Drug Catalog - Product Detail
NATEGLINIDE TB 60MG 90
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 55111-0328-90 | DR.REDDY'S LABORATORIES, INC. | 90 | 60MG | TABLET |
PACKAGE FILES
Generic Name
NATEGLINIDE
Substance Name
NATEGLINIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA077461
Description
11 DESCRIPTION Nateglinide is 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 an off-white to white powder with a molecular weight of 317.43 g/mol. 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 : carnauba wax, copovidone, croscarmellose sodium, mannitol, silicon dioxide, sodium lauryl sulfate, sodium stearyl fumarate, corn starch and talc.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Nateglinide tablets USP are available as 60 mg white to off-white, round, biconvex tablets embossed with ‘RDY’ on one side and ‘328’ on other side and they are supplied in bottles of 30, 90, 100, 500 and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-328-30 Bottles of 90 NDC 55111-328-90 Bottles of 100 NDC 55111-328-01 Bottles of 500 NDC 55111-328-05 Unit dose package of 100 (10 x 10) NDC 55111-328-78 Nateglinide tablets USP are available as 120 mg white to off-white, round, biconvex tablets embossed with ‘RDY’ on one side and ‘329’ on other side and they are supplied in bottles of 30, 90, 100, 500 and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-329-30 Bottles of 90 NDC 55111-329-90 Bottles of 100 NDC 55111-329-01 Bottles of 500 NDC 55111-329-05 Unit dose package of 100 (10 x 10) NDC 55111-329-78 Storage and Handling Store at 20° to 25°C (68°-77°F); excursions permitted to 15° to 30°C (59°-86°F) [See USP Controlled Room Temperature]. Dispense in a tight container, USP.
Indications & Usage
1 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 is 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 and Administration
2 DOSAGE AND 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 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 )