Easy to read patient leaflet for Nizoral. Includes indications, proper use, special instructions, precautions, and possible side effects.
Learn about the prescription medication Nizoral Ketoconazole, drug uses, dosage, side effects, drug interactions, warnings, reviews and patient labeling.
Consumer information about the medication KETOCONAZOLE - ORAL Nizoral, includes side effects, drug interactions, recommended dosages, and storage.
Nizoral Description. Nizoral is a synthetic broad-spectrum antifungal agent available in scored white tablets, each containing 200 mg ketoconazole base for oral.
Nizoral® is 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, magnesium stearate, microcrystalline cellulose, and povidone. Ketoconazole is cis-1- acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxyl]phenyl] piperazine and has the following structural formula: Mean peak plasma concentrations of approximately 3.5 µg/mL are reached within 1 to 2 hours, following oral administration of a single 200 mg dose taken with a meal. Oral bioavailability is maximal when the tablets are taken with a meal. Absorption of Nizoral® Tablets is reduced in subjects with reduced gastric acidity, such as subjects taking medications known as acid neutralizing medicines (e.g. aluminum hydroxide) and gastric acid secretion suppressors (e.g. H2-receptor antagonists, proton pump inhibitors) or subjects with achlorhydria caused by certain diseases. (See Section PRECAUTIONS: Drug Interactions.) Absorption of ketoconazole under fasted conditions in these subjects is increased when Nizoral® Tablets are administered with an acidic beverage (such as non-diet cola). After pretreatment with omeprazole, a proton pump inhibitor, the bioavailability of a single 200-mg dose of ketoconazole under fasted conditions was decreased to 17% of the bioavailability of ketoconazole administered alone. When ketoconazole was administered with non-diet cola after pretreatment with omeprazole, the bioavailability was 65% of that after administration of ketoconazole alone. Following absorption from the gastrointestinal tract, Nizoral® is converted into several inactive metabolites. In vitro studies have shown that CYP3A4 is the major enzyme involved in the metabolism of ketoconazole. The major identified metabolic pathways are oxidation and degradation of the imidazole and piperazine rings, by hepatic microsomal enzymes. In addition, oxidative O-dealkylation and aromatic hydroxylation does occur. Ketoconazole has not been demonstrated to induce its own metabolism. Drug Class Contraindicated Not Recommended Use with Caution Comments Under no circumstances should the drug be coadministered with Nizoral® Tablets, and up to one week after discontinuation of treatment with ketoconazole. The use of the drug should be avoided during and up to one week after discontinuation of treatment with Nizoral® Tablets, unless the benefits outweigh the potentially increased risks of side effects. If coadministration cannot be avoided, clinical monitoring for signs or symptoms of increased or prolonged effects or side effects of the interacting drug is recommended, and its dosage should be reduced or interrupted as deemed necessary. When appropriate, plasma concentrations should be measured. The label of the coadministered drug should be consulted for information on dose adjustment and adverse effects. Careful monitoring is recommended when the drug is coadministered with Nizoral® Tablets. Upon coadministration, patients should be monitored closely for signs or symptoms of increased or prolonged effects or side effects of the interacting drug, and its dosage should be reduced as deemed necessary. When appropriate, plasma concentrations should be measured. The label of the coadministered drug should be consulted for information on dose adjustment and adverse effects. Alpha Blockers tamsulosin Analgesics methadone alfentanil, buprenorphine IV and sublingual, fentanyl, oxycodone, sufentanil Methadone: The potential increase in plasma concentrations of methadone when coadministered with Nizoral® Tablets may increase the risk of serious cardiovascular events including QT prolongation and torsade de pointes, or respiratory or CNS depression. [See CONTRAINDICATIONS. ] Fentanyl: The potential increase in plasma concentrations of fentanyl when coadministered with Nizoral® Tablets may increase the risk of potentially fatal respiratory depression. Sufentanil: No human pharmacokinetic data of an interaction with ketoconazole are available. In vitro data suggest that sufentanil is metabolized by CYP3A4 and so potentially increased sufentanil plasma concentrations would be expected when coadministered with Nizoral® Tablets. How is Nizoral Supplied Nizoral® (ketoconazole) is available as white, scored tablets containing 200 mg of ketoconazole debossed "JANSSEN" and on the reverse side debossed "Nizoral". They are supplied in bottles of 100 tablets (NDC 50458-220-10). Store at controlled room temperature 15°–25°C (59°–77°F). MEDICATION GUIDE Nizoral® (ketoconazole) Tablets What is the most important information I should know about Nizoral® Tablets? Nizoral® Tablets is 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 Nizoral® Tablets are right for you. Nizoral® Tablets can cause serious side effects, including: The most common side effects of Nizoral® Tablets include nausea, headache, diarrhea, stomach pain, and abnormal liver function tests. These are not all the possible side effects of Nizoral® 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.','url':'http://www.drugs.com/pro/nizoral.html','og_descr':'Nizoral official prescribing information for healthcare professionals. Includes: indications, dosage, adverse reactions, pharmacology and more.
