Medidex is not a provider of medical services and all information is provided for the convenience of the user. No medical decisions should be made based on the information provided on this website without first consulting a licensed healthcare provider.This website is intended for persons 18 years or older. No person under 18 should consult this website without the permission of a parent or guardian.
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?
Sorry No records found.
What should I talk to my health care provider before I take Prandin?
Sorry No records found
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?
Sorry No Records found
What are the warnings of Prandin?
Sorry No Records found
What are the precautions of Prandin?
Sorry No Records found
What are the side effects of Prandin?
Sorry No records found
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 found
Clinical 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/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
Clonazepam Description
Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake.
Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula:
C15H10ClN3O3 M.W. 315.72
×
Tips
Tips
×
Interactions
Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib).
228 major drug interactions (854 brand and generic names)
210 moderate drug interactions (691 brand and generic names)
2 minor drug interactions (4 brand and generic names)
Show all medications in the database that may interact with Imbruvica (ibrutinib).
