na-TEG-li-nide

Therapeutic Classification: antidiabetics

Pharmacologic Classification: meglitinides

• To improve glycemic control in patients with type 2 diabetes (with diet and exercise); may also be used with metformin or a thiazolidinedione (pioglitazone).

• Stimulates the release of insulin from pancreatic beta cells by closing potassium channels, which results in the opening of calcium channels in beta cells. This is followed by release of insulin. Requires functioning pancreatic beta cells.

• Lowering of blood glucose.

Absorption: Well absorbed (73%) following oral administration; absorption is rapid.

Distribution: Unknown.

Protein Binding: 98%.

Metabolism/Excretion: Mostly metabolized by the liver (CYP2C9 [70%] and CYP3A4 [30%]); 16% excreted unchanged in urine.

Half-life: 1.5 hr.

(effect on blood glucose)

Contraindicated in:

• Hypersensitivity
• Diabetic ketoacidosis
• Type 1 diabetes
• OB: Insulin recommended to control diabetes during pregnancy
• Lactation: Lactation.

Use Cautiously in:

• Malnourished patients, patients with pituitary or adrenal insufficiency (↑ susceptibility to hypoglycemia)
• Strenuous physical exercise, insufficient caloric intake (↑ risk of hypoglycemia)
• Poor metabolizers of CYP2C9 (↑ risk of hypoglycemia)
• Autonomic neuropathy (hypoglycemia may be masked)
• Moderate to severe liver impairment
• Fever, infection, trauma, or surgery (may lead to transient loss of glycemic control; insulin may be required)
• Pedi: Safety and effectiveness not established in children
• Geri: May have ↑ sensitivity to drug effects (↑ risk of hypoglycemia).

Endo: HYPOGLYCEMIA.

GI: diarrhea.

MS: arthropathy, back pain.

Neuro: dizziness.

Resp: bronchitis, cough, upper respiratory infection.

Misc: flu symptoms.

Drug-Drug:

• Concurrent use with beta blockers may mask hypoglycemia.
• Alcohol, combination with other antidiabetics, NSAIDs, MAO inhibitors, nonselective beta blockers, amiodarone, fluconazole, miconazole, or oxandrolone may ↑ the risk of hypoglycemia.
• Hypoglycemic effects may be ↓ by thiazide diuretics, corticosteroids, thyroid supplements, sympathomimetic (adrenergic) agents, somatropin, rifampin, or phenytoin.

Drug-Food:

• Blood levels and effects are significantly ↓ when administered prior to a liquid meal.

• PO (Adults): 120 mg 3 times daily before meals; patients who are approaching glycemic control may be started at 60 mg 3 times daily.

(Generic available)

• Tablets: 60 mg; 120 mg;

• Observe for signs and symptoms of hypoglycemic reactions (sweating, hunger, weakness, dizziness, tremor, tachycardia, anxiety).

• Monitor serum glucose and HbA_1c periodically during therapy to evaluate effectiveness.
  • May cause ↑ uric acid levels.

• Overdose is manifested by symptoms of hypoglycemia. Mild hypoglycemia may be treated with administration of oral glucose. Severe hypoglycemia should be treated with IV D50W followed by continuous IV infusion of more dilute dextrose solution at a rate sufficient to keep serum glucose at approximately 100 mg/dL.

• Patients stabilized on a diabetic regimen who are exposed to stress, fever, trauma, infection, or surgery may require administration of insulin.
• PO: Administer 1–30 min prior to meals.
  • May be administered concurrently with metformin, or pioglitazone.

