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Riomet is a brand name for Metformin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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…
Verbatim from this product's FDA label. Tap a section to expand.
1 Adult Dosage • Measure the RIOMET dose in the RIOMET specific dosing cup. 5 mL) once a day, given with meals. 5 mL) per day, given in divided doses. • Doses above 2,000 mg (20 mL) may be better tolerated given in divided doses 3 times a day with meals.
2 Pediatric Dosage • Measure the RIOMET dose in the RIOMET specific dosing cup. • The recommended starting dose of RIOMET for pediatric patients 10 years of age and older is 500 mg (5 mL) orally twice a day, given with meals. • 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) per day, given in divided doses twice daily.
3 Recommendations for Use in Renal Impairment • Assess renal function prior to initiation of RIOMET and periodically thereafter. 73 m 2 . 73 m 2 is not recommended. 73 m 2 , assess the benefit risk of continuing therapy. 1) ]. 73 m 2 ; 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 if renal function is stable.
3)] The most common adverse reactions are diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache. 1) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. 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. 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-treated patients, are listed in Table 1.
3.
Table 1:
Adverse Reactions from a Clinical Trial of Metformin HCl Tablets Occurring >5% and More Common than Placebo in Patients with Type 2 Diabetes Mellitus 1. Metformin HCl Tablets (n = 141) 1. Placebo (n = 145) 1. Diarrhea 1. 53% 1. 12% 1. Nausea/Vomiting 1.
26% 1. 8% 1. Flatulence 1. 12% 1. 6% 1. Asthenia 1. 9% 1. 6% 1. Indigestion 1. 7% 1. 4% 1. Abdominal Discomfort 1. 6% 1. 5% 1. Headache 1. 6% 1. 5% 1. Diarrhea led to discontinuation of metformin HCl tablets in 6% of patients. Additionally, the following adverse reactions were reported in ≥ 1% to ≤ 5% of patients treated with metformin HCl tablets and were more commonly reported than placebo: abnormal stools, hypoglycemia, myalgia, lightheaded, dyspnea, nail disorder, rash, sweating increased, taste disorder, chest discomfort, chills, flu syndrome, flushing, palpitation.
2. Pediatric Patients 3. In clinical trials with metformin HCl tablets in pediatric patients with type 2 diabetes mellitus, the profile of adverse reactions was similar to that observed in adults. 4. Laboratory Tests 5. Vitamin B 12 Concentrations 6.
5 WARNINGS AND PRECAUTIONS • Lactic acidosis: See boxed warning. 1) • Vitamin B 12 deficiency: Metformin may lower vitamin B 12 levels. Measure hematological parameters annually and vitamin B 12 at 2 to 3 year intervals and manage any abnormalities.
2) • Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues: Increased risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue. 1 Lactic Acidosis • There have been postmarketing cases of metformin-associated lactic acidosis, including fatal cases.
These cases had a subtle onset and were accompanied by nonspecific symptoms such as malaise, myalgias, abdominal pain, respiratory distress, or increased somnolence; however, hypotension and resistant bradyarrhythmias have occurred with severe acidosis.
Metformin‑associated lactic acidosis was characterized by elevated blood lactate concentrations (> 5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), and an increased lactate: pyruvate ratio; metformin plasma levels were generally > 5 mcg/mL.
Metformin decreases liver uptake of lactate increasing lactate blood levels which may increase the risk of lactic acidosis, especially in patients at risk. • If metformin-associated lactic acidosis is suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of RIOMET.
In RIOMET treated patients with a diagnosis or strong suspicion of lactic acidosis, prompt hemodialysis is recommended to correct the acidosis and remove accumulated metformin (metformin hydrochloride is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions).
Hemodialysis has often resulted in reversal of symptoms and recovery. • Educate patients and their families about the symptoms of lactic acidosis and, if these symptoms occur, instruct them to discontinue RIOMET and report these symptoms to their healthcare provider.
