Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include seizures; symptoms of low blood sugar (eg, increased hunger or sweating, fast heartbeat, anxiety, dizziness or headache, tremors, chills, vision changes).
Proper storage of Repandin:
Store Repandin below 77 degrees F (25 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Repandin out of the reach of children and away from pets.
Overdose of Repandin in details
When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
In a clinical trial, patients received increasing doses of Repandin 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 Repandin 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.
What should I avoid while taking Repandin?
Avoid drinking alcohol. It lowers blood sugar and may interfere with your diabetes treatment.
Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
Monitor blood glucose to determine minimum effective dose, detect primary failure, and to detect secondary failure. Monitor glycosylated hemoglobin levels (A 1c ) to determine patient’s longerî“¸term response to therapy.
Category C. Insulin is recommended to be used during pregnancy to maintain blood glucose levels as close to normal as possible.
Safety and efficacy not established.
Elderly may be more susceptible to the hypoglycemic action of Repandin. Hypoglycemia may be difficult to recognize in the elderly.
Initiate therapy with 0.5 mg dose in patients with severe renal function impairment and use caution when titrating dose.
Use with caution. Allow longer intervals between dosage adjustments.
Proper patient selection, dosage, and instructions to patients are important to avoid hypoglycemic episodes. Elderly, debilitated, or malnourished patients, and patients with adrenal, pituitary, hepatic, or severe renal function impairment may be particularly susceptible to the hypoglycemic action of glucoseî“¸lowering drugs.
Loss of glycemic control
Patients stabilized on any diabetic regimen may experience loss of glycemic control when exposed to stress, including trauma, fever, infection, or surgery. At such times, it may be necessary to discontinue Repandin and administer insulin.
What should I discuss with my healthcare provider before taking Repandin?
Some medical conditions may interact with Repandin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have adrenal, pituitary, liver, or kidney problems, or if you have a history of high blood acid levels (acidosis)
if you drink alcohol, have very poor health, have a high fever, have a severe infection or injury, or have had poor nutrition
if you will be having surgery
Some MEDICINES MAY INTERACT with Repandin. Tell your health care provider if you are taking any other medicines, especially any of the following:
NPH insulin because the risk of certain heart problems (eg, myocardial ischemia, chest pain) may be increased
Anticoagulants (eg, warfarin), beta-blockers (eg, propranolol), chloramphenicol, cyclosporine, deferasirox, gemfibrozil, imidazoles (eg, itraconazole, ketoconazole), macrolides (eg, clarithromycin, erythromycin), mifepristone, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), montelukast, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), probenecid, salicylates (eg, aspirin), sulfonamides (eg, sulfamethoxazole), telithromycin, or trimethoprim because the risk of side effects, such as low blood sugar, may be increased
Calcium channel blockers (eg, nifedipine), corticosteroids (eg, prednisone), diuretics (eg, furosemide, hydrochlorothiazide), estrogen, hormonal contraceptives (eg, birth control pills), isoniazid, nicotinic acid, phenothiazines (eg, chlorpromazine), phenytoin, sympathomimetics (eg, pseudoephedrine), or thyroid hormones (eg, levothyroxine) because the risk of high blood sugar may be increased
Insulin because it may increase the risk of Repandin's side effects
Barbiturates (eg, phenobarbital), carbamazepine, or rifamycins (eg, rifampin) because they may decrease Repandin's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if Repandin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
Repandin is not indicated for use in combination with NPH-insulin.
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Repandin or any other anti-diabetic drug.
All oral blood glucose-lowering drugs including Repandin are capable of producing hypoglycemia. Proper patient selection, dosage, and instructions to the patients are important to avoid hypoglycemic episodes. Hepatic insufficiency may cause elevated Repandin blood levels and may diminish gluconeogenic capacity, both of which increase the risk of serious hypoglycemia. Elderly, debilitated, or malnourished patients, and those with adrenal, pituitary, hepatic, or severe renal insufficiency may be particularly susceptible to the hypoglycemic action of glucose-lowering drugs.
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 HbA1c is less than 8%. Repandin should be administered with meals to lessen the risk of hypoglycemia.
