Some of these cases had neither pre-existing liver disease nor a serious underlying medical condition, and some of these cases developed within the first week of treatment. Based on an oral radiolabeled dose, fecal excretion of unchanged drug ranges from 3% to 18% of the dose.As re-distribution of Itraconazole from keratinous tissues appears to be negligible, elimination of Itraconazole from these tissues is related to epidermal regeneration. The absorption of Itraconazole may be decreased with the concomitant administration of antacids or gastric acid secretion suppressors. 'What is the most important information I should know about itraconazole capsules?Before taking itraconazole capsules, tell your healthcare provider about all of your medical conditions, including if you: What should I avoid while taking itraconazole capsules? This site needs JavaScript to work properly. Doses above 200 mg/day should be given in two divided doses.In life-threatening situations, a loading dose should be used.Treatment should be continued for a minimum of three months and until clinical parameters and laboratory tests indicate that the active fungal infection has subsided. It is recommended that liver function monitoring be done in patients with pre-existing hepatic function abnormalities or those who have experienced liver toxicity with other medications. Studies conducted under fasted conditions demonstrated that administration with 8 ounces of a non-diet cola beverage resulted in increased absorption of Itraconazole in AIDS patients with relative or absolute achlorhydria. (See Adverse event data were derived from 602 patients treated for systemic fungal disease in U.S. clinical trials who were immunocompromised or receiving multiple concomitant medications. Itraconazole is an inhibitor of the drug transporters P-glycoprotein and breast cancer resistance protein (BCRP). Consequently, ItraconazoleAlthough many of the clinical drug interactions in Table 1 are based on information with a similar azole antifungal, ketoconazole, these interactions are expected to occur with Itraconazole.Itraconazole is mainly metabolized through CYP3A4. This increase relative to the effects of a full meal is unknown. Heart problems and other serious medical problems.Do not take Itraconazole capsules if you also take the following medicines:Stop taking Itraconazole capsules and call your healthcare provider right away if you have any of these symptoms of liver problems:"What are the possible side effects of Itraconazole capsules?
Adverse events infrequently reported in all studies included constipation, gastritis, depression,insomnia, tinnitus, menstrual disorder, adrenal insufficiency, gynecomastia, and male breast pain.Patients in these trials were on a continuous dosing regimen of 200 mg once daily for 12 consecutive weeks.The following adverse events led to temporary or permanent discontinuation of therapy.The following adverse events occurred with an incidence of greater than or equal to 1% (N=112):headache: 10%; rhinitis: 9%; upper respiratory tract infection: 8%; sinusitis, injury: 7%; diarrhea,dyspepsia, flatulence, abdominal pain, dizziness, rash: 4%; cystitis, urinary tract infection, liver function abnormality, myalgia, nausea: 3%; appetite increased, constipation, gastritis, gastroenteritis, pharyngitis, asthenia, fever, pain, tremor, herpes zoster, abnormal dreaming: 2%.Adverse Events Reported in Fingernail Onychomycosis Clinical TrialsPatients in these trials were on a course regimen consisting of two 1-week treatment periods of 200 mg twice daily, separated by a 3-week period without drug.The following adverse events led to temporary or permanent discontinuation of therapy.The following adverse events occurred with an incidence of greater than or equal to 1% (N=37): headache: 8%; pruritus, nausea, rhinitis: 5%; rash, bursitis, anxiety, depression, constipation, abdominal pain, dyspepsia, ulcerative stomatitis, gingivitis, hypertriglyceridemia, sinusitis, fatigue, malaise, pain, injury: 3%.In addition, the following adverse drug reaction was reported in patients who participated in itraconazole capsules clinical trials: Hepatobiliary Disorders: hyperbilirubinemia.The following is a list of additional adverse drug reactions associated with itraconazole that have been reported in clinical trials of itraconazole oral solution and itraconazole IV excluding the adverse reaction term “Injection site inflammation” which is specific to the injection route of administration:Cardiac Disorders: cardiac failure, left ventricular failure, tachycardia;General Disorders and Administration Site Conditions: face edema, chest pain, chills;Hepatobiliary Disorders: hepatic failure, jaundice;Investigations: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, blood urea increased, gamma-glutamyltransferase increased, urine analysis abnormal;Metabolism and Nutrition Disorders: hyperglycemia, hyperkalemia, hypomagnesemia;Respiratory, Thoracic and Mediastinal Disorders: dysphonia, cough;Skin and Subcutaneous Tissue Disorders: rash erythematous, hyperhidrosis;Adverse drug reactions that have been first identified during post-marketing experience with itraconazole capsules (all formulations) are listed in the table below. doi: 10.1111/j.1365-2125.2006.02613.x. Some of these cases had neither pre-existing liver disease nor a serious underlying medical condition.
