Ketoconazole Tablets

Ketoconazole Tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections.

Ketoconazole Tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks.

Ketoconazole Tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Ketoconazole Tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid.

Drug Interactions

Coadministration of a number of CYP3A4 substrates such as dofetilide, quinidine, cisapride and pimozide is contraindicated with Ketoconazole Tablets. Coadministration with ketoconazole can cause elevated plasma concentrations of these drugs and may increase or prolong both therapeutic and adverse effects to such an extent that a potentially serious adverse reaction may occur. For example, increased plasma concentrations of some of these drugs can lead to QT prolongation and sometimes

resulting in life-threatening ventricular tachyarrhythmias including occurrences of Torsades de pointes, a potentially fatal arrhythmia. (See PRECAUTIONS: Drug Interactions.)

Additionally, the following other drugs are contraindicated with Ketoconazole Tablets: methadone, disopyramide, dronedarone, ergot alkaloids such as dihydroergotamine, ergometrine, ergotamine, methylergometrine, irinotecan, lurasidone, oral midazolam, alprazolam, triazolam, felodipine, nisoldipine, ranolazine, tolvaptan, eplerenone, lovastatin, simvastatin and colchicine. (See PRECAUTIONS: Drug Interactions.)

Enhanced Sedation

Coadministration of Ketoconazole Tablets with oral midazolam, oral triazolam or alprazolam has resulted in elevated plasma concentrations of these drugs. This may potentiate and prolong hypnotic and sedative effects, especially with repeated dosing or chronic administration of these agents. Concomitant administration of Ketoconazole Tablets with oral triazolam, oral midazolam, or alprazolam is contraindicated. (See PRECAUTIONS: Drug Interactions.)

Myopathy

Coadministration of CYP3A4 metabolized HMG-CoA reductase inhibitors such as simvastatin, and lovastatin is contraindicated with Ketoconazole Tablets. (See PRECAUTIONS: Drug Interactions.)

Ergotism

Concomitant administration of ergot alkaloids such as dihydroergotamine and ergotamine with Ketoconazole Tablets is contraindicated. (See PRECAUTIONS: Drug Interactions.)

Liver Disease

The use of Ketoconazole Tablets is contraindicated in patients with acute or chronic liver disease.

Hypersensitivity

Ketoconazole is contraindicated in patients who have shown hypersensitivity to the drug.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The following adverse reactions were reported in clinical trials:

Immune System Disorders: anaphylactoid reaction

Endocrine Disorders: gynecomastia

Metabolism and Nutrition Disorders: alcohol intolerance, anorexia, hyperlipidemia, increased appetite

Psychiatric Disorders: insomnia, nervousness

Nervous System Disorders: headache, dizziness, paresthesia, somnolence

Eye Disorders: photophobia

Vascular Disorders: orthostatic hypotension

Respiratory, Thoracic and Mediastinal Disorders: epistaxis

Gastrointestinal Disorders: vomiting, diarrhea, nausea, constipation, abdominal pain, abdominal pain upper, dry mouth, dysgeusia, dyspepsia, flatulence, tongue discoloration

Hepatobiliary Disorders: hepatitis, jaundice, hepatic function abnormal

Skin and Subcutaneous Tissues Disorders: erythema multiforme, rash, dermatitis, erythema, urticaria, pruritus, alopecia, xeroderma

Musculoskeletal and Connective Tissue Disorders: myalgia

Reproductive System and Breast Disorders: menstrual disorder

General Disorders and Administration Site Conditions: asthenia, fatigue, hot flush, malaise, edema peripheral, pyrexia, chills

Investigations: platelet count decreased

Post-Marketing Experience: The following adverse reactions have been identified during post-approval use of Ketoconazole Tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions were reported during post-marketing experience:

Blood and Lymphatic System Disorders: thrombocytopenia

Immune System Disorders: allergic conditions including anaphylactic shock, anaphylactic reaction, angioneurotic edema

Endocrine Disorders: adrenocortical insufficiency

Nervous System Disorders: reversible intracranial pressure increased (e.g. papilloedema, fontanelle bulging in infants)

Hepatobiliary Disorders: serious hepatotoxicity including hepatitis cholestatic, biopsy-confirmed hepatic necrosis, cirrhosis, hepatic failure including cases resulting in transplantation or death

Skin and Subcutaneous Tissue Disorders: acute generalized exanthematous pustulosis, photosensitivity

Musculoskeletal and Connective Tissue Disorders: arthralgia

Reproductive System and Breast Disorders: erectile dysfunction; with doses higher than the recommended therapeutic dose of 200 mg or 400 mg daily, azoospermia.

There should be laboratory as well as clinical documentation of infection prior to starting ketoconazole tablet therapy. The usual duration of therapy for systemic infection is 6 months. Treatment should be continued until active fungal infection has subsided.

Adults

The recommended starting dose of Ketoconazole Tablets is a single daily administration of 200 mg (one tablet). If clinical responsiveness is insufficient within the expected time, the dose of Ketoconazole Tablets may be increased to 400 mg (two tablets) once daily.

Children

In small numbers of children over 2 years of age, a single daily dose of 3.3 to 6.6 mg/kg has been used. Ketoconazole Tablets have not been studied in children under 2 years of age.

Ketoconazole Tablets, USP are available containing 200 mg of ketoconazole, USP.

