Indications and Usage
FORTAMET® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Dosage and Administration
There is no fixed dosage regimen for the management of hyperglycemia in patients with type 2 diabetes with FORTAMET® or any other pharmacologic agent. Dosage of FORTAMET® must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily dose. The maximum recommended daily dose of FORTAMET® Extended-Release Tablets in adults is 2500 mg.
FORTAMET® should be taken with a full glass of water once daily with the evening meal. FORTAMET® should be started at a low dose, with gradual dose escalation, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient.
During treatment initiation and dose titration (see Recommended Dosing Schedule ), fasting plasma glucose should be used to determine the therapeutic response to FORTAMET® and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately three months. The therapeutic goal should be to decrease both fasting plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of FORTAMET®, either when used as monotherapy or in combination with sulfonylurea or insulin.
Monitoring of blood glucose and glycosylated hemoglobin will also permit detection of primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication, and secondary failure, i.e., loss of an adequate blood glucose lowering response after an initial period of effectiveness.
Short-term administration of FORTAMET® may be sufficient during periods of transient loss of control in patients usually well-controlled on diet alone.
Recommended Dosing Schedule
The usual starting dose of FORTAMET® (metformin hydrochloride) Extended-Release Tablets is 1000 mg taken with a full glass of water once daily with the evening meal, although 500 mg may be utilized when clinically appropriate. Dosage increases should be made in increments of 500 mg weekly, up to a maximum of 2500 mg once daily with the evening meal (see CLINICAL PHARMACOLOGY, Clinical Studies ).
In randomized trials, patients currently treated with immediate-release metformin were switched to FORTAMET®. Results of this trial suggest that patients receiving immediate-release metformin treatment may be safely switched to FORTAMET® once daily at the same total daily dose, up to 2500 mg once daily. Following a switch from immediate-release metformin to FORTAMET®, glycemic control should be closely monitored and dosage adjustments made accordingly (see CLINICAL PHARMACOLOGY, Clinical Studies ).
Pediatrics – There is no pediatric information available for FORTAMET®.
Transfer From Other Antidiabetic Therapy
When transferring patients from standard oral hypoglycemic agents other than chlorpropamide to FORTAMET®, no transition period generally is necessary. When transferring patients from chlorpropamide, care should be exercised during the first two weeks because of the prolonged retention of chlorpropamide in the body, leading to overlapping drug effects and possible hypoglycemia.
Concomitant FORTAMET
®and Oral Sulfonylurea Therapy in Adult Patients
If patients have not responded to four weeks of the maximum dose of FORTAMET® monotherapy, consideration should be given to gradual addition of an oral sulfonylurea while continuing FORTAMET® at the maximum dose, even if prior primary or secondary failure to a sulfonylurea has occurred. Clinical and pharmacokinetic drug-drug interaction data are currently available only for metformin plus glyburide (also known as glibenclamide). With concomitant FORTAMET® and sulfonylurea therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug. However, attempts should be made to identify the minimum effective dose of each drug to achieve this goal. With concomitant FORTAMET® and sulfonylurea therapy, the risk of hypoglycemia associated with sulfonylurea therapy continues and may be increased. Appropriate precautions should be taken (see Package Insert of the respective sulfonylurea).
If patients have not satisfactorily responded to one to three months of concomitant therapy with the maximum dose of FORTAMET® and the maximum dose of an oral sulfonylurea, consider therapeutic alternatives including switching to insulin with or without FORTAMET®.
Concomitant FORTAMET
®and Insulin Therapy in Adult Patients
The current insulin dose should be continued upon initiation of FORTAMET® therapy. FORTAMET® therapy should be initiated at 500 mg once daily in patients on insulin therapy. For patients not responding adequately, the dose of FORTAMET® should be increased by 500 mg after approximately 1 week and by 500 mg every week thereafter until adequate glycemic control is achieved. The maximum recommended daily dose for FORTAMET® Extended-Release Tablets is 2500 mg. It is recommended that the insulin dose be decreased by 10% to 25% when fasting plasma glucose concentrations decrease to less than 120 mg/dL in patients receiving concomitant insulin and FORTAMET®. Further adjustment should be individualized based on glucose-lowering response.