• Instruct patient to take medication at same time each day. Take missed doses as soon as remembered unless almost time for next dose. Do not take if unable to eat.
• Explain to patient that this medication controls hyperglycemia but does not cure diabetes. Therapy is long term.
• Review signs of hypoglycemia and hyperglycemia with patient. If hypoglycemia occurs, advise patient to take a glass of orange juice or 2–3 tsp of sugar, honey, or corn syrup dissolved in water and notify health care professional.
• Encourage patient to follow prescribed diet, medication, and exercise regimen to prevent hypoglycemic or hyperglycemic episodes.
• Instruct patient in proper testing of serum glucose and ketones. These tests should be closely monitored during periods of stress or illness and health care professional notified if significant changes occur.
• May occasionally cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications, especially aspirin and alcohol.
• Advise patient to inform health care professional of medication regimen prior to treatment or surgery.
• Rep: Insulin is the recommended method of controlling blood glucose during pregnancy. Counsel female patients to use a form of contraception other than oral contraceptives and to notify health care professional promptly if pregnancy is planned or suspected.
• Advise patient to carry a form of sugar (sugar packets, candy) and identification describing disease process and medication regimen at all times.
• Emphasize the importance of routine follow-up exams.

• Control of blood glucose levels without the appearance of hypoglycemic or hyperglycemic episodes.

Starlix

NDC Code^*

• 0078- Novartis Pharmaceuticals Corporation
  • 0078-0351- Starlix
    • 0078-0351-05- 100 TABLET in 1 BOTTLE (0078-0351-05)

• 0078- Novartis Pharmaceuticals Corporation
  • 0078-0352- Starlix
    • 0078-0352-05- 100 TABLET in 1 BOTTLE (0078-0352-05)

• 0591- Actavis Pharma, Inc.
  • 0591-3354- Nateglinide
    • 0591-3354-01- 100 TABLET in 1 BOTTLE, PLASTIC (0591-3354-01)

• 0591- Actavis Pharma, Inc.
  • 0591-3355- Nateglinide
    • 0591-3355-01- 100 TABLET in 1 BOTTLE, PLASTIC (0591-3355-01)

• 42291- AvKARE, Inc.
  • 42291-636- Nateglinide
    • 42291-636-01- 100 TABLET, COATED in 1 BOTTLE (42291-636-01)

• 42291- AvKARE, Inc.
  • 42291-637- Nateglinide
    • 42291-637-01- 100 TABLET, COATED in 1 BOTTLE (42291-637-01)

• 49884- Par Pharmaceutical, Inc.
  • 49884-984- Nateglinide
    • 49884-984-01- 100 TABLET, COATED in 1 BOTTLE, PLASTIC (49884-984-01)

• 49884- Par Pharmaceutical, Inc.
  • 49884-985- Nateglinide
    • 49884-985-01- 100 TABLET, COATED in 1 BOTTLE, PLASTIC (49884-985-01)

• 52536- Wilshire Pharmaceuticals, Inc.
  • 52536-063- Nateglinide
    • 52536-063-10- 100 TABLET in 1 BOTTLE (52536-063-10)

• 52536- Wilshire Pharmaceuticals, Inc.
  • 52536-063- Nateglinide
    • 52536-063-50- 500 TABLET in 1 BOTTLE (52536-063-50)

• 52536- Wilshire Pharmaceuticals, Inc.
  • 52536-067- Nateglinide
    • 52536-067-10- 100 TABLET in 1 BOTTLE (52536-067-10)

• 52536- Wilshire Pharmaceuticals, Inc.
  • 52536-067- Nateglinide
    • 52536-067-50- 500 TABLET in 1 BOTTLE (52536-067-50)

• 55111- Dr. Reddy's Laboratories Limited
  • 55111-328- Nateglinide
    • 55111-328-01- 100 TABLET in 1 BOTTLE (55111-328-01)

• 55111- Dr. Reddy's Laboratories Limited
  • 55111-328- Nateglinide
    • 55111-328-05- 500 TABLET in 1 BOTTLE (55111-328-05)

• 55111- Dr. Reddy's Laboratories Limited
  • 55111-328- Nateglinide
    • 55111-328-30- 30 TABLET in 1 BOTTLE (55111-328-30)

• 55111- Dr. Reddy's Laboratories Limited
  • 55111-328- Nateglinide
    • 55111-328-78- 10 BLISTER PACK in 1 CARTON (55111-328-78) > 10 TABLET in 1 BLISTER PACK (55111-328-79)

