Repaglinide and Metformin hydrochloride
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Vignesh Ponnusamy, M.B.B.S. [2]
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Black Box Warning
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WARNING: LACTIC ACIDOSIS
See full prescribing information for complete Boxed Warning.
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Overview
Repaglinide and Metformin hydrochloride is a meglitinide and biguanide combination that is FDA approved for the {{{indicationType}}} of type 2 diabetes mellitus. There is a Black Box Warning for this drug as shown here. Common adverse reactions include hypoglycemia, headache. diarrhea, nausea and vomiting.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Type 2 Diabetes Mellitus
- 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.
- Patients Inadequately Controlled with Metformin HCl Monotherapy
- If therapy with a combination tablet containing repaglinide and metformin HCl is considered appropriate for a patient with type 2 diabetes mellitus inadequately controlled with metformin HCl alone, the recommended starting dose of PrandiMet is 1 mg repaglinide/500 mg metformin HCl administered twice daily with meals, with gradual dose escalation (based on glycemic response) to reduce the risk of hypoglycemia with repaglinide.
- Patients Inadequately Controlled with Meglitinide Monotherapy
- If therapy with a combination tablet containing repaglinide and metformin HCl is considered appropriate for a patient with type 2 diabetes mellitus inadequately controlled with repaglinide alone, the recommended starting dose of the metformin HCl component of PrandiMet should be 500 mg metformin HCl twice a day, with gradual dose escalation (based on glycemic response) to reduce gastrointestinal side effects associated with metformin HCl.
- Patients Currently Using Repaglinide and Metformin HCl Concomitantly
- For patients switching from repaglinide co-administered with metformin HCl, PrandiMet can be initiated at the dose of repaglinide and metformin HCl similar to (but not exceeding) the patient's current doses, then may be titrated to the maximum daily dose as necessary to achieve targeted glycemic control.
- No studies have been performed examining the safety and efficacy of PrandiMet in patients previously treated with other oral antihyperglycemic agents and switched to PrandiMet. Any change in therapy should be undertaken with care and with appropriate monitoring as changes in glycemic control can occur.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
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- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
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There is limited information regarding Off-Label Guideline-Supported Use of Repaglinide and Metformin hydrochloride in adult patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Repaglinide and Metformin hydrochloride in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
- Dosing Information
- Dosage
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There is limited information regarding FDA-Labeled Use of Repaglinide and Metformin hydrochloride in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Repaglinide and Metformin hydrochloride in pediatric patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Repaglinide and Metformin hydrochloride in pediatric patients.
Contraindications
- Renal impairment (e.g., serum creatinine levels ≥1.5 mg/dL [males], ≥1.4 mg/dL [females], or abnormal creatinine clearance).
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin.
- Patients receiving gemfibrozil.
- Patients with known hypersensitivity to repaglinide, metformin HCl or any inactive ingredients in PrandiMet.
Warnings
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WARNING: LACTIC ACIDOSIS
See full prescribing information for complete Boxed Warning.
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Precautions
- Lactic Acidosis
- Metformin hydrochloride
- Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with PrandiMet; when it occurs, it is fatal in approximately 50% of cases. Lactic acidosis may also occur in association with a number of pathophysiologic conditions, including diabetes mellitus, and whenever there is significant tissue hypoperfusion and hypoxemia. Lactic acidosis is characterized by elevated blood lactate levels (>5 mmol/L), decreased blood pH, electrolyte disturbances with an increased anion gap, and an increased lactate/pyruvate ratio. When metformin is implicated as the cause of lactic acidosis, metformin plasma levels >5 µg/mL are generally found.
