What are the possible side effects of Glustazon?
Get emergency medical help if you have any of these signs of an allergic reaction to Glustazon: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using Glustazon and call your doctor at once if you have symptoms of liver damage: nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).
Call your doctor at once if you have:
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shortness of breath (even with mild exertion), swelling, rapid weight gain;
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pink or red urine, painful or difficult urination, urinating more than usual;
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changes in your vision; or
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sudden unusual pain in your hand, arm, or foot.
Common Glustazon side effects may include:
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headache;
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muscle pain; or
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cold symptoms such as stuffy nose, sinus pain, sneezing, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of Glustazon in details
The following serious adverse reactions are discussed elsewhere in the labeling:
- Congestive heart failure
- Edema
- Fractures
Clinical Trials Experience
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.
Over 8500 patients with type 2 diabetes have been treated with Glustazon in randomized, double-blind, controlled clinical trials, including 2605 patients with type 2 diabetes and macrovascular disease treated with Glustazon in the PROactive clinical trial. In these trials, over 6000 patients have been treated with Glustazon for six months or longer, over 4500 patients have been treated with Glustazon for one year or longer, and over 3000 patients have been treated with Glustazon for at least two years.
In six pooled 16-to 26-week placebo-controlled monotherapy and 16-to 24-week add-on combination therapy trials, the incidence of withdrawals due to adverse events was 4.5% for patients treated with Glustazon and 5.8% for comparator-treated patients. The most common adverse events leading to withdrawal were related to inadequate glycemic control, although the incidence of these events was lower (1.5%) with Glustazon than with placebo (3.0%).
In the PROactive trial, the incidence of withdrawals due to adverse events was 9.0% for patients treated with Glustazon and 7.7% for placebo-treated patients. Congestive heart failure was the most common serious adverse event leading to withdrawal occurring in 1.3% of patients treated with Glustazon and 0.6% of patients treated with placebo.
Common Adverse Events: 16-to 26-Week Monotherapy Trials
A summary of the incidence and type of common adverse events reported in three pooled 16-to 26-week placebo-controlled monotherapy trials of Glustazon is provided in Table 1. Terms that are reported represent those that occurred at an incidence of > 5% and more commonly in patients treated with Glustazon than in patients who received placebo. None of these adverse events were related to Glustazon dose.
Table 1: Three Pooled 16-to 26-Week Placebo-Controlled Clinical Trials of Glustazon Monotherapy: Adverse Events Reported at an Incidence > 5% and More Commonly in Patients Treated with Glustazon than in Patients Treated with Placebo
| % of Patients | ||
| Placebo N=259 | Glustazon N=606 | |
| Upper Respiratory Tract Infection | 8.5 | 13.2 |
| Headache | 6.9 | 9.1 |
| Sinusitis | 4.6 | 6.3 |
| Myalgia | 2.7 | 5.4 |
| Pharyngitis | 0.8 | 5.1 |
Common Adverse Events: 16-to 24-Week Add-on Combination Therapy Trials
A summary of the overall incidence and types of common adverse events reported in trials of Glustazon add-on to sulfonylurea is provided in Table 2. Terms that are reported represent those that occurred at an incidence of > 5% and more commonly with the highest tested dose of Glustazon.
Table 2: 16-to 24-Week Clinical Trials of Glustazon Add-on to Sulfonylurea
| 16-Week Placebo-Controlled Trial Adverse Events Reported in > 5% of Patients and More Commonly in Patients Treated with Glustazon 30 mg + Sulfonylurea than in Patients Treated with Placebo + Sulfonylurea | |||
| % of Patients | |||
| Placebo + Sulfonylurea N=187 | Glustazon 15 mg + Sulfonylurea N=184 | Glustazon 30 mg + Sulfonylurea N=189 | |
| Edema | 2.1 | 1.6 | 12.7 |
| Headache | 3.7 | 4.3 | 5.3 |
| Flatulence | 0.5 | 2.7 | 6.3 |
| Weight Increased | 0 | 2.7 | 5.3 |
| 24-Week Non-Controlled Double-Blind Trial Adverse Events Reported in >5% of Patients and More Commonly in Patients Treated with Glustazon 45 mg + Sulfonylurea than in Patients Treated with Glustazon 30 mg + Sulfonylurea | |||
| % of Patients | |||
| Glustazon 30 mg + Sulfonylurea N=351 | Glustazon 45 mg + Sulfonylurea N=351 | ||
| Hypoglycemia | 13.4 | 15.7 | |
| Edema | 10.5 | 23.1 | |
| Upper Respiratory Tract Infection | 12.3 | 14.8 | |
| Weight Increased | 9.1 | 13.4 | |
| Urinary Tract Infection | 5.7 | 6.8 | |
| Note: The preferred terms of edema peripheral, generalized edema, pitting edema and fluid retention were combined to form the aggregate term of “edema.” |
A summary of the overall incidence and types of common adverse events reported in trials of Glustazon add-on to metformin is provided in Table 3. Terms that are reported represent those that occurred at an incidence of > 5% and more commonly with the highest tested dose of Glustazon.
