April 30, 2017
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Prandin

"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, "...

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Prandin




Indications
Dosage
How Supplied

INDICATIONS

PRANDIN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitation Of Use:

PRANDIN should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

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

Dosage adjustments are recommended in patients taking concomitant strong CYP3A4 or CYP2C8 inhibitors or strong CYP3A4 or CYP2C8 inducers [see DRUG INTERACTIONS, CLINICAL PHARMACOLOGY].

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].

Do not exceed a total daily dose of 6 mg of PRANDIN in patients receiving cyclosporine [see DRUG INTERACTIONS, CLINICAL PHARMACOLOGY].

HOW SUPPLIED

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
NDC 0169-0081-81
NDC 0169-0081-82
1 mg tablets (yellow) Bottles of 100
Bottles of 500
NDC 0169-0082-81
NDC 0169-0082-82
2 mg tablets (peach) Bottles of 100
Bottles of 500
NDC 0169-0084-81
NDC 0169-0084-82

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 2017

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/13/2017

Indications
Dosage
How Supplied

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