The 200 mg tablet is a white to off-white round, scored tablet debossed with M above the score and 261 below the score on one side of the tablet and blank on the other side. They are available as follows:

    NDC 0378-0261-01
    bottles of 100 tablets

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Protect from moisture.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Keep out of reach of children.

PHARMACIST: Dispense a Medication Guide with each prescription.

Ketoconazole Tablets, USP
(kee” toe kon’ a zole)
200 mg

What is the most important information I should know about Ketoconazole Tablets?

Ketoconazole Tablets are not the only medicine available to treat fungal infections and should only be used when other medicines are not right for you. Talk to your healthcare provider to find out if Ketoconazole Tablets are right for you.

Ketoconazole tablets can cause serious side effects, including:

• liver problems (hepatotoxicity). Some people who were treated with ketoconazole, the active ingredient in ketoconazole tablets, had serious liver problems that led to death or the need for a liver transplant. Call your healthcare provider right away if you have any of the following symptoms: • loss of appetite or start losing weight (anorexia) • nausea or vomiting • feel tired • stomach pain or tenderness • dark urine or light colored stools • yellowing of your skin or the whites of your eyes • fever or rash • changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heart beats that can be life threatening. This can happen when Ketoconazole Tablets are taken with certain medicines, such as dofetilide, quinidine, pimozide, cisapride, methadone, disopyramide, dronedarone, and ranolazine. Talk to your healthcare provider about other medicines you are taking before you start taking Ketoconazole Tablets. Tell your healthcare provider right away if you feel faint, lightheaded, dizzy, or feel your heart beating irregularly or fast. These may be symptoms related to QT prolongation.

What are Ketoconazole Tablets?

• Ketoconazole Tablets are prescription medicine used to treat serious fungal infections including: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. • Ketoconazole Tablets are not for people with fungal nail infections. • Ketoconazole Tablets have not been approved for the treatment of advanced prostate cancer or Cushing’s syndrome. The safety and efficacy have not been established. • Ketoconazole Tablets should only be used in children if prescribed by the healthcare provider who has determined that the benefits outweigh the risks.

Who should not take Ketoconazole Tablets?

• Do not take Ketoconazole Tablets if you: • have liver problems • take simvastatin, and lovastatin. Ketoconazole Tablets when taken with these medicines may cause muscle problems. • take eplerenone, dihydroergotamine, ergotamine, and nisoldipine. • take triazolam, midazolam, or alprazolam. Taking Ketoconazole Tablets with these medicines may make you very drowsy and make your drowsiness last longer. • are allergic to ketoconazole or any of the ingredients in Ketoconazole Tablets. See the end of this Medication Guide for a complete list of ingredients in Ketoconazole Tablets.

Before you take Ketoconazole Tablets, tell your healthcare provider if you:

• have had an abnormal heart rhythm tracing (ECG) or anyone in your family have or have had a heart problem called “congenital long QT syndrome”. • have adrenal insufficiency. • are pregnant or plan to become pregnant. It is not known if Ketoconazole Tablets will harm your unborn baby. • are breast-feeding or plan to breast-feed. Ketoconazole can pass into your breast milk. You and your healthcare provider should decide if you will take Ketoconazole Tablets or breast-feed. You should NOT do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Using Ketoconazole Tablets with certain other medicines may affect each other. Using Ketoconazole Tablets with other medicines can cause serious side effects.

How should I take Ketoconazole Tablets?

• Take Ketoconazole Tablets one time each day. • Do not stop taking Ketoconazole Tablets without first talking to your healthcare provider.

What should I avoid while taking Ketoconazole Tablets?

• Do not drink alcohol while taking Ketoconazole Tablets.

What are the possible side effects of Ketoconazole Tablets?

Ketoconazole Tablets may cause serious side effects, including:

• See “What is the most important information I should know about Ketoconazole Tablets?” • adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Ketoconazole Tablets may cause adrenal insufficiency if you take a high dose. Your healthcare provider will follow you closely if you have adrenal insufficiency or if you are taking prednisone or other similar medicines for long periods of time. Call your healthcare provider right away if you have symptoms of adrenal insufficiency such as tiredness, weakness, dizziness, nausea, and vomiting. • serious allergic reactions. Some people can have a serious allergic reaction to Ketoconazole Tablets. Stop taking Ketoconazole Tablets and go to the nearest hospital emergency room right away if you get a rash, itching, hives, fever, swelling of the lips or tongue, chest pain, or have trouble breathing. These could be signs of a serious allergic reaction. • muscle problems. Taking certain medicines with Ketoconazole Tablets may cause muscle problems. See “Who should not take Ketoconazole Tablets?”

The most common side effects of Ketoconazole Tablets include nausea, headache, diarrhea, stomach pain, and abnormal liver function tests.

These are not all the possible side effects of Ketoconazole Tablets. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Ketoconazole Tablets?

• Store Ketoconazole Tablets at 20° to 25°C (68° to 77°F). • Keep Ketoconazole Tablets dry.

General information about the safe and effective use of Ketoconazole Tablets.

Medications are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Ketoconazole Tablets for a condition for which it was not prescribed. Do not give Ketoconazole Tablets to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about Ketoconazole Tablets.

If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about Ketoconazole Tablets that is written for health professionals.

What are the ingredients in Ketoconazole Tablets, USP?

Active ingredient: ketoconazole, USP

Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Revised: 9/2017
KTCZ:R5m/MG:KTCZ:R2m