Prandimet Information
Prandimet () 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.
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.
Prandimet () Dosage And Administration
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.
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.
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.
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.
Prandimet () Contraindications
Prandimet () is contraindicated in:
Prandimet () Warnings And Precautions
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 [].
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 [].
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 [].
Metformin is substantially excreted by the kidney and the risk of metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Therefore, patients with renal impairment should not receive Prandimet () [].
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 [].
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 [].
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
Gemfibrozil significantly increased repaglinide exposure. Therefore, patients should not take Prandimet () with gemfibrozil [].
In controlled clinical trials of metformin HCl of 29 weeks' duration, a decrease to subnormal levels of previously normal serum vitamin B levels, without clinical manifestations, was observed in approximately 7% of patients. This finding, possibly due to interference with B absorption from the B-intrinsic factor complex, is rarely associated with anemia and appears to be rapidly reversible with discontinuation of metformin HCl or vitamin B 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 B or calcium intake or absorption) appear to be predisposed to developing subnormal vitamin B levels. In these patients, routine serum vitamin B measurements at 2- to 3-year intervals may be useful.
Prandimet () Adverse Reactions
Repaglinide
In clinical trials of repaglinide, hypoglycemia is the most common adverse reaction (> 5%) leading to withdrawal of patients treated with 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.
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.
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%) [].
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.
Prandimet () Drug Interactions
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. 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 [].
Prandimet () Use In Specific Populations
Pregnancy Category C. All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. This background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. It is essential for patients with diabetes or history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy. Careful monitoring of glucose control is essential in these patients.
Animal reproduction studies have not been conducted with Prandimet () . 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.
Repaglinide
Repaglinide was not teratogenic in rats at doses 40 times, and rabbits approximately 0.8 times the clinical exposure (on a mg/m basis) throughout pregnancy. Offspring of rat dams exposed to repaglinide at 15 times clinical exposure on a mg/m 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/m 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.
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.
Healthy volunteers treated with repaglinide 2 mg before each of 3 meals, showed no significant differences in repaglinide pharmacokinetics between the group of patients
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 [].
Prandimet () Overdosage
No data are available with regard to overdose of Prandimet () . Findings related to the individual active substances are listed below.
In a clinical trial, dizziness, headache, and diarrhea were reported in subjects receiving increasing doses of repaglinide up to 80 mg a day for 14 days. Hypoglycemia did not occur when meals were given with these high doses.
Hypoglycemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage and/or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Patients should be closely monitored for a minimum of 24 to 48 hours, since hypoglycemia may recur after apparent clinical recovery. There is no evidence that repaglinide is dialyzable using hemodialysis. Severe hypoglycemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medical emergencies requiring immediate hospitalization. If hypoglycemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dL.
Overdose of metformin HCl has occurred, including ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with metformin HCl has been established. Lactic acidosis has been reported in approximately 32% of metformin HCl overdose cases ]. Metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin HCl overdosage is suspected.
Prandimet () Description
Prandimet () (repaglinide and metformin HCl) tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes: repaglinide and metformin HCl. The concomitant use of repaglinide and metformin HCl has been previously approved based on clinical trials in patients with type 2 diabetes inadequately controlled on exercise, diet, and metformin HCl alone.
Repaglinide, S(+)2-ethoxy-4(2((3-methyl-1-(2-(1-piperidinyl) phenyl)-butyl) amino)-2-oxoethyl) benzoic acid, is chemically unrelated to the oral sulfonylurea insulin secretagogues. Repaglinide is a white to off-white powder with molecular formula C H N O and a molecular weight of 452.6 with the structural formula as shown below. Repaglinide is freely soluble in methanol and ethanol. The pKa of repaglinide in acid is 3.9, and the pKa in amine is 6.0.
Metformin HCl (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. Metformin HCl is a white to off-white crystalline compound with a molecular formula of CHN∙HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin HCl is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula of metformin HCl is:
Prandimet () is available as a tablet for oral administration containing 1 mg repaglinide with 500 mg metformin HCl (1 mg/500 mg) or 2 mg repaglinide with 500 mg metformin HCl (2 mg/500 mg) formulated with the following inactive ingredients: poloxamer 188, microcrystalline cellulose, polacrillin potassium, magnesium stearate, hypromellose 3cp or 6cp, povidone, meglumine, sorbitol, talc, titanium dioxide, red or yellow iron oxide, and polyethylene glycol. Propylene glycol is present in the 2 mg/500 mg Prandimet () tablets.
Prandimet () Clinical Pharmacology
Prandimet ()
Prandimet () combines two anti-hyperglycemic agents with different mechanisms of action to improve glycemic control in patients with type 2 diabetes.
Repaglinide lowers blood glucose levels by stimulating the release of insulin from the pancreas. This action is dependent upon functioning beta (ß) cells in the pancreatic islets.
Repaglinide closes ATP-dependent potassium channels in the ß-cell membrane by binding at characterizable sites. This potassium channel blockade depolarizes the ß-cell, which leads to an opening of calcium channels. The resulting increased calcium influx induces insulin secretion. The ion channel mechanism is highly tissue selective with low affinity for heart and skeletal muscle.
Metformin is an anti-hyperglycemic agent, which improves glucose tolerance in patients with type 2 diabetes by lowering both the basal and postprandial plasma glucose. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. With metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may actually decrease.
Prandimet ()
The results of a bioequivalence study in healthy subjects (Table 2) demonstrated that Prandimet () (repaglinide/metformin HCl) 1 mg/500 mg and 2 mg/500 mg combination tablets are bioequivalent to co-administration of corresponding doses of repaglinide and metformin HCl as individual tablets.
