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JAMP REPAGLINIDE is a brand name for Repaglinide, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations There is no fixed dosage regimen for the management of type 2 diabetes with JAMP REPAGLINIDE (repaglinide). JAMP REPAGLINIDE doses are usually taken 15 minutes before the meal but time may vary from immediately before 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. Short-term administration of JAMP REPAGLINIDE may be sufficient during periods of transient loss of control in patients usually controlled by their diet.
5 mg with each meal preprandially. For patients previously treated with blood glucose-lowering drugs or whose HbA1c is ≥ 8%, the initial dose is 1 or 2 mg with each meal preprandially. Transfer from other therapies When JAMP REPAGLINIDE is used to replace therapy with other oral hypoglycemic agents, JAMP REPAGLINIDE may be started on the day after the final dose is given.
Patients should then be observed carefully for hypoglycemia due to potential overlapping of drug effects. , chlorpropamide) to JAMP REPAGLINIDE, close monitoring may be indicated for up to one week or longer. Titration Dosing adjustments should be determined by blood glucose response, usually fasting blood glucose.
The preprandial dose should be doubled up to 4 mg until satisfactory blood glucose response is achieved. A minimum of one week should elapse between titration steps to assess response after each dose adjustment. 0 mg taken with meals.
JAMP REPAGLINIDE offers flexible dietary options and may be dosed preprandially 2, 3 or 4 times a day in response to changes in the patient’s meal pattern. The recommended maximum daily dose is 16 mg. Long-term efficacy should be monitored by measurement of HbA1C levels every 3 months.
Failure to follow an appropriate dosage regimen may precipitate hypoglycemia or hyperglycemia. Patients who do not adhere to their prescribed dietary and drug regimen are more prone to exhibit unsatisfactory response to therapy, including hypoglycemia.
JAMP REPAGLINIDE Product Monograph Page 16 of 41 For patients maintained in tight glucose control, repaglinide treatment has less associated risk of hypoglycemia when meals are missed than does treatment with agents with a longer half-life.
Combination Therapy If JAMP REPAGLINIDE monotherapy does not result in adequate glycemic control, metformin or rosiglitazone may be added. Or, if metformin or rosiglitazone monotherapy does not provide adequate control, JAMP REPAGLINIDE may be added.
JAMP REPAGLINIDE (repaglinide) is contraindicated in patients: with known hypersensitivity to the drug or any of its components. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the Product Monograph.
with diabetic ketoacidosis, with or without coma. with Type 1 diabetes. with severe liver disease. who are using gemfibrozil (see ADVERSE REACTIONS and DRUG INTERACTIONS). who are using clopidogrel (see DRUG INTERACTIONS). WARNINGS AND PRECAUTIONS General JAMP REPAGLINIDE is effective as a prandial glucose regulator and should be taken before meals (2, 3 or 4 times a day preprandially).
Therefore, if a meal is missed or delayed, the dose of repaglinide should be skipped or delayed as appropriate. Carcinogenesis and Mutagenesis See TOXICOLOGY. Cardiovascular The administration of insulin secretagogues in general has been reported to be associated with increased cardiovascular (CV) mortality as compared to treatment with diet alone or diet plus insulin.
In controlled clinical trials comparing repaglinide with glyburide and other sulfonylureas, there was no excess mortality with repaglinide use. 2 per 100 patient years. In clinical trials, the incidence of serious cardiovascular treatment emergent adverse events was higher for repaglinide than for glyburide but lower than that for glipizide (see ADVERSE REACTIONS and CLINICAL TRIALS).
Endocrine and Metabolism Hypoglycemia:
JAMP REPAGLINIDE is capable of inducing hypoglycemia. Proper patient selection, dosage, and instructions to the patient are important to avoid hypoglycemic episodes. Hepatic insufficiency may cause elevated repaglinide levels in the blood and may also diminish gluconeogenic capacity, both of which increase the risk of serious hypoglycemic reactions (see WARNINGS AND PRECAUTIONS – Hepatic/Biliary/Pancreatic).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The starting dose and dose adjustments for JAMP REPAGLINIDE combination therapy is the same as for JAMP REPAGLINIDE monotherapy. The dose of each drug should be carefully adjusted to determine the minimal dose required to achieve the desired pharmacologic effect.
Failure to do so could result in an increase in the incidence of hypoglycemic episodes. Appropriate monitoring of FPG and HbA1C measurements should be used to ensure that the patient is not subjected to excessive drug exposure or increased probability of secondary drug failure.
Missed Dose If a dose is missed, the next dose should be taken as usual. The dose should not be doubled. OVERDOSAGE In a clinical trial, patients received increasing doses of repaglinide up to 80 mg a day for 14 days. There were few adverse effects other than those associated with the intended pharmacodynamic 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 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.