Specific Patient Populations
FORTAMET® is not recommended for use in pregnancy, and is not recommended in patients below the age of 17 years.
The initial and maintenance dosing of FORTAMET® should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Any dosage adjustment should be based on a careful assessment of renal function. Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of FORTAMET®.
Monitoring of renal function is necessary to aid in prevention of lactic acidosis, particularly in the elderly (see WARNINGS ).
Contraindications
FORTAMET® is contraindicated in patients with:
- Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dL [males], ≥1.4 mg/dL [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see WARNINGS and PRECAUTIONS ).
- Known hypersensitivity to metformin.
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.
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 (see also PRECAUTIONS ).
Adverse Reactions
Enter section text here
FORTAMET® Clinical Studies
In the controlled clinical studies of FORTAMET® in patients with type 2 diabetes, a total of 424 patients received FORTAMET® therapy (up to 2500 mg/day) and 430 patients received immediate-release metformin. Adverse reactions reported in ≥5% of the FORTAMET® or immediate-release metformin patients are listed in Table 6 . These pooled results show that the most frequently reported adverse reactions in the FORTAMET® group were infection, diarrhea, and nausea. Similar incidences of these adverse reactions were seen in the immediate-release metformin group.
|
|
FORTAMET®
(N=424) |
Immediate-Release Metformin
(N=430) |
||
|
Body
System
Preferred Term |
n | (%) | n | (%) |
| Body as a Whole |
|
|
|
|
| Accidental Injury | 31 | (7.3) | 24 | (5.6) |
| Headache | 20 | (4.7) | 22 | (5.1) |
| Infection | 87 | (20.5) | 90 | (20.9) |
| Digestive System |
|
|
|
|
| Diarrhea | 71 | (16.7) | 51 | (11.9) |
| Dyspepsia | 18 | (4.2) | 22 | (5.1) |
| Nausea | 36 | (8.5) | 32 | (7.4) |
| Respiratory System |
|
|
|
|
| Rhinitis | 18 | (4.2) | 24 | (5.6) |
The most frequent adverse events thought to be related to FORTAMET® were diarrhea, nausea, dyspepsia, flatulence, and abdominal pain. The frequency of dyspepsia was 4.2% in the FORTAMET® group compared to 5.1% in the immediate-release group, the frequency of flatulence was 3.5% in the FORTAMET® group compared to 3.7% in the immediate-release group, and the frequency of abdominal pain was 3.3% in the FORTAMET® group compared to 4.4% in the immediate-release group.
In the controlled studies, 4.7% of patients treated with FORTAMET® and 4.9% of patients treated with immediate-release metformin were discontinued due to adverse events.
Immediate-Release Metformin
Immediate-Release Metformin Phase III Clinical Studies
In a U.S. double-blind clinical study of immediate-release metformin in patients with type 2 diabetes, a total of 141 patients received immediate-release metformin therapy (up to 2550 mg per day) and 145 patients received placebo. Adverse reactions reported in greater than 5% of the immediate-release metformin patients, and that were more common in immediate-release metformin than placebo-treated patients, are listed in Table 7.
|
|
Immediate-Release Metformin Monotherapy (n = 141) |
Placebo (n = 145) |
|
|
||
| Adverse Reaction | % of Patients |
|
| Diarrhea | 53.2 | 11.7 |
| Nausea/Vomiting | 25.5 | 8.3 |
| Flatulence | 12.1 | 5.5 |
| Asthenia | 9.2 | 5.5 |
| Indigestion | 7.1 | 4.1 |
| Abdominal Discomfort | 6.4 | 4.8 |
| Headache | 5.7 | 4.8 |
* Reactions that were more common in immediate-release metformin that placebo-treated patients
Diarrhea led to discontinuation of study medication in 6% of patients treated with immediate-release metformin. Additionally, the following adverse reactions were reported in ≥1.0 - ≤5.0% of immediate-release metformin patients and were more commonly reported with immediate-release metformin than placebo: abnormal stools, hypoglycemia, myalgia, lightheaded, dyspnea, nail disorder, rash, sweating increased, taste disorder, chest discomfort, chills, flu syndrome, flushing, palpitation.
