IMPORTANT INFORMATION FOR RIOMET®

INDICATIONS AND USAGE

RIOMET is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.

DOSAGE AND ADMINISTRATION

Individualize the dose based on effectiveness and tolerability, while not exceeding the maximum recommended daily dose of 2550 mg (25.5 mL) for adults and 2000 mg (20 mL) for pediatric patients (10 to 16 years of age).
Start RIOMET at a low dose, with gradual dose escalation.
Adult Dosage: The usual starting dose of RIOMET is 500 mg (5 mL) twice a day or 850 mg (8.5mL) once a day, given with meals.
Pediatrics Dosage: The usual starting dose of RIOMET is 500 mg (5 mL) twice a day, given with meals.

IMPORTANT SAFETY INFORMATION FOR RIOMET
Rx only

WARNING: LACTIC ACIDOSIS

 

See full prescribing information for complete boxed warning

 
Lactic acidosis can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure.
Symptoms include malaise, myalgias, respiratory distress, increasing somnolence, and non specific abdominal distress. Laboratory abnormalities include low pH, increased anion gap, and elevated blood lactate.
If acidosis is suspected, discontinue RIOMET and hospitalize the patient immediately.

SUMMARY OF RISK INFORMATION FOR RIOMET

CONTRAINDICATIONS

RIOMET is contraindicated in patients with:

Renal disease or renal dysfunction.
Metabolic acidosis, including diabetic ketoacidosis.
Known hypersensitivity to metformin hydrochloride.

WARNINGS AND PRECAUTIONS

Lactic acidosis: Warn against excessive alcohol intake. RIOMET is not recommended in hepatic impairment and is contraindicated in renal impairment. Ensure normal renal function before initiating and at least annually thereafter.
Temporarily discontinue in patients undergoing radiologic studies with intravascular administration of iodinated contrast materials or any surgical procedures necessitating restricted intake of food and fluids.
Vitamin B12 deficiency: Metformin may lower Vitamin B12 levels. Measure hematologic parameters annually.
Macrovascular outcomes: No conclusive evidence of macrovascular risk reduction with RIOMET or any other antidiabetic drug.

ADVERSE REACTIONS

Most common adverse reactions (incidence > 5% and that were more common in metformin- than placebo-treated patients) are: diarrhea, nausea, vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache.

To report SUSPECTED ADVERSE REACTIONS, contact Ranbaxy Laboratories Inc. at 1-888-RANBAXY (726-2299) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Furosemide: Pharmacokinetic parameters of both compounds were affected by co-administration
Nifedipine: Co-administration of nifedipine increased plasma metformin Cmax and AUC andincreased the amount excreted in the urine
Cationic drugs: May reduce metformin elimination. Use with caution in patients who are taking cationic medications eliminated by renal tubular secretion.

USE IN SPECIFIC POPULATIONS

Pediatric Use: The safety and effectiveness have been established in children aged 10 to 16 years. Studies have not been conducted in children below the age of 10 years.
Geriatric Use: Caution should be used when prescribing RIOMET to elderly patients because reduced renal functions are associated with increasing age.

For more information, please see Section 17 for PATIENT COUNSELING INFORMATION at the end of the full Prescribing Information.

PLEASE SEE FULL PRESCRIBING INFORMATION FOR BOXED WARNING, CONTRAINDICATIONS, AND OTHER IMPORTANT WARNINGS AND PRECAUTIONS.