Classes
DEA Class; Rx
Common Brand Names; PrandiMet
- Antidiabetics, Biguanides/Meglitinides
Description
Combination of a meglitinide oral antidiabetic agent, repaglinide, and the biguanide metformin
Used in adults to treat type 2 diabetes mellitus; most commonly used in patients not achieving goals with either agent alone
Boxed warning regarding lactic acidosis
Indications
Indicated as 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, or who have inadequate glycemic control on a meglitinide alone or metformin alone
Contraindications
Severe renal disease: eGFR <30 ml/min/1.73 m²
Acute or chronic metabolic acidosis, including diabetic ketoacidosis
Concomitant gemfibrozil and itraconazole
Hypersensitivity to repaglinide or metformin
Adverse Effects
Diarrhea
Nausea/vomiting
Symptomatic hypoglycemia
Headache
Upper respiratory infection
Hypoglycemia
Warnings
Risk of lactic acidosis due to accumulation of metformin; if metformin-associated lactic acidosis suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of therapy; in patients with a diagnosis or strong suspicion of lactic acidosis, prompt hemodialysis is recommended to correct acidosis and remove accumulated metformin (metformin hydrochloride is dialyzable, with a clearance of up to170 mL/minute under good hemodynamic conditions); hemodialysis has often resulted in reversal of symptoms and recovery
Use caution in hepatic impairment
Several of the postmarketing cases of metformin-associated lactic acidosis occurred in setting of acute congestive heart failure (particularly when accompanied by hypoperfusion and hypoxemia); cardiovascular collapse (shock) acute myocardial infarction, sepsis, and other conditions associated with hypoxemia have been associated with lactic acidosis and may also cause prerenal azotemia; discontinue therapy when such events occur
Avoid excessive alcohol
Can cause severe hypoglycemia, which can cause seizures, may be life-threatening, or cause death; hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery); the elderly at at risk of hypoglycemia; symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers), or in patients who experience recurrent hypoglycemia; patients should administer therapy before meals and be instructed to skip dose if a meal is skipped; in patients who experience hypoglycemia, the dose should be reduced; patients and caregivers must be educated to recognize and manage hypoglycemia; self-monitoring of blood glucose plays an essential role in prevention and management of hypoglycemia; in patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring recommended
May decrease levels of Vit B12
Withholding of food and fluids during surgical or other procedures may increase risk for volume depletion, hypotension, and renal impairment; therapy should be temporarily discontinued while patients have restricted food and fluid intake; suspend temporarily for any surgical procedure until patient is no longer NPO and normal renal function has resumed
During loss of blood sugar control: suspend PrandiMet temporarily and administer insulin
Pregnancy and Lactation
Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications
Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity
No data on the presence of repaglinide in human milk, the effects on the breastfeeding infant, or the effects on milk production
Metformin is present in breast milk
Maximum Dosage
Repaglinide 10 mg/day PO; metformin 2,500 mg/day PO.
In general, do not titrate to the adult maximum dosage.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Metformin/repaglinide
tablet
- 500mg/1mg
- 500mg/2mg