"Despite the unanimous backing of a Food and Drug Administration (FDA) advisory committee back in May, Novo Nordisk has announced there is to be a 3-month delay on a decision regarding US approval of its new injectable product, IDegLira, "...
DOSAGE AND ADMINISTRATION
Recommended Dosage And Administration
The recommended starting dose for patients whose HbA1c is less than 8% is 0.5 mg orally before each meal. For patients whose HbA1c is 8% or greater the starting dose is 1 or 2 mg orally before each meal.
The recommended dose range is 0.5 mg to 4 mg before meals, with a maximum daily dose of 16 mg. The patient’s dose should be doubled up to 4 mg with each meal until satisfactory glycemic control is achieved. At least one week should elapse to assess response after each dose adjustment.
Instruct patients to take PRANDIN within 30 minutes before meals. PRANDIN may be dosed 2, 3, or 4 times a day in response to changes in the patient’s meal pattern.
In patients who skip meals, instruct patients to skip the scheduled dose of PRANDIN to reduce the risk of hypoglycemia. In patients who experience hypoglycemia, the dose of PRANDIN should be reduced [see WARNINGS AND PRECAUTIONS].
Patients With Severe Renal Impairment
In patients with severe renal impairment (CrCl = 20 – 40 mL/min) initiate PRANDIN 0.5 mg orally before each meal. Gradually titrate the dose, if needed to achieve glycemic control.
Dose Modifications For Drug Interactions
Concomitant use with gemfibrozil is contraindicated [see CONTRAINDICATIONS].
Avoid concomitant use of PRANDIN with clopidogrel. If concomitant use can not be avoided, initiate PRANDIN at 0.5 mg before each meal and do not exceed a total daily dose of 4 mg [see DRUG INTERACTIONS, CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
- 0.5 mg tablets (white, biconvex tablets, embossed with the Novo Nordisk (Apis) bull symbol)
- 1 mg tablets (yellow, biconvex tablets, embossed with the Novo Nordisk (Apis) bull symbol)
- 2 mg tablets (peach, biconvex tablets, embossed with the Novo Nordisk (Apis) bull symbol)
Storage And Handling
PRANDIN (repaglinide) tablets are supplied as biconvex tablets available in 0.5 mg (white), 1 mg (yellow) and 2 mg (peach) strengths and are embossed with the Novo Nordisk (Apis) bull symbol.
|0.5 mg tablets (white)||Bottles of 100
Bottles of 500
|1 mg tablets (yellow)||Bottles of 100
Bottles of 500
|2 mg tablets (peach)||Bottles of 100
Bottles of 500
Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature].
Protect from moisture. Keep bottles tightly closed.
Dispense in tight containers with safety closures.
Manufactured for: Novo Nordisk A/S DK-2880 Bagsvaerd, Denmark. Revised: Feb 2017This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/13/2017
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