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Pharmacological Class: Glimepiride: Antidiabetic. Sulfonylurea. Metformin: Antidiabetic. Biguanide. ATC code: A10BD02.
Pharmacology: Glimepiride, the active ingredients of Amaryl M is a blood sugar-lowering agent belonging to the sulfonylurea group. The decrease in blood sugar is achieved principally by means of the stimulation of insulin release from pancreatic β-cells. This effect is predominantly based on improved responsiveness of these cells to the physiological glucose stimulus. Glimepiride augments the normal action of insulin on peripheral glucose uptake. Moreover, it mimics such action as well as the glucose output of the liver. Good metabolic control over 24 hours can be achieved with a single dose of Amaryl M. In patients with insufficient response to the maximum dose, combined use with an additional oral antidiabetic containing metformin or with insulin improves metabolic control.
Metformin, the active ingredients of Amaryl M, is a blood sugar-lowering agent belonging to the biguanide group. The decrease in blood sugar is achieved principally by not increasing insulin secretion. Moreover, metformin is not metabolized in the liver; excretion is through urine and feces.
Toxicology: Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term carcinogenicity studies have been performed in rats (dosing duration of 104 weeks) and mice (dosing duration of 91 weeks) at doses up to and including 900mg/kg/day and 1500mg/kg/day, respectively. These doses are both approximately three times the maximum recommended human daily dose on a body surface area basis. No evidence of carcinogenicity with metformin was found in either male or female mice. Similarly, there was no tumorigenic potential observed with metformin in male rats. However, an increased incidence of benign stromal uterine polyps was seen in female rats treated with 900 mg/kg/day.
No evidence of a mutagenic potential of metformin was found in the Ames test (S. typhimurium), gene mutation test (mouse lymphoma cells), chromosomal aberration test (human lymphocytes), or in vivo micronuclei formation test (mouse bone marrow).
Fertility of male or female rats was unaffected by metformin administration at doses as high as 600 mg/kg/day, or approximately two times the maximum recommended human daily dose on a body surface area basis.
Drug abuse and dependence: Metformin hydrochloride product possesses no pharmacodynamics properties, either primary or secondary, which could be expected to result in abuse as a recreational drug or addiction.
