"The U.S. Food and Drug Administration today approved Farxiga (dapaglifozin) tablets to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.
Type 2 diabetes affects about 24 million people and accounts for "...
PRANDIN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
DOSAGE AND ADMINISTRATION
The patient's blood glucose should be monitored periodically to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of an adequate blood glucose-lowering response after an initial period of effectiveness. Glycosylated hemoglobin levels are of value in monitoring the patient's longer term response to therapy.
Short-term administration of PRANDIN may be sufficient during periods of transient loss of control in patients usually well controlled on diet.
PRANDIN doses are usually taken within 15 minutes of the meal but time may vary from immediately preceding the meal to as long as 30 minutes before the meal.
For patients not previously treated or whose HbA1c is < 8%, the starting dose should be 0.5 mg with each meal. For patients previously treated with blood glucose-lowering drugs and whose HbA1c is > 8%, the initial dose is 1 or 2 mg with each meal preprandially (see previous paragraph).
Dosing adjustments should be determined by blood glucose response, usually fasting blood glucose. Postprandial glucose levels testing may be clinically 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.
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.
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.
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
|Bottles of 100||NDC||00169-0081-81|
|Bottles of 500||NDC||00169-0081-82|
|Bottles of 1000||NDC||00169-0081-83|
|1 mg tablets
|Bottles of 100||NDC||00169-0082-81|
|Bottles of 500||NDC||00169-0082-82|
|Bottles of 1000||NDC||00169-0082-83|
|2 mg tablets
|Bottles of 100||NDC||00169-0084-81|
|Bottles of 500||NDC||00169-0084-82|
|Bottles of 1000||NDC||00169-0084-83|
Do not store above 25° C (77° F).
Protect from moisture. Keep bottles tightly closed.
Dispense in tight containers with safety closures.
Manufactured in Germany for Novo Nordisk Inc. Princeton, NJ 08540. 1-800-727-6500. www.novonordisk-us.com. Date of Issue: March 1, 2012.
Last reviewed on RxList: 3/14/2012
This monograph has been modified to include the generic and brand name in many instances.
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