• 55111- Dr. Reddy's Laboratories Limited
  • 55111-328- Nateglinide
    • 55111-328-90- 90 TABLET in 1 BOTTLE (55111-328-90)

• 55111- Dr. Reddy's Laboratories Limited
  • 55111-329- Nateglinide
    • 55111-329-01- 100 TABLET in 1 BOTTLE (55111-329-01)

• 55111- Dr. Reddy's Laboratories Limited
  • 55111-329- Nateglinide
    • 55111-329-05- 500 TABLET in 1 BOTTLE (55111-329-05)

• 55111- Dr. Reddy's Laboratories Limited
  • 55111-329- Nateglinide
    • 55111-329-30- 30 TABLET in 1 BOTTLE (55111-329-30)

• 55111- Dr. Reddy's Laboratories Limited
  • 55111-329- Nateglinide
    • 55111-329-78- 10 BLISTER PACK in 1 CARTON (55111-329-78) > 10 TABLET in 1 BLISTER PACK (55111-329-79)

• 55111- Dr. Reddy's Laboratories Limited
  • 55111-329- Nateglinide
    • 55111-329-90- 90 TABLET in 1 BOTTLE (55111-329-90)

• 60429- Golden State Medical Supply, Inc.
  • 60429-434- Nateglinide
    • 60429-434-01- 100 TABLET, COATED in 1 BOTTLE, PLASTIC (60429-434-01)

• 60429- Golden State Medical Supply, Inc.
  • 60429-435- Nateglinide
    • 60429-435-01- 100 TABLET, COATED in 1 BOTTLE, PLASTIC (60429-435-01)

• 68084- American Health Packaging
  • 68084-458- Nateglinide
    • 68084-458-21- 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-458-21) > 1 TABLET, COATED in 1 BLISTER PACK (68084-458-11)

• 68084- American Health Packaging
  • 68084-459- Nateglinide
    • 68084-459-21- 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-459-21) > 1 TABLET, COATED in 1 BLISTER PACK (68084-459-11)

• 68382- Zydus Pharmaceuticals (USA) Inc.
  • 68382-721- Nateglinide
    • 68382-721-01- 100 TABLET, FILM COATED in 1 BOTTLE (68382-721-01)

• 68382- Zydus Pharmaceuticals (USA) Inc.
  • 68382-721- Nateglinide
    • 68382-721-05- 500 TABLET, FILM COATED in 1 BOTTLE (68382-721-05)

• 68382- Zydus Pharmaceuticals (USA) Inc.
  • 68382-721- Nateglinide
    • 68382-721-06- 30 TABLET, FILM COATED in 1 BOTTLE (68382-721-06)

• 68382- Zydus Pharmaceuticals (USA) Inc.
  • 68382-721- Nateglinide
    • 68382-721-10- 1000 TABLET, FILM COATED in 1 BOTTLE (68382-721-10)

• 68382- Zydus Pharmaceuticals (USA) Inc.
  • 68382-721- Nateglinide
    • 68382-721-16- 90 TABLET, FILM COATED in 1 BOTTLE (68382-721-16)

• 68382- Zydus Pharmaceuticals (USA) Inc.
  • 68382-721- Nateglinide
    • 68382-721-77- 10 BLISTER PACK in 1 CARTON (68382-721-77) > 10 TABLET, FILM COATED in 1 BLISTER PACK

• 68382- Zydus Pharmaceuticals (USA) Inc.
  • 68382-722- Nateglinide
    • 68382-722-01- 100 TABLET, FILM COATED in 1 BOTTLE (68382-722-01)

• 68382- Zydus Pharmaceuticals (USA) Inc.
  • 68382-722- Nateglinide
    • 68382-722-05- 500 TABLET, FILM COATED in 1 BOTTLE (68382-722-05)

• 68382- Zydus Pharmaceuticals (USA) Inc.
  • 68382-722- Nateglinide
    • 68382-722-06- 30 TABLET, FILM COATED in 1 BOTTLE (68382-722-06)