Pediatric Patients
No pediatric clinical studies have been conducted with FORTAMET®. In clinical trials with immediate-release metformin in pediatric patients with type 2 diabetes, the profile of adverse reactions was similar to that observed in adults.
Overdosage
Hypoglycemia has not been seen even with ingestion of up to 85 grams of immediate-release metformin, although lactic acidosis has occurred in such circumstances (see WARNINGS ). 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 over-dosage is suspected.
Description
FORTAMET® (metformin hydrochloride) Extended-Release Tablets contain an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N, N-dimethylimidodicarbonimidic diamide hydrochloride) is a member of the biguanide class of oral antihyperglycemics and is not chemically or pharmacologically related to any other class of oral antihyperglycemic agents. The empirical formula of metformin hydrochloride is C4H11N5•HCl and its molecular weight is 165.63. Its structural formula is:
Metformin hydrochloride is a white to off-white crystalline powder that is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68.
FORTAMET® Extended-Release Tablets are designed for once-a-day oral administration and deliver 500 mg or 1000 mg of metformin hydrochloride. In addition to the active ingredient metformin hydrochloride, each tablet contains the following inactive ingredients: candellila wax, cellulose acetate, hypromellose, magnesium stearate, polyethylene glycols (PEG 400, PEG 8000), polysorbate 80, povidone, sodium lauryl sulfate, synthetic black iron oxides, titanium dioxide, and triacetin.
FORTAMET® meets USP Dissolution Test 5.
image of chemical structureClinical Pharmacology
Mechanism of Action
Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycemic agents. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Unlike sulfonylureas, metformin does not produce hypoglycemia in either patients with type 2 diabetes or normal subjects (except in special circumstances, see PRECAUTIONS ) and does not cause hyperinsulinemia. With metformin therapy, insulin secretion remains unchanged while fasting plasma insulin levels and day-long plasma insulin response may actually decrease.
Clinical Studies
In a double-blind, randomized, active-controlled, multicenter U.S. clinical study, which compared FORTAMET® q.d. to immediate-release metformin b.i.d., 680 patients with type 2 diabetes who had been taking metformin-containing medication at study entry were randomly assigned in equal numbers to double-blind treatment with either FORTAMET® or immediate-release metformin. Doses were adjusted during the first six weeks of treatment with study medication based on patients' FPG levels and were then held constant over a period of 20 weeks. The primary efficacy endpoint was the change in HbA1c from baseline to endpoint. The primary objective was to demonstrate the clinical non-inferiority of FORTAMET® compared to immediate-release metformin on the primary endpoint.
FORTAMET® and metformin patients had mean HbA1c changes from baseline to endpoint equal to +0.40 and +0.14, respectively ( Table 3 ). The least-square (LS) mean treatment difference was 0.25 (95% CI = 0.14, 0.37) demonstrating that FORTAMET® was clinically similar to metformin according to the pre-defined criterion to establish efficacy.