- The reported incidence of lactic acidosis in patients receiving metformin HCl is very low (approximately 0.03 cases/1,000 patient-years of exposure, with approximately 0.015 fatal cases/1,000 patient-years of exposure). In more than 20,000 patient-years exposure to metformin HCl in clinical trials, there were no reports of lactic acidosis. Reported cases have occurred primarily in diabetic patients with significant renal impairment, including both intrinsic renal disease and renal hypoperfusion, often in the setting of multiple concomitant medical/surgical problems and multiple concomitant medications. Patients with congestive heart failure requiring pharmacologic management, in particular those with unstable or acute congestive heart failure who are at risk of hypoperfusion and hypoxemia, are at increased risk of lactic acidosis. The risk of lactic acidosis increases with the degree of renal impairment and the patient's age. The risk of lactic acidosis may, therefore, be significantly decreased by regular monitoring of renal function in patients taking PrandiMet and by use of the minimum effective dose of PrandiMet. In particular, treatment of the elderly should be accompanied by careful monitoring of renal function. Treatment with PrandiMet should not be initiated in patients ≥80 years of age unless measurement of creatinine clearance demonstrates that renal function is not reduced, as these patients are more susceptible to developing lactic acidosis. In addition, PrandiMet should be promptly withheld in the presence of any condition associated with hypoxemia, dehydration, or sepsis. Because impaired hepatic function may significantly limit the ability to clear lactate, PrandiMet should generally be avoided in patients with clinical or laboratory evidence of hepatic disease. Patients should be cautioned against excessive alcohol intake, either acute or chronic, when taking PrandiMet, since alcohol potentiates the effects of metformin HCl on lactate metabolism. In addition, PrandiMet should be temporarily discontinued prior to any intravascular radiocontrast study and for any surgical procedure [see Warnings and Precautions (5.3), (5.5), and (5.10)].
- 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. There may be associated hypothermia, hypotension, and resistant bradyarrhythmias with more marked acidosis. The patient and the patient's physician must be aware of the possible importance of such symptoms and the patient should be instructed to notify the physician immediately if they occur (see also Warnings and Precautions). PrandiMet should be withdrawn until the situation is clarified. Serum electrolytes, ketones, blood glucose and, if indicated, blood pH, lactate levels, and even blood metformin levels may be useful. Once a patient is stabilized on any dose level of PrandiMet, gastrointestinal symptoms, which are common during initiation of therapy, are unlikely to be drug related. Later occurrence of gastrointestinal symptoms could be due to lactic acidosis or other serious disease.
- Levels of fasting venous plasma lactate above the upper limit of normal but less than 5 mmol/L in patients taking PrandiMet do not necessarily indicate impending lactic acidosis and may be explainable by other mechanisms, such as poorly controlled diabetes or obesity, vigorous physical activity or technical problems in sample handling [see Warnings and Precautions (5.11), (5.14)].
- Lactic acidosis should be suspected in any diabetic patient with metabolic acidosis lacking evidence of ketoacidosis (ketonuria and ketonemia).
- Lactic acidosis is a medical emergency that must be treated in a hospital setting. In a patient with lactic acidosis who is taking PrandiMet, the drug should be discontinued immediately and general supportive measures promptly instituted. Because metformin HCl is dialyzable (with a clearance of up to 170 mL/min under good hemodynamic conditions), prompt hemodialysis is recommended to correct the acidosis and remove the accumulated metformin. Such management often results in prompt reversal of symptoms and recovery [see Contraindications (4)].
- Metformin hydrochloride
- Impaired Renal Function
- Patients with renal impairment should not receive PrandiMet [see Warnings and Precautions (5.1), Contraindications (4)].
- As metformin is substantially excreted by the kidney, before initiation of therapy with PrandiMet and at least annually thereafter, renal function should be assessed and verified as normal. In patients in whom development of renal impairment is anticipated, renal function should be assessed more frequently and PrandiMet discontinued if evidence of renal impairment is present [see Clinical Pharmacology (12.3)].
- Radiologic Studies with Intravascular Iodinated Contrast Materials
- Intravascular contrast studies with iodinated materials can lead to acute alteration of renal function and have been associated with lactic acidosis in patients receiving metformin HCl [see Contraindications (4)]. Therefore, in patients in whom any such study is planned, PrandiMet should be temporarily discontinued at the time of or prior to the procedure, and withheld for 48 hours subsequent to the procedure and reinstituted only after renal function has been re-evaluated and found to be normal.
