y helpful in patients whose pre-meal blood glucose levels are satisfactory but whose overall glycemic control (HbA1c) is inadequate. The preprandial dose should be doubled up to 4 mg with each meal until satisfactory blood glucose response is achieved. At least one week should elapse to assess response after each dose adjustment.
The recommended dose range is 0.5 mg to 4 mg taken with meals. PRANDIN may be dosed preprandially 2, 3, or 4 times a day in response to changes in the patient's meal pattern. The maximum recommended daily dose is 16 mg.
Patient Management
Long-term efficacy should be monitored by measurement of HbA1c levels approximately every 3 months. Failure to follow an appropriate dosage regimen may precipitate hypoglycemia or hyperglycemia. Patients who do not adhere to their prescribed dietary and drug regimen are more prone to exhibit unsatisfactory response to therapy including hypoglycemia. When hypoglycemia occurs in patients taking a combination of PRANDIN and a thiazolidinedione or PRANDIN and metformin, the dose of PRANDIN should be reduced.
Patients Receiving Other Oral Hypoglycemic Agents
When PRANDIN is used to replace therapy with other oral hypoglycemic agents, PRANDIN may be started on the day after the final dose is given. Patients should then be observed carefully for hypoglycemia due to potential overlapping of drug effects. When transferred from longer half-life sulfonylurea agents (e.g., chlorpropamide) to repaglinide, close monitoring may be indicated for up to one week or longer.
Combination Therapy
If PRANDIN 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, PRANDIN may be added. The starting dose and dose adjustments for PRANDIN combination therapy is the same as for PRANDIN 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
PRANDIN (repaglinide) tablets are supplied as unscored, biconvex tablets available in 0.5 mg (white), 1 mg (yellow) and 2 mg (peach) strengths. Tablets are embossed with the Novo Nordisk (Apis) bull symbol and colored to indicate strength.
0.5 mg tablets (white)Bottles of 100NDC 00169-0081-81Bottles of 500NDC 00169-0081-82Bottles of 1000NDC 00169-0081-831 mg tablets (yellow)Bottles of 100NDC 00169-0082-81Bottles of 500NDC 00169-0082-82Bottles of 1000NDC 00169-0082-832 mg tablets (peach)Bottles of 100NDC 00169-0084-81Bottles of 500NDC 00169-0084-82Bottles of 1000NDC 00169-0084-83
STORAGE AND HANDLING
Do not store above 25C (77F).
Protect from moisture. Keep bottles tightly closed.
Dispense in tight containers with safety closures.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
DRUG: Prandin
GENERIC: Repaglinide
DOSAGE: TABLET
ADMINSTRATION: ORAL
NDC: 49349-559-20
STRENGTH:2 mg
COLOR: pink
SHAPE: ROUND
SCORE: No score
SIZE: 5 mm
IMPRINT: 100
QTY: 100
PRANDIN
repaglinide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49349-559(ND |
