Repaglinide (Page 7 of 7)

Combination Therapy

If repaglinide monotherapy does not result in adequate glycemic control, metformin or a thiazolidinedione may be added. If metformin or thiazolidinedione monotherapy does not provide adequate control, repaglinide may be added. The starting dose and dose adjustments for repaglinide combination therapy is the same as for repaglinide monotherapy. The dose of each drug should be carefully adjusted to determine the minimal dose required to achieve the desired pharmacologic effect. Failure to do so could result in an increase in the incidence of hypoglycemic episodes. Appropriate monitoring of FPG and HbA1c measurements should be used to ensure that the patient is not subjected to excessive drug exposure or increased probability of secondary drug failure.

HOW SUPPLIED

Repaglinide Tablets, USP

The 2 mg tablets are light green, round, unscored tablets debossed with M on one side of the tablet and R23 on the other side. They are available as follows:

NDC 0378-3123-01
bottles of 100 tablets

NDC 0378-3123-05
bottles of 500 tablets

NDC 69189-3123-1 single dose pack with 1 tablet as repackaged by Avera McKennan Hospital

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Protect from moisture.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

REVISED SEPTEMBER 2014
RPGD:R6

Principal Display Panel

Repaglinide 2 mg tablet
(click image for full-size original)

REPAGLINIDE
repaglinide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69189-3123(NDC:0378-3123)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
REPAGLINIDE (REPAGLINIDE) REPAGLINIDE 2 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
MAGNESIUM STEARATE
MEGLUMINE
CELLULOSE, MICROCRYSTALLINE
POLACRILIN POTASSIUM
POVIDONES
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
D&C YELLOW NO. 10
Product Characteristics
Color GREEN (light green) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code M;R23
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69189-3123-1 1 TABLET in 1 DOSE PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090252 01/22/2016
Labeler — Avera McKennan Hospital (068647668)
Establishment
Name Address ID/FEI Operations
Avera McKennan Hospital 068647668 relabel (69189-3123), repack (69189-3123)

Revised: 03/2017 Avera McKennan Hospital

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