Glimitus M

Glimepiride is a sulfonylurea antidiabetic medicine that lowers blood glucose. It works mainly by stimulating the release of insulin from functioning beta cells in the pancreas. It acts together with glucose, making the beta cells more sensitive to the normal glucose signal so that they release insulin. Glimepiride may also work outside the pancreas. It can reduce basal glucose production in the liver, and it can make peripheral tissues more sensitive to insulin and increase their glucose uptake. In diabetic patients who haven't fasted, a single dose of Glimepiride keeps lowering blood glucose for 24 hours.

Metformin Hydrochloride is a biguanide type of oral antihyperglycemic medicine, used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from that of the sulfonylureas, and it does not produce hypoglycemia. Metformin Hydrochloride decreases glucose production in the liver and reduces the absorption of glucose from the intestine. It also improves insulin sensitivity by increasing glucose uptake and utilization in peripheral tissues.

Pregnancy

For the Glimepiride + Metformin combination, each part has to be considered separately. Glimepiride must not be taken during pregnancy, because there is a risk of harm to the child. The patient must change over to insulin during pregnancy. Patients who are planning a pregnancy must tell their doctor, and it is recommended that they change over to insulin too. As for metformin, diabetes should not be treated with metformin when the patient plans to become pregnant or during pregnancy. Insulin should be used instead, to keep blood glucose as close to normal as possible and so lower the risk of fetal malformations linked with abnormal blood glucose levels.

Lactation

Glimepiride must not be taken by breast-feeding women, since it could pass into the breast milk and possibly harm the child. If necessary, the patient must change over to insulin or stop breastfeeding. Metformin is excreted into milk in lactating rats. Similar data is not available in humans, so a decision should be made whether to stop nursing or to stop metformin, taking into account how important the medicine is to the mother.

Children: There isn't enough data to recommend this Glimepiride + Metformin tablet for children.

Renal impairment: Assess the GFR before starting any metformin-containing product, and then at least once a year. If a patient is at increased risk of further progression of renal impairment, or is elderly, check renal function more often, for example every 3 to 6 months. The maximum daily dose of metformin should preferably be divided into 2 to 3 doses a day. Before starting metformin in a patient with GFR<60 mL/min, review the factors that may increase the risk of lactic acidosis. If no suitable strength of this tablet is available, use the individual single-ingredient medicines instead of the fixed dose combination.

With a GFR of 60-89 ml/min, the maximum daily dose of metformin is 3000 mg, and a dose reduction may be considered as renal function declines. For glimepiride, the highest recommended dose per day is 8 mg. When the GFR is 45-59 ml/min, the maximum daily dose of metformin is 2000 mg, and the starting dose is at most half of that maximum. At 30-44 ml/min, the maximum daily dose of metformin is 1000 mg, and again the starting dose is at most half of the maximum dose. If the GFR is <30 ml/min, metformin is contraindicated. For glimepiride at this level, a change-over to insulin is indicated, not least to achieve the best metabolic control.

For Glimepiride: An acute overdose of glimepiride, or long-term treatment with too high a dose, may lead to severe, life-threatening hypoglycaemia. Once an overdose has been discovered, a physician must be told without delay. The patient must take sugar straight away, if possible as glucose, unless a physician has already taken charge of treating the overdose. Careful monitoring is essential until the physician is confident the patient is out of danger. Hypoglycaemia can come back after the patient first recovers. Admission to hospital may sometimes be necessary, even just as a precaution. Significant overdoses, and severe reactions such as loss of consciousness or other serious neurological disorders, are medical emergencies. They need immediate treatment and admission to hospital. If the patient is unconscious, for example, an intravenous injection of concentrated glucose solution is indicated (for adults, starting with 40 ml of 20% solution, for example). Alternatively, in adults, glucagon may be considered, e.g. in doses of 0.5 to 1 mg i.v., s.c. or i.m. When hypoglycaemia is due to accidental intake of glimepiride in infants and young children, the dose of glucose must be adjusted very carefully because it could produce dangerous hyperglycaemia. It must be controlled by close monitoring of blood glucose. Patients who have taken life-threatening amounts of glimepiride need detoxification (e.g. by gastric lavage and medicinal charcoal). After the acute glucose replacement is finished, an intravenous glucose infusion in lower concentration is usually needed so that the hypoglycaemia does not return. The patient's blood glucose level should be monitored carefully for at least 24 hours. In severe cases with a protracted course, hypoglycaemia, or the danger of slipping back into it, may last for several days.

For Metformin: Hypoglycaemia has not been seen with metformin doses of up to 85 g, although lactic acidosis has occurred in such circumstances. A high overdose or concomitant risks of metformin may lead to lactic acidosis. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and metformin is haemodialysis. Pancreatitis may occur in the context of a metformin overdose.

Keep Glimepiride + Metformin in a cool, dry place where the temperature doesn't go above 25°C, and away from light.