Riomet 500 mg/5mL
Metformin Hydrochloride · SOLUTION · Sun Pharmaceutical Industries, Inc.
Riomet is a liquid oral medication containing metformin that is used to treat type 2 diabetes by helping control blood sugar levels. It comes as a solution with 500 mg of metformin in each 5 mL dose and requires a prescription.
Key Facts
- Brand Name
- Riomet
- Generic Name
- Metformin Hydrochloride
- NDC Code (Product)
10631-206- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Strength
- 500 mg/5mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- NDA021591
- Marketing Start
- 01/04/2004
Recall History
SUN PHARMACEUTICAL INDUSTRIES INC
CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
Sun Pharmaceutical Industries, Inc.
Microbial Contamination of Non-Sterile Products
SUN PHARMACEUTICAL INDUSTRIES INC
Microbial Contamination of Non-Sterile Product
Sun Pharmaceutical Industries, Inc.
Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE RIOMET 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 is a biguanide 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. (1)
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Adult Dosage for RIOMET : • Starting dose: 500 mg (5 mL) orally twice a day or 850 mg (8.5 mL) once a day, with meals (2.1) • Increase the dose in increments of 500 mg (5 mL) weekly or 850 mg (8.5 mL) every 2 weeks, up to a maximum dose of 2,550 mg (25.5 mL) per day, given in divided doses (2.1) • Doses above 2,000 mg (20 mL) may be better tolerated given in divided doses 3 times a day with meals (2.1) Pediatric Dosage for RIOMET : • Starting dose: 500 mg (5 mL) orally twice a day, with meals (2.2) • Increase dosage in increments of 500 mg (5 mL) weekly up to a maximum of 2,000 mg (20 mL) per day, given in divided doses twice daily (2.2) Renal Impairment : • Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR) (2.3) • Do not use in patients with eGFR below 30 mL/minute/1.73 m 2 (2.3) • Initiation is not recommended in patients with eGFR between 30 to 45 mL/minute/1.73 m 2 (2.3) • Assess risk/benefit of continuing RIOMET if eGFR falls below 45 mL/minute/1.73 m 2 (2.3) • Discontinue if eGFR falls below 30 mL/minute/1.73 m 2 (2.3) Discontinuation for Iodinated Contrast Imaging Procedures: • RIOMET may need to be discon…
Contraindications
4 CONTRAINDICATIONS 1. RIOMET is contraindicated in patients with: 2. Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) [see Warnings and Precautions (5.1) ]. 3. Hypersensitivity to metformin. 4. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. • Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) (4, 5.1) • Hypersensitivity to metformin (4) • Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. (4)
Drug Interactions
7 DRUG INTERACTIONS 1. Table 2 presents clinically significant drug interactions with RIOMET. 2. Table 2: Clinically Significant Drug Interactions with RIOMET 1. Carbonic Anhydrase Inhibitors 1. Clinical Impact: 1. Carbonic anhydrase inhibitors frequently cause a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with RIOMET may increase the risk for lactic acidosis. 1. Intervention: 1. Consider more frequent monitoring of these patients. 1. Examples: 1. Topiramate, zonisamide, acetazolamide or dichlorphenamide. 1. Drugs that Reduce RIOMET Clearance 1. Clinical Impact: 1. Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT 2 ] / multidrug and toxin extrusion [MATE] inhibitors) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [see Clinical Pharmacology (12.3)]. 1. Intervention: 1. Consider the benefits and risks of concomitant use with RIOMET. 1. Examples: 1. Ranolazine, vandetanib, dolutegravir, and cimetidine. 1. Alcohol 1. Clinical Impact: 1. Alcoh…
Adverse Reactions
6 ADVERSE REACTIONS • The following adverse reactions are also discussed elsewhere in the labeling: • Lactic Acidosis [see Boxed Warning and Warnings and Precautions (5.1)] • Vitamin B 12 Deficiency [see Warnings and Precautions (5.2)] • Hypoglycemia [see Warnings and Precautions (5.3)] The most common adverse reactions are diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch 6.1 Clinical Studies Experience 1. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. 2. In a U.S. clinical trial of metformin HCl tablets in patients with type 2 diabetes mellitus, a total of 141 patients received metformin HCl tablets up to 2,550 mg per day. Adverse reactions reported in greater than 5% of patients treated with metformin HCl tablets and that were more common than in placebo-trea…
Frequently Asked Questions
What is Riomet used for?
Riomet is a liquid oral medication containing metformin that is used to treat type 2 diabetes by helping control blood sugar levels. It comes as a solution with 500 mg of metformin in each 5 mL dose and requires a prescription.
Is Riomet a controlled substance?
Riomet is not classified as a controlled substance by the DEA.
What is the generic name for Riomet?
The generic name for Riomet is Metformin Hydrochloride. There are 11 other brand versions of Metformin Hydrochloride.
What is the NDC code for Riomet 500 mg/5mL?
The NDC (National Drug Code) for Riomet 500 mg/5mL is 10631-206, listed by Sun Pharmaceutical Industries, Inc..
Other Metformin Brands
See all →- Metformin hydrochloride ER750 mg/172789-106
- Metformin Hydrochloride850 mg/10615-8577
- Metformin Hydrochloride1000 mg/183301-0010
- Metformin Hydrochloride500 mg/111788-037
- Metformin Hydrochloride850 mg/125000-131
- Metformin hydrochloride1000 mg/133342-143
- Metformin hydrochloride500 mg/133342-239
- Metformin Hydrochloride500 mg/143063-527
- Metformin Hydrochloride750 mg/150090-5246
- Metformin Hydrochloride500 mg/150090-6858
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)