Ketoconazole Tablets

Active Ingredients: Ketoconazole

Ketoconazole Tablets are used to prevent and treat certain serious fungal infections. It is typically given after other treatments have failed or have caused too many adverse effects. This medication is also used to treat skin infections that cannot be treated topically or with griseofulvin.

Ketoconazole shows activity against several types of fungi and is commonly used for systemic fungal infections such as blastomycosis, chromomycosis, coccidioidomycosis, histoplasmosis, and paracoccidioidomycosis.

Ketoconazole belongs to the class of medicines known as azole antifungals. It works by interfering with ergosterol production within the fungi, which is a necessary component of the fungal cell membrane. This activity helps to slow the growth of fungi that cause infection.

Ketoconazole Tablets are produced with a dosage of 200mg. These tablets are available in two packaging options: a bottle of 1000 tablets or a box containing 100 tablets.

AdvaCare Pharma also manufactures Ketoconazole Cream as a topical treatment option for fungal infections.

AdvaCare Pharma is a trusted global supplier of Ketoconazole Tablets. We offer a wide range of high-quality and cost-effective medications that are available for distribution. Our factories are GMP-certified and meet the high standards necessary to comply with WHO guidelines and standards.

We are a Ketoconazole manufacturer engaged in the global distribution of 200+ oral solid pharmaceutical products in tablet dosage form.

As an American-owned and operated company, we are devoted to the manufacture and supply of superior quality, yet cost-effective pharmaceuticals to improve access to healthcare solutions worldwide. AdvaCare Pharma manufactures Ketoconazole Tablets, and over 500 other pharmaceutical treatments, according to strict GMP regulations as part of our global commitment to bring efficacious medicines to pharmaceutical distributors, hospitals, pharmacies and other medical institutions.

What is Ketoconazole used for?

How are Ketoconazole Tablets used?

This medication is intended to be taken orally. Ketoconazole Tablets can be taken with or without food. It is important to note that antacids interfere with the absorption of Ketoconazole. This medication should be taken 2 hours before or 1 hour after taking an antacid.

If a patient has reduced gastric acidity, they should take Ketoconazole Tablets with an acidic drink.

=== #Can Ketoconazole be stopped when symptoms improve? This medicine should be used for the full prescribed length of time and should not be stopped early if symptoms improve.

Stopping treatment early or skipping doses may result in a Ketoconazole-resistant infection.

What dose should be taken?

Adult Dosing For fungal infections, the usual dose is 200-400mg taken once per day. The initial starting dose should be 200mg each day. If the clinical response is insufficient the dose can be increased to 400mg. The duration of treatment is about 6 months but varies depending on the type of infection and severity of illness. The tablets should be taken with food. Ketoconazole should be used for patients who are intolerant or have failed other forms of treatment. This drug is indicated for systemic fungal infections such as blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, or paracoccidioidomycosis.

For castration-resistant prostate cancer (off-label), the usual dose is 400mg taken every 8 hours. The tablets should be taken with food. Ketoconazole is not a 1st line treatment. It can be used as monotherapy or in combination with hydrocortisone.

To inhibit steroidogenesis associated with Cushing syndrome (off-label), the usual dose is 400-1600mg per day, divided and taken 2-4 times per day. The dose should be adjusted based on clinical response and either urinary-free cortisol levels or serum cortisol levels. Caution should be used, as required therapeutic doses are often at toxic levels.

For recurrent tinea versicolor (off-label), the usual dose is 400mg taken once per month.

Renal Dosing No adjustments are necessary for patients with renal impairment. No adjustments or supplements are necessary for patients on HD/PD.

Hepatic Dosing This medication is contraindicated in patients with acute or chronic hepatic disease.

Pediatric Dosing For fungal infections, the usual dose for children over 2 years old is 3.3-6.6mg/kg per dose, taken once each day. The duration of treatment varies depending on the type of infection and severity illness. The tablets should be taken with food.

Renal Dosing for pediatrics No adjustments are necessary for children with renal impairment. No adjustments or supplements are necessary for patients on HD/PD.

Hepatic Dosing for pediatrics This medication is contraindicated in children with acute or chronic hepatic disease.

The dosage is based on medical condition, response to treatment, age, and weight. Refer to a doctor or pharmacist for guidelines on dosage. Do not exceed what they advise.

Who can use Ketoconazole?

Ketoconazole Tablets can be given to adults and children, but caution is advised for specific groups of patients.

