorption. Do not take with antacids, H2 blockers, or proton pump inhibitors. If such medications are necessary, take Ketotab at least 2 hours before or 2 hours after.

Mechanism of Action

Ketoconazole inhibits the synthesis of ergosterol, a vital component of fungal cell membranes, by interfering with the fungal cytochrome P450 enzyme 14α-demethylase. This leads to increased permeability of the fungal cell membrane, leakage of cellular contents, and ultimately cell death.

Pharmacokinetics

Onset

Clinical effects typically observed within days to weeks depending on the infection.

Excretion

Mainly excreted in bile (approx. 57%) and feces, with a small amount (13%) excreted in urine.

Half life

Biphasic; initial half-life about 2 hours, terminal half-life about 8 hours.

Absorption

Variable and pH-dependent. Improved with acidic environment. Bioavailability can be significantly reduced by antacids, H2 blockers, and proton pump inhibitors.

Metabolism

Extensively metabolized in the liver, primarily via CYP3A4, into inactive metabolites.

Side Effects

Contraindications

Hypersensitivity to ketoconazole or any component of the tablet.
Acute or chronic liver disease.
Concomitant administration with drugs metabolized by CYP3A4 that can prolong QTc interval (e.g., astemizole, cisapride, dofetilide, dronedarone, eplerenone, ergot alkaloids, halofantrine, levacetylmethadol, mizolastine, pimozide, quinidine, ranolazine, sertindole, simvastatin, lovastatin, triazolam, midazolam, nisoldipine).

Drug Interactions

CYP3A4 substrates

Ketoconazole is a potent inhibitor of CYP3A4 and can significantly increase plasma concentrations of drugs metabolized by this enzyme, leading to increased adverse effects or toxicity (e.g., statins, benzodiazepines, cyclosporine, tacrolimus, calcium channel blockers, oral anticoagulants, antiretrovirals).

QTc-prolonging drugs

Concomitant use is contraindicated due to increased risk of serious ventricular arrhythmias (e.g., astemizole, cisapride, dofetilide, quinidine).

Gastric pH-altering drugs

Antacids, H2 blockers, proton pump inhibitors decrease ketoconazole absorption. Take ketoconazole at least 2 hours before or after these medications.

Storage

Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.

Overdose

Symptoms of overdose may include nausea, vomiting, abdominal pain, and possibly liver dysfunction. Treatment is symptomatic and supportive, including gastric lavage and activated charcoal. Monitor liver function closely.

Pregnancy & Lactation

Pregnancy Category C. Use only if potential benefit justifies potential risk to the fetus. Ketoconazole is excreted in breast milk; advise caution or consider alternative treatment or cessation of breastfeeding.

Frequently Asked Questions

Common questions about this medicine

Pack Sizes

10 tablets30 tablets

Shelf Life

3 years from manufacturing date.

Availability

Pharmacies, Hospitals

Approval Status

Approved by drug regulatory authorities (e.g., FDA, DGDA)

Patent Status

Off-patent (generic available)

Clinical Trials

Early clinical trials established efficacy for various fungal infections. Subsequent trials and post-marketing surveillance highlighted concerns about hepatotoxicity and drug interactions, leading to restricted use for oral formulations in many regions. Current research focuses on topical applications and safer systemic antifungals.

Lab Monitoring

Liver function tests (ALT, AST, alkaline phosphatase, bilirubin) before treatment and at frequent intervals during treatment (e.g., weekly or bi-weekly).
Serum electrolytes (potassium, magnesium) if concomitant QTc-prolonging drugs are used or patient is at risk.
Adrenal function in patients with suspected adrenal insufficiency.

Doctor Notes

Emphasize the black box warning for hepatotoxicity and drug interactions.
Ensure patient understands the need for regular liver function monitoring.
Carefully review concomitant medications for potential interactions, especially CYP3A4 substrates and QTc prolonging agents.
Educate patients on symptoms of liver injury and adrenal insufficiency.

Patient Guidelines

Take this medicine exactly as prescribed by your doctor.
Do not stop taking this medicine without consulting your doctor, even if you feel better.
Report any signs of liver problems immediately (e.g., unusual tiredness, dark urine, pale stools, yellowing of skin/eyes, persistent nausea/vomiting).
Avoid alcohol during treatment.
Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.

Missed Dose Advice

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose.