Glimepiride Tablets 2mg
Pack : Strip of 10 tablets (ALU-ALU).
COMPOSITION : Each tablet contains:-
PACK : Strip of 10 tablets (ALU-ALU).
Glimepiride belongs to a blood sugar lowering group of medicines called sulfonylurea. Glimepiride increases the amount of insulin released by the pancreas, and thereby decreases the blood sugar level.
In healthy subjects, the time to reach maximal effect (minimum blood glucose concentrations) was approximately 2-3 hours after single oral doses. The effects on HbA1c, fasting plasma glucose, and post-prandial glucose have been assessed in clinical trials.
Studies with single oral doses of glimepiride in healthy subjects and with multiple oral doses in patients with type 2 diabetes showed peak drug concentrations (Cmax) 2 to 3 hours post-dose. When glimepiride was given with meals, the mean Cmax and AUC (area under the curve) were decreased by 8% and 9%, respectively.
Glimepiride does not accumulate in serum following multiple dosing. The pharmacokinetics of glimepiride does not differ between healthy subjects and patients with type 2 diabetes. Clearance of glimepiride after oral administration does not change over the 1 mg to 8 mg dose range, indicating linear pharmacokinetics.
In healthy subjects, the intra- and inter-individual variabilities of glimepiride pharmacokinetic parameters were 15-23% and 24-29%, respectively.
After intravenous dosing in healthy subjects, the volume of distribution (Vd) was 8.8 L (113 mL/kg), and the total body clearance (CL) was 47.8 mL/min. Protein binding was greater than 99.5%.
Glimepiride is completely metabolized by oxidative biotransformation after either an intravenous or oral dose. The major metabolites are the cyclohexyl hydroxy methyl derivative (M1) and the carboxyl derivative (M2). Cytochrome P450 2C9 is involved in the biotransformation of glimepiride to M1. M1 is further metabolized to M2 by one or several cytosolic enzymes. M2 is inactive. In animals, M1 possesses about one-third of the pharmacological activity of glimepiride, but it is unclear whether M1 results in clinically meaningful effects on blood glucose in humans.
When 14C-glimepiride was given orally to 3 healthy male subjects, approximately 60% of the total radioactivity was recovered in the urine in 7 days. M1 and M2 accounted for 80-90% of the radioactivity recovered in the urine. The ratio of M1 to M2 in the urine was approximately 3:2 in two subjects and 4:1 in one subject. Approximately 40% of the total radioactivity was recovered in feces. M1 and M2 accounted for approximately 70% (ratio of M1 to M2 was 1:3) of the radioactivity recovered in feces. No parent drug was recovered from urine or feces. After intravenous dosing in patients, no significant biliary excretion of glimepiride or its M1 metabolite was observed.
INDICATION : Type 2 diabetes mellitus.
DOSAGE : Adult : Initially 1-2 mg daily, Max. 6mg daily.
Elderly : Initially 1mg once daily.
SIDE EFFECTS : Severe renal or hepatic impairment. Patient exposed to stress.Dizziness, headache, nausea,increased serum ALT, flu like symptoms.
|S. No.||COMPETITIOR||COMPANY||MRP / Tab|
|1||Glimy||Dr. Reddy ‘s||138.86/10|