Full Prescribing Info
Each tablet contains glimepiride 2 mg.
Glimepiride is an oral antidiabetic agent that belongs to the class of sulfonylureas. It is used adjunctively in the management of type 2 diabetes mellitus.
Pharmacology: Pharmacodynamics and Pharmacokinetics: Glimepiride, like other sulfonylureas, lowers blood glucose levels in patients with type 2 diabetes by stimulating the release of insulin from pancreatic beta cells. Glimepiride also produces an increase in the sensitivity of peripheral tissues to insulin via an extrapancreatic mechanism.
Following oral administration, glimepiride is readily absorbed from the gastrointestinal tract. Peak plasma concentrations occur in 2 to 3 hours. Glimepiride is highly protein bound and has a half-life of about 2 to 4 hours. It is metabolized mainly in the liver. Glimepiride is extensively metabolized to two main metabolites, a hydroxy derivative and a carboxy derivative. Glimepiride is excreted chiefly in the urine. About 60% of the dose is eliminated in the urine and 40% in the feces.
Glimepiride is used in the treatment of type 2 diabetes mellitus.
Dosage/Direction for Use
Glimepiride is used in the treatment of type 2 diabetes mellitus (NIDDM) when diet and exercise programs fail to reduce symptoms and/or blood glucose levels. Glimepiride should be considered in addition to caloric restriction, weight loss and exercise.
Usual starting dose is 1-2 mg daily, given after the first main meal. The dose should then be titrated regularly or increased gradually, adjusting by 1-2 mg daily at intervals of 1-2 weeks, depending on the patient's response, as well as results of fasting blood sugar. Long-term efficacy is tested with a glycosylated hemoglobin assay every 3-6 months. Maintenance doses usually range from 1-4 mg per day. Maximum dose is 8 mg daily.
If the patient's hyperglycemia is not controlled with maximal doses of glimepiride, combination therapy with metformin or insulin may be considered. Frequent monitoring of blood sugar levels should be done, and the physician must strive to use the minimum doses of each drug to achieve adequate blood sugar control.
Or as prescribed by the physician.
Glimepiride overdose can cause life-threatening hypoglycemia that necessitates immediate and aggressive treatment. Symptoms of severe hypoglycemia include extreme weakness, confusion, tremors, sweating, trouble speaking, blurred vision, nausea, fainting and seizure. Emergency medical attention is required if these symptoms are experienced.
Admission to the hospital may be necessary for severe instances such as loss of consciousness or other neurological disorders.
In acute poisoning with sulfonylureas, within 1 hour of ingestion and if the patient is awake, gastric lavage should be done and/or activated charcoal should be given. Hypoglycemia should be treated with urgency.
The use of octreotide has been considered for the treatment of severe refractory cases of hypoglycemia caused by sulfonylureas.
Patients should be carefully monitored as hypoglycemia may recur or persist for several days.
Glimepiride is contraindicated in patients with known hypersensitivity to the drug.
All sulfonylureas are capable of producing severe and prolonged hypoglycemia. Hypoglycemia should be avoided with proper patient selection, dosage, and instructions concerning diet, exercise, laboratory tests and follow-up procedures. Patients with impaired renal function may be more sensitive to the glucose-lowering effect of glimepiride.
Secondary failure, or a loss of blood sugar control, may occur when a patient stabilized on any diabetic regimen is exposed to stress such as fever, trauma, infection, or surgery. At such times, it may be necessary to add insulin in combination with glimepiride, or even use insulin monotherapy.
Glimepiride should not be used in the treatment of insulin-dependent (type 1) diabetes mellitus. Use in type 2 diabetes mellitus is contraindicated in patients with ketoacidosis (with or without coma) and in those with severe infections, trauma or other severe conditions where glimepiride is unlikely to control the hyperglycemia. Insulin should be used in such situations.
Use In Pregnancy & Lactation
Glimepiride is contraindicated during pregnancy and must not be taken by breastfeeding women. Insulin is preferred for therapy during pregnancy.
Adverse Reactions
As with all sulfonylureas, hypoglycemia may occur with glimepiride therapy. Hypoglycemia is more likely to occur during reduced caloric intake, following ingestion of alcohol, following intense or prolonged exercise, or when more than one glucose-lowering medication is used.
Adverse effects reported were dizziness, asthenia, headache, and nausea, vomiting, gastrointestinal pain, and diarrhea, allergic reactions with skin rashes and pruritus, hyponatremia, leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, pancytopenia have also been reported with sulfonylureas.
Drug Interactions
Blood glucose-lowering effect of glimepiride may be potentiated by intake of the following drugs. Other oral antidiabetic agents, insulin, ACE inhibitors, coumarin derivatives, quinolones, sulfonamides, tetracyclines, chloramphenicol, MAOI's, cyclophosphamide, fibrates, guanethidine, high dose pentoxifylline, salicylates, phenylbutazone, sulfinpyrazone and probenecid.
Acetazolamide, corticosteroids, estrogens, progesterone, barbiturates, diuretics, epinephrine and other sympathomimetic agents, high doses of nicotinic acid, phenothiazines and phenytoin may weaken blood glucose-lowering action of glimepiride.
Alcohol, beta-blockers, H2 receptor antagonists, clonidine and reserpine may either potentiate or weaken the blood glucose-lowering effect of glimepiride.
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
A10BB12 - glimepiride ; Belongs to the class of sulfonylureas. Used in the treatment of diabetes.
Tab 2 mg (white to off-white, round, biconvex, bisected on one side and plain on the other side) x 100's.
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