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STARLIX (NATEGLINIDE): PRESCRIBING INFORMATION
Starlix (Nateglinide) is an oral antidiabetic agent used in the management of type 2 diabetes mellitus, also known as non-insulin dependent diabetes mellitus (NIDDM) or adult-onset
diabetes. Starlix, (-)-N-[(trans-4-isopropylcyclohexane)carbonyl]-D-phenylalanine, is structurally unrelated to the oral sulfonylurea insulin secretagogues.
Nateglinide is a white powder with a molecular weight of 317.43. It is freely soluble in methanol, ethanol, and chloroform, soluble in ether, sparingly soluble in acetonitrile and
octanol, and practically insoluble in water. Starlix biconvex tablets contain 60 mg, 120 mg, or 180 mg of nateglinide for oral administration.
Inactive Ingredients: croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, iron oxides (red or yellow), magnesium stearate, polyethylene glycol, microcrystalline cellulose, povidone, talc, and titanium dioxide.
Starlix clinical pharmacology
Starlix clinical studies
INDICATIONS AND USAGE
Starlix (Nateglinide) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Starlix (Nateglinide) is contraindicated in patients with:
1. Known hypersensitivity to the drug or its inactive ingredients.
2. Type 1 diabetes.
3. Diabetic ketoacidosis. This condition should be treated with insulin.
Starlix adverse reactions
In a clinical study in patients with type 2 diabetes, Starlix (Nateglinide) was administered in increasing doses up to 720 mg a day for 7 days and there were no clinically significant adverse events reported. There have been no instances of overdose with Starlix in clinical trials. However, an overdose may result in an exaggerated glucose-lowering effect with the development of hypoglycemic symptoms. Hypoglycemic symptoms without loss of consciousness or neurological findings should be treated with oral glucose and adjustments in dosage and/or meal patterns. 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.
DOSAGE AND ADMINISTRATION
Starlix (Nateglinide) should be taken 1 to 30 minutes prior to meals.
Monotherapy and Combination with Metformin or a Thiazolidinedione
The recommended starting and maintenance dose of Nateglinide (Starlix), alone or in combination with metformin or a thiazolidinedione, is 120 mg three times daily before meals.
The 60-mg dose of Starlix, either alone or in combination with metformin or a thiazolidinedione, may be used in patients who are near goal HbA1C when treatment is initiated.
Dosage in Geriatric Patients
No special dose adjustments are usually necessary. However, greater sensitivity of some individuals to Starlix (Nateglinide) therapy cannot be ruled out.
Dosage in Renal and Hepatic Impairment
No dosage adjustment is necessary in patients with mild-to-severe renal insufficiency or in patients with mild hepatic insufficiency. Dosing of patients with moderate-to-severe hepatic dysfunction has not been studied. Therefore, Starlix (Nateglinide) should be used with caution in patients with moderate-to-severe liver disease.
Starlix (Nateglinide) tablets
Pink, round, beveled edge tablet with "Starlix" debossed on one side and "60" on the other.
Bottles of 100
Yellow, ovaloid tablet with "Starlix" debossed on one side and "120" on the other.
Bottles of 100
Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F).
Dispense in a tight container, USP.
Manufactured and distributed by Novartis pharmaceutical company and its divisions.
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