4 CONTRAINDICATIONS 1. RIOMET is contraindicated in patients with: 2. 1) ]. 3. Hypersensitivity to metformin. 4. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. 1) • Hypersensitivity to metformin (4) • Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
(4)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In clinical trials of 29-week duration with metformin HCl tablets, a decrease to subnormal levels of previously normal serum vitamin B 12 levels was observed in approximately 7% of patients. 2 Postmarketing Experience • The following adverse reactions have been identified during post approval use of metformin.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. • Cholestatic, hepatocellular, and mixed hepatocellular liver injury have been reported with postmarketing use of metformin.
• For each of the known and possible risk factors for metformin-associated lactic acidosis, recommendations to reduce the risk of and manage metformin-associated lactic acidosis are provided below: • Before initiating RIOMET, obtain an estimated glomerular filtration rate (eGFR).
73 m 2 [see Contraindications (4) ]. 73 m 2 . • Obtain an eGFR at least annually in all patients taking RIOMET. , the elderly), renal function should be assessed more frequently. 73 m 2 , assess the benefit and risk of continuing therapy.
• Renal impairment —The postmarketing metformin-associated lactic acidosis cases primarily occurred in patients with significant renal impairment. • The risk of metformin accumulation and metformin-associated lactic acidosis increases with the severity of renal impairment because metformin is substantially excreted by the kidney.
3) ]: • Before initiating RIOMET, obtain an estimated glomerular filtration rate (eGFR). 73 m 2 [see Contraindications (4) ]. 73 m 2 . • Obtain an eGFR at least annually in all patients taking RIOMET. , the elderly), renal function should be assessed more frequently.
73 m 2 , assess the benefit and risk of continuing therapy. • Drug interactions — The concomitant use of RIOMET with specific drugs may increase the risk of metformin-associated lactic acidosis: those that impair renal function, result in significant hemodynamic change, interfere with acid-base balance, or increase metformin accumulation.
Consider more frequent monitoring of patients [see Drug Interactions (7)] . • Age 65 or greater — The risk of metformin-associated lactic acidosis increases with the patient’s age because elderly patients have a greater likelihood of having hepatic, renal, or cardiac impairment than younger patients.
Assess renal function more frequently in elderly patients. • Radiologic studies with contrast — Administration of intravascular iodinated contrast agents in metformin-treated patients has led to an acute decrease in renal function and the occurrence of lactic acidosis.
73 m 2 ; in patients with a history of hepatic impairment, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure, and restart RIOMET if renal function is stable.
• Surgery and other procedures — Withholding of food and fluids during surgical or other procedures may increase the risk for volume depletion, hypotension, and renal impairment. RIOMET should be temporarily discontinued while patients have restricted food and fluid intake.
• Hypoxic states — Several of the postmarketing cases of metformin-associated lactic acidosis occurred in the setting of acute congestive heart failure (particularly when accompanied by hypoperfusion and hypoxemia). Cardiovascular collapse (shock), acute myocardial infarction, sepsis, and other conditions associated with hypoxemia have been associated with lactic acidosis and may cause prerenal azotemia.
When such an event occurs, discontinue RIOMET. • Excessive alcohol intake — Alcohol potentiates the effect of metformin on lactate metabolism. Patients should be warned against excessive alcohol intake while receiving RIOMET. • Hepatic impairment — Patients with hepatic impairment have developed cases of metformin-associated lactic acidosis.
This may be due to impaired lactate clearance resulting in higher lactate blood levels. Therefore, avoid use of RIOMET in patients with clinical or laboratory evidence of hepatic disease. 2 Vitamin B 12 Deficiency 1. In clinical trials of 29-week duration with metformin hydrochloride (HCl) tablets, a decrease to subnormal levels of previously normal serum vitamin B 12 levels was observed in approximately 7% of patients.
Such decrease, possibly due to interference with B 12 absorption from the B 12 -intrinsic factor complex, may be associated with anemia but appears to be rapidly reversible with discontinuation of metformin or vitamin B 12 supplementation.
Certain individuals (those with inadequate vitamin B 12 or calcium intake or absorption) appear to be predisposed to developing subnormal vitamin B 12 levels. 1) ]. , sulfonylurea) are known to cause hypoglycemia. RIOMET may increase the risk of hypoglycemia when combined with insulin and/or an insulin secretagogue.
Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with RIOMET [see Drug Interactions (7)]. 4 Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with RIOMET.