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GLIMEPIRIDE | GLIMEPIRIDE [DirectRX] | BioPortfolio

13:18 EST 27th January 2019 | BioPortfolio

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Glimepiride tablets are formulated as:1 mg - speckled pink, rectangular shaped, flat-faced, beveled edge tablets debossed “37” bisect “44” on one side and debossed “V” bisect “V” on the reverse side2 mg - green, rectangular shaped, flat-faced, beveled edge tablets debossed “37” bisect “45” on one side and debossed “V” bisect “V” on the reverse side4 mg - blue, rectangular shaped, flat-faced, beveled edge tablets debossed “37” bisect “46” on one side and debossed “V” bisect “V” on the reverse side

An overdosage of glimepiride, as with other sulfonylureas, can produce severe hypoglycemia. Mild episodes of hypoglycemia can be treated with oral glucose. Severe hypoglycemic reactions constitute medical emergencies requiring immediate treatment. Severe hypoglycemia with coma, seizure, or neurological impairment can be treated with glucagon or intravenous glucose. Continued observation and additional carbohydrate intake may be necessary because hypoglycemia may recur after apparent clinical recovery [see Warnings and Precautions (5.1)].

Glimepiride tablets USP are an oral sulfonylurea that contains the active ingredient glimepiride. Chemically, glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C24H34N4O5S) with a molecular weight of 490.62. Glimepiride is a white to yellowish-white, crystalline, odorless to practically odorless powder and is practically insoluble in water.

The structural formula is:

This the structural formula of Glimepiride.

Glimepiride tablets USP contain the active ingredient glimepiride and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, povidone, and sodium starch glycolate. In addition, glimepiride 1 mg tablets contain Iron Oxide Red, glimepiride 2 mg tablets contain FD&C Blue #2 Aluminum Lake and Iron Oxide Yellow, and glimepiride 4 mg tablets contain FD&C Blue #2 Aluminum Lake.

13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility

Studies in rats at doses of up to 5000 parts per million (ppm) in complete feed (approximately 340 times the maximum recommended human dose, based on surface area) for 30 months showed no evidence of carcinogenesis. In mice, administration of glimepiride for 24 months resulted in an increase in benign pancreatic adenoma formation that was dose-related and was thought to be the result of chronic pancreatic stimulation. No adenoma formation in mice was observed at a dose of 320 ppm in complete feed, or 46 to 54 mg/kg body weight/day. This is about 35 times the maximum human recommended dose of 8 mg once daily based on surface area.

Glimepiride was non-mutagenic in a battery of in vitro and in vivo mutagenicity studies (Ames test, somatic cell mutation, chromosomal aberration, unscheduled DNA synthesis, and mouse micronucleus test).

There was no effect of glimepiride on male mouse fertility in animals exposed up to 2500 mg/kg body weight (>1,700 times the maximum recommended human dose based on surface area). Glimepiride had no effect on the fertility of male and female rats administered up to 4000 mg/kg body weight (approximately 4,000 times the maximum recommended human dose based on surface area).

Manufacturer

DirectRX

Active Ingredients

Source

Drugs and Medications [105 Associated Drugs and Medications listed on BioPortfolio]

Glimepiride [direct rx]

GLIMEPIRIDE

Glimepiride [directrx]

GLIMEPIRIDE

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Clinical Trials [96 Associated Clinical Trials listed on BioPortfolio]

Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects

The purpose of the study is to determine the effect of glimepiride on dapagliflozin and the effect of dapagliflozin on glimepiride in healthy volunteers. In addition, the safety and toler...

Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5mg and Glimepiride 4mg

A randomized, open-label, multiple dosing, three treatment, three period, two sequence clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin...

Efficacy of Pioglitazone and Glimepiride Combination Therapy in Treating Subjects With Type 2 Diabetes Mellitus.

The purpose of this study is to determine the effect of pioglitazone, once daily (QD), and glimepiride combination therapy compared to glimepiride monotherapy in subjects with Type 2 Diabe...

Teneligliptin-Glimepiride DDI Study

An open label, one sequence study to investigate the pharmacokinetic drug interaction between Teneligliptin and Glimepiride in healthy male subjects

Efficacy Study of Pioglitazone and Glimepiride on the Rate of Progression of Atherosclerotic Disease.

The primary purpose of this study is to compare the effects of pioglitazone, once daily (QD), versus glimepiride on the amount of thickening of the carotid artery.

PubMed Articles [7 Associated PubMed Articles listed on BioPortfolio]

Efficacy and safety of dulaglutide monotherapy compared with glimepiride in Chinese patients with type 2 diabetes: Post hoc analyses of a randomized, double-blind, phase 3 study.

To investigate the efficacy/safety of dulaglutide once-weekly monotherapy versus glimepiride in Chinese patients with type 2 diabetes.

Simultaneous determination of metformin and glimepiride in human serum by ultra high performance liquid chromatography quadrupole time of flight mass spectrometry detection.

This work proposes a simple method for the simultaneous determination of two antidiabetic compounds, metformin and glimepiride, by ultra-high performance liquid chromatography using quadrupole time of...

Development and Validation of Liquid Chromatography Method for Determination of Glimepiride in Presence of (Vimto) Soft Drinks in Rats: Application to Pharmacokinetics Studies.

Diet and beverages are thought to have notable effects on drugs. Recently, this relationship has received significant consideration.

Empagliflozin versus Dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin, glimepiride and dipeptidyl peptide 4 inhibitors: A 52-week Prospective Observational Study.

To directly compare the effectiveness and safety between two distinct sodium-glucose co-transporter 2 (SGLT2) inhibitors, empagliflozin and dapagliflozin, as part of a quadruple oral antidiabetic agen...

Simultaneous Determination of Anti-diabetic Drugs in Their Combined Dosage Forms Using HPLC: An Experimental Design Approach.

A liquid chromatographic method has been established for the separation of five presently existing anti-diabetic drugs-metformin, pioglitazone, glibenclamide, glimepiride and repaglinide using design ...

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