Your doctor has prescribed FORTAMET for you because you have been diagnosed with the most common form of diabetes – type 2 diabetes – also referred to as high blood sugar. Your sugar level is controlled by insulin, which turns the food you eat into energy. When your body does not produce enough insulin or your body ignores the insulin it makes, high levels of sugar will remain in your bloodstream. Over time, constant high sugar levels can cause damage to your eyes, heart, kidneys, and nerves.1
The information below will help you understand FORTAMET and how it can help you in your treatment. If you would like more detailed information, ask you doctor, pharmacist, or healthcare provider, and be sure to view the full Prescribing Information including the Boxed Warning associated with metformin products.
FORTAMET is prescribed for patients with type 2 diabetes to help control their blood sugar level, when combined with a healthy diet and exercise.
FORTAMET is an extended-release (long acting) tablet that should be taken once per day either alone or in conjunction with a sulfonylurea or insulin.
Remind your doctor and/or pharmacist of all medications that you are taking, since some drugs may interfere with each other and the way they should work. When taking FORTAMET with a sulfonylurea or insulin, you may see increased weight gain or hypoglycemia (low blood sugar). FORTAMET rarely causes hypoglycemia when taken alone and it is not associated with weight gain.
FORTAMET lowers the amount of sugar in your blood by controlling how much sugar is released by the liver. FORTAMET does not cause your body to produce more insulin; however, it helps your body to better use its own insulin.
FORTAMET is not for everyone with type 2 diabetes. FORTAMET has not been tested in children or pregnant women. FORTAMET is not indicated for patients under the age of 17.
Tell your doctor if you plan to become pregnant or have become pregnant. As with other oral glucose-control medications, you should not take FORTAMET during pregnancy.
FORTAMET tablets should not be cut, crushed, or chewed. FORTAMET should be taken once a day with the evening meal with a full glass of water. Occasionally, the inactive ingredients of FORTAMET may be eliminated as a soft mass in your stool that may look like the original tablet; this is not harmful and will not affect the way FORTAMET works to control your diabetes.
Clinical studies have shown that less than five percent of patients treated with FORTAMET discontinued the therapy due to adverse events. FORTAMET may cause side effects; however, most are minor and will go away within a few weeks. In clinical studies, the most common side effects were diarrhea, nausea, abdominal (belly) pain, and upset stomach. To help reduce the side effects, FORTAMET should be taken once a day with your evening meal.
Although these side effects are minor and are likely to go away, call your doctor if you have severe discomfort or if these effects last for more than a few weeks.
Lactic acidosis is a rare, but serious, complication, which is caused by the build up of lactic acid in the blood. It can occur during treatment with all metformins, and occurs primarily in people whose kidneys are not working normally. Lactic acidosis has been reported in about one in 33,000 patients taking metformin over the course of a year. Although rare, if lactic acidosis does occur, it can be fatal in up to half the cases.
It is also important for your liver to be working normally when you take FORTAMET. Your liver helps to remove lactic acid from your bloodstream. Your doctor will monitor your diabetes and may perform blood tests on you from time to time to make sure your kidneys and your liver are functioning normally. There is no evidence that FORTAMET causes harm to the kidneys or liver.
Your risk of developing lactic acidosis from taking FORTAMET is very low as long as your kidneys and liver are healthy. However, some factors can increase your risk because they may affect kidney and liver function. You should discuss your risk with your physician. You should not take FORTAMET if:
Signs of lactic acidosis include lack of energy, muscle pain, breathing problems, sleepiness, chills, unusual or unexpected discomfort in the belly or abdominal area, dizziness, or suddenly developing a slow or irregular heartbeat. If you notice these symptoms, or if your medical condition has suddenly changed, stop taking FORTAMET and call your doctor right away.
Tell your doctor if you have an illness that results in severe vomiting, diarrhea and/or fever, or, if your intake of fluids is generally reduced. These situations can lead to severe dehydration and it may be necessary to stop taking FORTAMET temporarily. FORTAMET should also be stopped temporarily if you are going to have any surgery or specialized X-ray procedures that require injection of contrast agents.
If you would like to learn more about once-daily FORTAMET for type 2 diabetes, consult your physician or contact us today. FORTAMET is available by prescription only. Be sure to read the important safety information and full Prescribing Information before beginning treatment with FORTAMET.
FORTAMET, used as a once-per-day monotherapy, is indicated as an adjunct to diet and exercise to lower blood glucose. FORTAMET can be used concomitantly with a sulfonylurea or insulin to improve glycemic control in adults. FORTAMET is indicated in patients 17 years of age or older as either monotherapy or in combination therapy.
There is a black box warning associated with metformin products. Lactic acidosis due to metformin accumulation during treatment with FORTAMET is a rare but potentially fatal occurrence. Lactic acidosis may also occur in association with a number of pathophysiologic conditions and whenever there is significant tissue hypoperfusion and hypoxemia. Patients with congestive heart failure requiring pharmacologic management, in particular those with unstable or acute congestive heart failure who are at risk of hypoperfusion and hypoxemia, are at increased risk of lactic acidosis. The onset of lactic acidosis often is subtle, and can be accompanied only by nonspecific symptoms. The patient and the patient's physician must be aware of the possible importance of such symptoms and the patient should be instructed to notify the physician immediately if they occur. The risk of lactic acidosis increases with the degree of renal dysfunction and the patient's age. Treatment should not be initiated in patients ≥ 80 years of age unless renal function is not reduced. The risk of lactic acidosis while on FORTAMET therapy may be significantly decreased by: Initial and regular monitoring of renal and liver function; using the minimum effective dose of FORTAMET; promptly withholding FORTAMET in the presence of any condition associated with hypoxemia, dehydration, or sepsis; avoidance of FORTAMET in patients with hepatic disease; cautioning patients against excessive alcohol intake, either acute or chronic; and temporarily discontinuing FORTAMET prior to any intravascular radiocontrast study or surgical procedure. Lactic acidosis is a medical emergency requiring immediate discontinuation of FORTAMET and prompt institution of general supportive measures. Because metformin is dialyzable, prompt hemodialysis is recommended to correct the acidosis and remove the accumulated metformin.
FORTAMET is contraindicated in patients with renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels of ≥ 1.5 mg/dL in males, ≥ 1.4 mg/dL in females, or abnormal creatinine clearance), congestive heart failure, known hypersensitivity to metformin, acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
FORTAMET should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function.
In pooled phase II and III studies (N=424), the most frequent adverse events associated with FORTAMET were infection (20.5%), diarrhea (16.7%), nausea (8.5%), accidental injury (7.3%), dyspepsia (4.2%), and rhinitis (4.2%). In controlled studies, 4.7% of patients treated with FORTAMET (N=424) were discontinued as a result of an adverse event.
FORTAMET should be avoided in patients with impaired hepatic function or excessive alcohol intake (chronic or acute). In elderly patients, particularly those ≥80 years of age, renal function should be monitored regularly and, generally, FORTAMET should not be titrated to the maximum dose. FORTAMET should be withheld in the presence of any condition associated with hypoxia, dehydration, or sepsis.
FORTAMET alone does not usually cause hypoglycemia, although it may occur when FORTAMET is used in conjunction with oral sulfonylureas and/or insulin. When initiating combination therapy, the risks, symptoms, and treatment of hypoglycemia, as well as conditions that predispose its development, should be explained to patients and responsible family members.
The safety and efficacy of FORTAMET has not been evaluated in pediatric patients or pregnant women.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088
1. American Diabetes Association. Available at http://www.diabetes.org/diabetes-basics/type-2/. Accessed February 26, 2010.
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