Riomet Oral Suspension Dosage

Adult Dosage

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Measure the RIOMET ER dose of suspension in RIOMET ER specific dosing cup supplied.

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The reconstituted suspension is 500 mg/5 mL [see Dosage and Administration (2.5)].

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The recommended starting dose of RIOMET ER is 500 mg (5 mL) orally once daily with the evening meal.

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Increase the dose in increments of 500 mg (5 mL) weekly on the basis of glycemic control and tolerability, up to a maximum dose of 2,000 mg (20 mL) once daily with the evening meal.

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If glycemic control is not achieved with RIOMET ER 2,000 mg (20 mL) once daily, consider a trial of RIOMET ER 1,000 mg (10 mL) twice daily. If higher doses are required, switch to metformin hydrochloride (HCl) immediate-release at total daily doses up to 2,550 mg (25.5 mL) administered in divided daily doses, as described above.

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Patients receiving metformin HCl immediate-release treatment may be switched to RIOMET ER once daily at the same total daily dose, up to 2,000 mg (20 mL) once daily.

Pediatric Dosage

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Measure the RIOMET ER dose of suspension in the RIOMET ER specific dosing cup supplied.

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The reconstituted suspension is 500 mg/5 mL [see Dosage and Administration (2.5)].

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The recommended starting dose of RIOMET ER for pediatric patients 10 years of age and older is 500 mg (5 mL) orally once daily, with the evening meal.

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Increase dosage in increments of 500 mg (5 mL) weekly on the basis of glycemic control and tolerability, up to a maximum of 2,000 mg (20 mL) once daily with the evening meal.

Recommendations for Use in Renal Impairment

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Assess renal function prior to initiation of RIOMET ER and periodically thereafter.

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RIOMET ER is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m2.

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Initiation of RIOMET ER in patients with an eGFR between 30 to 45 mL/minute/1.73 m2 is not recommended.

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In patients taking RIOMET ER whose eGFR later falls below 45 mL/min/1.73 m2, assess the benefit risk of continuing therapy.

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Discontinue RIOMET ER if the patient’s eGFR later falls below 30 mL/minute/1.73 m2 [see Warnings and Precautions (5.1)].

Discontinuation for Iodinated Contrast Imaging Procedures

Discontinue RIOMET ER at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m2; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart RIOMET ER if renal function is stable.

Reconstitution Instructions for the Pharmacist

RIOMET ER is supplied as a powder for oral suspension which must be reconstituted with the accompanying diluent prior to dispensing. Both the powder and diluent contain metformin HCl.

Please read these instructions completely before you begin.

Round Bottle Pack

Step-A Remove the bottle containing Drug Pellets and Drug Diluent bottle along with RIOMET ER dosing cup from the box. Do not use if: The expiration date has passed. The bottle appears damaged or defective.

Step-B Remove the child-resistant cap (push down and turn) from the bottle containing Drug Pellets and Drug Diluent Bottle, and retain.

Step-C Pour the contents of bottle containing Drug Pellets in to the Drug Diluent bottle and discard the empty Pellet bottle (See Figure 1).

Figure 1

Step-D Close the Drug Diluent bottle with child-resistant cap.

Step-E Shake the Drug Diluent bottle continuously in an up and down direction for at least 2 full minutes. This is important for the product to mix evenly. The reconstituted suspension is 500 mg/5 mL.

Figure 2

Store reconstituted suspension in the original bottle between 20°C to 25°C (68°F to 77°F). Do not repackage.