Disclaimer:
Medidex is not a provider of medical services and all information is provided for the convenience of the user. No medical decisions should be made based on the information provided on this website without first consulting a licensed healthcare provider.This website is intended for persons 18 years or older. No person under 18 should consult this website without the permission of a parent or guardian.
Nateglinide
Overview
What is Nateglinide?
Nateglinide Tablets, USP are 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]. Nateglinide,(-)-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. It is freely soluble in methanol, ethanol, and chloroform, soluble in ether, sparingly soluble in acetonitrile and octanol, and practically insoluble in water. Nateglinide biconvex tablets contain 60 mg, or 120 mg, of nateglinide for oral administration.
Inactive Ingredients:
What does Nateglinide look like?
What are the available doses of Nateglinide?
Sorry No records found.
What should I talk to my health care provider before I take Nateglinide?
Sorry No records found
How should I use Nateglinide?
Nateglinide Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus.
Nateglinide Tablets USP should be taken 1 to 30 minutes prior to meals.
What interacts with Nateglinide?
- Nateglinide Tablets are contraindicated in patients with:
- Known hypersensitivity to the drug or its inactive ingredients.
- Type 1 diabetes.
- Diabetic ketoacidosis. This condition should be treated with insulin.
What are the warnings of Nateglinide?
Sorry No Records found
What are the precautions of Nateglinide?
Macrovascular Outcomes:
Hypoglycemia:
Hepatic Impairment:
Loss of Glycemic Control
Transient loss of glycemic control may occur with fever, infection, trauma, or surgery. Insulin therapy may be needed instead of nateglinide therapy at such times. Secondary failure, or reduced effectiveness of nateglinide over a period of time, may occur.
Information for Patients
Patients should be informed of the potential risks and benefits of nateglinide and of alternative modes of therapy. The risks and management of hypoglycemia should be explained. Patients should be instructed to take nateglinide 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 nateglinide.
Laboratory Tests
Response to therapies should be periodically assessed with glucose values and HbA
levels.
Drug Interactions
Nateglinide is highly bound to plasma proteins (98%), mainly albumin.
displacement studies with highly protein-bound drugs such as furosemide, propranolol, captopril, nicardipine, pravastatin, glyburide, warfarin, phenytoin, acetylsalicylic acid, tolbutamide, and metformin showed no influence on the extent of nateglinide protein binding. Similarly, nateglinide had no influence on the serum protein binding of propranolol, glyburide, nicardipine, warfarin, phenytoin, acetylsalicylic acid and tolbutamide
. However, prudent evaluation of individual cases is warranted in the clinical setting.
Certain drugs, including nonsteroidal anti-inflammatory agents (NSAIDs), salicylates, monoamine oxidase inhibitors, and non-selective beta-adrenergic-blocking agents, guanethidine, and CYP2C9 inhibitors (e.g., fluconazole, amiodarone, miconazole, oxandrolone) may potentiate the hypoglycemic action of nateglinide and other oral antidiabetic drugs.
Certain drugs including thiazides, corticosteroids, thyroid products, sympathomimetics, somatropin, rifampin, phenytoin and dietary supplements (St. John’s wort) may reduce the hypoglycemic action of nateglinide and other oral antidiabetic drugs. Somatostatin analogues may potentiate or attenuate the hypoglycemic action of nateglinide.
When these drugs are administered to or withdrawn from patients receiving nateglinide, the patient should be observed closely for changes in glycemic control.
Drug/Food Interactions
The pharmacokinetics of nateglinide were not affected by the composition of a meal (high protein, fat, or carbohydrate). However, peak plasma levels were significantly reduced when nateglinide was administered 10 minutes prior to a liquid meal. Nateglinide did not have any effect on gastric emptying in healthy subjects as assessed by acetaminophen testing.
Carcinogenesis and Mutagenesis and Impairment of Fertility
Array
Array
Array
Pregnancy
Nateglinide was not teratogenic in rats at doses up to 1000 mg/kg (approximately 60 times the human therapeutic exposure with a recommended nateglinide dose of 120 mg, three times daily before meals). In the rabbit, embryonic development was adversely affected and the incidence of gallbladder agenesis or small gallbladder was increased at a dose of 500 mg/kg (approximately 40 times the human therapeutic exposure with a recommended nateglinide dose of 120 mg, three times daily before meals). There are no adequate and well-controlled studies in pregnant women. Nateglinide should not be used during pregnancy.
