Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

FORTAMET is contraindicated in patients with:

• Severe renal impairment (eGFR below 30 mL/min/1.73 m²
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin

Initiation of FORTAMET is not recommended in patients with eGFR between 30 to 45 mL/min/1.73 m².

Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (> 5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL.

Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic 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.

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.

Discontinue FORTAMET 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 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 FORTAMET if renal function is stable.

Reported decrease to subnormal levels of previously normal serum Vitamin B12 levels.

Patients should be counseled against excessive alcohol intake, either acute or chronic, while receiving FORTAMET.

Furosemide increased the metformin plasma and blood Cmax by 22% and blood AUC by 15%, without any significant change in metformin renal clearance.

Nifedipine appears to enhance the absorption of metformin.

Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis.

Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are administered to a patient receiving FORTAMET, the patient should be closely observed for loss of blood glucose control.

Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently causes a decrease in serum bicarbonate and induce nonanion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with FORTAMET may increase the risk for lactic acidosis.

FORTAMET should not be used during pregnancy unless clearly needed.There are no adequate and well-controlled studies in pregnant women with immediate-release metformin or FORTAMET.

Animal studies show that metformin is excreted into milk and reaches levels comparable to those in plasma. Similar studies have not been conducted in nursing mothers. Because the potential for hypoglycemia in nursing infants may exist, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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• Use in patients under the age of 18. GoToSource

• Anti-aging. GoToSource

• Reduce glucose-induced P. aeruginosa infections. GoToSource

• Idiopathic cyclic edema. GoToSource

• Antipsychotic-related hyperprolactinemia. GoToSource

• Prodromal alzheimer’s disease. GoToSource

• Diabetic nephropathy and polycystic ovary syndrome. GoToSource

• Adjunctive treatment for solid tumors, stage III-IV head and neck squamous cell cancer, prostate cancer, breast cancer, kidney cancer,pancreatic cancer, ovarian, fallopian tube, or primary peritoneal cancer. GoToSource

Hyperglycemia (high blood sugar), serious allergic reaction, gastrointestinal intolerance and myocardial infarction. GoToSource

Increased risk of meningioma. GoToSource

Vitamin D deficiency. GoToSource

Generalized fixed drug eruption. GoToSource

Increased risk of neurodegenerative diseases including dementia and parkinson’s disease. GoToSource

Obesity. GoToSource

Vitamin B12 deficiency. GoToSource

Lactic acidosis (too much acid in body). GoToSource

No major injury lawsuits reported.