(See CLINICAL PHARMACOLOGY: Special Populations, WARNINGS, and PRECAUTIONS. Itraconazole has been shown to cross the placenta in a rat model. In post-marketing experience, heart failure was more frequently reported in patients receiving a total daily dose of 400 mg although there were also cases reported among those receiving lower total daily doses.Calcium channel blockers can have negative inotropic effects which may be additive to those of Itraconazole. Do not drive or operate machinery until you know how itraconazole capsules affects you. A statistically significant reduction in mean CWhen Itraconazole was administered intravenously to anesthetized dogs, a dose-related negative inotropic effect was documented.
Adverse events infrequently reported in all studies included constipation, gastritis, depression,insomnia, tinnitus, menstrual disorder, adrenal insufficiency, gynecomastia, and male breast pain.Patients in these trials were on a continuous dosing regimen of 200 mg once daily for 12 consecutive weeks.The following adverse events led to temporary or permanent discontinuation of therapy.The following adverse events occurred with an incidence of greater than or equal to 1% (N=112):headache: 10%; rhinitis: 9%; upper respiratory tract infection: 8%; sinusitis, injury: 7%; diarrhea,dyspepsia, flatulence, abdominal pain, dizziness, rash: 4%; cystitis, urinary tract infection, liver function abnormality, myalgia, nausea: 3%; appetite increased, constipation, gastritis, gastroenteritis, pharyngitis, asthenia, fever, pain, tremor, herpes zoster, abnormal dreaming: 2%.Adverse Events Reported in Fingernail Onychomycosis Clinical TrialsPatients in these trials were on a course regimen consisting of two 1-week treatment periods of 200 mg twice daily, separated by a 3-week period without drug.The following adverse events led to temporary or permanent discontinuation of therapy.The following adverse events occurred with an incidence of greater than or equal to 1% (N=37): headache: 8%; pruritus, nausea, rhinitis: 5%; rash, bursitis, anxiety, depression, constipation, abdominal pain, dyspepsia, ulcerative stomatitis, gingivitis, hypertriglyceridemia, sinusitis, fatigue, malaise, pain, injury: 3%.In addition, the following adverse drug reaction was reported in patients who participated in itraconazole capsules clinical trials: Hepatobiliary Disorders: hyperbilirubinemia.The following is a list of additional adverse drug reactions associated with itraconazole that have been reported in clinical trials of itraconazole oral solution and itraconazole IV excluding the adverse reaction term “Injection site inflammation” which is specific to the injection route of administration:Cardiac Disorders: cardiac failure, left ventricular failure, tachycardia;General Disorders and Administration Site Conditions: face edema, chest pain, chills;Hepatobiliary Disorders: hepatic failure, jaundice;Investigations: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, blood urea increased, gamma-glutamyltransferase increased, urine analysis abnormal;Metabolism and Nutrition Disorders: hyperglycemia, hyperkalemia, hypomagnesemia;Respiratory, Thoracic and Mediastinal Disorders: dysphonia, cough;Skin and Subcutaneous Tissue Disorders: rash erythematous, hyperhidrosis;Adverse drug reactions that have been first identified during post-marketing experience with itraconazole capsules (all formulations) are listed in the table below. doi: 10.1111/j.1365-2125.2006.02613.x. Some of these cases had neither pre-existing liver disease nor a serious underlying medical condition.
(See CLINICAL PHARMACOLOGY: Special Populations, WARNINGS, and PRECAUTIONS. Itraconazole has been shown to cross the placenta in a rat model. In post-marketing experience, heart failure was more frequently reported in patients receiving a total daily dose of 400 mg although there were also cases reported among those receiving lower total daily doses.Calcium channel blockers can have negative inotropic effects which may be additive to those of Itraconazole. Do not drive or operate machinery until you know how itraconazole capsules affects you. A statistically significant reduction in mean CWhen Itraconazole was administered intravenously to anesthetized dogs, a dose-related negative inotropic effect was documented.