Special populations Paediatric population An active controlled clinical trial glimepiride up to 8 mg daily or metformin up to 2, mg daily of 24 weeks duration was performed in children years of age with type 2 diabetes. Both glimepiride and metformin exhibited a significant decrease from baseline in HbA1c glimepiride However, glimepiride did not achieve the criteria of non-inferiority to metformin in mean change from baseline of HbA1c.
The difference between treatments was 0. The upper limit 1. Following glimepiride treatment, there were no new safety concerns noted in children compared to adult patients with type 2 diabetes mellitus. No long-term efficacy and safety data are available in paediatric patients. Food intake has no relevant influence on absorption, only absorption rate is slightly diminished. Maximum serum concentrations Cmax are reached approx. Distribution Glimepiride has a very low distribution volume approx.
In animals, glimepiride is excreted in milk. Glimepiride is transferred to the placenta. Passage of the blood brain barrier is low.
Biotransformation and elimination Mean dominant serum half-life, which is of relevance for the serum concentrations under multiple-dose conditions, is about 5 to 8 hours.
After high doses, slightly longer half-lives were noted. No unchanged substance was detected in the urine. Two metabolites - most probably resulting from hepatic metabolism major enzyme is CYP2C9 - were identified both in urine and faeces: After oral administration of glimepiride, the terminal half-lives of these metabolites were 3 to 6 and 5 to 6 hours respectively.
Comparison of single and multiple once-daily dosing revealed no significant differences in pharmacokinetics, and the intraindividual variability was very low. There was no relevant accumulation. Special populations Pharmacokinetics were similar in males and females, as well as in young and elderly above 65 years patients. In patients with low creatinine clearance, there was a tendency for glimepiride clearance to increase and for average serum concentrations to decrease, most probably resulting from a more rapid elimination because of lower protein binding.
Renal elimination of the two metabolites was impaired. Overall no additional risk of accumulation is to be assumed in such patients. Blood Potentially life-threatening changes in the blood picture may occur, such as thrombocytopenia and, in isolated cases, leucopenia.
Allergic or pseudoallergic reactions may occur such as itching, urticaria or rashes. These mild reactions may develop into serious and even life-threatening reactions with dyspnoea and a fall in blood pressure, sometimes progressing to shock. In the event of urticaria a physician must therefore be notified immediately.
In isolated cases, a decrease in serum sodium concentration has been seen and allergic vasculitis or hypersensitivity of the skin to light may occur. If any of these reactions occur a doctor should be consulted. This may, for example, affect the ability to drive or to operate machinery. Clinical signs of a still insufficiently lowered blood glucose hyperglycaemia are e. In the initial weeks of treatment, the risk of hypoglycaemia may he increased and necessitates especially careful monitoring.
Factors favouring hypoglycaemia include: Imbalance between physical exertion and carbohydrate intake. Consumption of alcohol, especially in combination with skipped meals. Severe impairment of liver function.
Certain uncompensated disorders of the endocrine system affecting carbohydrate metabolism or counter-regulation of hypoglycaemia as for example in certain disorders of thyroid function and in anterior pituitary or corticoadrenal insufficiency.
Concurrent administration of certain other medicines refer to "Interactions". The patient must inform the physician about such factors and about hypoglycaemic episodes since they may indicate the need for particularly careful monitoring. This also applies whenever illness occurs during therapy or the patient's life-style changes. Persons allergic to other sulfonamide derivatives may develop an allergic reaction to glimepiride as well. Hypoglycemia All sulfonylurea drugs are capable of producing severe hypoglycemia.
Proper patient selection, dosage, and instructions are important to avoid hypoglycemic episodes. A starting dose of 1 mg once daily followed by appropriate dose titration is recommended in those patients. Debilitated or malnourished patients, and those with adrenal, pituitary, or hepatic insufficiency are particularly susceptible to the hypoglycemic action of glucose-lowering drugs.
