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Metformin (Generic Glucophage)

Manufacturer : Bristol-Myers Squibb (Merck)
Drug Class : Oral Antidiabetic Agents

Generic name: Metformin hydrochloride

Indications And Use :

GLUCOPHAGE (metformin hydrochloride tablets), as monotherapy, is indicated as an adjunct to diet to lower blood glucose in patients with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed on diet alone.

GLUCOPHAGE may be used concomitantly with a sulfonylurea or insulin to improve glycemic control.

In initiating treatment for type 2 diabetes, diet should be emphasized as the primary form of treatment.

Caloric restriction and weight loss are essential in the obese diabetic patient. Proper dietary management alone may be effective in controlling the blood glucose and symptoms of hyperglycemia. Loss of blood glucose control in diet-managed patients may be transient, thus requiring only short-term pharmacologic therapy. The importance of regular physical activity should also be stressed, and cardiovascular risk factors should be identified and corrective measures taken where possible. If this treatment program fails to reduce symptoms and/or blood glucose, the use of GLUCOPHAGE alone or GLUCOPHAGE plus a sulfonylurea should be considered.

If, after a suitable trial of such treatments, glucose control still has not been achieved, consideration should be given to the use of insulin. Judgments should be based on regular clinical and laboratory evaluations

Actions :

The biguanide metformin (dimethylbiguanide) is an oral antihyperglycaemic agent used in the management of non-insulin-dependent diabetes mellitus (NIDDM). It reduces blood glucose levels, predominantly by improving hepatic and peripheral tissue sensitivity to insulin without affecting the secretion of this hormone. Metformin also appears to have potentially beneficial effects on serum lipid levels and fibrinolytic activity, although the long-term clinical implications of these effects are unclear.
Metformin appears to act principally by improving the sensitivity of peripheral tissue (chiefly skeletal muscle) and the liver to insulin, thus opposing the insulin resistance of non-insulin-dependent diabetes mellitus (NIDDM). Metformin does not increase pancreatic insulin secretion and does not induce hypoglycaemia.
Improved glucose disposal has been observed in both patients with NIDDM and normoglycaemic hyperinsulinaemic individuals, under fasting and hyperinsulinaemic euglycaemic clamp conditions. Studies of up to 12 weeks duration typically demonstrated increases in insulin-stimulated glucose disposal of 18-29% after metformin 0.5-3 g/day. In vitro data also suggest a metformin-associated improvement in glucose uptake and storage by erythrocytes from patients with NIDDM.
Results of studies of the effect of metformin on plasma levels of insulin and related products are consistent with the view that metformin improves peripheral and hepatic sensitivity to insulin. Furthermore, treatment with metformin 1000-2550 mg/day for up to 3 months resulted in reductions in hepatic glucose production of 9-30% relative to baseline or placebo. Evidence is conflicting with regard to the effect of metformin on insulin binding to cell membranes, but the drug appears to increase the rate of insulin-stimulated glucose transport across cell membranes.
Metformin has beneficial effects on serum lipid profiles in obese and lean patients with NIDDM, and in other patients with concomitant NIDDM, hypertension and/or hyperlipidaemia. In particular, reduced circulating levels of free fatty acids, triglycerides and low-density lipoprotein cholesterol levels have been reported. Potentially beneficial vascular properties, eg increased fibrinolytic activity and decreased platelet density and aggregability, have also been observed in nondiabetic volunteers and patients with NIDDM after treatment with metformin ?3 g/day for up to 6 months.
Possible long-term clinical benefits of metformin with regard to cardiovascular mortality and morbidity are not yet established but are being assessed in a major ongoing study. Since metformin does not promote weight gain or hypoglycaemia, it should be considered as first-line pharmacotherapy in obese patients with NIDDM inadequately controlled by nonpharmacological measures. Metformin appears similarly effective for the pharmacological management of NIDDM in non-obese patients.

Indications :

Non-insulin-dependent diabetes mellitus (type II diabetes mellitus) in particular, in overweight subjects and when diet has failed. Metformin can be given alone as initial therapy or can be administered in combination with other oral antidiabetics.
Insulin-treated diabetes in addition to insulin therapy in type I diabetes mellitus (IDD) and type II diabetes mellitus, particularly in cases combining severe overweight with secondary resistance to the action of insulin.

Dosage :

Therapy with metformin should be initiated with a dosage of 0.5-1 g/day, in divided doses with or after meals. This may be gradually increased as necessary to a maximum of five 500-mg or three 850-mg tabs daily in the USA, although dosages of up to 3 g/day are used in other countries. The drug may be co-administered with a sulfonylurea if desired.

ADULTS :

The usual starting dose is one 500-milligram tablet twice a day, taken with morning and evening meals. Your doctor may increase your daily dose by 500 milligrams at weekly intervals, based on your response up to a total of 2,000 milligrams.

An alternative starting dose is one 850-milligram tablet a day, taken with the morning meal. Your doctor may increase this by 850 milligrams at 14-day intervals, to a maximum of 2,550 milligrams a day.

The usual maintenance dose ranges from 1,500 to 2,550 milligrams daily. If you take more than 2,000 milligrams a day, your doctor may recommend that the medication be divided into three doses, taken with each meal.

CHILDREN :

For children 10 to 16 years old, the usual starting dose is one 500-milligram tablet twice a day with meals. The dosage may be increased by 500 milligrams at weekly intervals up to a maximum of 2,000 milligrams daily. Glucophage has not been tested in children younger than 10.

