Nateglinide 60 mg - Starlix Tablet (Nateglinide): Side Effects, Interactions, Warning, Dosage & Uses
The extent of serum protein binding is independent of drug concentration over the test range of 0. Metabolism Nateglinide is metabolized by the mixed-function oxidase system prior to elimination. The major routes of metabolism are hydroxylation followed by glucuronide conjugation, nateglinide 60 mg. The major metabolites are less potent antidiabetic agents than nateglinide.
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The isoprene minor metabolite possesses potency similar to that of the parent compound nateglinide. Excretion Nateglinide and its metabolites are rapidly and completely eliminated following oral administration. In all studies of nateglinide volunteers and patients nateglinide Type 2 diabetesnateglinide 60 mg, nateglinide plasma concentrations declined rapidly with an average elimination half-life of approximately 1.
Consistent with this short elimination half-life, there was no apparent accumulation of nateglinide upon multiple dosing of up to mg three times daily for 7 days, nateglinide 60 mg. Nateglinide is a potential inhibitor of the CYP2C9 isoenzyme in vivo as indicated by its ability to inhibit the in vitro metabolism of tolbutamide.
Inhibition of CYP3A4 metabolic reactions was not detected in in vitro experiments. Glyburide In a randomized, multiple-dose crossover studypatients with Type 2 diabetes were administered mg nateglinide three times a day before meals for 1 day in combination with glyburide 10 mg daily.
There were no clinically relevant alterations in the pharmacokinetics of either agent. Metformin When nateglinide mg three times daily before meals was administered in combination with metformin mg three times daily to patients with Type 2 diabetes, there were no clinically relevant changes in the pharmacokinetics of either agent, nateglinide 60 mg. Digoxin When nateglinide mg before meals was administered in combination with a single 1mg dose of digoxin to healthy volunteers, there were no clinically relevant changes in the pharmacokinetics of either agent.
Warfarin When healthy subjects were administered nateglinide mg three times daily before meals for four days in combination with a single dose of warfarin 30 mg on day 2, there were no alterations in the pharmacokinetics of either agent. Prothrombin time was not affected. Diclofenac Administration of morning and lunch doses of nateglinide mg in combination with a single 75 mg dose of diclofenac in healthy volunteers resulted in no significant changes to the pharmacokinetics of either agent.
Special Populations Geriatric Age did not influence the pharmacokinetic properties of nateglinide. Therefore, no nateglinide adjustments are necessary for elderly patients. Gender No clinically significant differences in nateglinide pharmacokinetics were observed between men and women, nateglinide 60 mg.
Therefore, no dose adjustment based on gender is necessary. Race Results of a population pharmacokinetic analysis including subjects of Caucasian, Black, and other ethnic origins suggest that race has little influence on the pharmacokinetics of nateglinide.
Patients with Type 2 diabetes and renal failure on dialysis exhibited reduced overall drug exposure. However, nateglinide 60 mg, hemodialysis patients also experienced reductions in plasma protein binding compared to the matched healthy volunteers. Nateglinide should be used with caution in patients with chronic liver disease.
Pharmacodynamics Nateglinide is rapidly absorbed and stimulates pancreatic insulin secretion within 20 minutes of oral administration, nateglinide 60 mg. When nateglinide is dosed three times daily before meals there is a rapid rise in plasma insulin, with peak levels approximately 1 hour after dosing and a buying nitroglycerin ointment to baseline by 4 hours after dosing.
In a double-blind, controlled clinical trial in which nateglinide was administered before each of three meals, plasma glucose levels were determined over a hour, daytime period after 7 weeks of treatment. Nateglinide was administered 10 minutes before meals.
Nateglinide produced statistically significant decreases in fasting and postprandial glycemia compared to placebo. Clinical Studies A total of 3, patients were randomized in nine double-blind, placebo- or nateglinide studies 8 to nateglinide weeks in duration to evaluate the safety and efficacy of nateglinide, nateglinide 60 mg.
In nateglinide studies nateglinide was administered up to 30 minutes before each of three main meals daily. Baseline HbA1C ranged from 7.
Patients previously treated nateglinide antidiabetic medications were required to discontinue that medication for at least 2 months before randomization. The addition of nateglinide before meals resulted in statistically significant reductions in mean HbA1C and mean fasting plasma glucose FPG compared to placebo see Table 1.
No patients experienced hypoglycemia that required third party assistance. Patients treated with nateglinide had statistically significant mean increases in weight compared to placebo see Table 1.
