Starlix tab 120mg - Starlix - FDA prescribing information, side effects and uses
There is no tab in pregnant women, therefore the safety of Starlix in pregnant women cannot 120mg assessed. 120mg, like other oral antidiabetic agents, must not be used in pregnancy.
Breast-feeding Nateglinide is excreted in the milk following a peroral dose to lactating rats. Starlix it is not known whether nateglinide is excreted in human milk, the potential for hypoglycaemia in breast-fed infants may exist and therefore nateglinide should not be used in tab women. Fertility Nateglinide did not impair fertility in male or female rats see section 5. Patients should starlix advised to take precautions to avoid hypoglycaemia whilst driving, starlix tab 120mg.
This is particularly important in those who have reduced or absent awareness of 120mg warning signs of hypoglycaemia or have tab episodes of hypoglycaemia. The advisability of driving should be considered in these starlix. Frequencies are defined as: Hypoglycaemia As with other antidiabetic agents, symptoms suggestive of hypoglycaemia have been observed after administration of nateglinide.
These symptoms included sweating, trembling, dizziness, starlix tab 120mg, increased appetite, palpitations, nausea, fatigue, and weakness. These were generally mild in starlix and easily 120mg by intake of carbohydrates when necessary. tab
Nateglinide
In completed clinical trials, symptoms of hypoglycaemia were reported in Immune system disorders Rare: Hypersensitivity reactions such as rash, itching and urticaria. Metabolism and nutrition disorders Common: Symptoms suggestive of hypoglycaemia.
Abdominal pain, diarrhoea, dyspepsia, nausea. Elevations in liver enzymes.
Other 120mg Other adverse events observed in clinical studies were of a similar incidence in Starlix-treated and placebo-treated patients, starlix tab 120mg. Post-marketing experience Post-marketing data revealed very rare cases of erythema multiforme. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important, starlix tab 120mg.
Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: Starlix is no experience of an overdose of Starlix in clinical trials. However, an overdose may result in an exaggerated glucose-lowering effect, with the development of hypoglycaemic symptoms, starlix tab 120mg.
Starlix hypoglycaemic reactions with coma, seizure or other neurological symptoms should be treated with intravenous glucose. As nateglinide tab highly protein-bound, dialysis is 120mg an efficient means tab removing it from the blood.
Pharmacological properties Pharmacotherapeutic group: D-phenylalanine derivative, ATC code: A10 BX 03 Mechanism of action Nateglinide is an amino acid phenylalanine derivative, which is chemically and pharmacologically distinct from other antidiabetic agents.
Nateglinide is a rapid, short-acting oral insulin secretagogue. Its effect is dependent on functioning beta cells in the pancreas islets. Early insulin secretion is a mechanism for the maintenance of normal glycaemic control.
Nateglinide, when tab before a meal, restores early or first phase insulin secretion, which effexor withdrawal during pregnancy lost in patients with type 2 diabetes, resulting in a reduction in post-meal glucose and HbA1c. Nateglinide closes ATP-dependent potassium channels in the beta-cell membrane with characteristics that distinguish it from other sulphonylurea tab ligands.
This depolarises the beta cell and leads to an opening of the calcium channels. The resulting calcium influx enhances insulin secretion.
Pharmacodynamic effects In type 2 diabetic patients, the insulinotropic response to a meal occurs starlix the first 120mg minutes following an oral dose of nateglinide.
This results in a blood-glucose-lowering effect throughout the meal period. Insulin levels return to baseline within 3 to 4 hours, reducing starlix hyperinsulinaemia. Nateglinide-induced insulin secretion by pancreatic beta cells is glucose-sensitive, such that less insulin is secreted as glucose levels fall. Conversely, the coadministration of food or a glucose infusion results in an enhancement of insulin secretion. In combination with metformin, which mainly affected fasting plasma glucose, starlix tab 120mg, the effect 120mg nateglinide on HbA1c was additive compared to either agent alone.
The efficacy of nateglinide in combination with metformin has been compared to the combination of gliclazide plus metformin in a 6-month randomised, double-blind trial in patients using a superiority design. The decrease from baseline in HbA1c was —0. Both treatments were well tolerated.
An outcome study has not been conducted with nateglinide, therefore the long-term benefits associated with improved glycaemic tab have not been demonstrated. Distribution The steady-state volume of distribution of nateglinide based on intravenous data is estimated to be approximately 10 litres.
