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Riomet Clinical Data

 

Important Safety Information about RIOMET®

RIOMET as monotherapy, is indicated, as an adjunct to diet and exercise, to improve glycemic control in patients 10 years of age and older with type 2 diabetes. RIOMET may be used concomitantly with a sulfonylurea or insulin to improve glycemic control in adults (17 years of age and older).

RIOMET is contraindicated in patients with renal disease or dysfunction, acute or chronic metabolic acidosis, including diabetic ketoacidosis or known hypersensitivity to Metformin hydrochloride.

RIOMET should be avoided in patients >= 80 years old (unless measured creatinine clearance is normal), with impaired hepatic function, excessive alcohol intake (chronic or acute), or in the presence of any condition associated with hypoxemia, dehydration, or sepsis.

Temporarily discontinue in patients receiving intravascular iodinated contrast materials for radiologic studies. Diarrhea, nausea, vomiting, abdominal bloating, anorexia, or flatulence may occur, especially during initiation of therapy.

Not recommended for pediatric patients (under 10 years of age) or pregnant women.

Hypoglycemia does not occur in patients receiving RIOMET alone under usual circumstances of use. Hypoglycemia could occur when caloric intake is deficient, when strenuous exercise is not compensated by caloric supplementation, or during concomitant use with other glucose-lowering agents (such as sulfonylureas and insulin) or ethanol.

Please see full Prescribing Information, including boxed WARNING regarding lactic acidosis

Please consult with your healthcare professional to see if RIOMET is right for you. The content of this Web site is not a substitute for professional medical advice and should not be interpreted as treatment recommendations or relied on for medical diagnosis or treatment.

References:
1. Data on file. A Prospective, Open Label, Parallel Group Study Comparing the Tolerability Profile of Tabular Metformin and Liquid Riomet®  in Patients with Type 2 Diabetes Mellitus. Ranbaxy Laboratories, Inc. Clinical Study Report. October 11, 2005