Labor and Delivery
The effect of nateglinide on labor and delivery in humans is not known.
Nursing Mothers
Studies in lactating rats showed that nateglinide is excreted in the milk; the AUC
ratio in milk to plasma was approximately 1:4. During the peri- and postnatal period body weights were lower in offspring of rats administered nateglinide at 1000 mg/kg (approximately 60 times the human therapeutic exposure with a recommended nateglinide dose of 120 mg, three times daily before meals). It is not known whether nateglinide is excreted in human milk. Because many drugs are excreted in human milk, nateglinide should not be administered to a nursing woman.
Pediatric Use
Clinical trials to demonstrate the safety and effectiveness in pediatric patients have not been conducted.
Geriatric Use
No differences were observed in safety or efficacy of nateglinide between patients age 65 and over, and those under age 65. However, greater sensitivity of some older individuals to nateglinide therapy cannot be ruled out.
What are the side effects of Nateglinide?
In clinical trials, approximately 2,600 patients with Type 2 diabetes 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.
Hypoglycemia was relatively uncommon in all treatment arms of the clinical trials. Only 0.3% of nateglinide patients discontinued due to hypoglycemia. Symptoms suggestive of hypoglycemia have been observed after administration of nateglinide. These symptoms included sweating, trembling, dizziness, increased appetite, palpitations, nausea, fatigue and weakness.
Gastrointestinal symptoms, especially diarrhea and nausea, were no more common in patients using the combination of nateglinide and metformin than in patients receiving metformin alone. Likewise, peripheral edema was no more common in patients using the combination of nateglinide and rosiglitazone than in patients receiving rosiglitazone alone. The following table lists events that occurred more frequently in nateglinide patients than placebo patients in controlled clinical trials.
During post-marketing experience, rare cases of hypersensitivity reactions such as rash, itching and urticaria have been reported. Similarly, cases of jaundice, cholestatic hepatitis and elevated liver enzymes have been reported.
| Upper Respiratory Infection | 8.1 | 10.5 |
| Back Pain | 3.7 | 4.0 |
| Flu Symptoms | 2.6 | 3.6 |
| Dizziness | 2.2 | 3.6 |
| Arthropathy | 2.2 | 3.3 |
| Diarrhea | 3.1 | 3.2 |
| Accidental Trauma | 1.7 | 2.9 |
| Bronchitis | 2.6 | 2.7 |
| Coughing | 2.2 | 2.4 |
| Hypoglycemia | 0.4 | 2.4 |
Laboratory Abnormalities
Array
To report SUSPECTED ADVERSE REACTIONS contact AvKARE, Inc. at 1-855-361-3993; email
; or FDA at 1-800-FDA-1088 or
.
Array
Array
Array
drugsafety@avkare.com
www.fda.gov/medwatch
What should I look out for while using Nateglinide?
Nateglinide Tablets are contraindicated in patients with:
What might happen if I take too much Nateglinide?
In a clinical study in patients with Type 2 diabetes, 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 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.
How should I store and handle Nateglinide?