- Impaired Hepatic Function
- Hepatic impairment has been associated with some cases of lactic acidosis. Therefore, PrandiMet should generally be avoided in patients with hepatic impairment [see Clinical Pharmacology (12.3)].
- Alcohol Intake
- Alcohol potentiates the effect of metformin on lactate metabolism. Patients should be warned against excessive alcohol intake while receiving PrandiMet.
- Combination with NPH-insulin
- Repaglinide
- Repaglinide is not indicated for use in combination with NPH-insulin.
- Across seven controlled clinical trials, there were six serious adverse events (1.4%) of myocardial ischemia with repaglinide in combination with NPH-insulin compared to one event (0.3%) in patients using insulin alone [see Adverse Reactions (6.2)].
- Repaglinide
- Drug Interactions
- Repaglinide is partly metabolized by CYP2C8 and CYP3A4 and appears to be a substrate for active hepatic uptake transporter (organic anion transporting protein OATP1B1). Drugs that inhibit CYP2C8, CYP3A4, or OATP1B1 (e.g., cyclosporine) may increase plasma concentrations of repaglinide. Dose reduction of repaglinide may be needed [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)].
- Gemfibrozil significantly increased repaglinide exposure. Therefore, patients should not take PrandiMet with gemfibrozil [see Contraindications (4) and Clinical Pharmacology (12.3)].
- Hypoglycemia
- Most blood glucose-lowering drugs, including repaglinide, can cause hypoglycemia. Patients who have not previously been treated with a meglitinide should be started on the lowest available repaglinide component of PrandiMet to reduce the risk of hypoglycemia. Elderly, debilitated or malnourished patients and those with adrenal or pituitary insufficiency or alcohol intoxication are particularly susceptible to hypoglycemia. Hypoglycemia may be difficult to recognize in the elderly and in people who are taking β-adrenergic blocking drugs [see Adverse Reactions (6.1)].
- Vitamin B12 Levels
- In controlled clinical trials of metformin HCl of 29 weeks' duration, a decrease to subnormal levels of previously normal serum vitamin B12 levels, without clinical manifestations, was observed in approximately 7% of patients. This finding, possibly due to interference with B12 absorption from the B12-intrinsic factor complex, is rarely associated with anemia and appears to be rapidly reversible with discontinuation of metformin HCl or vitamin B12 supplementation. Measurement of hematologic parameters on an annual basis is advised in patients on PrandiMet and any apparent abnormalities should be appropriately investigated and managed.
- Certain individuals (those with inadequate vitamin B12 or calcium intake or absorption) appear to be predisposed to developing subnormal vitamin B12 levels. In these patients, routine serum vitamin B12 measurements at 2- to 3-year intervals may be useful.
- Surgical Procedures
- Use of PrandiMet should be temporarily suspended for any surgical procedure (except minor procedures not associated with restricted intake of food and fluids) and should not be restarted until the patient's oral intake has resumed and renal function has been evaluated as normal.
- Loss of Control of Blood Glucose
- When a patient stabilized on any diabetic regimen is exposed to stress such as fever, trauma, infection, or surgery, a temporary loss of glycemic control may occur. At such times, it may be necessary to withhold PrandiMet and temporarily administer insulin. PrandiMet may be reinstituted after the acute episode is resolved.
- Use of Concomitant Medications Affecting Renal Function or Metformin Disposition
- Concomitant medication(s) that may affect renal function or result in significant hemodynamic change or may interfere with the disposition of metformin, such as cationic drugs that are eliminated by renal tubular secretion should be used with caution.
- Hypoxic States
- Cardiovascular collapse (shock) from whatever cause, acute congestive heart failure, acute myocardial infarction, and other conditions characterized by hypoxemia have been associated with lactic acidosis and may also cause prerenal azotemia. When such events occur in patients receiving PrandiMet, the drug should be promptly discontinued.
- Change in Clinical Status of Patients with Previously Controlled Type 2 Diabetes
- A patient with type 2 diabetes previously well-controlled on PrandiMet who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis. Evaluation should include serum electrolytes and ketones, blood glucose and, if indicated, blood pH, lactate, pyruvate, and metformin levels. If acidosis of either form occurs, PrandiMet must be stopped immediately and other appropriate corrective measures initiated.
