Metformin hydrochloride tablets
Product Name:Metformin hydrochloride tablet
Nombre del Producto: Metformina Clorhidrato, tableta
Specification: 250mg, 500mg
Package: 10tablets/blister/box, 1blister/box, 10blister/box
Standard: BP & USP
• In adults,metformin 850mg tablets may be used as monotherapy or in combination with other oral anti-diabetic agents, or with insulin.
• In children from 10 years of age and adolescents, Metformin tablets may be used as monotherapy or in combination with insulin.
A reduction of diabetic complications has been shown in overweight type 2 diabetic patients treated with metformin as first-line therapy after diet failure
Posology and method of administration
Monotherapy and combination with other oral antidiabetic agents:
• The usual starting dose is one tablet 2 or 3 times daily given during or after meals. After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability.
The maximum recommended dose of metformin is 3g daily, taken as 3 divided doses.
• If transfer from another oral anti-diabetic is intended, discontinue the other agent and initiate metformin at the dose indicated above.
Combination with insulin:
Metformin and insulin may be used in combination therapy to achieve better blood glucose control. Metformin is given at the usual starting dose of one tablet 2-3 times daily, while insulin dosage is adjusted on the basis of blood glucose measurements.
Elderly: Due to potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary
Children and adolescents:
Monotherapy and combination with insulin
• Metformin tablets can be used in children from 10 years of age and adolescents.
• The usual starting dose is one tablet of 500 mg or 850 mg once daily, given during meals or after meals.
After 10 to 15 days the should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability. The maximum recommended dose of metformin is 2 g daily, taken as 2 or 3 divided doses.
• Hypersensitivity to metformin hydrochloride or to any of the excipients.
• Diabetic ketoacidosis, diabetic pre-coma
• Renal failure or renal dysfunction (creatinine clearance < 60 mL/min)
• Acute conditions with the potential to alter renal function such as:
- severe infection
- intravascular administration of iodinated contrast agents
• Acute or chronic disease which may cause tissue hypoxia such as:
- cardiac or respiratory failure
- recent myocardial infarction
• Hepatic insufficiency, acute alcohol intoxication, alcoholism
Special warnings and precautions for use
Lactic acidosis is a rare, but serious (high mortality in the absence of prompt treatment), metabolic complication that can occur due to metformin accumulation. Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with significant renal failure. The 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.
The risk of lactic acidosis must be considered in the event of non-specific signs such as muscle cramps with digestive disorders as abdominal pain and severe asthenia.
Lactic acidosis is characterised by acidotic dyspnea, abdominal pain and hypothermia followed by coma. Diagnostic laboratory findings are decreased blood pH, plasma lactate levels above 5mmol/L and an increased anion gap and lactate/pyruvate ratio. If metabolic acidosis is suspected, Metformin hydrochloride should be discontinued and patient should be hospitalised immediately.
As metformin is excreted by the kidneys, serum creatinine levels should be determined before initiating treatment and regularly thereafter:
• at least annually in patients with normal renal function.
• at least two to four times a year in patients with serum creatinine levels at the upper 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 when initiating antihypertensive therapy or diuretic therapy and when starting therapy with an NSAID
Administration of iodine contrast agent:
As the intravenous administration of iodinated contrast material in radiologic studies can lead to renal failure, metformin should be discontinued prior to, or at the time of the test and not to be reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal
Metformin Hydrochloride should be discontinued 48 hours before elective surgery under general, spinal or peridural anaesthesia. Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and only if normal renal function has been established.
Children and adolescents:
The diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin is initiated.
No effect of metformin on growth and puberty has been detected during controlled clinical studies of one-year duration but no long-term on these specific points are available.
Therefore, a careful follow-up of the effect of metformin on these parameters in metformin-treated children, especially pre-pubescent children, is recommended
Children aged between 10 to 12 years:
Only 15 subjects aged between 10 and 12 years were included in the controlled clinical studies conducted in children and adolescents. Although metformin efficacy and safety in children below 12 did not differ from efficacy and safety in older children, particular caution is recommended when prescribing to children aged between 10 and 12 years.
• All patients should continue their diet with a regular distribution of carbohydrate intake during the day. Overweight patients should continue their energy-restricted diet.
• The usual laboratory tests for diabetes monitoring should be performed regularly.
• Metformin alone never causes hypoglycaemia, although caution is advised when it is used in combination with insulin and sulfonylureas.
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