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses.Nateglinide Tablets, USP60 mgPink color coated, round biconvex, beveled edge tablet debossed with “P 984” on one side and plain on the other sideBottles of 100..........NDC 42291-636-01120 mgOrange color coated, oval shaped biconvex, tablet debossed with “P 985” on one side and plain on the other sideBottles of 100........NDC 42291-637-01StorageStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].Dispense in a tight, light resistant containers.Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 02/16 AV 04/16 (P) Nateglinide Tablets, USP60 mgPink color coated, round biconvex, beveled edge tablet debossed with “P 984” on one side and plain on the other sideBottles of 100..........NDC 42291-636-01120 mgOrange color coated, oval shaped biconvex, tablet debossed with “P 985” on one side and plain on the other sideBottles of 100........NDC 42291-637-01StorageStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].Dispense in a tight, light resistant containers.Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 02/16 AV 04/16 (P) Nateglinide Tablets, USP60 mgPink color coated, round biconvex, beveled edge tablet debossed with “P 984” on one side and plain on the other sideBottles of 100..........NDC 42291-636-01120 mgOrange color coated, oval shaped biconvex, tablet debossed with “P 985” on one side and plain on the other sideBottles of 100........NDC 42291-637-01StorageStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].Dispense in a tight, light resistant containers.Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 02/16 AV 04/16 (P) Nateglinide Tablets, USP60 mgPink color coated, round biconvex, beveled edge tablet debossed with “P 984” on one side and plain on the other sideBottles of 100..........NDC 42291-636-01120 mgOrange color coated, oval shaped biconvex, tablet debossed with “P 985” on one side and plain on the other sideBottles of 100........NDC 42291-637-01StorageStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].Dispense in a tight, light resistant containers.Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 02/16 AV 04/16 (P) Nateglinide Tablets, USP60 mgPink color coated, round biconvex, beveled edge tablet debossed with “P 984” on one side and plain on the other sideBottles of 100..........NDC 42291-636-01120 mgOrange color coated, oval shaped biconvex, tablet debossed with “P 985” on one side and plain on the other sideBottles of 100........NDC 42291-637-01StorageStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].Dispense in a tight, light resistant containers.Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 02/16 AV 04/16 (P) Nateglinide Tablets, USP60 mgPink color coated, round biconvex, beveled edge tablet debossed with “P 984” on one side and plain on the other sideBottles of 100..........NDC 42291-636-01120 mgOrange color coated, oval shaped biconvex, tablet debossed with “P 985” on one side and plain on the other sideBottles of 100........NDC 42291-637-01StorageStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].Dispense in a tight, light resistant containers.Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 02/16 AV 04/16 (P) Nateglinide Tablets, USP60 mgPink color coated, round biconvex, beveled edge tablet debossed with “P 984” on one side and plain on the other sideBottles of 100..........NDC 42291-636-01120 mgOrange color coated, oval shaped biconvex, tablet debossed with “P 985” on one side and plain on the other sideBottles of 100........NDC 42291-637-01StorageStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].Dispense in a tight, light resistant containers.Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 02/16 AV 04/16 (P) Nateglinide Tablets, USP60 mgPink color coated, round biconvex, beveled edge tablet debossed with “P 984” on one side and plain on the other sideBottles of 100..........NDC 42291-636-01120 mgOrange color coated, oval shaped biconvex, tablet debossed with “P 985” on one side and plain on the other sideBottles of 100........NDC 42291-637-01StorageStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].Dispense in a tight, light resistant containers.Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 02/16 AV 04/16 (P) Nateglinide Tablets, USP60 mgPink color coated, round biconvex, beveled edge tablet debossed with “P 984” on one side and plain on the other sideBottles of 100..........NDC 42291-636-01120 mgOrange color coated, oval shaped biconvex, tablet debossed with “P 985” on one side and plain on the other sideBottles of 100........NDC 42291-637-01StorageStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].Dispense in a tight, light resistant containers.Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 02/16 AV 04/16 (P) Nateglinide Tablets, USP60 mgPink color coated, round biconvex, beveled edge tablet debossed with “P 984” on one side and plain on the other sideBottles of 100..........NDC 42291-636-01120 mgOrange color coated, oval shaped biconvex, tablet debossed with “P 985” on one side and plain on the other sideBottles of 100........NDC 42291-637-01StorageStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].Dispense in a tight, light resistant containers.Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 02/16 AV 04/16 (P) Nateglinide Tablets, USP60 mgPink color coated, round biconvex, beveled edge tablet debossed with “P 984” on one side and plain on the other sideBottles of 100..........NDC 42291-636-01120 mgOrange color coated, oval shaped biconvex, tablet debossed with “P 985” on one side and plain on the other sideBottles of 100........NDC 42291-637-01StorageStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].Dispense in a tight, light resistant containers.Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 02/16 AV 04/16 (P) Nateglinide Tablets, USP60 mgPink color coated, round biconvex, beveled edge tablet debossed with “P 984” on one side and plain on the other sideBottles of 100..........NDC 42291-636-01120 mgOrange color coated, oval shaped biconvex, tablet debossed with “P 985” on one side and plain on the other sideBottles of 100........NDC 42291-637-01StorageStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].Dispense in a tight, light resistant containers.Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 02/16 AV 04/16 (P) Nateglinide Tablets, USP60 mgPink color coated, round biconvex, beveled edge tablet debossed with “P 984” on one side and plain on the other sideBottles of 100..........NDC 42291-636-01120 mgOrange color coated, oval shaped biconvex, tablet debossed with “P 985” on one side and plain on the other sideBottles of 100........NDC 42291-637-01StorageStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].Dispense in a tight, light resistant containers.Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 02/16 AV 04/16 (P) Nateglinide Tablets, USP60 mgPink color coated, round biconvex, beveled edge tablet debossed with “P 984” on one side and plain on the other sideBottles of 100..........NDC 42291-636-01120 mgOrange color coated, oval shaped biconvex, tablet debossed with “P 985” on one side and plain on the other sideBottles of 100........NDC 42291-637-01StorageStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].Dispense in a tight, light resistant containers.Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 02/16 AV 04/16 (P)
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Nateglinide is an amino-acid derivative that 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+
) 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.
