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Prandin
Overview
What is Prandin?
PRANDIN (repaglinide) is an oral blood
glucose-lowering drug of the meglitinide class used in the management of type 2
diabetes mellitus (also known as non-insulin dependent diabetes mellitus or
NIDDM). 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.
What does Prandin look like?
What are the available doses of Prandin?
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What should I talk to my health care provider before I take Prandin?
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How should I use Prandin?
PRANDIN is indicated as an adjunct to diet and exercise to
improve glycemic control in adults with type 2 diabetes mellitus.
There is no fixed dosage regimen for the management of type 2
diabetes with PRANDIN.
The patient's blood glucose should be monitored periodically to determine the
minimum effective dose for the patient; to detect primary failure, i.e.,
inadequate lowering of blood glucose at the maximum recommended dose of
medication; and to detect secondary failure, i.e., loss of an adequate blood
glucose-lowering response after an initial period of effectiveness. Glycosylated
hemoglobin levels are of value in monitoring the patient's longer term response
to therapy.
Short-term administration of PRANDIN may be sufficient during periods of
transient loss of control in patients usually well controlled on diet.
PRANDIN doses are usually taken within 15 minutes of the meal but time may
vary from immediately preceding the meal to as long as 30 minutes before the
meal.
What interacts with Prandin?
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What are the warnings of Prandin?
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What are the precautions of Prandin?
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What are the side effects of Prandin?
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What should I look out for while using Prandin?
PRANDIN is contraindicated in patients with:
What might happen if I take too much Prandin?
In a clinical trial, patients received increasing doses of
PRANDIN up to 80 mg a day for 14 days. There were few adverse effects other than
those associated with the intended effect of lowering blood glucose.
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 may 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.
How should I store and handle Prandin?
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:PRANDIN (repaglinide) tablets are supplied as unscored, biconvex tablets available in 0.5 mg (white), 1 mg (yellow) and 2 mg (peach) strengths. Tablets are embossed with the Novo Nordisk (Apis) bull symbol and colored to indicate strength.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Non-Clinical Toxicology
PRANDIN is contraindicated in patients with:The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors.
In patients receiving concomitant corticosteroids and chronic use of aspirin, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance.
Butalbital, Aspirin, and Caffeine Capsules, USP may enhance the effects of:
Butalbital, Aspirin, and Caffeine Capsules, USP may diminish the effects of:
Uricosuric agents such as probenecid and sulfinpyrazone, reducing their effectiveness in the treatment of gout. Aspirin competes with these agents for protein binding sites.
PRANDIN is not indicated for use in combination with NPH-insulin (See ).
Macrovascular Outcomes:
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with PRANDIN or any other anti-diabetic drug.
Hypoglycemia:
Hypoglycemia may be difficult to recognize in the elderly and in people taking beta-adrenergic blocking drugs. Hypoglycemia is more likely to occur when caloric intake is deficient, after severe or prolonged exercise, when alcohol is ingested, or when more than one glucose-lowering drug is used.
The frequency of hypoglycemia is greater in patients with type 2 diabetes who have not been previously treated with oral blood glucose-lowering drugs (naïve) or whose HbAis less than 8%. PRANDIN should be administered with meals to lessen the risk of hypoglycemia.
Loss of Control of Blood Glucose:
Information for Patients
Patients should be informed of the potential risks and advantages of PRANDIN 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 and HbA. 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 responsible family members. Primary and secondary failure should also be explained.
Laboratory Tests
Response to all diabetic therapies should be monitored by periodic measurements of fasting blood glucose and glycosylated hemoglobin levels with a goal of decreasing these levels towards the normal range. During dose adjustment, fasting glucose can be used to determine the therapeutic response. Thereafter, both glucose and glycosylated hemoglobin should be monitored. Glycosylated hemoglobin may be especially useful for evaluating long-term glycemic control. Postprandial glucose level testing may be clinically helpful in patients whose pre-meal blood glucose levels are satisfactory but whose overall glycemic control (HbA) is inadequate.
In vitro
CLINICAL PHARMACOLOGY
Repaglinide appears to be a substrate for active hepatic uptake transporter (organic anion transporting protein OATP1B1). Drugs that inhibit OATP1B1 (e.g. cyclosporine) may likewise have the potential to increase plasma concentrations of repaglinide. See section, .
In vivo
CLINICAL PHARMACOLOGY
Gemfibrozil significantly increased PRANDIN exposure. Therefore, patients should not take PRANDIN with gemfibrozil. See section, , and .
