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Bullet Important Information
Bullet Special Populations
Bullet Indications, Dosage and Use
Bullet Contraindications
Bullet Lactic Acidosis Warning

Special Populations

Patients with Type 2 Diabetes
In the presence of normal kidney function, there are no differences between single- or multiple-dose (pharmacokinetics) bodily reactions to metformin between patients with type 2 diabetes and normal subjects nor is there any accumulation of metformin in either group at usual clinical doses.

Decreased Kidney Function
In patients with decreased kidney function, the time it takes for half of the levels of metformin to leave your body is prolonged and the excretion by the kidney is decreased in proportion to the decrease in creatinine clearance

Decreased Liver Function
No pharmacokinetic studies of metformin have been conducted in patients with decreased liver function

Geriatrics
Limited data from controlled pharmacokinetic studies of metformin in healthy elderly subjects suggest that total plasma clearance of metformin is decreased, the half-life is prolonged, and peak level in the blood is increased, compared to healthy young subjects.

From these data, it appears that the change in metformin pharmacokinetics with aging is primarily accounted for by a change in kidney function.

RIOMET (metformin hydrochloride oral solution) treatment should not be started in patient >= 80 years of age unless measurement of creatinine clearance demonstrates that kidney function is not reduced.

Pediatrics
The safety and effectiveness of metformin for the treatment of type-2 diabetes have been established in pediatric patient ages 10-16 years (studies have not been conducted in pediatric patients below the age of 10 years).

Gender
Metformin pharmacokinetic parameters did not differ significantly between normal subjects and patients with type 2 diabetes when analyzed according to gender.

Race
No studies of metformin pharmacokinetic parameters according to race have been performed. In controlled clinical studies of metformin in patients with type 2 diabetes, the elevated blood sugar lowering effect was comparable in whites (n= 249), blacks (n= 51), and Hispanics (n= 24).

 

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.