Indications
InformetĀ® (Metformin Hydrochloride), as monotherapy, is indicated as an adjunct to diet to lower blood glucose especially in
overweight patients with non-insulin-dependent diabetes mellitus (NIDDM) or type 2 diabetes mellitus whose hyperglycemia
cannot be satisfactorily managed on diet alone. InformetĀ® (Metformin Hydrochloride) may be used concomitantly with a
sulfonylurea when diet and metformin hydrochloride or sulfonylureas alone do not result in adequate glycemic control.
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Contraindications
ā Hypersensitivity to metformin hydrochloride or to any of the excipients of the medication.
ā Diabetic ketoacidosis, diabetic pre-coma
ā Renal failure or renal dysfunction (creatinine clearance < 60 mL/min)
ā Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock, intravascular
administration of iodinated contrast agents.
ā Acute or chronic disease which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial
infarction, shock
ā Hepatic insufficiency, acute alcohol intoxication, alcoholism
ā Lactation
Administration of iodinated contrast agent
As the intravascular administration of iodinated contrast materials in radiologic studies can lead to renal failure, metformin
should be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal
function has been re-evaluated and found to be normal.
Surgery
Metformin hydrochloride should be discontinued 48 hours before elective surgery with general anesthesia and should not be
usually resumed earlier than 48 hours afterwards.
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 data 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 and 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.
Other precautions
ā¢ All patients should continue their diet with a regular distribution of carbohydrate intake during the day. Overweight patients
should continue their energy-restricted diet.
ā¢ The usual laboratory tests for diabetes monitoring should be performed regularly.
Metformin alone never causes hypoglycemia, although caution is advised when it is used in combination with insulin or sulphonylureas.
Combinations requiring precautions for use
Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. These drugs include thiazide and
other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid,
sympathomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are administered to a patient receiving
Metformin HCl, the patient should be closely observed to maintain adequate glycemic control. Inform the patient and
perform more frequent blood glucose monitoring, especially at the beginning of treatment. If necessary, adjust the dosage of
the antidiabetic drug during therapy with the other drug and upon its discontinuation.
Nifedipine
Nifedipine appears to enhance the absorption of Metformin. Metformin has minimal effects on nifedipine.
ACE-inhibitors may decrease the blood glucose levels. If necessary, adjust the dosage of the antidiabetic drug during therapy
with the other drug and upon its discontinuation.
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