- Macrovascular Outcomes
- There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with PrandiMet or any other oral anti-diabetic drug.
Adverse Reactions
Clinical Trials Experience
- Most Frequently Observed Adverse Reactions
- Repaglinide
- In clinical trials of repaglinide, hypoglycemia is the most common adverse reaction (> 5%) leading to withdrawal of patients treated with repaglinide.
- Repaglinide
- Metformin HCl
- Gastrointestinal reactions (e.g., diarrhea, nausea, vomiting) are the most common adverse reactions (> 5%) with metformin HCl treatment and are more frequent at higher metformin HCl doses.
- Metformin HCl
- Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Patients with Inadequate Glycemic Control on Metformin HCl Monotherapy
- Table 1 summarizes the most common adverse reactions occurring in a 6-month randomized study of repaglinide added to metformin HCl in patients with type 2 diabetes inadequately controlled on metformin HCl alone.
T1
Cardiovascular Events in repaglinide monotherapy trials
- In one-year trials comparing repaglinide to sulfonylurea drugs, the incidence of angina was 1.8% for both treatments, with an incidence of chest pain of 1.8% for repaglinide and 1.0% for sulfonylureas. The incidence of other selected cardiovascular events (hypertension, abnormal electrocardiogram, myocardial infarction, arrhythmias, and palpitations) was ≤ 1% and not different between repaglinide and the comparator drugs.
- The incidence of total serious cardiovascular adverse events, including ischemia, was higher for repaglinide (51/1228 or 4%) than for sulfonylurea drugs (13/498 or 3%) in controlled clinical trials. In 1-year controlled trials, repaglinide treatment was not associated with excess mortality when compared to the rates observed with other oral hypoglycemic agent therapies such as glyburide and glipizide.
- Seven controlled clinical trials included repaglinide combination therapy with NPH-insulin (n=431), insulin formulations alone (n=388) or other combinations (sulfonylurea plus NPH-insulin or repaglinide plus metformin HCl) (n=120). There were six serious adverse events of myocardial ischemia in patients treated with repaglinide plus NPH-insulin (1.4%) from two studies, and one event in patients using insulin formulations alone from another study (0.3%).
Postmarketing Experience
- Repaglinide
- The following additional adverse reactions have been identified during postapproval use of repaglinide. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or a causal relationship to drug exposure.
- Postmarketing experience with repaglinide includes infrequent reports of the following adverse events; alopecia, hemolytic anemia, pancreatitis, Stevens-Johnson Syndrome, and severe hepatic dysfunction including jaundice and hepatitis.
Drug Interactions
- Cationic Drugs
- Cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, and vancomycin) that are eliminated by renal tubular secretion theoretically have the potential for interaction with metformin by competing for common renal tubular transport systems. Careful patient monitoring and dose adjustment of PrandiMet and/or the interfering drug is recommended in patients who are taking cationic medications that are excreted via the proximal renal tubular secretory system.
- CYP2C8 and CYP3A4 Inhibitors/Inducers
- Repaglinide is metabolized by CYP2C8 and to a lesser extent by CYP3A4. Drugs that inhibit 2C8 (gemfibrozil, trimethoprim, deferasirox), inhibit 3A4 (itraconazole, ketaconazole), or induce CYP2C8/3A4 (rifampin) may alter the pharmacokinetics and pharmacodynamics of repaglinide. In vivo data from a study that evaluated the co-administration of gemfibrozil and repaglinide in healthy subjects showed a significant increase in repaglinide blood levels. Administration of PrandiMet and gemfibrozil to the same patient is not recommended.
- Repaglinide exposures are increased more than 20-fold in patients taking both gemfibrozil and itraconazole.
Use in Specific Populations
Pregnancy
- Pregnancy Category C
- There are no adequate and well-controlled studies in pregnant women with PrandiMet or its individual components. Because animal reproduction studies are not always predictive of human response, PrandiMet like other antidiabetic medications, should be used during pregnancy only if clearly needed.
