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STARLIX (NATEGLINIDE) TABLETS: PRESCRIBING INFORMATION

DESCRIPTION

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-4isopropylcyclohexane) 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, or 120 mg, of nateglinide for oral administration.

Inactive Ingredients: croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl methylcellulose, iron oxides (red or yellow), magnesium stearate, lactose monohydrate, microcrystalline cellulose, povidone, polyethylene glycol, talc, titanium dioxide.


CLINICAL PHARMACOLOGY

Starlix clinical pharmacology


PHARMACOKINETICS

Starlix pharmacokinetics


PHARMACOKINETICS IN SPECIAL POPULATIONS

Starlix pharmacokinetics in special populations


DRUG INTERACTIONS

Starlix drug interactions


CLINICAL STUDIES

Starlix clinical studies


CLINICAL STUDIES FOR COMBINATION THERAPY

Starlix clinical studies for combination therapy


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.


CONTRAINDICATIONS

Starlix (Nateglinide) antidiabetic pills are contraindicated in patients with:

  • Type 1 diabetes.
  • Diabetic ketoacidosis. This condition should be treated with insulin.
  • Known hypersensitivity to the drug or its inactive ingredients.


    PRECAUTIONS

    Starlix precautions


    DRUG-DRUG INTERACTIONS

    Starlix drug-drug interactions


    INFORMATION FOR PATIENTS

    Patients should be informed of the potential risks and benefits of Nateglinide (Starlix) tablets and of alternative modes of therapy. The risks and management of hypoglycemia should be explained. Patients should be instructed to take Starlix 1 to 30 minutes before ingesting a meal, but to skip their scheduled dose if they skip the meal so that the risk of hypoglycemia will be reduced. Drug interactions should be discussed with patients. Patients should be informed of potential drug-drug interactions with Starlix.


    NONCLINICAL TOXICOLOGY

    Starlix nonclinical toxicology


    USE IN SPECIFIC POPULATIONS

    Starlix use in specific populations


    ADVERSE REACTIONS

    Starlix adverse reactions


    OVERDOSAGE

    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 dosage and administration


    HOW SUPPLIED, STORAGE AND HANDLING

    Starlix (Nateglinide) 60 mg tablets

    Pink, round, beveled edge tablet with "STARLIX" debossed on one side and "60" on the other. Bottles of 100.

    Starlix (Nateglinide) 120 mg tablets

    Yellow, ovaloid tablet with "STARLIX" debossed on one side and "120" on the other. Bottles of 100.

    Storage

    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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