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. Serious hepatotoxicity was reported both by patients receiving high doses for short treatment durations and by patients receiving low doses for long durations. Cases of hepatitis have been reported in children. Patients should be advised against alcohol consumption while on treatment.
Prompt recognition of liver injury is essential. During the course of treatment, serum ALT should be monitored weekly for the duration of treatment. If ALT values increase to a level above the upper limit of normal or 30 percent above baseline, or if the patient develops symptoms, ketoconazole treatment should be interrupted and a full set of liver tests should be obtained.
Liver tests should be repeated to ensure normalization of values. Hepatotoxicity has been reported with restarting oral ketoconazole rechallenge. If it is decided to restart oral ketoconazole, monitor the patient frequently to detect any recurring liver injury from the drug. Co-administration of the following drugs with ketoconazole is contraindicated: Ketoconazole can cause elevated plasma concentrations of these drugs which may prolong the QT interval, sometimes resulting in life-threatening ventricular dysrhythmias such as torsades de pointes.
This effect is not shared with other azoles. The recommended dose of mg - mg daily should not be exceeded. Adrenal function should be monitored in patients with adrenal insufficiency or with borderline adrenal function and in patients under prolonged periods of stress major surgery, intensive care , etc. Adverse Reactions Associated with Unapproved Uses Ketoconazole has been used in high doses for the treatment of advanced prostate cancer and for Cushing's syndrome when other treatment options have failed.
The safety and effectiveness of ketoconazole have not been established in these settings and the use of ketoconazole for these indications is not approved by FDA. It is not possible to ascertain from the information available whether death was related to ketoconazole therapy or adrenal insufficiency in these patients with serious underlying disease. Hypersensitivity Anaphylaxis has been reported after the first dose.
Several cases of hypersensitivity reactions including urticaria have also been reported. This may potentiate and prolong hypnotic and sedative effects, especially with repeated dosing or chronic administration of these agents. Testosterone levels are impaired with doses of mg per day and abolished by mg per day. Clinical manifestations of decreased testosterone concentrations may include gynecomastia , impotence and oligospermia.
Information for Patients Patients should be instructed to report any signs and symptoms which may suggest liver dysfunction so that appropriate biochemical testing can be done. Carcinogenesis, Mutagenesis, Impairment of Fertility Ketoconazole did not show any signs of mutagenic potential when evaluated using the dominant lethal mutation test or the Ames Salmonella microsomal activator assay.
Pregnancy Teratogenic effects Pregnancy Category C: However, these effects may be related to maternal toxicity, evidence of which also was seen at this and higher dose levels. Hepatoxicity, including fatal cases and cases requiring liver transplantation, have been reported in patients who received ketoconazole for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections. Hypersensitivity Anaphylaxis has been reported after the first dose.
Several cases of hypersensitivity reactions including urticaria have also been reported. Once therapy with ketoconazole has been discontinued, serum testosterone levels return to baseline values.
Testosterone levels are impaired with doses of mg per day and abolished by mg per day. Clinical manifestations of decreased testosterone concentrations may include gynecomastia, impotence and oligospermia. Other substances that either share this metabolic pathway or modify CYP3A4 activity may influence the pharmacokinetics of ketoconazole.
Similarly, ketoconazole may modify the pharmacokinetics of other substances that share this metabolic pathway. When using concomitant medication, the corresponding label should be consulted for information on the route of metabolism and the possible need to adjust dosages. Interaction studies have only been performed in adults. The relevance of the results from these studies in pediatric patients is unknown. Drugs that may decrease ketoconazole plasma concentrations Drugs that reduce the gastric acidity e.
These drugs should be used with caution when coadministered with Ketoconazole Tablets: Ketoconazole Tablets should be administered with an acidic beverage such as non-diet cola upon co-treatment with drugs reducing gastric acidity. Acid neutralizing medicines e. Upon coadministration, the antifungal activity should be monitored and the Ketoconazole Tablets dose increased as deemed necessary. Coadministration of Ketoconazole Tablets with potent enzyme inducers of CYP3A4 may decrease the bioavailability of ketoconazole to such an extent that efficacy may be reduced.
The use of these drugs should be avoided from 2 weeks before and during treatment with Ketoconazole Tablets, unless the benefits outweigh the risk of potentially reduced ketoconazole efficacy. These drugs should be used with caution when coadministered with Ketoconazole Tablets. Patients who must take Ketoconazole Tablets concomitantly with potent inhibitors of CYP3A4 should be monitored closely for signs or symptoms of increased or prolonged pharmacologic effects of ketoconazole, and the Ketoconazole Tablets dose should be decreased as deemed necessary.
When appropriate, ketoconazole plasma concentrations should be measured. These elevated plasma concentrations may increase or prolong both therapeutic and adverse effects of these drugs.
CYP3A4- metabolized drugs known to prolong the QT interval may be contraindicated with Ketoconazole Tablets, since the combination may lead to ventricular tachyarrhythmias, including occurrences of torsade de pointes, a potentially fatal arrhythmia. Examples of drugs that may have their plasma concentrations increased by ketoconazole presented by drug class with advice regarding coadministration with Ketoconazole Tablets: Store at room temperature away from moisture and heat.
What happens if I miss a dose? Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at What should I avoid while taking ketoconazole?
Avoid taking antacids , stomach acid reducers, or medicines to treat stomach ulcer or gastroesophageal reflux disease Axid , Nexium , Pepcid , Prevacid Prilosec , sucralfate , Tagamet , Zantac , and others.
These medications can make it harder for your body to absorb ketoconazole. It may increase your risk of liver damage while you are taking ketoconazole. Ketoconazole side effects Get emergency medical help if you have signs of an allergic reaction: Call your doctor at once if you have:
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