Where can I get more information (Amaryl)?
Your pharmacist can provide more information about Glimepirid.
WHAT IS GLIMIPIRIDE?
Glimepirid is an oral diabetes medicine that helps control blood sugar levels. This medication helps your body respond better to insulin produced by your pancreas.
Glimepirid is used together with diet and exercise to treat type 2 (non-insulin dependent) diabetes. When required, other diabetes medicines are sometimes used in combination with Glimepirid.
COMMON BRAND(S): Amaryl
GENERIC NAME(S): Glimepirid
OTHER NAME(S): Glimepirid Tablet
Glimepirid is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. It may also be used with other diabetes medications. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Glimepirid belongs to the class of drugs known as sulfonylureas. It lowers blood sugar by causing the release of your body's natural insulin.
Drug that treats low blood sugar
Diazoxide can decrease the effect of Glimepirid and cause high blood sugar.
What are the uses for Glimepirid?
- Glimepirid is used for controlling blood sugar in adults with type 2 diabetes in addition to diet and exercise.
- Management of blood sugar with Glimepirid can help decrease the risk of eye, kidney, and nerve damage.
- It is not used for treating type 1 diabetes.
6.2 Postmarketing Experience
The following adverse reactions have been identified during postapproval use of Glimepirid. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Serious hypersensitivity reactions, including anaphylaxis, angioedema, and Stevens-Johnson Syndrome
- Hemolytic anemia in patients with and without G6PD deficiency
- Impairment of liver function (e.g., with cholestasis and jaundice), as well as hepatitis, which may progress to liver failure.
- Porphyria cutanea tarda, photosensitivity reactions and allergic vasculitis
- Leukopenia, agranulocytosis, aplastic anemia, and pancytopenia
- Thrombocytopenia (including severe cases with platelet count less than 10,000/μL) and thrombocytopenic purpura
- Hepatic porphyria reactions and disulfiram-like reactions
- Hyponatremia and syndrome of inappropriate antidiuretic hormone secretion (SIADH), most often in patients who are on other medications or who have medical conditions known to cause hyponatremia or increase release of antidiuretic hormone
To report SUSPECTED ADVERSE REACTIONS contact AvKARE, Inc. at 1-855-361-3993; email email@example.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Mechanism of Action
Glimepirid primarily lowers blood glucose by stimulating the release of insulin from pancreatic beta cells. Sulfonylureas bind to the sulfonylurea receptor in the pancreatic beta-cell plasma membrane, leading to closure of the ATP-sensitive potassium channel, thereby stimulating the release of insulin.
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Drug-drug. Androgens (such as testosterone), chloramphenicol, clofibrate, guanethidine, MAO inhibitors, nonsteroidal anti-inflammatory drugs (except diclofenac), salicylates, sulfonamides, tricyclic antidepressants: increased risk of hypoglycemia
Beta-adrenergic blockers: altered response to Glimepirid, necessitating dosage change; prolonged hypoglycemia (with nonselective agents)
Calcium channel blockers, corticosteroids, estrogens, hydantoins, hormonal contraceptives, isoniazid, nicotinic acid, phenothiazines, phenytoin, rifampin, sympathomimetics, thiazide diuretics, thyroid preparations: decreased hypoglycemic effect of Glimepirid
Warfarin: initially increased, then decreased, effects of both drugs
Drug-diagnostic tests. Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urea nitrogen, cholesterol, liver function tests: increased values
Glucose, granulocytes, hemoglobin, platelets, white blood cells: decreased values
Drug-herbs. Agoral marshmallow, aloe (oral), bitter melon, burdock, chromium, coenzyme Q10, dandelion, eucalyptus, fenugreek: additive hypoglycemic effects
Glucosamine: impaired glycemic control
Drug-behaviors. Alcohol use: disulfiram-like reaction
Sun exposure: increased risk of photosensitivity
- Store Glimepirid at room temperature. Keep it at a temperature between 68ºF and 77ºF (20°C and 25°C).
- Don’t freeze Glimepirid.
- Keep this drug away from light.
- Don’t store this medication in moist or damp areas, such as bathrooms.
The pharmacokinetics, efficacy and safety of AMARYL have been evaluated in pediatric patients with type 2 diabetes as described below. AMARYL is not recommended in pediatric patients because of its adverse effects on body weight and hypoglycemia.
The pharmacokinetics of a 1 mg single dose of AMARYL was evaluated in 30 patients with type 2 diabetes (male = 7; female = 23) between ages 10 and 17 years. The mean (± SD) AUC (339±203 ngÂ·hr/mL), Cmax (102±48 ng/mL) and t½ (3.1±1.7 hours) for Glimepirid were comparable to historical data from adults (AUC(0-last) 315±96 ngÂ·hr/mL, Cmax 103±34 ng/mL and t½ 5.3±4.1 hours).
The safety and efficacy of AMARYL in pediatric patients was evaluated in a single-blind, 24-week trial that randomized 272 patients (8-17 years of age) with type 2 diabetes to AMARYL (n=135) or metformin (n=137). Both treatment-naive patients (those treated with only diet and exercise for at least 2 weeks prior to randomization) and previously treated patients (those previously treated or currently treated with other oral antidiabetic medications for at least 3 months) were eligible to participate. Patients who were receiving oral antidiabetic agents at the time of study entry discontinued these medications before randomization without a washout period. AMARYL was initiated at 1 mg, and then titrated up to 2, 4 or 8 mg (mean last dose 4 mg) through Week 12, targeting a self-monitored fasting fingerstick blood glucose
The profile of adverse reactions in pediatric patients treated with AMARYL was similar to that observed in adults .
Hypoglycemic events documented by blood glucose values 65 years of age. No overall differences in safety or effectiveness were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
There were no significant differences in glimepir > 65 years (n=42) .
Glimepirid is substantially excreted by the kidney. Elderly patients are more likely to have renal impairment. In addition, hypoglycemia may be difficult to recognize in the elderly . Use caution when initiating AMARYL and increasing the dose of AMARYL in this patient population.
The pharmacokinetics, efficacy and safety of Glimepirid have been evaluated in pediatric patients with type 2 diabetes as described below. Glimepirid tablets are not recommended in pediatric patients because of its adverse effects on body weight and hypoglycemia.
The pharmacokinetics of a 1 mg single dose of Glimepir >(0-last) (339±203 ng•hr/mL), C max (102±48 ng/mL) and t 1/2 (3.1±1.7 hours) for Glimepir >(0-last) 315±96 ng•hr/mL, C max 103±34 ng/mL and t 1/2 5.3±4.1 hours).
The safety and efficacy of Glimepir >
After 24 weeks, the overall mean treatment difference in HbA 1c between Glimepirid and metformin was 0.2%, favoring metformin (95% confidence interval -0.3% to +0.6%).
Based on these results, the trial d >1c with Glimepirid compared to metformin.