The hypoglycemic action of oral blood glucose-lowering agents may be potentiated by certain drugs including nonsteroidal anti-inflammatory agents and other drugs that are highly protein bound, salicylates, sulfonamides, cyclosporine, chloramphenicol, coumarins, probenecid, monoamine oxidase inhibitors, and beta adrenergic blocking agents. When such drugs are administered to a patient receiving oral blood glucose-lowering agents, the patient should be observed closely for hypoglycemia. When such drugs are withdrawn from a patient receiving oral blood glucose-lowering agents, the patient should be observed closely for loss of glycemic control.
Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. When these drugs are administered to a patient receiving oral blood glucose-lowering agents, the patient should be observed for loss of glycemic control. When these drugs are withdrawn from a patient receiving oral blood glucose-lowering agents, the patient should be observed closely for hypoglycemia.
Long-term carcinogenicity studies were performed for 104 weeks at doses up to and including 120 mg/kg body weight/day (rats) and 500 mg/kg body weight/day (mice) or approximately 60 and 125 times clinical exposure, respectively, on a mg/m basis. No evidence of carcinogenicity was found in mice or female rats. In male rats, there was an increased incidence of benign adenomas of the thyroid and liver. The relevance of these findings to humans is unclear. The no-effect doses for these observations in male rats were 30 mg/kg body weight/day for thyroid tumors and 60 mg/kg body weight/day for liver tumors, which are over 15 and 30 times, respectively, clinical exposure on a mg/m basis.
Repaglinide was non-genotoxic in a battery of and studies: Bacterial mutagenesis (Ames test), forward cell mutation assay in V79 cells (HGPRT), chromosomal aberration assay in human lymphocytes, unscheduled and replicating DNA synthesis in rat liver, and mouse and rat micronucleus tests.
Fertility of male and female rats was unaffected by repaglinide administration at doses up to 80 mg/kg body weight/day (females) and 300 mg/kg body weight/day (males); over 40 times clinical exposure on a mg/m basis.
Pregnancy category C
Teratogenic Effects
Because recent information suggests that abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities, many experts recommend that insulin be used during pregnancy to maintain blood glucose levels as close to normal as possible.
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 (see ) could be induced in control pups nursed by treated dams, although this occurred to a lesser degree than those pups treated . Although it is not known whether repaglinide is excreted in human milk some oral agents are known to be excreted by this route. Because the potential for hypoglycemia in nursing infants may exist, and because of the effects on nursing animals, a decision should be made as to whether PRANDIN should be discontinued in nursing mothers, or if mothers should discontinue nursing. If PRANDIN is discontinued and if diet alone is inadequate for controlling blood glucose, insulin therapy should be considered.
No studies have been performed in pediatric patients.
In repaglinide clinical studies of 24 weeks or greater duration, 415 patients were over 65 years of age. In one-year, active-controlled trials, no differences were seen in effectiveness or adverse events between these subjects and those less than 65 other than the expected age-related increase in cardiovascular events observed for PRANDIN and comparator drugs. There was no increase in frequency or severity of hypoglycemia in older subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals to PRANDIN therapy cannot be ruled out.
Hypoglycemia: See and sections.
PRANDIN has been administered to 2931 individuals during clinical trials. Approximately 1500 of these individuals with type 2 diabetes have been treated for at least 3 months, 1000 for at least 6 months, and 800 for at least 1 year. The majority of these individuals (1228) received PRANDIN in one of five 1-year, active-controlled trials. The comparator drugs in these 1-year trials were oral sulfonylurea drugs (SU) including glyburide and glipizide. Over one year, 13% of PRANDIN patients were discontinued due to adverse events, as were 14% of SU patients. The most common adverse events leading to withdrawal were hyperglycemia, hypoglycemia, and related symptoms (see ). Mild or moderate hypoglycemia occurred in 16% of PRANDIN patients, 20% of glyburide patients, and 19% of glipizide patients.
The table below lists common adverse events for PRANDIN patients compared to both placebo (in trials 12 to 24 weeks duration) and to glyburide and glipizide in one year trials. The adverse event profile of PRANDIN was generally comparable to that for sulfonylurea drugs (SU).
In one-year trials comparing PRANDIN to sulfonylurea drugs, the incidence of angina was comparable (1.8%) for both treatments, with an incidence of chest pain of 1.8% for PRANDIN and 1.0% for sulfonylureas. The incidence of other selected cardiovascular events (hypertension, abnormal EKG, myocardial infarction, arrhythmias, and palpitations) was ≤ 1% and not different between PRANDIN and the comparator drugs.
The incidence of total serious cardiovascular adverse events, including ischemia, was higher for repaglinide (4%) than for sulfonylurea drugs (3%) in controlled comparator clinical trials. In 1-year controlled trials, PRANDIN treatment was not associated with excess mortality when compared to the rates observed with other oral hypoglycemic agent therapies
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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