NATEGLINIDE (Page 4 of 4)

14.4 Add-On Combination Therapy with Rosiglitazone

A 24-week, double blind, multicenter, placebo-controlled trial was performed in patients with type 2 diabetes not adequately controlled on rosiglitazone 8 mg daily. The addition of Nateglinide Tablets (120 mg three times per day with meals) was associated with statistically significantly greater reductions in HbA1C compared to placebo as add-on to rosiglitazone. The mean change in weight from baseline was +3 kg for patients treated with Nateglinide Tablets compared to +1 kg for patients treated with placebo when added to rosiglitazone.

Table 9: Endpoint Results for a 24-week Study of the Effect of Adding Nateglinide Tablets or Placebo to Rosiglitazone
Placebo + rosiglitazone 8 mg once daily Nateglinide Tablets 120 mg before meals + rosiglitazone 8 mg once daily
HbA1C (%) N=191 N=194
Baseline (mean) 8.4 8.3
Change from baseline (mean) 0.03 -0.7
Difference from rosiglitazone (mean) -0.7 a

a p-value ≤0.0001

14.5 Add-On Combination Therapy with Glyburide

In a 12-week study of patients with type 2 diabetes inadequately controlled on glyburide 10 mg once daily, the addition of Nateglinide Tablets (60 mg or 120 mg three times daily before meals) did not produce any additional benefit.

Table 10: Endpoint Results for a 12-week Study of the Effect of Adding Nateglinide Tablets or Placebo to Glyburide
Placebo + glyburide 10 mg once daily Nateglinide Tablets 60 mg before meals + glyburide 10 mg once daily Nateglinide Tablets 120 mg before meals + glyburide 10 mg once daily
HbA1C (%) N=58 N=55 N=54
Baseline (mean) 8.7 8.7 8.7
Change from baseline (mean) 0.3 0.2 -0.02
Difference from glyburide (mean) -0.1 a -0.3 b

Placebo or Nateglinide Tablets given 10 minutes prior to breakfast, lunch, and dinner; glyburide given with the breakfast dose of Nateglinide Tablets or placebo.
a p-value 0.6959b p-value 0.1246

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied
60 mg
Pink, round shaped, biconvex, film-coated tablets, debossed with “N7” on one side and plain on other side.
Bottles of 90 ……………………. NDC 16571-758-09
Bottles of 100 ………………….. NDC 16571-758-01
Bottles of 500 ………………….. NDC 16571-758-50
120 mg
Yellow, oval shaped, biconvex, film-coated tablets, debossed with “N5” on one side and plain on other side.
Bottles of 90 ……………………. NDC 16571-759-09
Bottles of 100 ………………….. NDC 16571-759-01
Bottles of 500 ………………….. NDC 16571-759-50
Storage and Handling
Store at 25ºC (77ºF); excursions permitted to 15ºC-30ºC (59ºF-86ºF). Dispense in a tight container, USP.

17 PATIENT COUNSELING INFORMATION

Administration
Instruct patients to take Nateglinide Tablets 1 to 30 minutes before meals. Instruct patients that skip meals to skip their dose of Nateglinide Tablets [see Dosage and Administration (2)].
Hypoglycemia
Inform patients that Nateglinide Tablets 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 [see Warnings and Precautions (5.1)].
Lactation

Advise patients that use of Nateglinide Tablet is not recommended while breastfeeding [see Use in Specific Populations (8.2)].
Drug Interactions
Discuss potential drug interactions with patients and inform them of potential drug-drug interactions with Nateglinide Tablets.
Manufactured by:
USV Private Limited
H-13,16,16A,17,18,19,20,21,E-22,
OIDC, Mahatma Gandhi Udyog Nagar,
Dabhel, Daman 396 210, India.
nateglinide-logo
Manufactured for:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
Made In India
Revised: 08/2022
PIR75950-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 60MG

Rising® NDC 16571-758- 01
PHARMACEUTICALS
Nateglinide
Tablets, USP
60mg 100 Tablets Rx only

nateglinide-label60
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 120MG

Rising® NDC 16571-759 -01
PHARMACEUTICALS

Nateglinide
Tablets, USP

120 mg

100 Tablets Rx only

nateglinide-label120
(click image for full-size original)

NATEGLINIDE nateglinide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16571-758
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NATEGLINIDE (NATEGLINIDE) NATEGLINIDE 60 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MANNITOL
TALC
STARCH, CORN
POVIDONE K30
SODIUM STEARYL FUMARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color PINK Score no score
Shape ROUND Size 10mm
Flavor Imprint Code N7;Plain
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16571-758-09 90 TABLET in 1 BOTTLE None
2 NDC:16571-758-01 100 TABLET in 1 BOTTLE None
3 NDC:16571-758-50 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205544 12/16/2020
NATEGLINIDE nateglinide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16571-759
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NATEGLINIDE (NATEGLINIDE) NATEGLINIDE 120 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MANNITOL
TALC
STARCH, CORN
POVIDONE K30
SODIUM STEARYL FUMARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 17mm
Flavor Imprint Code N5;Plain
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16571-759-09 90 TABLET in 1 BOTTLE None
2 NDC:16571-759-01 100 TABLET in 1 BOTTLE None
3 NDC:16571-759-50 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205544 12/16/2020
Labeler — Rising Pharmaceuticals, Inc. (835513529)
Establishment
Name Address ID/FEI Operations
USV Private Limited 650434348 ANALYSIS (16571-758), ANALYSIS (16571-759), LABEL (16571-758), LABEL (16571-759), MANUFACTURE (16571-758), MANUFACTURE (16571-759), PACK (16571-758), PACK (16571-759)

Revised: 08/2022 Rising Pharmaceuticals, Inc.

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