In another randomized, double-blind, week, active- and placebo-controlled study, nateglinide 60 mg, patients with Type 2 diabetes were randomized to receive nateglinide mg nateglinide times daily before mealsnateglinide 60 mg, metformin mg three times dailynateglinide 60 mg, a combination of nateglinide mg three times daily before meals and metformin mg three times dailyor placebo. Baseline HbA1C ranged from 8.
Renal Impairment No dosage adjustment is recommended in patients with mild to severe renal impairment [see Clinical Pharmacology Hepatic Impairment No dose adjustment is recommended for patients nateglinide mild hepatic impairment. Use of Nateglinide in patients with moderate-to-severe hepatic impairment has not been studied and therefore, should be used with caution in these patients [see Clinical Pharmacology Overdosage There have been no instances of overdose with Nateglinide in clinical trials, nateglinide 60 mg.
However, an overdose may result in an exaggerated glucose-lowering effect with the development of hypoglycemic symptoms.
Severe hypoglycemic reactions with coma, seizure, or other neurological symptoms should be treated with intravenous glucose. As Nateglinide is highly protein bound, dialysis is not an efficient means of removing it from the blood.
Nateglinide Description Nateglinide is an oral blood glucose-lowering drug of the glinide class. Nateglinide, - -N-[ trans isopropylcyclohexane carbonyl]-D-phenylalanine, is structurally unrelated to the oral sulfonylurea insulin secretagogues. The structural formula is as shown: Nateglinide, USP is a white powder with a molecular weight of It is freely soluble in methanol and alcohol, nateglinide 60 mg, soluble in ether, sparingly soluble in acetonitrile and octanol, practically insoluble in water, nateglinide 60 mg.
In addition, nateglinide 60 mg, each tablet contains the following inactive ingredients: Additionally, each mg tablet nateglinide iron nateglinide red and iron oxide yellow. Nateglinide - Clinical Pharmacology Mechanism of Action Nateglinide lowers blood glucose levels by nateglinide insulin secretion from the pancreas.
This action is dependent upon functioning beta-cells in the pancreatic islets.
Nateglinide
The subsequent depolarization of the beta cell opens the calcium channel, producing calcium influx and insulin secretion. The extent of insulin release is glucose dependent and diminishes at low glucose levels.
Nateglinide is highly tissue selective with low affinity for heart and skeletal muscle. Pharmacodynamics Nateglinide stimulates pancreatic insulin secretion within 20 minutes of oral administration.
When Nateglinide is dosed before meals, nateglinide 60 mg, the peak rise in plasma insulin occurs approximately 1 hour after dosing and falls to baseline by 4 hours after dosing. Pharmacokinetics In patients with Type 2 diabetes, multiple dose administration of Nateglinide over the dosage range of 60 mg to mg shows linear pharmacokinetics for both AUC and Cmax.
In patients with Type 2 diabetes, nateglinide 60 mg, there is no apparent accumulation of Nateglinide upon multiple dosing of up to mg three times daily for 7 days.
Plasma profiles are characterized by multiple plasma concentration peaks nateglinide Nateglinide is administered under fasting conditions. This effect is diminished when Nateglinide is taken prior to a meal.
Following oral administration immediately prior to a meal, nateglinide 60 mg, the mean peak plasma Nateglinide concentrations Cmax generally occur within 1 hour Tmax after dosing. Tmax is independent of dose. The pharmacokinetics of Nateglinide are not affected by the composition of a meal high protein, fat, or carbohydrate. However, peak plasma levels are significantly reduced when Nateglinide is administered 10 minutes prior to a liquid meal as compared to solid meal.
When given with or after meals, nateglinide 60 mg, the extent of Nateglinide absorption AUC remains unaffected. Nateglinide tablets did not have any effect on gastric emptying in healthy subjects as assessed by acetaminophen nateglinide. Distribution Following intravenous IV administration of Nateglinide, the steady-state volume of distribution of Nateglinide is estimated to be approximately 10 L in healthy subjects.
The extent of serum protein binding is independent of drug concentration over nateglinide test range of 0.
Elimination In healthy volunteers and patients with type 2 diabetes mellitus, Nateglinide plasma concentrations declined with an average elimination half-life of approximately 1, nateglinide 60 mg. The major routes of metabolism are hydroxylation followed by glucuronide conjugation.
The major metabolites are less potent antidiabetic agents than Nateglinide. nateglinide
The isoprene minor metabolite possesses potency similar to that of the parent compound Nateglinide. Excretion Nateglinide and its metabolites are rapidly and completely eliminated following oral administration, nateglinide 60 mg.
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