OLDER ADULTS :

Older people and those who are malnourished or in a weakened state are generally given lower doses of Glucophage because their kidneys may be weaker, making side effects more likely.

Overdosage :

Hypoglycemia has not been seen with ingestion up to 85 g of metformin. Metformin is dialyzable with a clearance of up to 70 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdosage is suspected.

Contraindications : Patients with renal or hepatic impairment, cardiovascular disease or hypoxic conditions which cause lactate accumulation, acute or chronic metabolic acidosis, pregnancy, lactation and excessive alcohol intake. Metformin should be temporarily withheld in patients undergoing radiologic studies involving parenteral administration of iodinated contrast materials.

Warnings :

Lactic acidosis is a biguanide-related adverse effect of most concern. Although serious, it is rare, and may be minimized during metformin therapy by strict adherence to prescribing guidelines and contraindications (particularly the presence of renal or hepatic failure and medical conditions with increased tissue production of lactate). Hypoglycaemia does not occur with metformin and the incidence of metformin-associated lactic acidosis is lower than that of sulfonylurea-induced hypoglycaemia.
The reported incidence of lactic acidosis in patients receiving metformin is very low (approximately 0.03 cases/1000 patient-years).

Adverse Reactions :

Acute, reversible adverse effects, mainly of gastrointestinal origin, occur in 5-20% of patients treated with metformin. These may be minimized by taking the drug with or after food, and starting therapy with low dosages which may be increased slowly. Diarrhea may occur in up to 20% of patients and may respond to a reduction in dosage. It is estimated that <5% of patients are unable to tolerate metformin.

Drug Interactions :

The glucosidase inhibitor (acarbose) significantly reduced the acute bioavailability of metformin 1 g for the first 9 hrs after oral co-administration in 6 healthy volunteers. Acarbose 100 mg reduced the mean peak plasma metformin concentration by 35%, but the time taken to reach peak plasma metformin concentration was not significantly altered. Co-administration of guar gum; 10 g of metformin with a standard meal to 6 healthy volunteers also resulted in a significant reduction in the rate of absorption of metformin and a 40% reduction in blood metformin concentrations up to 6 hrs after administration, compared with metformin alone.
A competitive inhibition of renal tubular secretion of metformin has been reported after co-administration with the histamine H2-receptor antagonist (cimetidine).
Co-administration was associated with an increase in the area under the plasma metformin concentration-time curve (by 50%) and a decrease in 24-hr renal excretion of metformin (by 27%). An increase in the required dosage of the oral anticoagulant phenprocoumon associated with increased elimination of this drug was observed after concomitant administration of metformin at an oral dosage of 1-3 g/day. The basis of the interaction remains uncertain, but may reflect increased liver blood flow and hepatic extraction rather than an effect on microsomal enzyme activity.

How Supplied :

Glucophage: Tab 500 mg (film-coated) x 100’s.
Glucophage 850: Tab 850 mg (film-coated) x 100’s.

What are GLUCOPHAGE and GLUCOPHAGE XR?

GLUCOPHAGE and GLUCOPHAGE XR are used to treat type 2 diabetes. This is also known
as non-insulin-dependent diabetes mellitus. People with type 2 diabetes are not able
to make enough insulin or respond normally to the insulin their bodies make. When
this happens, sugar (glucose) builds up in the blood. This can lead to serious
medical problems including kidney damage, amputations, and blindness. Diabetes is
also closely linked to heart disease. The main goal of treating diabetes is to lower
your blood sugar to a normal level.

High blood sugar can be lowered by diet and exercise, by a number of medicines taken
by mouth, and by insulin shots. Before you take GLUCOPHAGE or GLUCOPHAGE XR, try to
control your diabetes by exercise and weight loss. While you take your diabetes
medicine, continue to exercise and follow the diet advised for your diabetes. No
matter what your recommended diabetes management plan is, studies have shown that
maintaining good blood sugar control can prevent or delay complications of diabetes,
such as blindness.

GLUCOPHAGE and GLUCOPHAGE XR have the same active ingredient. However,

GLUCOPHAGE XR works longer in your body. Both of these medicines help control your
blood sugar in a number of ways. These include helping your body respond better to
the insulin it makes naturally, decreasing the amount of sugar your liver makes, and
decreasing the amount of sugar your intestines absorb. GLUCOPHAGE and GLUCOPHAGE XR
do not cause your body to make more insulin. Because of this, when taken alone, they
rarely cause hypoglycemia (low blood sugar), and usually do not cause weight gain.
However, when they are taken with a sulfonylurea or with insulin, hypoglycemia is
more likely to occur, as is weight gain.

Diabetes is widely recognized as one of the leading causes of death and disability in the United States. In 1999, about 450,000 deaths occurred among adults with diabetes.

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Metformin hydrochloride, sold by Bristol-Myers Squibb under the brand name Glucophage is the most prescribed drug for lowering blood sugar levels in people with type-2 diabetes.

Other names of Metformin:

• Adecco
• Adimet
• Aglumet
• Aglurab
• Amaryl m
• Anglucid
• Bagomet
• Baligluc
• Ben-q-met
• Benofomin
• Bi-euglucon m
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• Biguanil
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• Diabiformin
• Diafac
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• Humamet
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This page is not endorsed or affiliated with the company
Bristol-Myers Squibb (Merck),
All trademarks and registered trademarks are of their respective companies.
Glucophage is a registered trademark of Bristol-Myers Squibb (Merck)