|
|
FORTAMET ® | Immediate-Release Metformin |
Treatment difference for
change from baseline (FORTAMET ® minus Immediate-Release Metformin) LS mean (2 sided 95% CI a ) |
|---|---|---|---|
| HbA 1c (%) |
|
|
|
| N | 327 | 332 | 0.25 |
| Baseline (mean ± SD) | 7.04 ± 0.88 | 7.07 ± 0.76 | (0.14,0.37)b |
| Change from baseline (mean ± SD) | 0.40 ± 0.75 | 0.14 ± 0.75 |
|
| Fasting Plasma Glucose (mg/dL) |
|
|
|
| N | 329 | 333 | 6.43 |
| Baseline (mean ± SD) | 146.8 ± 32.1 | 145.6 ± 29.5 | (0.57, 12.29) |
| Change from baseline (mean ± SD) | 10.0 ± 40.8 | 4.2 ± 35.9 |
|
| Plasma Insulin (μu/mL) |
|
|
|
| N | 304 | 316 | 0.02 |
| Baseline (mean ± SD) | 17.9 ± 15.1 | 17.3 ± 10.5 | (-1.47, 1.50) |
| Change from baseline (mean ± SD) | -3.6 ± 13.8 | -3.2 ± 8.6 |
|
| Body Weight (kg) |
|
|
|
| N | 313 | 320 | 0.30 |
| Baseline (mean ± SD) | 94.1 ± 17.8 | 93.3 ± 17.4 | (-0.22, 0.81) |
| Change from baseline(mean ± SD) | 0.3 ± 2.9 | 0.0 ± 3.7 |
|
| Body Mass Index (kg/m 2 ) |
|
|
|
| N | 313 | 320 | 0.08 |
| Baseline (mean ± SD) | 31.1 ±4.7 | 31.4 ± 4.5 | (-0.11, 0.26) |
| Change from baseline(mean ± SD) | 0.1 ± 1.1 | 0.0 ± 1.3 |
|
a CI=Confidence Interval
b FORTAMET® was clinically similar to immediate-release metformin based on the pre-defined criterion to establish efficacy. While demonstrating clinical similarity, the response to FORTAMET® compared to immediate-release metformin was also shown to be statistically smaller as seen by the 95% CI for the treatment difference which did not include zero.
Footnote: Patients were taking metformin-containing medications at baseline that were prescribed by their personal physicians.
The mean changes for FPG (
Table 3
)
and plasma insulin (
Table 3
) were
small for both FORTAMET® and immediate-release metformin,
and were not clinically meaningful. Seventy-six (22%) and 49 (14%) of the
FORTAMET® and immediate-release patients, respectively,
discontinued prematurely from the trial. Eighteen (5%) patients on FORTAMET® withdrew because of a stated lack of efficacy, as compared
with 8 patients (2%) on immediate-release metformin (p=0.047).
Results from this study also indicated that neither FORTAMET® nor immediate-release metformin were associated with weight gain or increases in body mass index.
A 24-week, double blind, placebo-controlled study of immediate-release metformin plus insulin, versus insulin plus placebo, was conducted in patients with type 2 diabetes who failed to achieve adequate glycemic control on insulin alone ( Table 4 ). Patients randomized to receive immediate-release metformin plus insulin achieved a reduction in HbA1c of 2.10%, compared to a 1.56% reduction in HbA1c achieved by insulin plus placebo. The improvement in glycemic control was achieved at the final study visit with 16% less insulin, 93.0 U/day versus 110.6 U/day, immediate-release metformin plus insulin versus insulin plus placebo, respectively, p=0.04.
|
|
Immediate-Release
Metformin /Insulin (n = 26) |
Placebo/Insulin (n = 28) |
Treatment difference Mean ± SE |
|---|---|---|---|
| HbA 1c (%) |
|
|
|
| Baseline | 8.95 | 9.32 |
|
| Change at FINAL VISIT | -2.10 | -1.56 | -0.54 ± 0.43a |
| Insulin Dose (U/day) |
|
|
|
| Baseline | 93.12 | 94.64 |
|
| Change at FINAL VISIT | -0.15 | 15.93 | -16.08 ± 7.77b |
a Statistically significant using analysis of covariance with baseline as covariate (p=0.04).
