Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)
PD-Rx Pharmaceuticals, Inc.
KETOCONAZOLE
KETOCONAZOLE 200 mg
ORAL
PRESCRIPTION DRUG
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. 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 tha
Ketoconazole Tablets, USP are available containing 200 mg of ketoconazole, USP. The 200 mg tablets are white to off-white round, scored tablets 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 43063-036-30 bottles of 30 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.
Abbreviated New Drug Application
PD-Rx Pharmaceuticals, Inc. ---------- MEDICATION GUIDE Ketoconazole Tablets, USP (kee” toe kon’ a zole) 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 cance Прочетете целия документ
KETOCONAZOLE- KETOCONAZOLE TABLET PD-RX PHARMACEUTICALS, INC. ---------- WARNING Because ketoconazole tablets have been associated with serious adverse reactions (see WARNINGS section), 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. HEPATOTOXICITY: Serious hepatotoxicity, including cases with a fatal outcome or requiring liver transplantation has occurred with the use of oral ketoconazole. Some patients had no obvious risk factors for liver disease. Patients receiving this drug should be informed by the physician of the risk and should be closely monitored. (See WARNINGS section.) QT PROLONGATION AND DRUG INTERACTIONS LEADING TO QT PROLONGATION: Co-administration of the following drugs with ketoconazole is contraindicated: dofetilide, quinidine, pimozide, cisapride, methadone, disopyramide, dronedarone, ranolazine. Ketoconazole can cause elevated plasma concentrations of these drugs and may prolong QT intervals, sometimes resulting in life- threatening ventricular dysrhythmias such as Torsades de pointes. (See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS: Drug Interactions sections.) DESCRIPTION Ketoconazole tablets, USP are a synthetic broad-spectrum antifungal agent available in scored white tablets, each containing 200 mg ketoconazole base for oral administration. Inactive ingredients are colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Ketoconazole is (±)- _cis_-1-Acetyl-4-[p-[[2-(2,4-dichlorophenyl)-2-(imidazol- 1-ylmethyl)-1,3-dioxolan-4-yl]methoxyl]phenyl] piperazine and has the following structural formula: Ketoconazole, USP is a white or almost white powder, odorless powder, soluble in acids, with a molecular weight of 531.43. CLINICAL PHARMACOLOGY PHARMACOKINETICS _A Прочетете целия документ