Product Details

Metformin hydrochloride oral solution is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes. An oral medicine that helps control blood sugar levels. Used together with diet and exercise to improve blood sugar control in patients with type 2 diabetes. Not for treatment for type 1 diabetics.

Metformin hydrochloride oral solution contains the biguanidine antihyperglycemic agent metformin in the form of monohydrochloride salt. Metformin hydrochloride, is N,N-dimethylimidodicarbonimidic diamide hydrochloride.

Indications and Usage

Metformin hydrochloride oral solution is recommended for use with a proper diet and exercise program to control high blood sugar in patients with type 2 diabetes. Metformin hydrochloride works by helping to restore the body’s proper response to the insulin it naturally produces and decreasing the amount of sugar that your liver makes and the intestines absorb.

Dosage and Administration

Adult Dosage: Recommended starting dose of metformin hydrochloride oral solution is 500 mg (5 mL) orally twice a day or 850 mg (8.5 mL) once a day, given with meals.

Increase the dose in increments of 500 mg (5 mL) weekly or 850 mg (8.5 mL) every 2 weeks on the basis of glycemic control and tolerability, up to a maximum dose of 2,550 mg (25.5 mL) per day, given in divided doses.

Pediatric Dosage: Recommended starting dose of metformin hydrochloride solution for pediatric patients 10 years and older is 500 mg (5mL) orally twice a day, given with meals.

Increase the dose in increments of 500 mg (5mL) weekly on the basis of glycemic control and tolerability, up to a maximum of 2,000 mg (20mL) per day, given in divided doses twice daily.

Information for the Patient

1. Use the supplied dosing cup to measure the prescribed amount of medication.

2. Risk of lactic acidosis. Discontinue use immediately and promptly notify healthcare provider if unexplained hyperventilation, myalgias, malaise, unusual somnolence or other nonspecific symptoms occur. Excessive alcohol intake cautioned. Perform regular testing of renal function while receiving metformin hydrochloride oral solution.

3. Hypoglycemia may occur when metformin hydrochloride oral solution is coadministered with oral sulfonylureas and insulin.

4. Treatment with metformin hydrochloride oral solution may result in ovulation in some premenopausal anovulatory women which may lead to unintended pregnancy.

5. Measure hematologic parameters on an annual basis.

Warnings

Always consult your physician if you experience any adverse reactions. Inform all caregivers and doctors when you are taking metformin hydrochloride oral solution.

Geriatric patients should assess renal function more frequently and use dose selection cautiously, starting with low end of the dosing range.