Pregnant Ketoconazole should only be used in pregnant women if the benefits outweigh its risks. Based on limited human data, the risk of teratogenicity is not expected, but animal studies show a risk of embryo-fetal toxicity at 2x MRHD and a risk of dystocia at 0.25x MRHD.

Breastfeeding This drug should only be used in breastfeeding women if there is a clear need, and the benefits outweigh the risks of its use. Ketoconazole is known to pass in milk. There is not enough human data to evaluate the risk of infant harm.

Children Adequate studies concerning the safety and efficiency of the use of this medicine have not been conducted. Ketoconazole should not be used in children unless the benefit outweighs the risks. Dosage should be based on weight. Ketoconazole is not recommended for children under 2 years old.

Geriatric There have not been sufficient studies performed to assess problems specific to elderly patients. It is important to note that geriatric patients may have a greater sensitivity to side effects.

How should Ketoconazole Tablets be stored?

It is recommended to keep this medication at room temperature. It should be protected from moisture, light, and heat.

Other warnings

Ketoconazole is recommended only if other effective therapies are not available or not tolerated by the patient.

There have been reports of severe hepatotoxicity, including fatalities, associated with oral ketoconazole. This includes patients with no known risk factors for hepatic disease. Ketoconazole is contraindicated for patients with acute or chronic liver disease.

Caution is advised for patients taking CYP450 3A4 inducers or drugs that reduce gastric acidity. The infection should be monitored, and the dose of ketoconazole should be increased as necessary.

This drug is associated with an increased risk of QT prolongation. Ketoconazole is contraindicated with the concurrent use of dofetilide, quinidine, pimozide, cisapride, methadone, disopyramide, dronedarone, and ranolazine.

This drug is contraindicated for concurrent therapy with cisapride, ergot derivatives, or triazolam, as there is an increased risk of fatal cardiac arrhythmias.

For patients taking CYP450 3A4 inhibitors, it is recommended to use caution and monitor for any signs of prolonged or increased effects of this medication. It may be necessary to decrease the dosage of Ketoconazole. Plasma levels should be checked as needed.

It is not advised to exceed a daily dose of 200-400mg, as ketoconazole decreases adrenal corticosteroid secretion at doses greater than 400mg. Other azole antifungals do not display this effect. The adrenal function should be monitored in patients with adrenal insufficiency or with borderline adrenal function and patients under prolonged stress, such as major surgery.

As with all pharmaceuticals, some unwanted effects can occur from the use of Ketoconazole Tablets.

For a comprehensive understanding of all potential side effects, consult a medical professional.

If any symptoms persist or worsen, or you notice any other symptoms, please call your doctor immediately.

Serious drug interactions can occur. Consult with your doctor about any medications you are taking before treatment with ketoconazole. Ketoconazole is known to interact with drugs, such as cisapride, colchicine, irinotecan, methadone, and tolvaptan. It is also known to interact with certain antipsychotics sedatives (e.g. alprazolam, midazolam, triazolam), heart medications (e.g. disopyramide, dofetilide, dronedarone, eplerenone, felodipine, nisoldipine, quinidine, ranolazine), ergot medications, and some types of medicine for cholesterol. This is not a complete list.

Do not drink alcohol while being treated with ketoconazole.

Some patients may need routine blood tests in order to assess liver function while taking ketoconazole.

The use of ketoconazole may increase sensitivity to the sun. It is recommended to avoid sunlight, wear protective clothing, and use sunscreen while being treated with ketoconazole.

Ketoconazole and candidiasis: a controlled study

This is a double-blind, placebo-controlled study that was undertaken to determine the efficacy of ketoconazole in the treatment of candidiasis.

The drug was administered orally at a dosage of 200mg/m² of body surface area per day for two weeks to cancer patients with oral candidiasis. Patients were randomized in a 2:1 ratio, resulting in 36 patients receiving ketoconazole and 20 receiving a placebo. Visible lesions regressed in 26 (72%) of the 36 ketoconazole-treated patients compared to four (20%) of the 20 untreated patients. Eradication of culturable organisms was achieved in 12 (36%) of the 33 ketoconazole-treated patients, compared to one (7%) of the 14 untreated patients. Resolution of lesions along with eradication of Candida albicans occurred in nine (25%) of the 36 ketoconazole-treated patients and one (5%) of the 20 untreated patients.

The conclusion of this study is that ketoconazole can be effective in eradicating Candida albicans.