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 loss of glycemic control may occur. At such times, it may be necessary to discontinue Repandin and administer insulin. The effectiveness of any hypoglycemic drug in lowering blood glucose to a desired level decreases in many patients over a period of time, which may be due to progression of the severity of diabetes or to diminished responsiveness to the drug. This phenomenon is known as secondary failure, to distinguish it from primary failure in which the drug is ineffective in an individual patient when the drug is first given. Adequate adjustment of dose and adherence to diet should be assessed before classifying a patient as a secondary failure.
Information for Patients
Patients should be informed of the potential risks and advantages of Repandin 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 HbA1c. 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.
Patients should be instructed to take Repandin before meals (2, 3, or 4 times a day preprandially). 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. Patients who skip a meal (or add an extra meal) should be instructed to skip (or add) a dose for that meal.
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 (HbA1c) is inadequate.
In vitro data indicate that Repandin is metabolized by cytochrome P450 enzymes 2C8 and 3A4. Consequently, Repandin metabolism may be altered by drugs which influence these cytochrome P450 enzyme systems via induction and inhibition. Caution should therefore be used in patients who are on Repandin and taking inhibitors and/or inducers of CYP2C8 and CYP3A4. The effect may be very significant if both enzymes are inhibited at the same time resulting in a substantial increase in Repandin plasma concentrations. Drugs that are known to inhibit CYP3A4 include antifungal agents like ketoconazole, itraconazole, and antibacterial agents like erythromycin. Drugs that are known to inhibit CYP2C8 include agents like trimethoprim, gemfibrozil and montelukast. Drugs that induce the CYP3A4 and/or 2C8 enzyme systems include rifampin, barbiturates, and carbamezapine. See CLINICAL PHARMACOLOGY section, Drug-Drug Interactions.
Repandin 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 Repandin. See CLINICAL PHARMACOLOGY section, Drug-Drug Interactions.
In vivo data from a study that evaluated the co-administration of a cytochrome P450 enzyme 3A4 inhibitor, clarithromycin, with Repandin resulted in a clinically significant increase in Repandin plasma levels. In addition, an increase in Repandin plasma levels was observed in studies that evaluated the co-administration of Repandin with trimethoprim and Repandin with deferasirox, both cytochrome P-450 enzyme 2C8 inhibitors. These increases in Repandin plasma levels may necessitate a Repandin dose adjustment. See CLINICAL PHARMACOLOGY section, Drug-Drug Interactions.
Gemfibrozil significantly increased Repandin exposure. Therefore, patients should not take Repandin with gemfibrozil. See CLINICAL PHARMACOLOGY section, Drug-Drug Interactions, and CONTRAINDICATIONS.
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.
Carcinogenesis, Mutagenesis, Impairment of Fertility
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/m2 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/m2 basis.
Repandin was non-genotoxic in a battery of in vivo and in vitro studies: Bacterial mutagenesis (Ames test), in vitro forward cell mutation assay in V79 cells (HGPRT), in vitro chromosomal aberration assay in human lymphocytes, unscheduled and replicating DNA synthesis in rat liver, and in vivo mouse and rat micronucleus tests.
Fertility of male and female rats was unaffected by Repandin 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/m2 basis.
Pregnancy Category C
Safety in pregnant women has not been established. Repandin was not teratogenic in rats or rabbits at doses 40 times (rats) and approximately 0.8 times (rabbit) clinical exposure (on a mg/m2 basis) throughout pregnancy. Because animal reproduction studies are not always predictive of human response, Repandin should be used during pregnancy only if it is clearly needed.
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.
Offspring of rat dams exposed to Repandin 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 Repandin administration throughout pregnancy or lactation cannot be established.
In rat reproduction studies, measurable levels of Repandin 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. Although it is not known whether Repandin 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 Repandin should be discontinued in nursing mothers, or if mothers should discontinue nursing. If Repandin 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 Repandin 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 Repandin 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 Repandin therapy cannot be ruled out.
What happens if I miss a dose of Repandin?
When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.
Take the missed dose as soon as you remember, but only if you are getting ready to eat a meal. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Use Repandin regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
DailyMed. "REPAGLINIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).