Repaglinide dose proportionality was demonstrated for Prandimet () (2 mg/500 mg) and Prandimet () (1 mg/500 mg).
Absorption and Bioavailability
Repaglinide
Metformin HCl
Distribution
Repaglinide
Metformin HCl
Metabolism and Elimination
Repaglinide
14
Metformin HCl
Specific populations
Renal Impairment
Prandimet ()
Because Prandimet () contains metformin HCl, it should not be used in patients with renal impairment [; ].
Repaglinide
Single-dose and steady-state pharmacokinetics of repaglinide were compared between patients with type 2 diabetes and normal renal function (CrCl > 80 mL/min), mild to moderate renal function impairment (CrCl = 40 - 80 mL/min), and severe renal function impairment (CrCl = 20 - 40 mL/min). Both AUC and C of repaglinide were similar in patients with normal and mild to moderately impaired renal function (mean values 56.7 ng/mL*hr vs 57.2 ng/mL*hr and 37.5 ng/mL vs 37.7 ng/mL, respectively). Patients with severely reduced renal function had elevated mean AUC and C values (98.0 ng/mL*hr and 50.7 ng/mL, respectively), but this study showed only a weak correlation between repaglinide levels and creatinine clearance.
Metformin HCl
In patients with decreased renal function (based on measured creatinine clearance), the plasma and blood half-life of metformin is prolonged and the renal clearance is decreased in proportion to the decrease in creatinine clearance.
Hepatic Impairment
Prandimet ()
Prandimet () should be avoided in patients with hepatic impairment [].
Repaglinide
A single-dose, open-label study was conducted in 12 healthy subjects and 12 patients with chronic liver disease (CLD) classified by Child-Pugh scale and caffeine clearance. Patients with moderate to severe impairment of liver function had higher and more prolonged serum concentrations of both total and unbound repaglinide than healthy subjects (AUC: 91.6 ng/mL*hr; AUC: 368.9 ng/mL*hr; C, : 46.7 ng/mL; C, : 105.4 ng/mL). AUC was statistically correlated with caffeine clearance. No difference in glucose profiles was observed across patient groups. Patients with impaired liver function may be exposed to higher concentrations of repaglinide and its associated metabolites than would patients with normal liver function receiving usual doses. Therefore, repaglinide should generally be avoided in patients with impaired liver function.
Metformin HCl
No pharmacokinetics studies with metformin HCl have been conducted in patients with hepatic impairment.
Geriatric Patients
Healthy volunteers treated with repaglinide 2 mg before each of 3 meals, showed no significant differences in repaglinide pharmacokinetics between the group of patients
Limited data from controlled pharmacokinetic studies of metformin HCl in healthy elderly subjects suggest that total plasma clearance is decreased, the half-life is prolonged, and C is increased, compared to healthy young subjects. From these data, it appears that the change in metformin pharmacokinetics with aging is primarily accounted for by a change in renal function [].
Drug Interactions
Prandimet () How Supplied/storage And Handling
Prandimet () tablets are supplied as biconvex tablets available in 1 mg/500 mg (yellow) and 2 mg/500 mg (pink) strengths. Tablets are debossed with the Novo Nordisk (Apis) bull symbol on one side and tablet strength on the other side. The tablets are colored to indicate strength.
Do not store above 25° C (77° F).
Protect from moisture. Keep bottles tightly closed.
Dispense in tight containers with safety closures.
Prandimet () Patient Counseling Information
Patients should be informed of the potential risks and advantages of Prandimet () and of alternative modes of therapy. They should also be informed about the importance of adherence to dietary instructions, of a regular exercise program, and of regular testing of blood glucose, HbA, renal function, and hematologic parameters. The risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development and concomitant administration of other glucose-lowering drugs should be explained to patients and family members. Medication requirements may change during periods of stress such as fever, trauma, infection, or surgery, due to loss of glycemic control. Patients should be advised to seek medical advice promptly.
The risks of lactic acidosis, its symptoms, and conditions that predispose to its development, as noted in the, should be explained to patients. Patients should be advised to discontinue Prandimet () immediately and to promptly notify their health practitioner if unexplained hyperventilation, myalgia, malaise, unusual somnolence, or other nonspecific symptoms occur. Once a patient is stabilized on any dose level of Prandimet () , gastrointestinal symptoms, which are common during initiation of metformin HCl therapy, are unlikely to be drug related. Later occurrence of gastrointestinal symptoms could be due to lactic acidosis or other serious disease.
Patients should be instructed to take Prandimet () with meals. Doses are usually 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 should be counseled against excessive alcohol intake, either acute or chronic, while receiving Prandimet () .
Initial and periodic monitoring of hematologic parameters (e.g., hemoglobin/hematocrit and red blood cell indices) and renal function (serum creatinine) should be performed, at least on an annual basis. Vitamin B deficiency should be excluded if megaloblastic anemia is detected.
Date of issue: September 09, 2011
Version: 4
Prandimet () is a registered trademark of Novo Nordisk A/S.
© 2008 - 2011 Novo Nordisk
US Patent No. 6,677,358
Manufactured for:
Novo Nordisk A/S
DK-2880 Bagsvaerd, Denmark
For information contact:
Novo Nordisk Inc.
100 College Road West
Princeton, New Jersey 08540, USA
1-800-727-6500
www.novonordisk-us.com
Prandimet () Principal Display Panel
1 mg/500 mg Tablets
NDC 0169-0093-01
List 009301
100 Tablets
Rx Only
Prandimet () Principal Display Panel
2 mg/500 mg Tablets
NDC 0169-0092-01
List 009201
100 Tablets
Rx Only
