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Absorption: Rosiglitazone is rapidly and completely absorbed after oral administration with negligible first-pass metabolism. The absolute bioavailability of rosiglitazone is 99%. Peak plasma concentrations are observed by 1 hour after dosing. Administration of rosiglitazone with food resulted in no change in overall exposure AUC ; but there was a decrease in the Cmax about 28% ; and a delay in Tmax of 1.75 hours. These changes are not likely to be clinically significant and AVANDIA may be administered with or without food. Distribution: The mean SD ; volume of distribution Vss ; of rosiglitazone after intravenous administration to healthy subjects is approximately 14.1 3.1 ; litres. Rosiglitazone is approximately 99.8% bound to plasma proteins, primarily albumin. Metabolism: Rosiglitazone is extensively metabolized with no unchanged drug excreted in the urine. The major routes of metabolism were N-demethylation and hydroxylation, followed by conjugation with sulfate and glucuronic acid. All the circulating metabolites are considerably less potent than the parent drug and, therefore, are not expected to contribute to the insulinsensitizing activity of rosiglitazone. In vitro data demonstrate that rosiglitazone is predominantly metabolized by Cytochrome P450 CYP ; isoenzyme 2C8, with CYP2C9 contributing as only a minor pathway. Excretion: Following oral or intravenous administration of [14C]rosiglitazone maleate, approximately 64% and 23% of the dose was eliminated in the urine and in the feces, respectively. The plasma half-life of [14C] related material ranged from 103 to 158 hours. Special Populations and Conditions Population pharmacokinetic analyses from three Phase III trials including 642 men and 405 women with type 2 diabetes aged 35 to 80 years ; showed that the pharmacokinetics of rosiglitazone are not influenced by age, race, smoking, or alcohol consumption. Both oral clearance CL F ; and oral steady-state volume of distribution Vss F ; were shown to increase and bactroban.
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Rezult avandia generic , rosiglitazone ; used along with diet and exercise to treat people with type 2 diabetes mellitus, alone or in combination with other drugs and baycol.

Therapy with AVANDIA in patients with mild liver enzyme elevations should proceed with caution and include close clinical follow-up, including more frequent liver enzyme monitoring, to determine if the liver enzyme elevations resolve or worsen. If at any time ALT levels increase to 3X the upper limit of normal in patients on therapy with AVANDIA, liver enzyme levels should be rechecked as soon as possible. If ALT levels remain 3X the upper limit of normal, therapy with AVANDIA should be discontinued. If any patient develops symptoms suggesting hepatic dysfunction, which may include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia and or dark urine, liver enzymes should be checked. The decision whether to continue the patient on therapy with AVANDIA should be guided by clinical judgement pending laboratory evaluations. If jaundice is observed, drug therapy should be discontinued. There are no data available from clinical trials to evaluate the safety of AVANDIA in patients who experienced liver abnormalities, hepatic dysfunction, or jaundice while on troglitazone. AVANDIA should not be used in patients who experienced jaundice while taking troglitazone. Laboratory Tests: Periodic fasting blood glucose and HbA1c measurements should be performed to monitor therapeutic response. Liver enzyme monitoring is recommended prior to initiation of therapy with AVANDIA in all patients and periodically thereafter see PRECAUTIONS, General, Hepatic Effects and ADVERSE REACTIONS, Laboratory Abnormalities, Serum Transaminase Levels ; . Information for Patients: Patients should be informed of the following: Management of type 2 diabetes should include diet control. Caloric restriction, weight loss, and exercise are essential for the proper treatment of the diabetic patient because they help improve insulin sensitivity. This is important not only in the primary treatment of type 2 diabetes, but in maintaining the efficacy of drug therapy. It is important to adhere to dietary instructions and to regularly have blood glucose and glycosylated hemoglobin tested. Patients should be advised that it can take 2 weeks to see a reduction in blood glucose and 2 to 3 months to see full effect. Patients should be informed that blood will be drawn to check their liver function prior to the start of therapy and periodically thereafter per the clinical judgement of the healthcare professional. Patients with unexplained symptoms of nausea, vomiting, abdominal pain, fatigue, anorexia, or dark urine should immediately report these symptoms to their physician. Patients who experience an unusually rapid increase in weight or edema or who develop shortness of breath or other symptoms of heart failure while on AVANDIA should immediately report these symptoms to their physician. AVANDIA can be taken with or without meals. When using AVANDIA in combination with other hypoglycemic agents, the risk of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be explained to patients and their family members. Therapy with AVANDIA, like other thiazolidinediones, may result in ovulation in some premenopausal anovulatory women. As a result, these patients may be at an increased risk for pregnancy while taking AVANDIA see PRECAUTIONS, Pregnancy, Pregnancy Category C ; . 19. AVANDIA 809m $1.2bn Metabolic & gastro-intestinal A member of the newest class of oral treatments for type 2 diabetes and buspar.
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