pharmacopeia
GET
/api/v1/drug/nateglinide

Mechanism of action

Sourced from openFDA

Nateglinide lowers blood glucose levels by stimulating insulin secretion from the pancreas. This action is dependent upon functioning beta-cells in the pancreatic islets.

Insulin ReceptorPotassium Channel

Indications

Sourced from openFDA
  • Nateglinide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: Nateglinide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.ICD-10: E10.9, E11.9

Contraindications

Sourced from openFDA
  • Nateglinide tablets are contraindicated in patients with a history of hypersensitivity to nateglinide or its inactive ingredients.contraindicated

Dosage & administration

Sourced from openFDA

The recommended dose of nateglinide is 120 mg orally three times daily before meals. The recommended dose of nateglinide is 60 mg orally three times daily before meals in patients who are near glycemic goal when treatment is initiated. Instruct patients to take nateglinide 1 to 30 minutes before meals. In patients who skip meals, instruct patients to skip the scheduled dose of nateglinide to reduce the risk of hypoglycemia [see Warnings and Precautions (5.1)] . Recommended dose is 120 mg three times daily (2) In patients who are near glycemic goal when treatment is initiated, 60 mg three times daily may be administered. (2) Administer 1 to 30 minutes before meals (2) If a meal is skipped, skip the scheduled dose to reduce the risk of hypoglycemia. (2, 5.1)

Warnings & precautions

Sourced from openFDA

Hypoglycemia: Nateglinide may cause hypoglycemia. Administer before meals to reduce the risk of hypoglycemia. Skip the scheduled dose of nateglinide if a meal is skipped to reduce the risk of hypoglycemia. (5.1) Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with nateglinide. (5.2) 5.1 Hypoglycemia All glinides, including nateglinide, can cause hypoglycemia [see Adverse Reactions (6.1)] . Severe hypoglycemia can cause seizures, may be life-threatening, or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery). Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic neuropathy (nerve disease), in patients using medications that block the sympathetic nervous system (e.g., beta-blockers) [see Drug Interactions (7)] , or in patients who experience recurrent hypoglycemia. Factors which may increase the risk of hypoglycemia include changes in meal pattern (e.g., macronutrient content), changes in level of physical activity, changes to coadministered medication [see Drug Interactions (7)] , and concomitant use with other antidiabetic agents.

Adverse reactions

Sourced from openFDA

The following serious adverse reaction is also described elsewhere in the labeling: Hypoglycemia [see Warnings and Precautions (5.1)] Common adverse reactions associated with nateglinide (3% or greater incidence) were upper respiratory tract infection, back pain, flu symptoms, dizziness, arthropathy, diarrhea. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Strides Pharma Inc at 1-877-244-9825 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, approximately 2,600 patients with type 2 diabetes mellitus were treated with nateglinide. Of these, approximately 1,335 patients were treated for 6 months or longer and approximately 190 patients for one year or longer. Table 1 shows the most common adverse reactions associated with nateglinide.

Use in specific populations

Sourced from openFDA

Lactation: Nateglinide is not recommended when breastfeeding (8.2) 8.1 Pregnancy Risk Summary The available data from published literature and the applicant's pharmacovigilance with use of nateglinide in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy ( see Clinical Considerations ). Nateglinide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In animal reproduction studies, there was no teratogenicity in rats and rabbits administered oral nateglinide during organogenesis at approximately 27 and 8 times the maximum recommended human dose (MRHD), respectively, based on body surface area (BSA). The estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with a HbA1c > 7 and has been reported to be as high as 20% to 25% in women with a HbA1c > 10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Pharmacokinetics

Sourced from openFDA
Metabolism
In patients with Type 2 diabetes, multiple dose administration of nateglinide over the dosage range of 60 mg to 240 mg shows linear pharmacokinetics for both area under the curve (AUC) and C max . In patients with Type 2 diabetes, there is no apparent accumulation of nateglinide upon multiple dosing of up to 240 mg three times daily for 7 days.

Overdosage

Sourced from openFDA

There have been no instances of overdose with nateglinide 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.

Approval history

Sourced from openFDA
  • Sep 9, 2009ANDAANDA077463Strides Pharma Intl
  • Sep 9, 2009ANDAANDA077461Dr Reddys Labs Ltd
  • Jul 6, 2016ANDAANDA205248Zydus Pharms
  • Jun 18, 2018ANDAANDA205544Rising
  • Apr 19, 2019ANDAANDA206432Cadila Pharms Ltd

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
1,329 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Blood Glucose Increased765.7%
  2. 2Diarrhoea654.9%
  3. 3Drug Ineffective654.9%
  4. 4Dyspnoea644.8%
  5. 5Fatigue584.4%
  6. 6Nausea574.3%
  7. 7Renal Failure513.8%
  8. 8Death483.6%
  9. 9Decreased Appetite473.5%
  10. 10Vomiting443.3%
  11. 11Dizziness433.2%
  12. 12Chronic Kidney Disease413.1%
  13. 13Acute Kidney Injury382.9%
  14. 14Lactic Acidosis372.8%
  15. 15Hypoglycaemia362.7%

Literature

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Recent PubMed references pinned to Nateglinide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 24 ClinicalTrials.gov registrations naming Nateglinide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Nateglinide work?
Nateglinide lowers blood glucose levels by stimulating insulin secretion from the pancreas. This action is dependent upon functioning beta-cells in the pancreatic islets.
What is Nateglinide used for?
According to FDA labeling, Nateglinide carries indications including: Nateglinide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: Nateglinide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Nateglinide?
Nateglinide is classified as Other blood glucose lowering drugs, excl. insulins, Glinide, Insulin Receptor Agonists, Potassium Channel Antagonists, Increased Insulin Secretion.
What are the contraindications for Nateglinide?
Nateglinide labeling lists contraindications including: Nateglinide tablets are contraindicated in patients with a history of hypersensitivity to nateglinide or its inactive ingredients.. Always consult the full prescribing information and a clinician.
Note. Data for nateglinide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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