Senvia Tablet_

Metformin hydrochloride extended-release tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

• Swallow metformin hydrochloride extended-release tablets whole and never crush, cut or chew Starting dose: 500 mg orally once daily with the evening meal Increase the dose in increments of 500 mg weekly, up to a maximum of 2,000 mg once daily with the evening meal Patients receiving metformin hydrochloride (HCl) tablets may be switched to metformin hydrochloride extended-release tablets once daily at the same total daily dose, up to 2,000 mg once daily Renal Impairment: Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR) Do not use in patients with eGFR below 30 mL/minute/1.73 m 2 Initiation is not recommended in patients with eGFR between 30 to 45 mL/minute/1.73 m 2 Assess risk/benefit of continuing if eGFR falls below 45 mL/minute/1.73 m 2 Discontinue if eGFR falls below 30 mL/minute/1.73 m 2 Discontinuation for Iodinated Contrast Imaging Procedures: Metformin hydrochloride extended-release tablets may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures Adult Dosage and Administration
• Swallow metformin hydrochloride extended-release tablets whole and never crush, cut or chew
• The recommended starting dose of metformin hydrochloride extended-release tablets is 500 mg orally once daily with the evening meal
• Increase the dose in increments of 500 mg weekly on the basis of glycemic control and tolerability, up to a maximum of 2,000 mg once daily with the evening meal. …

Extended-Release Tablets: 500 mg and 1,000 mg ( 3 ) Metformin hydrochloride extended-release tablets are available as: Extended-release tablets : 1,000 mg white-colored tablets imprinted with "NL1" on one side.

• Safety and effectiveness of metformin hydrochloride extended-release tablets
• Pediatric patients have not been established

Controlled clinical studies of metformin hydrochloride extended-release tablets did not include sufficient numbers of elderly patients to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug …

• Advise the patient to read the FDA-approved patient labeling (Patient Information)
• Lactic Acidosis: Explain the risks of lactic acidosis, its symptoms, and conditions that predispose to its development
• Advise patients to discontinue metformin hydrochloride extended-release tablets immediately and to promptly notify their healthcare provider if unexplained hyperventilation, myalgias, malaise, unusual somnolence or other nonspecific symptoms occur
• Counsel patients against excessive alcohol intake and inform patients about importance of regular testing of renal function while receiving metformin hydrochloride extended-release tablets. …

• Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) Hypersensitivity to metformin Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma
• Metformin hydrochloride extended-release tablets are contraindicated in patients with: Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) [see Warnings and Precautions ]
• Hypersensitivity to metformin. …

Carbonic anhydrase inhibitors may increase risk of lactic acidosis. Consider more frequent monitoring ( 7 ) Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine) may increase the accumulation of metformin. Consider the benefits and risks of concomitant use ( 7 ) Alcohol can potentiate the effect of metformin on lactate metabolism. Warn patients against excessive alcohol intake ( 7 ) Table 2 presents clinically significant drug interactions with metformin hydrochloride extended-release tablets. table2-1 table2-2

Lactic Acidosis: See boxed warning . ( 5.1 ) 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. ( 5.2 ) Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues: Increased risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue. Lower dose of insulin or insulin secretagogue may be required. ( 5.3 ) 5.1 Lactic Acidosis There have been postmarketing cases of metformin-associated lactic acidosis, including fatal cases. …

Common adverse reactions are diarrhea, nausea/vomiting, abdominal pain, constipation, abdomen distention, dyspepsia/heartburn, flatulence, dizziness, headache, upper respiratory infection, taste disturbance. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ingenus Pharmaceuticals, LLC Toll-Free at 1-877-748-1970 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

8.1 Pregnancy Risk Summary Limited data with metformin hydrochloride extended-release tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see Data ] . …

Overdose of metformin HCl has occurred, including ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with metformin has been established. Lactic acidosis has been reported in approximately 32% of metformin overdose cases [see Warnings and Precautions (5.1) ] . Metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdosage is suspected.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.