Diabemin XR Special Precautions

Lactic acidosis: Lactic acidosis is a rare, but serious (high mortality in the absence of prompt treatment), metabolic complication that can occur due to metformin accumulation. Then incidence of lactic acidosis can and should be reduced by assessing also other associated risk factors such as poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol intake, hepatic insufficiency and any condition associated with hypoxia. It is characterized by acidotic dyspnea, vomiting, abdominal pain with muscle cramps, and/or general feeling of malaise with severe fatigue and hypothermia followed by coma. Lactic acidosis is a medical emergency. If metabolic acidosis is suspected, metformin should be discontinued and the patient should be hospitalized immediately.
Renal function: As metformin is excreted mainly by the kidney, serum creatinine levels or creatinine clearance should be determined before initiating treatment (creatininemia <135 μmol/L in males and <110 μmol/L in females) and regularly thereafter; at least annually in patients with normal renal function and at least two to four times a year in patients with creatinine at the lower limit of normal and in elderly subjects. Decreased renal function in elderly subjects is frequent and asymptomatic. Special caution should be exercised in situations where renal function may become impaired, for example in the elderly when initiating antihypertensive therapy or diuretic therapy and when starting therapy with a nonsteroidal anti-inflammatory.
Administration of iodinated contrast agent: Intravascular administration of iodinated contrast materials in radiologic studies such as intravenous urography or angiography, may lead to renal failure, resulting in metformin accumulation and a risk of lactic acidosis. Metformin should be discontinued 48 hours prior to or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been reevaluated and found to be normal.
Surgery: If a patient is going to have an elective major surgery, treatment with metformin must be discontinued 48 hours before the surgery. Metformin should not be reinstituted until 48 hours after the surgery and only after ensuring that kidney function is normal.
The use of metformin is not advised in conditions which may cause dehydration or in patients suffering from serious infections or trauma.
Serum B₁₂ levels should annually be evaluated, in long-term therapy.
Metformin therapy in combination with a sulfonylurea should be monitored by blood-glucose readings as hypoglycemia may occur.
Combination therapy with insulin should be done in the hospital, until the correct ratio of the two medicines is determined.
Caution is advised in elderly patients because of the reduced renal function. Hence renal function should be monitored regularly.
Metformin is not recommended in children.
Patients should continue following any dietary advice the doctor has given including some energy-restricted diet for overweight patients. Patients should also get some regular exercise.
Consumption of alcoholic beverages has to be avoided.
The usual laboratory tests for diabetes monitoring should be performed regularly.
Effects on Ability to Drive and Use Machines: Metformin monotherapy does not cause hypoglycemia. However, patients should be alerted to the risk of hypoglycemia when metformin is used in combination with other antidiabetic agents (sulfonylureas, insulin, glinides or other hypoglycemic agents). It is important to be aware of the onset of hypoglycemia. Symptoms of hypoglycemia include weakness, dizziness, increased sweating, fast heartbeat, vision disorders or difficulty in concentration. When a patient starts to feel these symptoms, he should not drive or use machines.