nateglinide 120 MG Oral Tablet

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Clinical drug

nateglinide 120 MG Oral Tablet

120 MG · Oral Tablet · oral

A form of nateglinide →

nateglinide 120 MG Oral Tablet — Other blood glucose lowering drugs, excl. insulins. INDICATIONS AND USAGE Nateglinide Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2…

nateglinide 120 MG Oral Tablet

Active ingredient

Classification

Other blood glucose lowering drugs, excl. insulinsGlinide

Drug interactions

Nateglinide has several clinically significant drug interactions that can affect blood glucose levels.

  • moderateNSAIDs — May increase the blood-glucose-lowering effect of nateglinide and susceptibility to hypoglycemia.
  • moderatesalicylates — May increase the blood-glucose-lowering effect of nateglinide and susceptibility to hypoglycemia.
  • moderatemonoamine oxidase inhibitors — May increase the blood-glucose-lowering effect of nateglinide and susceptibility to hypoglycemia.
  • moderatenon-selective beta-adrenergic-blocking agents — May increase the blood-glucose-lowering effect of nateglinide and susceptibility to hypoglycemia.
  • moderateanabolic hormones (e.g., methandrostenolone) — May increase the blood-glucose-lowering effect of nateglinide and susceptibility to hypoglycemia.
  • moderateguanethidine — May increase the blood-glucose-lowering effect of nateglinide and susceptibility to hypoglycemia.
  • moderategymnema sylvestre — May increase the blood-glucose-lowering effect of nateglinide and susceptibility to hypoglycemia.
  • moderateglucomannan — May increase the blood-glucose-lowering effect of nateglinide and susceptibility to hypoglycemia.
  • moderatethioctic acid — May increase the blood-glucose-lowering effect of nateglinide and susceptibility to hypoglycemia.
  • moderateCYP2C9 inhibitors (e.g., amiodarone, fluconazole, voriconazole, sulfinpyrazone) — May increase the blood-glucose-lowering effect of nateglinide and susceptibility to hypoglycemia.
  • moderatealcohol — May increase the blood-glucose-lowering effect of nateglinide and susceptibility to hypoglycemia.
  • moderatethiazides — May reduce the blood-glucose-lowering effect of nateglinide and increase susceptibility to hyperglycemia.
  • moderatecorticosteroids — May reduce the blood-glucose-lowering effect of nateglinide and increase susceptibility to hyperglycemia.
  • moderatethyroid products — May reduce the blood-glucose-lowering effect of nateglinide and increase susceptibility to hyperglycemia.
  • moderatesympathomimetics — May reduce the blood-glucose-lowering effect of nateglinide and increase susceptibility to hyperglycemia.
  • moderatesomatropin — May reduce the blood-glucose-lowering effect of nateglinide and increase susceptibility to hyperglycemia.
  • moderatesomatostatin analogues (e.g., lanreotide, octreotide) — May reduce the blood-glucose-lowering effect of nateglinide and increase susceptibility to hyperglycemia.
  • moderateCYP inducers (e.g., rifampin, phenytoin, St John's Wort) — May reduce the blood-glucose-lowering effect of nateglinide and increase susceptibility to hyperglycemia.
  • unknownbeta-blockers — May blunt signs and symptoms of hypoglycemia.
  • unknownclonidine — May blunt signs and symptoms of hypoglycemia.
  • unknownguanethidine — May blunt signs and symptoms of hypoglycemia.
  • unknownreserpine — May blunt signs and symptoms of hypoglycemia.

Indications

INDICATIONS AND USAGE Nateglinide Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use : Nateglinide Tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Nateglinide Tablets are a glinide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use : Not for treating type 1 diabetes mellitus or diabetes ketoacidosis ( 1 )

Dosage

DOSAGE & ADMINISTRATION The recommended dose of nateglinide tablets is 120 mg orally three times daily before meals. The recommended dose of nateglinide tablets 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 tablets 1 to 30 minutes before meals. In patients who skip meals, instruct patients to skip the scheduled dose of nateglinide tablets 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

WARNINGS AND PRECAUTIONS Hypoglycemia : Nateglinide Tablets may cause hypoglycemia. Administer before meals to reduce the risk of hypoglycemia. Skip the scheduled dose of Nateglinide Tablets 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 Tablets. ( 5.2 ) 5.1 Hypoglycemia All glinides, including Nateglinide Tablets, 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. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia [see Use in Specific Populations ( 8.6 , 8.7 ), Clinical Pharmacology (12.3) ] . Patients should take Nateglinide Tablets before meals and be instructed to skip the dose of Nateglinide Tablets if a meal is skipped [see Dosage and Administration (2) ] . Patients and caregivers must be educated to recognize and manage hypoglycemia. Self-monitoring of blood glucose plays an essential role in the prevention and management 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. 5.2 Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Nateglinide Tablets.

Contraindications

CONTRAINDICATIONS Nateglinide Tablets are contraindicated in patients with a history of hypersensitivity to Nateglinide Tablets or its inactive ingredients. History of hypersensitivity to nateglinide or its inactive ingredients ( 4 )

Mechanism of action

Mechanism of Action Nateglinide lowers blood glucose levels by stimulating insulin secretion from the pancreas. This action is dependent upon functioning beta-cells in the pancreatic islets. Nateglinide interacts with the ATP- sensitive potassium (K + ATP ) channel on pancreatic beta-cells. The subsequent depolarization of the beta cell opens the calcium channel, producing calcium influx and insulin secretion. The extent of insulin release is glucose dependent and diminishes at low glucose levels. Nateglinide is highly tissue selective with low affinity for heart and skeletal muscle.

Indicated ICD-10 codes

Source: RxNorm + openFDA + RxClass + FAERS · 2026

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