Hypoglycemia may be difficult to recognize in patients with autonomic neuropathy, the elderly and in people who are taking beta-adrenergic blocking drugs or other sympatholytic agents. Hypoglycemia is more likely to occur when caloric intake is deficient, after severe or prolonged exercise, when alcohol is ingested, or when more than one glucose-lowering drug is used.
Combined use of glimepiride with insulin or metformin may increase the potential for hypoglycemia. Loss of control of blood glucose When a patient stabilized on any diabetic regimen is exposed to stress such as fever, trauma, infection, or surgery, a loss of control may occur. The effectiveness of any oral hypoglycemic drug, including AMARYL, in lowering blood glucose to a desired level decreases in many patients over a period of time, which may be due to progression of the severity of the diabetes or to diminished responsiveness to the drug.
This phenomenon is known as secondary failure, to distinguish it from primary failure in which the drug is ineffective in an individual patient when first given. Hemolytic anemia Treatment of patients with glucose 6-phosphate dehydrogenase G6PD deficiency with sulfonylurea agents can lead to hemolytic anemia.
Since AMARYL belongs to the class of sulfonylurea agents, caution should be used in patients with G6PD deficiency and a non-sulfonylurea alternative should be considered. In postmarketing reports, hemolytic anemia has been reported in patients who did not have known G6PD deficiency. They should also be informed about the importance of adherence to dietary instructions, of a regular exercise program, and of regular testing of blood glucose. The risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be explained to patients and responsible family members.
The potential for primary and secondary failure should also be explained. Laboratory Tests Fasting blood glucose should be monitored periodically to determine therapeutic response. Glycosylated hemoglobin should also be monitored, usually every 3 to 6 months, to more precisely assess long-term glycemic control.
In mice, administration of glimepiride for 24 months resulted in an increase in benign pancreatic adenoma formation which was dose related and is thought to be the result of chronic pancreatic stimulation.
This is about 35 times the maximum human recommended dose of 8 mg once daily based on surface area. The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. These problems generally get better after you stop taking Glimepiride Very rare side effects may affect up to 1 in 10, people of blood vessels, often with skin rash which may develop into serious reactions with difficulty in breathing, fall in blood pressure and sometimes progressing to shock.
Some mild allergic reactions may develop into serious reactions with swallowing or breathing problems, swelling of your lips, throat or tongue. This includes any possible side effects not listed in this leaflet.
M1 is further metabolized to M2 by one or several cytosolic enzymes. Glimepiride may pass into breast milk. The maximum recommended dose is 8 mg taken once per day. If you take the tablets out of the blister pack they may not keep well, amaryl 4mg 30 tablet fiyat. Dose range in patients with well controlled diabetes: UGDP reported that patients treated for 5 to 8 years with diet plus a fixed dose of tolbutamide 1. Proper patient selection, dosage, and instructions are important to avoid hypoglycemic episodes. Hypoglycemia All sulfonylurea drugs are capable of producing severe hypoglycemia. Passage of the blood brain barrier is low. The physiological response to acute physical exercise, i. Nausea, vomiting and epigastric pain may occur.
There were no significant differences in glimepiride pharmacokinetics between the two age groups. Lactation The excretion in fiyat milk is unknown. The upper limit 1. This applies even in cases where the patient is being switched from the maximum dose of another tablet antidiabetic, amaryl 4mg 30 tablet fiyat. Food intake has no relevant influence on absorption, only absorption rate is slightly diminished. You can also report side effects directly via the Yellow Card Scheme at www. What Glimepiride is and what it is amaryl for 2. Be sure to avoid doing this when the weather is very hot or arcoxia 60mg lääke cold. Make sure you check your blood glucose levels regularly. Distribution After intravenous dosing in healthy subjects, the volume of distribution Vd was 8. Loss of control of blood glucose When a patient stabilized on any diabetic regimen is exposed to stress such as fever, trauma, infection, or surgery, a loss of control may occur. This has been reported more frequently with the use of agents 4mg prolonged half-lives, amaryl 4mg 30 tablet fiyat.
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