Drug Catalog - Product Detail
NATEGLINIDE TB 120MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 49884-0985-01 | PAR PHARMACEUTICAL | 100 | 120MG | TABLET |
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Description
DESCRIPTION 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: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized 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. this is the structure
How Supplied
HOW SUPPLIED Nateglinide Tablets, USP 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 49884-984-01 Bottles of 500……………NDC 49884-984-05 Bottles of 1000…………..NDC-49884-984-10 120 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 49884-985-01 Bottles of 500……………NDC 49884-985-05 Bottles of 1000…………..NDC-49884-985-10 Storage Store 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 container. Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 Revised: 02/2016 OS984-01-1-06
Indications & Usage
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.
Dosage and Administration
DOSAGE AND ADMINISTRATION Nateglinide Tablets, USP should be taken 1 to 30 minutes prior to meals. Monotherapy and Combination with Metformin or a Thiazolidinedione The recommended starting and maintenance dose of nateglinide, alone or in combination with metformin or a thiazolidinedione, is 120 mg three times daily before meals. The 60 mg dose of nateglinide, either alone or in combination with metformin or a thiazolidinedione, may be used in patients who are near goal HbA 1c when treatment is initiated. Dosage in Geriatric Patients No special dose adjustments are usually necessary. However, greater sensitivity of some individuals to nateglinide therapy cannot be ruled out. Dosage in Renal and Hepatic Impairment No dosage adjustment is necessary in patients with mild-to-severe renal insufficiency or in patients with mild hepatic insufficiency. Dosing of patients with moderate-to-severe hepatic dysfunction has not been studied. Therefore, nateglinide should be used with caution in patients with moderate-to-severe liver disease (see PRECAUTIONS , Hepatic Impairment ).