For management of a suspected drug overdose, contact your regional Poison Control Centre immediately. ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action Repaglinide is an oral blood glucose-lowering drug used in the management of type 2 diabetes mellitus.
Repaglinide is a short-acting insulin secretagogue which lowers blood glucose levels (as measured by HbA1C and fasting plasma glucose) and is effective in regulating meal-related (prandial) glucose loads. Repaglinide lowers blood glucose levels by stimulating the release of insulin from the pancreas.
This action is dependent upon functioning beta cells in the pancreatic islets. Insulin release is glucose-dependent and diminishes at low glucose concentrations. JAMP REPAGLINIDE Product Monograph Page 17 of 41 Repaglinide is chemically unrelated to oral sulfonylurea insulin secretagogues used in the treatment of type 2 diabetes.
Repaglinide closes ATP-dependent potassium channels in the β-cell membrane by binding at characterizable sites. This potassium channel blockade depolarizes the β-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.
Pharmacokinetics Absorption:
After oral administration, repaglinide is rapidly and completely absorbed from the gastrointestinal tract. After single and multiple oral doses in healthy subjects or in patients, peak drug levels (Cmax) occur within 1 hour (Tmax). Repaglinide is rapidly eliminated from the blood stream with a half-life of approximately 1 hour.
The mean absolute bioavailability is 56%. When repaglinide was given with food, the mean Tmax was not changed, but the mean Cmax […]
JAMP REPAGLINIDE is contraindicated in patients with severe liver disease (see CONTRAINDICATIONS). JAMP REPAGLINIDE Product Monograph Page 5 of 41 Elderly, debilitated or malnourished patients and those with adrenal, pituitary or hepatic insufficiency are particularly susceptible to the hypoglycemic action of glucose-lowering drugs.
Hypoglycemia may be difficult to recognize in the elderly, and in people who are taking beta- adrenergic blocking drugs. Hypoglycemia is more likely to occur when caloric intake is deficient or when meals are skipped. Given the preprandial dosing regimen, patients taking JAMP REPAGLINIDE can adjust dosing according to their changing meal patterns, thereby reducing the risk of hypoglycemia when meals are missed (see DOSAGE AND ADMINISTRATION).
Hypoglycemia is also more likely to occur after strenuous or prolonged exercise, when alcohol is ingested, or when more than one glucose-lowering drug is used.
Loss of control of blood glucose:
When a patient, stabilized on JAMP REPAGLINIDE is exposed to stress such as fever, trauma, infection, or surgery, a loss of control of blood glucose may occur. At such times, it may be necessary to temporarily discontinue JAMP REPAGLINIDE and administer insulin.
Hepatic/Biliary/Pancreatic Patients with impaired liver function may be exposed to higher concentrations of repaglinide than would patients with normal liver functions receiving usual doses. JAMP REPAGLINIDE should be used cautiously in patients with impaired liver function.
Longer intervals between dose adjustments should be utilized to allow full assessment of response (see WARNINGS AND PRECAUTIONS – Endocrine and Metabolism and Monitoring and Laboratory Tests, ACTION AND CLINICAL PHARMACOLOGY – Special Populations and Conditions).
JAMP REPAGLINIDE is contraindicated in patients with severe liver disease (see CONTRAINDICATIONS). Neurologic 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 glucose solution, followed by a continuous infusion, according to standard medical practice. Renal Renal insufficiency Typically, JAMP REPAGLINIDE does not require initial dose adjustment in patients with reduced kidney function.
However, subsequent increases in JAMP REPAGLINIDE should be made carefully in patients with type 2 diabetes who have renal function impairment or renal failure requiring hemodialysis (see ACTION AND CLINICAL PHARMACOLOGY – Special Populations and Conditions).
JAMP REPAGLINIDE Product Monograph Page 6 of 41 Pre-operative considerations See WARNINGS AND PRECAUTIONS – Endocrine and Metabolism, Loss of control of blood glucose.
Special Populations Pregnant Women:
JAMP REPAGLINIDE is not recommended for use during pregnancy. The safety of JAMP REPAGLINIDE in pregnant women has not been established (see TOXICOLOGY).
Nursing Women:
The safety of JAMP REPAGLINIDE in nursing women has not been established. 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.
It is not known whether repaglinide is excreted in human milk. JAMP REPAGLINIDE is not recommended in nursing women because the potential for hypoglycemia in nursing infants may exist (see TOXICOLOGY).
Pediatrics (< 18 years of age):
The use of JAMP REPAGLINIDE is not recommended in pediatric patients. The safety and effectiveness in pediatrics has not been established. No studies of repaglinide have been performed in pediatric patients.
Geriatrics (> 65 years of age):
No special dose titration is necessary in elderly 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 […]