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H2-receptor antagonists, proton pump inhibitors or subjects with achlorhydria caused by certain diseases. Ketoconazole is widely distributed into tissues; however, only a negligible proportion reaches the cerebrospinal fluid. 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. Elimination Elimination from plasma is biphasic with a half-life of 2 hours during the first 10 hours and 8 hours thereafter. Special Populations Patients with Hepatic or Renal Impairment In patients with hepatic or renal impairment, the overall pharmacokinetics of ketoconazole was not significantly different when compared with healthy subjects.
Limited data suggest that absorption may be greater when the drug is administered as a suspension compared to a crushed tablet. Maximum plasma concentrations occurred 1 to 2 hours after dosing and were in the same general range as those seen in adults who received a — mg dose.
Electrocardiogram Pre-clinical electrophysiological studies have shown that ketoconazole inhibits the rapidly activating component of the cardiac delayed rectifier potassium current, prolongs the action potential duration, and may prolong the QTc interval. This results in an accumulation of methylated sterol precursors and a depletion of ergosterol within the cell membrane thus weakening the structure and function of the fungal cell membrane. 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.
Blood tests Before you are given Nizoral tablets your doctor will check your liver by testing your blood. Your doctor will then re-test your blood at weeks 2 and 4 of your treatment. If your treatment continues longer than this, your doctor will continue to re-test your blood every 4 weeks.
Adrenal gland problems The adrenal glands are involved in the response to stress. Tell your doctor if: Taking Nizoral tablets with food Always take Nizoral tablets with food as this helps your body to use the medicine.
Several medications interact with Nizoral and should either not be taken while you are taking Nizoral or only after discussion and instruction from your doctor: Drugs that decrease effectiveness of Nizoral: Always finish your course of tablets even if you feel better, if not, the infection may not clear up completely. Do not take medicines that neutralise stomach acid within 2 hours of taking Nizoral mg tablets, as sufficient stomach acid is required for Nizoral to be absorbed.
How long should you take Nizoral tablets? You should complete your course of Nizoral mg tablets as prescribed by your doctor, which may be days or longer, depending on what you are being treated for. Missed dose of Nizoral tablets If you miss a dose of Nizoral take it as soon as you remember with the next meal, unless it is time to take the next dose, then skip the missed dose.
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