Non-Clinical Toxicology
Nateglinide Tablets are contraindicated in patients with:Nateglinide is highly bound to plasma proteins (98%), mainly albumin. displacement studies with highly protein-bound drugs such as furosemide, propranolol, captopril, nicardipine, pravastatin, glyburide, warfarin, phenytoin, acetylsalicylic acid, tolbutamide, and metformin showed no influence on the extent of nateglinide protein binding. Similarly, nateglinide had no influence on the serum protein binding of propranolol, glyburide, nicardipine, warfarin, phenytoin, acetylsalicylic acid and tolbutamide . However, prudent evaluation of individual cases is warranted in the clinical setting.
Certain drugs, including nonsteroidal anti-inflammatory agents (NSAIDs), salicylates, monoamine oxidase inhibitors, and non-selective beta-adrenergic-blocking agents, guanethidine, and CYP2C9 inhibitors (e.g., fluconazole, amiodarone, miconazole, oxandrolone) may potentiate the hypoglycemic action of nateglinide and other oral antidiabetic drugs.
Certain drugs including thiazides, corticosteroids, thyroid products, sympathomimetics, somatropin, rifampin, phenytoin and dietary supplements (St. John’s wort) may reduce the hypoglycemic action of nateglinide and other oral antidiabetic drugs. Somatostatin analogues may potentiate or attenuate the hypoglycemic action of nateglinide.
When these drugs are administered to or withdrawn from patients receiving nateglinide, the patient should be observed closely for changes in glycemic control.
Macrovascular Outcomes:
Hypoglycemia:
Hepatic Impairment:
Loss of Glycemic Control
Transient loss of glycemic control may occur with fever, infection, trauma, or surgery. Insulin therapy may be needed instead of nateglinide therapy at such times. Secondary failure, or reduced effectiveness of nateglinide over a period of time, may occur.
In clinical trials, approximately 2,600 patients with Type 2 diabetes 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.
Hypoglycemia was relatively uncommon in all treatment arms of the clinical trials. Only 0.3% of nateglinide patients discontinued due to hypoglycemia. Symptoms suggestive of hypoglycemia have been observed after administration of nateglinide. These symptoms included sweating, trembling, dizziness, increased appetite, palpitations, nausea, fatigue and weakness.
Gastrointestinal symptoms, especially diarrhea and nausea, were no more common in patients using the combination of nateglinide and metformin than in patients receiving metformin alone. Likewise, peripheral edema was no more common in patients using the combination of nateglinide and rosiglitazone than in patients receiving rosiglitazone alone. The following table lists events that occurred more frequently in nateglinide patients than placebo patients in controlled clinical trials.
During post-marketing experience, rare cases of hypersensitivity reactions such as rash, itching and urticaria have been reported. Similarly, cases of jaundice, cholestatic hepatitis and elevated liver enzymes have been reported.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
Review
Read user comments about the side effects, benefits, and effectiveness of losartan oral.
Overall User Ratings
514Total User Reviews
User Reviews
Learn about
User Reviews
Professional
Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
Tips
Interactions
Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).