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These skeletal deformations were determined to be the result of nursing from mothers exposed to glimepiride. Prolonged severe hypoglycemia 4 to 10 days has been reported in neonates born to mothers who were receiving a sulfonylurea drug at the time of delivery. This has been reported more frequently with the use of agents with prolonged half-lives. Patients who are planning a pregnancy should consult their physician, and it is recommended that they change over to insulin for the entire course of pregnancy and lactation.
Nursing Mothers In rat reproduction studies, significant concentrations of glimepiride were observed in the serum and breast milk of the dams, as well as in the serum of the pups. Although it is not known whether glimepiride is excreted in human milk, other sulfonylureas are excreted in human milk. Because the potential for hypoglycemia in nursing infants may exist, and because of the effects on nursing animals, glimepiride should be discontinued in nursing mothers.
If glimepiride is discontinued, and if diet and exercise alone are inadequate for controlling blood glucose, insulin therapy should be considered. See above Pregnancy , Nonteratogenic Effects.
Pediatric Use The safety and efficacy of glimepiride were evaluated in an active-controlled, single-blind patients only , week trial involving pediatric patients, ranging from 8 to 17 years of age, with Type 2 diabetes. The profile of adverse reactions in pediatric patients treated with glimepiride was similar to that observed in adults. Geriatric Use In US clinical studies of glimepiride, of patients were 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.
The drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Elderly patients are particularly susceptible to hypoglycemic action of glucose-lowering drugs.
In elderly, debilitated, or malnourished patients, or in patients with renal and hepatic insufficiency, the initial dosing, dose increments, and maintenance dosage should be conservative based upon blood glucose levels prior to and after initiation of treatment to avoid hypoglycemic reactions. Glimepiride has been evaluated for safety in 2, patients in US controlled trials, and in 1, patients in foreign controlled trials.
More than 1, of these patients were treated for at least 1 year. In rare cases, there may be an elevation of liver enzyme levels. In isolated instances, impairment of liver function e.
Dermatologic Reactions Allergic skin reactions, e. These may be transient and may disappear despite continued use of glimepiride. If those hypersensitivity reactions persist or worsen e. Porphyria cutanea tarda, photosensitivity reactions, and allergic vasculitis have been reported with sulfonylureas, including glimepiride.
Hematologic Reactions Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, and pancytopenia have been reported with sulfonylureas, including glimepiride. Metabolic Reactions Hepatic porphyria reactions and disulfiram-like reactions have been reported with sulfonylureas, including glimepiride. Cases of hyponatremia have been reported with glimepiride and all other sulfonylureas, most often in patients who are on other medications or have medical conditions known to cause hyponatremia or increase release of antidiuretic hormone.
This is thought to be due to changes in blood glucose, and may be more pronounced when treatment is initiated. This condition is also seen in untreated diabetic patients, and may actually be reduced by treatment.
In placebo-controlled trials of glimepiride, the incidence of blurred vision was placebo, 0. Pediatric Patients In a clinical trial, pediatric patients with Type 2 diabetes were treated with glimepiride. Close monitoring should continue until the physician is assured that the patient is out of danger.
Severe hypoglycemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medical emergencies requiring immediate hospitalization. Patients should be closely monitored for a minimum of 24 to 48 hours, because hypoglycemia may recur after apparent clinical recovery. Short-term administration of glimepiride may be sufficient during periods of transient loss of control in patients usually controlled well on diet and exercise.
Usual Starting Dose The usual starting dose of glimepiride as initial therapy is mg once daily, administered with breakfast or the first main meal. Those patients who may be more sensitive to hypoglycemic drugs should be started at 1 mg once daily, and should be titrated carefully. No exact dosage relationship exists between glimepiride and the other oral hypoglycemic agents.
The maximum starting dose of glimepiride should be no more than 2 mg. Failure to follow an appropriate dosage regimen may precipitate hypoglycemia. Patients who do not adhere to their prescribed dietary and drug regimen are more prone to exhibit unsatisfactory response to therapy.
Usual Maintenance Dose The usual maintenance dose is 1 to 4 mg once daily. The maximum recommended dose is 8 mg once daily. Long-term efficacy should be monitored by measurement of HbA1c levels, for example, every 3 to 6 months. Glimepiride-Metformin Combination Therapy If patients do not respond adequately to the maximal dose of glimepiride monotherapy, addition of metformin may be considered. Published clinical information exists for the use of other sulfonylureas including glyburide, glipizide, chlorpropamide, and tolbutamide in combination with metformin.
With concomitant glimepiride and metformin therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug. However, attempts should be made to identify the minimum effective dose of each drug to achieve this goal. With concomitant glimepiride and metformin therapy, the risk of hypoglycemia associated with glimepiride therapy continues and may be increased.
Appropriate precautions should be taken. Glimepiride-Insulin Combination Therapy Combination therapy with glimepiride and insulin may also be used in secondary failure patients. The recommended glimepiride dose is 8 mg once daily administered with the first main meal.
After starting with low-dose insulin, upward adjustments of insulin can be done approximately weekly as guided by frequent measurements of fasting blood glucose. Once stable, combination-therapy patients should monitor their capillary blood glucose on an ongoing basis, preferably daily. Periodic adjustments of insulin may also be necessary during maintenance as guided by glucose and HbA1c levels. Specific Patient Populations Glimepiride tablets are not recommended for use in pregnancy or nursing mothers.
