Prandimet

What is Prandimet?

• Prandimet (repaglinide and Metformin HCL) is a meglitinide and biguanide combination product used to improve glycemic control in adults with type 2 diabetes mellitus.

Repaglinide

Repaglinide ball-and-stick

Metformin

Metformin molecule ball

What are the uses of this medicine?

• Prandimet (repaglinide and metformin HCl) used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a meglitinide and metformin HCl or who have inadequate glycemic control on a meglitinide alone or metformin HCl alone.

Limitation of use:

• Prandimet should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

How does this medicine work?

• Prandimet combines two anti-hyperglycemic agents with different mechanisms of action to improve glycemic control in patients with type 2 diabetes.

Repaglinide:

• Repaglinide (re pag' li nide) is an insulin secretagogue that is similar in action but different in structure from the sulfonylureas.
• It is a benzoid acid derivative that, like the sulfonylureas, stimulates insulin secretion by blocking ATP sensitive potassium channels in pancreatic beta-cells, causing cell membrane depolarization which results in calcium influx and insulin secretion.
• Repaglinide has been shown to reduce the postprandial increase in glucose in patients with type 2 diabetes and improve glycemic control.

Metformin:

• Metformin (met for' min) is a biguanine and acts as an insulin sensitizing agent, probably through activation of adenosine monophosphate dependent (AMP) kinase in liver and muscle tissue.
• Metformin is often associated with weight loss making it a preferred, first line agent for management of overweight patients with type 2 diabetes. Initial concerns about the possibility that metformin (like the related biguanine phenformin) could induce lactic acidosis have been largely resolved, although the agent is contraindicated in patients with renal dysfunction because of this reason and should be used with caution in patients with significant liver disease.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Renal impairment
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin.
• receiving gemfibrozil
• with known hypersensitivity to repaglinide, metformin HCl or any inactive ingredients in Prandimet

What drug interactions can this medicine cause?

• use with caution cationic drugs eliminated by renal tubular secretion may interfere with metformin elimination.
• Repaglinide is partly metabolized by CYP2C8 and CYP3A4. Use caution in patients taking inhibitors and/or inducers of CYP2C8 and CYP3A4.

Is this medicine FDA approved?

• Initial U.S. Approval: 2008

How should this medicine be used?

Recommended dosage:

• Start with 1 mg/500 mg twice daily unless the patient is already taking higher co-administered doses of repaglinide and metformin HCl.
• Do not exceed 10 mg repaglinide/2500 mg metformin HCl daily or 4 mg repaglinide/1000 mg metformin HCl per meal.

Administration:

• Prandimet doses should usually be taken within 15 minutes prior to the meal but the timing can vary from immediately preceding the meal up to 30 minutes before the meal.
• Patients who skip a meal should be instructed to skip the Prandimet dose for that meal.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Tablets:

• 1 mg repaglinide/500 mg metformin HCl
• 2 mg repaglinide/500 mg metformin HCl

This medicine is available in fallowing brand namesː

• Prandimet

What side effects can this medication cause?

The most common side effects of this medicine include:

• Hypoglycemia and headache
• Gastrointestinal reactions (e.g., diarrhea, nausea and vomiting) are the most common adverse reactions with metformin HCl treatment and are more frequent at higher metformin HCl doses

What special precautions should I follow?

• Metformin HCl is contraindicated in renal impairment. Assess renal function before initiating Prandimet and at least annually thereafter, and verify as normal.
• Temporarily discontinue Prandimet in patients receiving iodinated contrast for radiological studies.
• Hepatic impairment is associated with lactic acidosis. Recommend not using in patients with hepatic impairment.
• Alcohol potentiates the effect of metformin on lactate metabolism. Warn patients against excess alcohol intake.
• Prandimet should not be used in combination with NPH insulin.
• Gemfibrozil substantially increases repaglinide exposure. Coadministration of gemfibrozil and Prandimet is not recommended.
• The repaglinide component can cause hypoglycemia. Initiate Prandimet at the lowest available dose in patients naive to meglitinide therapy.
• Metformin can cause vitamin B12 deficiency. Measure hematological parameters annually.
• May need to discontinue Prandimet and temporarily use insulin if glycemic control deteriorates during periods of stress or if there is decreased intake of fluids and food (e.g., infection, surgery).
• There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Prandimet or any other oral anti-diabetic drug.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• It is not known whether Prandimet or its individual components can cause fetal harm when administered to a pregnant woman.
• Prandimet should be given to a pregnant woman only if clearly needed.

Can this medicine be used in children?

• Safety and effectiveness of Prandimet in pediatric patients have not been established.
• Prandimet is not recommended for use in children.

Who manufactures and distributes this medicine?

Manufactured for:

• Novo Nordisk A/S
• DK-2880 Bagsvaerd, Denmark

• Prandimet® is a registered trademark of Novo Nordisk A/S.

What should I know about storage and disposal of this medication?

• Do not store above 25° C (77° F).
• Protect from moisture.
• Keep bottles tightly closed.
• Dispense in tight containers with safety closures.

• Dailymed label info on Prandimet
• FDA Prandimet

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