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Nateglinide (Starlix)

Trade Name : Starlix

Novartis Pharmaceuticals Corporation

TABLET

Strength 60 mg/1

NATEGLINIDE Glinide [EPC],Potassium Channel Antagonists [MoA]

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Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Nateglinide (Starlix) which is also known as Starlix and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 60 mg/1 per ml. Read more

Nateglinide (Starlix) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • STARLIX is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  • Limitations of Use:
  • STARLIX should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
  • STARLIX (nateglinide) is a glinide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ()
  • Limitations of Use
  • The recommended dose of STARLIX is 120 mg orally three times daily before meals.
  • The recommended dose of STARLIX is 60 mg orally three times daily before meals in patients who are near glycemic goal when treatment is initiated.
  • Instruct patients to take STARLIX 1 to 30 minutes before meals.
  • In patients who skip meals, instruct patients to skip the scheduled dose of STARLIX to reduce the risk of hypoglycemia .
  • Recommended dose is 120 mg three times daily ()
  • In patients who are near glycemic goal when treatment is initiated, 60 mg three times daily may be administered. ()
  • Administer 1 to 30 minutes before meals ()
  • If a meal is skipped, skip the scheduled dose to reduce the risk of hypoglycemia. (, )
  • Tablets: 60 mg and 120 mg ()
  • STARLIX is contraindicated in patients with a history of hypersensitivity to STARLIX or its inactive ingredients.
  • History of hypersensitivity to nateglinide or its inactive ingredients ()
  • No data
  • Hypoglycemia:
  • Macrovascular Outcomes:
  • The following serious adverse reaction is also described elsewhere in the labeling:
  • To report SUSPECTED ADVERSE REACTIONS, contact Novartis at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Common adverse reactions associated with STARLIX (3% or greater incidence) were upper respiratory tract infection, back pain, flu symptoms, dizziness, arthropathy, diarrhea. ()
  • Table 2 includes a list of drugs with clinically important drug interactions when concomitantly administered or withdrawn with STARLIX and instructions for managing or preventing them.
  • Drugs That May Increase the Potential for Hypoglycemia:
  • Drugs That May Increase the Potential for Hyperglycemia:
  • Drugs That May Blunt Signs and Symptoms of Hypoglycemia:
  • No data
  • Nursing Mothers:
  • 8.3
  • 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 STARLIX is highly protein bound, dialysis is not an efficient means of removing it from the blood.
  • STARLIX (nateglinide) is an oral blood glucose-lowering drug of the glinide class. STARLIX, (-)-N-[(trans-4-isopropylcyclohexane)carbonyl]-D-phenylalanine, is structurally unrelated to the oral sulfonylurea insulin secretagogues.
  • The structural formula is as shown:
  • Nateglinide is a white powder with a molecular weight of 317.43 g/mol. 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:
  • No data
  • Carcinogenicity:
  • Mutagenesis:
  • in vitro
  • in vivo
  • Impairment of Fertility:
  • No data
  • How Supplied
  • 60 mg
  • Pink, round, beveled edge film-coated tablet with u201cSTARLIXu201d debossed on one side and u201c60u201d on the other.
  • Bottles of 100u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026.NDC 0078-0351-05
  • 120 mg
  • Yellow, ovaloid film-coated tablet with u201cSTARLIXu201d debossed on one side and u201c120u201d on the other.
  • Bottles of 100u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026.NDC 0078-0352-05
  • Storage and Handling
  • Store at 25u00baC (77u00baF); excursions permitted to 15u00baC-30u00baC (59u00baF-86u00baF). Dispense in a tight container, USP.
  • Administration
  • Instruct patients to take STARLIX 1 to 30 minutes before meals. Instruct patients that skip meals to skip their dose of STARLIX [see Dosage and Administration (2)].
  • Hypoglycemia
  • Inform patients that STARLIX can cause hypoglycemia and instruct patients and their caregivers on self-management procedures including glucose monitoring and management of hypoglycemia. Inform patients that their ability to concentrate and react may be impaired as a result of hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended [see Warnings and Precautions (5.1)].
  • Drug Interactions
  • Discuss potential drug interactions with patients and inform them of potential drug-drug interactions with STARLIX.
  • Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
  • u00a9 Novartis
  • T2018-74May 2018
  • Package Label u2013 n- 60 mg per tablet
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0351-05
  • Starlixu00ae (nateglinide) tablets
  • 60 mg per tablet
  • 100 Tablets
  • Package Label u2013 n- 120 mg per tablet
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0352-05
  • Starlixu00ae (nateglinide) tablets
  • 120 mg per tablet
  • 100 Tablets

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