Not significant using analysis of variance (values shown in table)
b Statistically significant for insulin (p=0.04)
A second double-blind, placebo-controlled study (n=51), with 16 weeks of randomized treatment, demonstrated that in patients with type 2 diabetes controlled on insulin for 8 weeks with an average HbA1c of 7.46 ± 0.97%, the addition of immediate-release metformin maintained similar glycemic control (HbA1c 7.15 ± 0.61 versus 6.97 ± 0.62 for immediate-release metformin plus insulin and placebo plus insulin, respectively) with 19% less insulin versus baseline (reduction of 23.68 ± 30.22 versus an increase of 0.43 ± 25.20 units for immediate-release metformin plus insulin and placebo plus insulin, p less than 0.01). In addition, this study demonstrated that the combination of immediate-release metformin plus insulin resulted in reduction in body weight of 3.11 ± 4.30 lbs, compared to an increase of 1.30 ± 6.08 lbs for placebo plus insulin, p=0.01.
How Supplied / Storage and Handling
FORTAMET® (metformin hydrochloride) Extended-Release Tablets are supplied as biconvex-shaped, film-coated extended-release tablets containing 500 mg or 1000 mg of metformin hydrochloride.
500 mg extended-release, white-colored tablets imprinted with Andrx logo and 574 on one side: bottles of 60 (NDC 54868-5558-0); and in bottles of 90 (NDC 54868-5558-1).
1000 mg extended-release, white-colored tablets imprinted with Andrx logo and 575 on one side: bottles of 30 (NDC 54868-2894-0).
Patient Counseling Information
Q1. Why do I need to take FORTAMET®?
Your doctor has prescribed FORTAMET® to treat your type 2 diabetes, a condition in which blood sugar (blood glucose) is elevated. There are two types of diabetes. FORTAMET® is indicated for the most common type, known as type 2 diabetes.
Q2. Why is it important to control type 2 diabetes?
Type 2 diabetes has multiple possible complications, including blindness, kidney failure, and circulatory and heart problems. Lowering your blood sugar to a normal level may prevent or delay these complications.
Q3. How is type 2 diabetes usually controlled?
High blood sugar can be lowered by diet and exercise, by a number of oral medications and by insulin injections. Your doctor may recommend that you try lifestyle modifications such as improved diet and exercise before initiating drug treatment for type 2 diabetes. Each patient will be treated individually by his or her physician, and should follow all treatment recommendations.
Q4. Does FORTAMET® work differently from other glucose control medications?
Yes. FORTAMET®, as well as other formulations of metformin, lowers the amount of sugar in your blood by controlling how much sugar is released by the liver. FORTAMET® (metformin hydrochloride) does not cause your body to produce more insulin. FORTAMET® rarely causes hypoglycemia (low blood sugar) and it does not usually cause weight gain when taken alone. However, if you do not eat enough, if you take other medications to lower blood sugar, or if you drink alcohol, you can develop hypoglycemia. Specifically, when FORTAMET® is taken together with a sulfonylurea or with insulin, hypoglycemia and weight gain are more likely to occur.
Q5. What happens if my blood sugar is still too high?
If your blood sugar is high, consult your physician. When blood sugar cannot be lowered enough by either FORTAMET® (metformin hydrochloride) Extended-Release Tablets or a sulfonylurea, the two medications can be effective when taken together. Other alternatives involve switching to other oral antidiabetic drugs (e.g., alpha glucoside inhibitors or glitazones). FORTAMET® may be stopped and replaced with other drugs and/or insulin. If you are unable to maintain your blood sugar with diet, exercise and glucose-control medications taken orally, then your doctor may prescribe injectable insulin to control your diabetes.
Q6. Why should I take FORTAMET® in addition to insulin if I am already on insulin alone?
Adding FORTAMET® to insulin can help you better control your blood sugar while reducing the insulin dose and possibly reducing your weight.
Q7. Can FORTAMET® cause side effects?
FORTAMET®, like all blood sugar-lowering medications, can cause side effects in some patients. Most of these side effects are minor and will go away after you've taken FORTAMET® for a while. However, there are also serious but rare side effects related to FORTAMET® (see below).