Ketoconazole can cause serious (possibly fatal) side effects and drug interactions. Therefore, it should only be used when other treatments have not worked, are not available, or cannot be taken by you. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for fungal infections, with your doctor. Ketoconazole has rarely caused very serious (possibly fatal) liver problems. Get medical help right away if you develop symptoms of liver problems, including persistent nausea/vomiting, stomach/abdominal pain, dark urine, yellowing eyes/skin, loss of appetite, or light colored stools. To reduce your risk for liver problems, your doctor should obtain liver function tests every week while you are taking this medication. Do not drink alcoholic beverages while taking ketoconazole because alcohol increases the risk of serious liver problems. See also Notes section. Ketoconazole must not be used with certain other medications because a serious, possibly fatal, drug interaction may occur. Ketoconazole interacts with drugs such as cisapride, disopyramide, dofetilide, dronedarone, methadone, pimozide, quinidine, ranolazine, among others. These interactions may increase the risk of a certain condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. Tell your doctor and pharmacist about all the medications and products you may be taking before you start ketoconazole treatment. See also Precautions section. See also Warning section. Ketoconazole is used to treat certain serious fungal infections in the body. Ketoconazole belongs to the class of drugs called azole antifungals. It works by stopping the growth of the fungus. Ketoconazole should not be used to treat fungal infections in the brain or on the skin and nails. OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. This drug may also be used to treat advanced prostate cancer. Read the Medication Guide provided by your pharmacist before you start taking ketoconazole and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually once a day. This medication may be taken with or without food, but taking it with food helps to reduce stomach upset. If you are taking an antacid, take ketoconazole at least 2 hours before or 1 hour after taking the antacid, otherwise ketoconazole may not be absorbed into the body. See also Drug Interactions for more information. The dosage and length of treatment is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). In children, the dosage is also based on weight. It may take from several days to several months to complete treatment. This medication works best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time each day. Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection. Tell your doctor if your condition persists or worsens. See also Warning section. Nausea and vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: headache, vision changes, mental/mood changes (such as depression, thoughts of suicide). Although unlikely, when ketoconazole is used at high doses, it may cause an adrenal gland problem (adrenal insufficiency), a decrease in testosterone levels, and a decrease in sperm production. Ketoconazole can also worsen existing adrenal gland function problems (See also Precautions section). The adrenal gland problem may make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication. Your doctor may order a blood test to monitor your adrenal gland function while you are taking ketoconazole. These effects usually go away after ketoconazole treatment is stopped. Tell your doctor right away if you have any serious side effects, including: unusual tiredness, weakness, dizziness upon standing, diarrhea, weight loss, menstrual period changes, decreased sexual interest or ability, enlarged/tender breasts in men. Get medical help right away if any of these rare but serious side effects occur: fast/irregular heartbeat, severe dizziness, fainting. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. See also Side Effects section. Before taking ketoconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungal drugs (such as fluconazole, itraconazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, alcohol use, low testosterone levels, decreased adrenal gland function problems (such as low cortisol levels, Addison's disease, adrenal insufficiency), little or no stomach acid production (achlorhydria). Ketoconazole may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using ketoconazole, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death). Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using ketoconazole safely. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Do not drink alcoholic beverages while taking this medication because alcohol increases the risk of serious liver problems. Avoiding alcoholic beverages will also decrease the risk of a rare reaction with ketoconazole that may result in flushing, headache, and nausea. Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above). During pregnancy, this medication should be used only when clearly needed. It may cause harm to an unborn baby if taken during the first 3 months of pregnancy. Discuss the risks and benefits with your doctor. This medication passes into breast milk. Consult your doctor before breast-feeding. See also Warning and How to Use sections. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Ketoconazole interacts with many prescription and nonprescription drugs. While you are taking ketoconazole, it is very important to tell your doctor or pharmacist of any changes in medications that you are taking. Some products that may interact with this drug include: other drugs that can cause liver problems (such as acetaminophen). Other medications can affect the removal of ketoconazole from your body, which may affect how ketoconazole works. Examples include isoniazid, nevirapine, rifamycins (such as rifabutin, rifampin), St. John's wort, among others. This medication can slow down the removal of many other medications from your body, which may affect how they work. Examples of affected drugs include some benzodiazepines (such as alprazolam, midazolam, triazolam), domperidone, eletriptan, eplerenone, ergot drugs (such as ergotamine), nisoldipine, drugs used to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, tadalafil), some drugs used to treat seizures (such as carbamazepine, phenytoin), some statin drugs (such as atorvastatin, lovastatin, simvastatin), among others. Ketoconazole requires acid in the stomach to be well absorbed. Therefore, if you are taking drugs that decrease the amount of stomach acid including antacids, heartburn/ulcer drugs (H2 blockers such as cimetidine, famotidine, ranitidine), sucralfate, or if you are taking drugs that slow down gut movement (anticholinergics such as dicyclomine, propantheline), take ketoconazole at least 2 hours before any of these drugs. If you are taking proton pump inhibitors (PPIs such as lansoprazole, omeprazole), ask your doctor or pharmacist for advice on how to reduce or avoid this interaction.','url':'http://www.webmd.com/drugs/2/drug-11195/nizoral-oral/details','og_descr':'Find patient medical information for Nizoral oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings.
Find patient medical information for Nizoral oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings.
Facts about Nizoral ketoconazole tablets. Antifungal drug indicated for the treatment of the following fungal infections when alternatives are not available or not.
Nizoral Generic Name: Ketoconazole Basics Dosage Side-Effects. What is Nizoral. Nizoral, is an antifungal drug used to treat several fungal infections within the.