Description
Metform® is a preparation of Metformin Hydrochloride. It is a biguanide type oral
antihyperglycemic agent used in the management of type 2 diabetes mellitus. It lowers both
basal and postprandial plasma glucose. Its mechanism of action is different from those of
sulfonylureas and it does not produce hypoglycemia. Metformin acts by decreasing intestinal
absorption of glucose, reducing hepatic glucose production, and improves insulin sensitivity
thus enhancing peripheral glucose uptake and utilization of glucose.
Indications
Metform as monotherapy is indicated as an adjunct to diet to lower blood glucose in patients
with non-insulin-dependent diabetes mellitus (NIDDM) whose hyperglycemia cannot be
satisfactorily managed on diet alone. Metform is also indicated for use concomitantly with a
sulfonylurea when diet and Metformin Hydrochloride or sulfonylureas alone do not result in
adequate glycemic control.
Dosage and administration:
Adults:
Metform 500 mg & 850mg: The usual starting dose of Metformin is 500 mg twice a day or
850 mg once a day, given with meals. Dosage increases should be made in increments of 500
mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses.
Patients can also be titrated from 500 mg twice a day to 850 mg twice a day after 2 weeks. For
those patients requiring additional glycemic control, Metform® may be given to a maximum
daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three
times a day with meals.
Metform® ER : The usual starting dose of Metform® ER (Metformin Hydrochloride extendedrelease
tablets) is 500 mg once daily with the evening meal. Dosage increases should be made
in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening
meal. If glycemic control is not achieved on Metform® ER 2000 mg once daily, a trial of
Metform® ER 1000 mg twice daily should be considered. If higher doses of Metformin are
required, Metform® should be used at total daily doses up to 2550 mg administered in divided
daily doses, as described above.
Concomitant Metform® or Metform® ER and oral sulfonylurea therapy in adult patients:
If patients have not responded to four weeks of the maximum dose of Metform & Metform
ER monotherapy, consideration should be given to gradual addition of an oral sulfonylurea.
Concomitant Metform® or Metform® ER and Insulin Therapy in Adult Patients:
The current insulin dose should be continued upon initiation of Metform® or Metform® ER
therapy. Metform® or Metform® ER therapy should be initiated at 500 mg once daily in patients
on insulin therapy. For patients not responding adequately, the dose of Metform® or Metform®
ER should be increased by 500 mg after approximately 1 week and by 500 mg every week
thereafter until adequate glycemic control is achieved. The maximum recommended daily dose
is 2500 mg for Metform® and 2000 mg for Metform® ER.
Children
The usual starting dose of Metform® is 500 mg twice a day, given with meals. Dosage increases
should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given
in divided doses.
Safety and effectiveness of Metform® ER in pediatric patients below 10 years has not been
established.
Geriatric Use:
Metform® should only be used in patients with normal renal function. Care should be taken in
dose selection and should be based on careful and regular monitoring of renal function.
Use in pregnancy & lactation
Safety of Metform® in pregnant woman has not been established. Metform® should be used
during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not
known whether Metform® is secreted in human milk. Because many drugs are excreted in
human milk, it should not be administered to a breast-feeding woman.
Side-effects
The most common side effect of Metformin is diarrhoea, nausea, vomiting, abdominal bloating,
flatulence, and anorexia. Lactic acidosis also rarely occurs. Long- term use of Metformin has
been associated with malabsorption of vitamin B12
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