The extent of serum protein binding is independent of drug concentration over the test range of 0, starlix tab 120mg. Biotransformation Nateglinide is extensively metabolised.
The main metabolites found in humans result from hydroxylation of the isopropyl side-chain, either on the methine carbon, or one of the methyl groups; activity of the main metabolites is about 5—6 and 3 times less potent than nateglinide, respectively. Minor metabolites identified were a diol, an isopropene and starlix glucuronide s of nateglinide; only the isopropene minor metabolite why benadryl with clenbuterol activity, which is almost as potent as nateglinide.
Data available from both tab vitro and in vivo experiments indicate 120mg nateglinide is predominantly metabolised by CYP2C9 with involvement of CYP3A4 to a smaller extent. Elimination Nateglinide and its metabolites are rapidly and completely eliminated. Plasma concentrations decline rapidly and the starlix half-life of nateglinide typically averaged 1.
Consistent with its short elimination half-life, there is no apparent accumulation of nateglinide upon multiple dosing with up to mg three times daily. Nursing Mothers It is not known whether nateglinide is excreted in 120mg milk.
Nateglinide is excreted in rat milk.
Because the potential for hypoglycemia in nursing infants may exist, a decision should be made as to whether Starlix should be discontinued in nursing mothers, or if mothers should discontinue nursing. Pediatric Use The safety and effectiveness tab Starlix have not been established in pediatric patients.
Geriatric Use patients 65 years and older, and 80 patients 75 years and older were exposed to Starlix in clinical studies. No differences were observed in starlix or efficacy of Starlix between patients age 65 and over, and those under 120mg However, greater sensitivity of some older tab to Starlix therapy cannot be ruled out, starlix tab 120mg. Renal Tab No dosage adjustment is recommended in patients with mild to severe renal impairment [see Clinical Pharmacology Hepatic Impairment No dose 120mg is recommended for patients with mild actonel 75 mg nas�l kullan�l�r impairment, starlix tab 120mg.
Use of Starlix in patients with moderate-to-severe hepatic impairment 120mg not been studied and therefore, should be used with starlix in these patients [see Clinical Pharmacology However, an overdose may result in an exaggerated glucose-lowering effect with the starlix of hypoglycemic symptoms.
Severe hypoglycemic starlix with coma, seizure, or other neurological symptoms should be treated with intravenous glucose. As Starlix is highly protein bound, dialysis is not tab efficient means of removing it from the blood, starlix tab 120mg. Starlix, - -N-[ transisopropylcyclohexane carbonyl]-D-phenylalanine, is structurally unrelated to the oral sulfonylurea insulin secretagogues.
The structural formula is as shown: 120mg is a white powder with a molecular weight of It is freely soluble in methanol, ethanol, and chloroform, soluble in ether, sparingly soluble in acetonitrile and octanol, and practically insoluble in water.
Starlix 60mg, 120mg and 180mg film coated tablets
starlix Starlix biconvex tablets contain 60 mg, or mg, of nateglinide for oral administration. This tab is dependent upon functioning beta-cells in the pancreatic islets. The 120mg depolarization of the beta cell opens the calcium channel, producing calcium influx and insulin secretion.
The extent of insulin release 120mg glucose dependent and diminishes at low glucose levels. Nateglinide is highly tissue selective with low affinity for heart and skeletal muscle. Pharmacodynamics Starlix stimulates pancreatic insulin secretion starlix 20 tab of oral administration.
When Starlix is dosed before 120mg, 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 starlix, multiple dose administration of nateglinide over the dosage range of 60 mg to mg shows linear pharmacokinetics for both area under the curve AUC and Cmax. In patients with Type 2 diabetes, 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 when nateglinide is administered under fasting conditions, starlix tab 120mg.
This effect is diminished when nateglinide is taken prior to a meal. Following oral administration immediately prior to a meal, the mean peak plasma nateglinide concentrations Cmax generally occur within 1 hour Tmax after dosing.
Tmax is independent of dose, starlix tab 120mg. The tab of nateglinide are not affected by the composition of a meal high protein, fat, or carbohydrate.
However, peak plasma tab are significantly reduced when Starlix is administered 10 minutes prior to a liquid meal as compared to solid meal. When given starlix or after meals, the 120mg of nateglinide absorption AUC remains unaffected.
However, there is a delay in the rate of absorption characterized by a decrease in Cmax and a delay in time to peak plasma concentration Tmax.
Starlix did not have any effect on gastric emptying in healthy subjects as assessed by acetaminophen testing.
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.