Glimepiride / Metformin

Glimepiride / Metformin

DAE Class; Rx

Common Brand Names; AMARYL M

• Antidiabetic

Glimepiride+Metformin is a combination medicine. It is used in the treatment of

 type 2 diabetes mellitus. It helps in controlling the blood sugar levels adequately. This combination is known to control blood sugar to a greater extent than metformin or glimepiride alone. It belongs to an anti-diabetic class of medicines. Glimepiride+Metformin is available in the form of tablet, capsule. Inform your doctor if you are pregnant, planning a pregnancy or breastfeeding and about all the medicines and supplements you take and all the conditions or diseases you suffer from before starting glimepiride+metformin.

Diabetes mellitus type 2, whenever blood sugar levels cannot be controlled adequately by diet, physical exercise and weight reduction. Also, it is for replacement therapy in diabetic patients stabilized on glimepiride (1 or 2 mg) with metformin (500 mg SR). Indicated for patients of 18 years of age and older.

This combination is not suitable for the treatment of diabetes mellitus type 1 (e.g. for the treatment of diabetics with a history of ketoacidosis), or of diabetic precoma or coma.
It must not be used in patients hypersensitive to metformin hydrochloride, glimepiride, sulfonylureas, other sulfonamides, or any of the excipients (risk of hypersensitivity reactions).
Impaired renal function; acute complications (severe infections, major operations and trauma); before x-ray examinations with iodinated contrast materials; liver damage; alcoholism; deficiencies of vitamin B12, folic acid and iron; ketosis-prone diabetes; severe cardiovascular or respiratory disease; general ill health (malnutrition, dehydration, etc); diabetes with significant late complications (nephropathy, retinopathy).

Hypoglycemia: As a result of the blood-sugar lowering action of glimepiride, hypoglycemia may occur and may also be prolonged.
Eyes: Especially at the start of treatment, temporary visual impairment may occur due to the change in blood sugar levels.
Digestive tract: Occasionally, nausea, vomiting, sensations of pressure or fullness in the epigastrium, abdominal pain and diarrhea may occur. In isolated cases, liver enzymes levels may increase, and impairment of liver function (e.g. with cholestasis and jaundice) and hepatitis may develop, possibly resulting in liver failure.
Blood: Rarely, thrombocytopenia and in isolated cases, leukopenia, hemolytic anemia, erythrocytopenia, granulocytopenia, agranulocytosis, and pancytopenia (e.g. due to myelosuppression) may develop.
Other adverse reactions: Allergic or pseudoallergic reactions like itching, urticaria or rashes may occur. Such reactions are mild but may become more serious and be accompanied by dyspnea, and a fall in blood pressure, sometimes progressing to shock. If urticaria occurs, a physician must be notified immediately. In isolated cases allergic vasculitis, hypersensitivity of the skin to light, and a decrease in serum sodium may occur.

Glimepiride: If risk factors for hypoglycemia are present, it may be necessary to adjust the dosage of glimepiride or the entire therapy. This also applies whenever illness occurs during therapy or the patient’s lifestyle changes.
Symptoms of hypoglycemia may be milder or absent in those situations where hypoglycemia develops gradually, in the elderly and in the patients with autonomic neuropathy or those receiving concurrent treatment with beta-blockers, clonidine, reserpine, guanethidine or other sympatholytic drugs.
Hypoglycemia can almost always be promptly controlled by immediate intake of carbohydrates (glucose or sugar, e.g. in the form of sugar lumps, sugar-sweetened fruit juice or sugar sweetened tea). For this purpose, patients must carry a minimum of 20 grams of glucose with them at all times. They may require assistance of other persons to avoid complication. Artificial sweeteners are ineffective in controlling hypoglycemia.
Continued close observation is necessary. Severe hypoglycemia requires immediate treatment and follow-up by a physician and in some circumstances, hospitalization.
In exceptional stress situations (e.g. trauma, surgery, infections with fever) blood sugar control may deteriorate, and temporary change to insulin may be necessary.
During treatment with glimepiride, glucose levels in blood and urine must be checked regularly, as should, additionally, the proportion of glycated hemoglobin. Alertness and reactions may be impaired due to hypoglycemia or hyperglycemia, especially when beginning or after altering treatment, or when glimepiride is not taken regularly. This may affect the ability to operate vehicle or machinery.
Metformin: Lactic Acidosis: Metformin can provoke lactic acidosis; however, the reported incidence is very low. Conditions like impaired hepatic function, renal dysfunction, hypoxemia, dehydration, sepsis, excessive alcohol intake can increase the risk of lactic acidosis. The risk can be decreased by regular monitoring of renal function and by use of minimum effective dose. In a patient with lactic acidosis, who is on metformin treatment, the drug should be discontinued immediately. Supportive measures and prompt hemodialysis should be started.
Impaired renal function: Caution should be exercised with concomitant therapies that may affect renal function or interfere with the disposition of metformin (eg, cationic drugs).
Use of Iodinated Contrast Media: The drug should be stopped at least two days before X-ray examination with iodinated contrast material and reinstituted only after renal function has been re-evaluated and found to be normal.
Hypoxic States: Metformin therapy should be promptly discontinued when such events occur in patients.
Surgical Procedures: The drug should be temporarily discontinued and restarted only when the patient resumes oral intake and has normal renal function.
Alcohol Intake: Patients should be warned against excessive alcohol intake, acute or chronic, while receiving metformin.
Impaired hepatic function: The drug should be generally avoided in patients with hepatic disease.
Hypoglycemia: Hypoglycemia does not normally occur when the drug is given alone but has been observed when given in combination with sulfonylureas and/or alcohol.
Deficiencies of folic acid, iron and vitamin B12: Serum vitamin B12 concentrations should be measured annually during long-term treatment.

If you have missed any dose of glimepiride+metformin, then take it as soon as you remember. If it is already time for the next dose, then skip the missed dose and follow the regular dosing schedule. Do not take a double dose to compensate for the missed one.

Glimepiride / Metformin