Drug Catalog - Product Detail
NATEGLINIDE TAB60MG 90
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68382-0721-16 | ZYDUS PHARMACEUTICALS (USA) | 90 | 60MG | TABLET |
PACKAGE FILES
Generic Name
NATEGLINIDE
Substance Name
NATEGLINIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA205248
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, USP is a white powder with a molecular weight of 317.43 g/mol. It is freely soluble in methanol and alcohol, soluble in ether, sparingly soluble in acetonitrile and octanol, practically insoluble in water. Each nateglinide tablet, USP intended for oral administration contains nateglinide, USP 60 mg and 120 mg. In addition, each tablet contains the following inactive ingredients: citric acid anhydrous, colloidal silicon dioxide, corn starch, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polysorbate 80, polyethylene glycol, povidone, talc and titanium dioxide. Additionally, each 120 mg tablet contains iron oxide red and iron oxide yellow. Image
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Nateglinide Tablets USP, 60 mg are white to off-white, round, biconvex with bevel-edge, film-coated tablets debossed '721' on one side and plain on the other side and are supplied as follows: NDC 68382-721-06 in bottle of 30 tablets with child-resistant closure NDC 68382-721-16 in bottle of 90 tablets with child-resistant closure NDC 68382-721-01 in bottle of 100 tablets NDC 68382-721-05 in bottle of 500 tablets NDC 68382-721-10 in bottle of 1000 tablets NDC 68382-721-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Nateglinide Tablets USP, 120 mg are light-orange to orange, oval, biconvex with bevel-edge, film-coated tablets debossed '722' on one side and plain on the other side and are supplied as follows: NDC 68382-722-06 in bottle of 30 tablets with child-resistant closure NDC 68382-722-16 in bottle of 90 tablets with child-resistant closure NDC 68382-722-01 in bottle of 100 tablets NDC 68382-722-05 in bottle of 500 tablets NDC 68382-722-10 in bottle of 1000 tablets NDC 68382-722-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Storage and Handling Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in tightly closed container.
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. ( 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 )