- No animal studies have been conducted with the combined products in PrandiMet. The following data are based on findings in studies performed with repaglinide or metformin individually.
- Repaglinide
- Repaglinide was not teratogenic in rats at doses 40 times, and rabbits approximately 0.8 times the clinical exposure (on a mg/m2 basis) throughout pregnancy. Offspring of rat dams exposed to repaglinide at 15 times clinical exposure on a mg/m2 basis during days 17 to 22 of gestation and during lactation developed nonteratogenic skeletal deformities consisting of shortening, thickening, and bending of the humerus during the postnatal period. This effect was not seen at doses up to 2.5 times clinical exposure (on a mg/m2 basis) on days 1 to 22 of pregnancy or at higher doses given during days 1 to 16 of pregnancy. Relevant human exposure has not occurred to date and therefore the safety of repaglinide administration throughout pregnancy or lactation cannot be established.
- Metformin HCl
- Metformin HCl alone was not teratogenic in rats or rabbits at doses up to 600 mg/kg/day. This represents an exposure of approximately two and six times the near-maximal efficacious human daily dose of 2000 mg of the metformin HCl component of PrandiMet based on body surface area comparisons for rats and rabbits, respectively. Determination of fetal concentrations demonstrated a partial placental barrier to metformin.
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Repaglinide and Metformin hydrochloride in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Repaglinide and Metformin hydrochloride during labor and delivery.
Nursing Mothers
- No studies in lactating animals have been conducted with the PrandiMet fixed dose combination. In studies performed with individual components, both repaglinide and metformin are excreted into milk of lactating rats.
- Repaglinide
- In rat reproduction studies, measurable levels of repaglinide were detected in the breast milk of the dams and lowered blood glucose levels were observed in the pups. Cross fostering studies indicated that skeletal changes could be induced in control pups nursed by treated dams, although this occurred to a lesser degree than those pups treated in utero.
- Metformin HCl
- Studies in lactating rats with metformin HCl show that it is excreted into milk and reaches levels comparable to those in plasma.
- It is not known whether repaglinide or metformin are excreted in human milk. PrandiMet is not recommended in nursing mothers because it may potentially cause hypoglycemia in nursing infants.
Pediatric Use
- Safety and effectiveness of PrandiMet in pediatric patients have not been established. PrandiMet is not recommended for use in children.
Geriatic Use
- Healthy volunteers treated with repaglinide 2 mg before each of 3 meals, showed no significant differences in repaglinide pharmacokinetics between the group of patients <65 years of age and those ≥65 years of age.
- In patients with advanced age, PrandiMet should be carefully titrated to establish the minimum dose for adequate glycemic effect, because aging is associated with reduced renal function. In elderly patients, particularly those ≥80 years of age, dose adjustment of PrandiMet should be based on a careful assessment of renal function.
Gender
There is no FDA guidance on the use of Repaglinide and Metformin hydrochloride with respect to specific gender populations.
Race
There is no FDA guidance on the use of Repaglinide and Metformin hydrochloride with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Repaglinide and Metformin hydrochloride in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Repaglinide and Metformin hydrochloride in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Repaglinide and Metformin hydrochloride in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Repaglinide and Metformin hydrochloride in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
- Intravenous
Monitoring
There is limited information regarding Monitoring of Repaglinide and Metformin hydrochloride in the drug label.
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Repaglinide and Metformin hydrochloride in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
- Description
Management
- Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Repaglinide and Metformin hydrochloride in the drug label.
Pharmacology
There is limited information regarding Repaglinide and Metformin hydrochloride Pharmacology in the drug label.
Mechanism of Action
Structure
This image is provided by the National Library of Medicine.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Repaglinide and Metformin hydrochloride in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Repaglinide and Metformin hydrochloride in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Repaglinide and Metformin hydrochloride in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Repaglinide and Metformin hydrochloride in the drug label.
How Supplied
Storage
There is limited information regarding Repaglinide and Metformin hydrochloride Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Patient Counseling Information of Repaglinide and Metformin hydrochloride in the drug label.
Precautions with Alcohol
- Alcohol-Repaglinide and Metformin hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- ®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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