Brand Name
Nateglinide
View Brand InformationFDA approval date: September 09, 2009
Classification: Glinide
Form: Tablet
What is Nateglinide?
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. 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 : Not for treating type 1 diabetes mellitus or diabetes ketoacidosis.
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Brand Information
Nateglinide (nateglinide)
1INDICATIONS AND USAGE
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.
2DOSAGE AND ADMINISTRATION
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
3DOSAGE FORMS AND STRENGTHS
- 60 mg tablets: Pink color coated, round biconvex, beveled edge tablet debossed with "P 984" on one side and plain on the other side
- 120 mg tablets: Orange color coated, oval shaped biconvex, tablet debossed with "P 985" on one side and plain on the other side
4CONTRAINDICATIONS
Nateglinide tablets are contraindicated in patients with a history of hypersensitivity to nateglinide or its inactive ingredients.
5ADVERSE REACTIONS
The following serious adverse reaction is also described elsewhere in the labeling:
- Hypoglycemia
5.1Clinical 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.
Hypoglycemia
Episodes of severe hypoglycemia (plasma glucose less than 36 mg/dL) were reported in two patients treated with nateglinide. Non-severe hypoglycemia occurred in 2.4 % of nateglinide treated patients and 0.4 % of placebo-treated patients
Weight Gain
Patients treated with nateglinide had statistically significant mean increases in weight compared to placebo. In clinical trials, the mean weight increases with nateglinide 60 mg (3 times daily) and nateglinide 120 mg (3 times daily) compared to placebo were 1.0 kg and 1.6 kg, respectively.
Laboratory Test
Increases in Uric Acid: There were increases in mean uric acid levels for patients treated with nateglinide alone, nateglinide in combination with metformin, metformin alone, and glyburide alone. The respective differences from placebo were 0.29 mg/dL, 0.45 mg/dL, 0.28 mg/dL, and 0.19 mg/dL.
5.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of nateglinide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Hypersensitivity Reactions: Rash, itching, and urticaria
- Hepatobiliary Disorders: Jaundice, cholestatic hepatitis, and elevated liver enzymes
6DRUG INTERACTIONS
Table 2 includes a list of drugs with clinically important drug interactions when concomitantly administered or withdrawn with nateglinide and instructions for managing or preventing them.
7OVERDOSAGE
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.
8DESCRIPTION
Nateglinide Tablets, USP are an oral blood glucose-lowering drug of the glinide class. 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: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (starch 1500®). Starch 1500®is partially pregelatinized maize starch. The 60 mg also contains iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. In addition, the 120 mg contains FD&C Yellow #6/Sunset Yellow Aluminum Lake, iron oxide yellow.
9HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
Nateglinide Tablets, USP are supplied in the following package and dose strength forms:
60 mg
Pink color coated, round biconvex, beveled edge tablet debossed with "P 984" on one side and plain on the other side.
Bottles of 100……………NDC 64380-167-01
Bottles of 90…………..…NDC 64380-167-02
120 mg
Orange color coated, oval shaped biconvex, tablet debossed with "P 985" on one side and plain on the other side.
Bottles of 100……………NDC 64380-168-01
Bottles of 90……..………NDC 64380-168-02
Storage and Handling
Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F). [See USP Controlled Room Temperature]
Dispense in a tight, light resistant container.
10PATIENT COUNSELING INFORMATION
Administration
Instruct patients to take nateglinide 1 to 30 minutes before meals. Instruct patients that skip meals to skip their dose of nateglinide
Hypoglycemia
Inform patients that nateglinide 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
Lactation
Advise patients that use of nateglinide is not recommended while breastfeeding
Drug Interactions
Discuss potential drug interactions with patients and inform them of potential drug-drug interactions with nateglinide.
Distributed by:
Strides Pharma Inc.
East Brunswick, NJ 00816
Rev. 02/2022
OS984-01-1-11
11PACKAGE LABEL PRINCIPAL DISPLAY PANEL
Package Label
Rx Only
NDC 64380-167-01
Nateglinide Tablets
60 mg
100 Tablets
Strides Pharma Inc.
12PACKAGE LABEL PRINCIPAL DISPLAY PANEL
Package Label
Rx Only
NDC 64380-168-01
Nateglinide Tablets
120 mg
100 Tablets
Strides Pharma Inc.