Q8. What kind of side effects can FORTAMET® cause?
If side effects occur, they usually occur during the first few weeks of therapy. They are normally minor ones such as diarrhea, nausea, abdominal pain and upset stomach. FORTAMET® is generally taken with meals, which reduce these side effects.
Although these side effects are likely to go away, call your doctor if you have severe discomfort or if these effects last for more than a few weeks. Some patients may need to have their doses lowered or stop taking FORTAMET®, either temporarily or permanently. You should tell your doctor if the problems come back or start later on during the therapy.
WARNING: A rare number of people who have taken metformin have developed a serious condition called lactic acidosis. Properly functioning kidneys are needed to help prevent lactic acidosis. You should not take FORTAMET® if you have impaired kidney function, as measured by a blood test (see Q9-13).
Q9. Are there any serious side effects that FORTAMET® can cause?
FORTAMET® rarely causes serious side effects. The most serious side effect that FORTAMET® can cause is called lactic acidosis.
Q10. What is lactic acidosis and can it happen to me?
Lactic acidosis is caused by a build-up of lactic acid in the blood. Lactic acidosis associated with metformin is rare and has occurred mostly in people whose kidneys were 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.
Q11. Are there other risk factors for lactic acidosis?
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 can affect kidney and liver function. You should discuss your risk with your physician. You should not take FORTAMET® if:
- You have some forms of kidney or liver problems
- You have congestive heart failure which is treated with medications, e.g., digoxin (Lanoxin®) or furosemide (Lasix®)
- You drink alcohol excessively (all the time or short-term “binge” drinking)
- You are seriously dehydrated (have lost a large amount of body fluids)
- You are going to have, within a few days, certain x-ray tests with injectable contrast agents
- You are going to have surgery
- You develop a serious condition such as a heart attack, severe infection, or a stroke
- You are 80 years of age or older and have NOT had your kidney function tested
Q12. What are the symptoms of lactic acidosis?
Some of the symptoms include feeling very weak, tired or uncomfortable, unusual muscle pain, trouble breathing, unusual or unexpected stomach discomfort, feeling cold, feeling dizzy or lightheaded, 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. Lactic acidosis is a medical emergency that must be treated in a hospital.
Q13. What does my doctor need to know to decrease my risk of lactic acidosis?
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. You should let your doctor know if you are going to have any surgery or specialized x-ray procedures that require injection of contrast agents. FORTAMET® therapy will need to be stopped temporarily in such instances.
Q14. Can I take FORTAMET® with other medications?
Remind your doctor and/or pharmacist that you are taking FORTAMET® when any new drug is prescribed or a change is made in how you take a drug already prescribed. FORTAMET® may interfere with the way some drugs work and some drugs may interfere with the action of FORTAMET®.
Q15. What if I become pregnant while taking FORTAMET®?
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. Usually your doctor will prescribe insulin while you are pregnant.
Q16. How do I take FORTAMET®?
FORTAMET® tablets should not be cut, crushed, or chewed and should be taken whole with a full glass of water once daily with the evening meal. 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 effect the way FORTAMET® works to control diabetes. FORTAMET® should be taken once a day with food. You will be started on a low dose of FORTAMET® and your dosage will be increased gradually until your blood sugar is controlled.
Q17. Where can I get more information about FORTAMET®?
This leaflet is a summary of the most important information about FORTAMET®. If you have any questions or problems, you should talk to your doctor or other healthcare provider about type 2 diabetes as well as FORTAMET® and its side effects.
Distributed by:
Sciele Pharma, Inc.
Atlanta, GA 30328
Manufactured by:
Watson Laboratories - Florida
Ft. Lauderdale, FL
33314
www.Fortamet.com
FORT-PI-08 Rev. 07/08 74200708
U.S. patent numbers 6,495,162; 6,866,866; 6,790,459; 6,099,859 - additional patents pending.