RX ITEM-Prandimet 1Mg 500Mg Tab 100 By Novo Nordisk Pharm

PRANDIMET- repaglinide and metformin hydrochloride tablet
Novo Nordisk

WARNING: LACTIC ACIDOSIS

Lactic acidosis is a rare but serious complication that can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure.



The onset of lactic acidosis often is subtle, and accompanied only by nonspecific symptoms such as malaise, myalgias , respiratory distress, increasing somnolence, and nonspecific abdominal distress.

Laboratory abnormalities include low pH, increased anion gap and elevated blood lactate.

If acidosis is suspected, PrandiMet should be discontinued and the patient hospitalized immediately [see Warnings and Precautions (5.1) ].

1 INDICATIONS AND USAGE

PrandiMet is indicated 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.

Important Limitations 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.

2 DOSAGE AND ADMINISTRATION

Recommended Dosing

The dosage of PrandiMet should be individualized on the basis of the patient's current regimen, effectiveness and tolerability. PrandiMet can be administered 2 to 3 times a day up to a maximum daily dose of 10 mg repaglinide/2500 mg metformin HCl. No more than 4 mg repaglinide/1000 mg metformin HCl should be taken per meal. Initiation and maintenance of combination therapy with PrandiMet should be individualized to the patient, and at the discretion of the health care provider. Blood glucose monitoring should be performed to determine the therapeutic response to PrandiMet.

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.

RX ITEM-Prandimet 1Mg 500Mg Tab 100 By N
NDC 00169-0093-01 UPC/GTIN No.3-01690-09301-4 Mfg.Part No.9301

Prandimet 1Mg 500Mg Tab 100 By Novo Nord
BRAND: PRANDIMET NDC: 00169-0093-01,169009301 UPC: 3-01690-09301-4,301690093014

Click above for REPAGLINIDE/METFORMIN HC
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