Precautions and warnings

Rosiglitazone should not be given to people with type 1 diabetes. Use this medicine carefully in patients who have swelling (edema). People taking rosiglitazone—either alone or with other diabetes medicines—may gain weight, especially at higher doses.

Metformin should not be used in patients whose blood tests show high levels of creatinine (a sign of kidney problems). Older patients need to start with a low dose and adjust carefully, since aging usually means weaker kidneys. The doctor will try to find the lowest dose that controls blood sugar.

Drug Interactions

Taking sulfonylureas along with this medication can increase their combined effects. Some other drugs—such as thiazide diuretics, corticosteroids, phenothiazines, birth control pills, sympathomimetics, niacin, calcium channel blockers, and isoniazid—can make it harder to control your blood sugar levels. ACE inhibitors may help lower fasting blood sugar. Cimetidine can increase the level of this medication in your blood.

Warning: Using iodinated contrast agents at the same time can increase the risk of a serious side effect called lactic acidosis from metformin.

Contraindications

This medicine should not be used in people with kidney disease or problems with kidney function (such as high creatinine levels in the blood—above 1.5 mg/dL for men and 1.4 mg/dL for women—or if they have abnormal creatinine clearance). It is also not for people with acute or long-term metabolic acidosis, including diabetic ketoacidosis (with or without coma), or anyone known to be allergic to rosiglitazone maleate or metformin HCl.

Mode of actions

**Rosiglitazone:**
Rosiglitazone lowers blood sugar by helping the body’s cells respond better to insulin. It doesn’t make the pancreas produce more insulin. Instead, it works by turning on a special receptor in the cell’s nucleus (called PPAR-gamma), which affects how the body processes sugar and fats.

**Metformin:**
Metformin is a type of medicine called a biguanide. It lowers blood sugar by reducing how much sugar the liver makes, decreasing how much sugar is absorbed from food in the gut, and helping the body use insulin more effectively. This improves blood sugar control, both between and after meals.

Dosage & Administration

The dosage should be individualized on the basis of effectiveness and tolerability while not exceeding the maximum recommended daily dose of 8mg/2000 mg (Rosiglitazone/Metformin).

In Drug-Naive Patients: The recommended starting dose of is 2 mg/500 mg once or twice daily.

For patients with HbA1c >11% or FPG>270 mg/dL, a starting dose of 2 mg/500 mg twice daily may be considered. The dose may be increased by increment of 2 mg/500 mg per day to a maximum of 8 mg/2,000 mg per day in divided doses if patients are not adequately controlled after 4 weeks.

For patients inadequately controlled on Metformin monotherapy, the usual starting dose is 4 mg Rosiglitazone (daily dose) plus the dose of Metformin already being taken.

For patients inadequately controlled on Rosiglitazone monotherapy, the usual starting dose is 1000 mg Metformin (daily dose) plus the dose of Rosiglitazone already being taken.

When switching from combination therapy of Rosiglitazone plus Metformin as separate tablets, the usual starting dose is the dose of Rosiglitazone and Metformin already being taken. If additional glycemic control is needed, the daily dose may be increased by increment of 4 mg Rosiglitazone and/or 500 mg Metformin, up to the maximum recommended total daily dose of 8 mg/2000 mg.

Pregnancy & Lactation

Although animal reproduction studies have shown an adverse effect even sometimes unable to demonstrate the risk on the fetus and there are no adequate and well-controlled studies in pregnant women, but during pregnancy, this medicine can be used just when definitely required.

Discuss with your doctors and tell them feedback about this medicine.

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