[Sun Pharma Press Release, February 26, 2020] – Sun Pharmaceutical Industries Ltd today announced the release of Riomet ER™ in the U.S., a novel liquid formulation of metformin hydrochloride extended-release. It 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 mellitus.
Riomet ER™ was approved by the U.S. Food and Drug Administration (FDA) on August 29, 2019. It is the first and only liquid formulation of metformin hydrochloride extended-release proven to be bioequivalent to metformin extended-release tablets.
The extended-release liquid formulation allows for once-daily dosing without the need to crush, break, or chew a tablet – an important consideration given that metformin pills should not be crushed, chewed, or cut. The availability of a liquid formulation addresses the needs of patients with type 2 diabetes mellitus, including residents in long-term care facilities, who often have issues swallowing solid medications.
The starting dose is 500 mg (5 mL) orally once daily with the evening meal; the dose can be increased in increments of 500 mg (5 mL) weekly, up to a maximum dose of 2000 mg (20 mL) once daily with the evening meal.
The label for Riomet ER™ carries a boxed warning about the risk of lactic acidosis with excessive alcohol intake, as alcohol increases the effect of Riomet ER™ on lactate metabolism. The label also includes a warning about the risk of vitamin B12 deficiency, as well as a warning about the risk of hypoglycemia with concomitant use with insulin and insulin secretagogues. In placebo-controlled clinical trials of Riomet ER™, the most common adverse reactions (occurring in greater than 5% of participants) were diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache
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