• 68382- Zydus Pharmaceuticals (USA) Inc.
  • 68382-722- Nateglinide
    • 68382-722-10- 1000 TABLET, FILM COATED in 1 BOTTLE (68382-722-10)

• 68382- Zydus Pharmaceuticals (USA) Inc.
  • 68382-722- Nateglinide
    • 68382-722-16- 90 TABLET, FILM COATED in 1 BOTTLE (68382-722-16)

• 68382- Zydus Pharmaceuticals (USA) Inc.
  • 68382-722- Nateglinide
    • 68382-722-77- 10 BLISTER PACK in 1 CARTON (68382-722-77) > 10 TABLET, FILM COATED in 1 BLISTER PACK

• 70771- Cadila Healthcare Limited
  • 70771-1015- Nateglinide
    • 70771-1015-0- 1000 TABLET, FILM COATED in 1 BOTTLE (70771-1015-0)

• 70771- Cadila Healthcare Limited
  • 70771-1015- Nateglinide
    • 70771-1015-1- 100 TABLET, FILM COATED in 1 BOTTLE (70771-1015-1)

• 70771- Cadila Healthcare Limited
  • 70771-1015- Nateglinide
    • 70771-1015-3- 30 TABLET, FILM COATED in 1 BOTTLE (70771-1015-3)

• 70771- Cadila Healthcare Limited
  • 70771-1015- Nateglinide
    • 70771-1015-4- 10 BLISTER PACK in 1 CARTON (70771-1015-4) > 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1015-2)

• 70771- Cadila Healthcare Limited
  • 70771-1015- Nateglinide
    • 70771-1015-5- 500 TABLET, FILM COATED in 1 BOTTLE (70771-1015-5)

• 70771- Cadila Healthcare Limited
  • 70771-1015- Nateglinide
    • 70771-1015-9- 90 TABLET, FILM COATED in 1 BOTTLE (70771-1015-9)

• 70771- Cadila Healthcare Limited
  • 70771-1016- Nateglinide
    • 70771-1016-0- 1000 TABLET, FILM COATED in 1 BOTTLE (70771-1016-0)

• 70771- Cadila Healthcare Limited
  • 70771-1016- Nateglinide
    • 70771-1016-1- 100 TABLET, FILM COATED in 1 BOTTLE (70771-1016-1)

• 70771- Cadila Healthcare Limited
  • 70771-1016- Nateglinide
    • 70771-1016-3- 30 TABLET, FILM COATED in 1 BOTTLE (70771-1016-3)

• 70771- Cadila Healthcare Limited
  • 70771-1016- Nateglinide
    • 70771-1016-4- 10 BLISTER PACK in 1 CARTON (70771-1016-4) > 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1016-2)

• 70771- Cadila Healthcare Limited
  • 70771-1016- Nateglinide
    • 70771-1016-5- 500 TABLET, FILM COATED in 1 BOTTLE (70771-1016-5)

• 70771- Cadila Healthcare Limited
  • 70771-1016- Nateglinide
    • 70771-1016-9- 90 TABLET, FILM COATED in 1 BOTTLE (70771-1016-9)

• 71209- Cadila Pharmaceuticals Limited
  • 71209-030- Nateglinide
    • 71209-030-05- 100 TABLET, COATED in 1 BOTTLE (71209-030-05)

• 71209- Cadila Pharmaceuticals Limited
  • 71209-031- Nateglinide
    • 71209-031-05- 100 TABLET, COATED in 1 BOTTLE (71209-031-05)

• 75834- Nivagen Pharmaceuticals, Inc.
  • 75834-205- NATEGLINIDE
    • 75834-205-01- 100 TABLET, COATED in 1 BOTTLE (75834-205-01)

• 75834- Nivagen Pharmaceuticals, Inc.
  • 75834-206- NATEGLINIDE
    • 75834-206-01- 100 TABLET, COATED in 1 BOTTLE (75834-206-01)