Data are insufficient to recommend pediatric use of glimepiride. Patients Receiving Other Oral Hypoglycemic Agents As with other sulfonylurea hypoglycemic agents, no transition period is necessary when transferring patients to glimepiride. Patients should be observed carefully weeks for hypoglycemia when being transferred from longer half-life sulfonylureas e. In patients not adequately controlled with the maximum daily dose of metformin, concomitant glimepiride therapy can be initiated.
While maintaining the metformin dose, the glimepiride therapy is started with a low dose, and is then titrated up depending on the desired level of metabolic control up to the maximum daily dose. The combination therapy should be initiated under close medical supervision. In patients not adequately controlled with the maximum daily dose of glimepiride, concomitant insulin therapy can be initiated if necessary.
While maintaining the glimepiride dose, insulin treatment is started at a low dose and titrated up depending on the desired level of metabolic control. Normally a single daily dose of glimepiride is sufficient. It is recommended that this dose be taken shortly before or during a substantial breakfast or - if none is taken - shortly before or during the first main meal.
If a dose is forgotten, this should not be corrected by increasing the next dose. If a patient has a hypoglycaemic reaction on 1 mg glimepiride daily, this indicates that they can be controlled by diet alone. In the course of treatment, as an improvement in control of diabetes is associated with higher insulin sensitivity, glimepiride requirements may fall.
To avoid hypoglycaemia timely dose reduction or cessation of therapy must therefore be considered. Change in dosage may also be necessary if there are changes in weight or life style of the patient, or other factors that increase the risk of hypo- or hyperglycaemia. Switch over from other oral hypoglycaemic agents to glimepiride A switch over from other oral hypoglycaemic agents to glimepiride can generally be done. For the switch over to glimepiride the strength and the half-life of the previous medicinal product has to be taken into account.
In some cases, especially in antidiabetics with a long half-life e. The recommended starting dose is 1 mg glimepiride per day. Based on the response the glimepiride dosage may be increased stepwise, as indicated earlier.
Switch over from insulin to glimepiride In exceptional cases, where type 2 diabetic patients are regulated on insulin, a changeover to glimepiride may be indicated.
The changeover should be undertaken under close medical supervision. Special Populations Patients with renal or hepatic impairment See section 4.
Mean urinary excretion of M1 plus M2 as a percentage of dose decreased from More than 1, of these patients were treated for at least 1 year. This complementary effect has been observed with metformin and other sulfonylureas, in multiple studies. Your doctor will write the number of refills authorized on your prescription. The pharmacodynamic responses to glimepiride were nearly identical in normal subjects receiving propranolol and placebo. When these drugs are withdrawn from a patient receiving glimepiride, the patient should be observed closely for hypoglycemia. If this happens, take 15 to 20 grams of glucose a type of sugar. Nonteratogenic Effects In some studies in rats, offspring of dams exposed to high levels of glimepiride during pregnancy and lactation developed skeletal deformities consisting of shortening, thickening, and bending of the humerus during the postnatal period. In addition, signs of adrenergic counter-regulation may be review such as sweating, clammy skin, glimepiride 2 mg review, anxiety, tachycardia, hypertension, palpitations, angina pectoris and cardiac arrhythmias. Storage Glimepiride glimepiride at room temperature.
If you have any questions about the drugs you are taking, glimepiride 2 mg review, check with your doctor, nurse or pharmacist. The drug is known to be substantially excreted by the kidney, glimepiride 2 mg review, and the risk of toxic reactions to this drug may be greater in patients review impaired renal function. 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. Blood sugar 1 to 2 hours after starting of a meal postprandial plasma glucose: When flying, never put it into a checked bag. The glucose-lowering effect in all active treatment groups was maintained over 24 hours. Nonteratogenic Effects In some studies in rats, offspring of dams exposed to review levels of glimepiride during pregnancy and lactation developed skeletal deformities consisting of shortening, thickening, and bending of the humerus during the postnatal period. If a dose is forgotten, this should not be corrected by increasing the next dose. In two week, placebo-controlled glimepiride in subjects, glimepiride 2 mg review, the average net reduction in HbA1c for glimepiride tablets patients treated with 8 mg once daily was 2. This complementary effect has been observed with metformin and other sulfonylureas, in multiple studies. In placebo-controlled trials of glimepiride, the incidence of blurred vision was placebo, 0. Pharmacokinetic Parameters The pharmacokinetic parameters of glimepiride obtained from a single-dose, crossover, dose-proportionality 1, 2, 4, and glimepiride mg study in normal subjects and from a single- and glimepiride, parallel, dose-proportionality 4 and 8 mg study in patients with Type 2 diabetes are summarized below: Mild episodes of hypoglycemia can be treated with oral glucose. No experience has been gained concerning the use of glimepiride tablets in patients with severe impairment of liver function or dialysis patients. The results showed that glimepiride serum levels decreased as renal function decreased, glimepiride 2 mg review. Treatment of patients with G6PD-deficiency with sulfonylurea agents can lead to hemolytic anaemia.
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