The SPECIAL WARNING of the WARNINGS IN INCREASING RISK OF CARDIOVASCULAR MORTALITY the oral hipoglicémicas drug administration has been disclosed to be associated to increasing cardiovascular mortality with respect to the treatment with the single diet or the diet plus the insulin. This warning is based on the study lead by the program of the diabetes of the group of the university (UGDP), of long term, the advance clinical test designed to evaluate the effectiveness of the glucose-low narcotizes in the prevention or the delay of complications you will tilt in patients with diabetes not-insulin-employee. The study implied 823 patients who were assigned randomly to one of four groups of the treatment (diabetes, 19 supl. UGDP disclosed that the patients treated by 5 to 8 years with diet plus a fixed dose about tolbutamide (1,5 grams per day) had an index of cardiovascular mortality approximately 2-1/2 times that of patients dealt with the single diet. A significant increase in total mortality was not observed, but the use of tolbutamide was continued based on the increase in cardiovascular mortality, thus limiting the opportunity so that the study demonstrates an increase in total mortality. In spite of the controversy with respect to the interpretation of these results, the results of the UGDP study provide a base adapted for this warning. The patient must be informed into the risks and the potential advantages of AMARYL (tablets of glimepiride) and of alternative ways of therapy. Although only one drug in the class of the sulfonylurea (tolbutamide) outside including in this study, is prudent of a point of view of the security to consider that this warning can also be applied to other oral hipoglicémicas drugs in this class, due to its near similarities in the way of action and chemical structure. The allergic people to other derivatives of sulfamide can also develop an allergic reaction glimepiride. The drugs of the sulfonylurea of general HypoglycemiaAll of the PRECAUTIONS are able to produce severe hypoglucaemia. The selection, the dosage, and the appropriate patient instructions are important to avoid hipoglicémicos episodes. The patients with the aggravated renal function can be more sensible in order that glucose-low of AMARYL.A that begins the dose of 1 magnesium followed once daily by the appropriate degree of the dose are recommended in those patients. The debilitated or subfed patients, and those with the adrenal, pituitary shortage, or hepatica is particularly susceptible to glucose-low the hipoglicémica drug action. The hypoglucaemia can be difficult to recognize in the patients with autonomic neuropathy, the old ones and in the people who are taking drugs antídotas simpatolíticos beta-adrenergic or other agents. The hypoglucaemia is more probable to happen when the caloric contribution is deficient, after severe or prolonged exercise, when the alcohol interferes, or when it is used more than a glucose-low drug. The use combined of glimepiride with the insulin or metformin can increase the potential for the hypoglucaemia. The loss of control of the blood glucoseWhen to a patient stabilized in any diabetic regime is exposed to the tension as fever, trauma, infection, or the surgery, a loss of control can happen. In such times, it can be necessary to add the insulin jointly with AMARYL or still to use monotherapy of the insulin. The cualquie effectiveness drugs oral hipoglicémica, including AMARYL, in the loss of the glucose of blood to wished level diminutions of many patients during the time, that can be due to the progression of severity of the diabetes or to the sensitivity diminished to the drug. This phenomenon is known like secondary lack, to distinguish it of the primary lack in which the drug is ineffective in individual patient when first it is given. If the secondary lack happens with monotherapy of AMARYL or metformin, the therapy combined with AMARYL and metformin or AMARYL and insulin can give rise to an answer. If the secondary lack happens with combined therapy of AMARYL/metformin, can be necessary to initiate therapy of the insulin. anemiaTreatment haemolytic of patients with deficiency of deshidrogenasa of phosphate of glucose 6 (G6PD) with the agents of the sulfonylurea can take to the haemolytic anemia. Since AMARYL belongs to the class of agents of the sulfonylurea, the precaution is due to use in patients with G6PD deficiency and an alternative of the no-sulfonylurea must be considered. The information for PatientsPatients must be informed into the risks and the potential advantages of AMARYL and alternative ways of therapy. They must also be informed on the importance into the adhesion to the dietetic instructions, into a program of the regular exercise, and the regular test of the blood glucose. The hypoglucaemia risks, its symptoms and treatment, and the conditions that predispose to their development must explain to the patients and the responsible members of family. The potential for the primary and secondary lack must also be explained. The glucose of blood of TestsFasting of the laboratory is due to supervise periodically to determine therapeutic answer. The hemoglobina Glycosylated is due to also supervise, generally each 3 to 6 months, to determines more exact control glycemic of long term. The carcinogenesis of the drug interactions (the PHARMACOLOGY is seen, the CLINICAL drug interactions), the mutagenesis, and the weakening of FertilityStudies in rats in the doses of up to 5000 PPM in the complete feeding (approximately 340 by the maximum recommended the human dose, cradle in the surface) by 30 months did not demonstrate any evidence of the carcinogenesis. In mice, the administration of glimepiride by 24 months gave rise to an increase in the benign pancreatic formation of the adenoma that was regarding the dose and is probably the result of the chronic pancreatic stimulus. The dose of the no-effect for the formation of the adenoma in mice in this study was 320 PPM in the complete feeding, or 46& #8211; 54 mg/kg of the corporal weight/day. This one is near 35 times that the recommended dose human principle of magnesium 8 based once daily on the surface. Glimepiride was no-mutágeno in a battery of Ines studies vitro and alive Ines of mutagenicity (test of You love, mutation of the somatic cell, chromosomic aberration, unexpected synthesis of the DNA, test of the micronucleus of the mouse). Mg/kg of the corporal weight was no effect of glimepiride on fertility of the male mouse in the animal exposed up to 2500 (& GT; 1,700 times the maximum recommended the human dose based on the surface). Glimepiride did not have ninguÌ  n effect on the fertility of masculine and the feminine rats administered up to 4000 mg/kg of the corporal weight (approximately 4,000 times the maximum recommended the human dose based on the surface). Glimepiride did not produce teratogénicos effects in the rats exhibited oral up to 4000 mg/kg of the corporal weight (approximately 4,000 times the maximum recommended the human dose based on the surface) nor in rabbits mg/kg of the corporal weight exposed up to 32 (approximately 60 times the maximum recommended the human dose based on the surface). Glimepiride has demonstrated to be until death intrauterine fetal associate in rats when it is given in the doses of until only 50 times the human dose based on the surface and rabbits when it is given in the doses of until only 0,1 times the human dose based on the surface. This fetotoxicity, only observed in the doses that induced maternal hypoglucaemia, has been observed similar with other sulfonylureas, and it is created to be related directly to the action (hipoglicémica) pharmacological of glimepiride. There are suitable and no well-controlled studies in pregnant women. On the basis of results of the animal studies, AMARYL (tablets of glimepiride) is not due to use during pregnancy. Because the recent information suggests that abnormal levels of the blood glucose during pregnancy are associated to one more a higher incidence of congenital abnormalitys, many experts recommend that the insulin is used during pregnancy to so close maintain levels of the glucose to the normal one as it is possible. Nonteratogenic EffectsIn some studies in rats, the descendant of the prey exhibited at the levels of glimepiride during pregnancy and the skeletal deformities developed lactancia that consist of the shortening, the inspissation, and the doblez of the chimney during the postnatal period. The significant concentrations of glimepiride were observed in the serum and the maternal milk of the prey as well as in the serum of the small dogs. These skeletal deformations were determined to be the result of the care of the mothers exhibited to glimepiride. The prolonged severe hypoglucaemia (4 to 10 days) has been disclosed in new born taken to the mothers who received a drug of the sulfonylurea at the time of delivery. This has been disclosed more frequently with the use of agents with prolonged periods. Patients who are planning a pregnancy must consult their doctor, and she is recommended that they change above to the insulin for the whole course of the pregnancy and the lactancia. The reproduction of the rate of MothersIn of the nurse office studies, the significant concentrations of glimepiride was observed in the serum and the maternal milk of the prey, as well as in the serum of the small dogs. Although it is not known if AMARYL is excreted in human milk, other sulfonylureas are excreted in milk h

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