Table 3: 16-to 24-Week Clinical Trials of Glustazon Add-on to Metformin
| 16-Week Placebo-Controlled Trial Adverse Events Reported in >5% of Patients and More Commonly in Patients Treated with Glustazon + Metformin than in Patients Treated with Placebo + Metformin | ||
| % of Patients | ||
| Placebo + Metformin N=160 | Glustazon 30 mg + Metformin N=168 | |
| Edema | 2.5 | 6 |
| Headache | 1.9 | 6 |
| 24-Week Non-Controlled Double-Blind Trial Adverse Events Reported in >5% of Patients and More Commonly in Patients Treated with Glustazon 45 mg + Metformin than in Patients Treated with Glustazon 30 mg + Metformin | ||
| % of Patients | ||
| Glustazon 30 mg + Metformin N=411 | Glustazon 45 mg + Metformin N=416 | |
| Upper Respiratory Tract Infection | 12.4 | 13.5 |
| Edema | 5.8 | 13.9 |
| Headache | 5.4 | 5.8 |
| Weight Increased | 2.9 | 6.7 |
| Note: The preferred terms of edema peripheral, generalized edema, pitting edema and fluid retention were combined to form the aggregate term of “edema.” |
Table 4 summarizes the incidence and types of common adverse events reported in trials of Glustazon add-on to insulin. Terms that are reported represent those that occurred at an incidence of > 5% and more commonly with the highest tested dose of Glustazon.
Table 4: 16-to 24-Week Clinical Trials of Glustazon Add-on to Insulin
| 16-Week Placebo-Controlled Trial Adverse Events Reported in >5% of Patients and More Commonly in Patients Treated with Glustazon 30 mg + Insulin than in Patients Treated with Placebo + Insulin | |||
| % of Patients | |||
| Placebo + Insulin N=187 | Glustazon 15 mg + Insulin N=191 | Glustazon 30 mg + Insulin N=188 | |
| Hypoglycemia | 4.8 | 7.9 | 15.4 |
| Edema | 7 | 12.6 | 17.6 |
| Upper Respiratory Tract Infection | 9.6 | 8.4 | 14.9 |
| Headache | 3.2 | 3.1 | 6.9 |
| Weight Increased | 0.5 | 5.2 | 6.4 |
| Back Pain | 4.3 | 2.1 | 5.3 |
| Dizziness | 3.7 | 2.6 | 5.3 |
| Flatulence | 1.6 | 3.7 | 5.3 |
| 24-Week Non-Controlled Double-Blind Trial Adverse Events Reported in >5% of Patients and More Commonly in Patients Treated with Glustazon 45 mg + Insulin than in Patients Treated with Glustazon 30 mg + Insulin | |||
| % of Patients | |||
| Glustazon 30 mg + Insulin N=345 | Glustazon 45 mg + Insulin N=345 | ||
| Hypoglycemia | 43.5 | 47.8 | |
| Edema | 22 | 26.1 | |
| Weight Increased | 7.2 | 13.9 | |
| Urinary Tract Infection | 4.9 | 8.7 | |
| Diarrhea | 5.5 | 5.8 | |
| Back Pain | 3.8 | 6.4 | |
| Blood Creatine Phosphokinase Increased | 4.6 | 5.5 | |
| Sinusitis | 4.6 | 5.5 | |
| Hypertension | 4.1 | 5.5 | |
| Note: The preferred terms of edema peripheral, generalized edema, pitting edema and fluid retention were combined to form the aggregate term of “edema.” |
A summary of the overall incidence and types of common adverse events reported in the PROactive trial is provided in Table 5. Terms that are reported represent those that occurred at an incidence of > 5% and more commonly in patients treated with Glustazon than in patients who received placebo.
Table 5: PROactive Trial: Incidence and Types of Adverse Events Reported in > 5% of Patients Treated with Glustazon and More Commonly than Placebo
| % of Patients | ||
| Placebo N=2633 | Glustazon N=2605 | |
| Hypoglycemia | 18.8 | 27.3 |
| Edema | 15.3 | 26.7 |
| Cardiac Failure | 6.1 | 8.1 |
| Pain in Extremity | 5.7 | 6.4 |
| Back Pain | 5.1 | 5.5 |
| Chest Pain | 5 | 5.1 |
| Mean duration of patient follow-up was 34.5 months. |
Congestive Heart Failure
A summary of the incidence of adverse events related to congestive heart failure is provided in Table 6 for the 16-to 24-week add-on to sulfonylurea trials, for the 16-to 24-week add-on to insulin trials, and for the 16-to 24-week add-on to metformin trials. None of the events were fatal.
Table 6: Treatment-Emergent Adverse Events of Congestive Heart Failure (CHF)
| Patients Treated with Glustazon or Placebo Added on to a Sulfonylurea | |||||
| Number (%) of Patients | |||||
| Placebo-Controlled Trial (16 weeks) | Non-Controlled Double-Blind Trial (24 weeks) | ||||
| Placebo + Sulfonylurea N=187 | Glustazon 15 mg + Sulfonylurea N=184 | Glustazon 30 mg + Sulfonylurea N=189 | Glustazon 30 mg + Sulfonylurea N=351 | Glustazon 45 mg + Sulfonylurea N=351 | |
| At least one congestive heart failure event | 2 (1.1%) | 0 | 0 | 1 (0.3%) | 6 (1.7%) |
| Hospitalized | 2 (1.1%) | 0 | 0 | 0 | 2 (0.6%) |
| Patients Treated with Glustazon or Placebo Added on to Insulin | |||||
| Number (%) of Patients | |||||
| Placebo-Controlled Trial (16 weeks) | Non-Controlled Double-Blind Trial (24 weeks) | ||||
| Placebo + Insulin N=187 | Glustazon 15 mg + Insulin N=191 | Glustazon 30 mg + Insulin N=188 | Glustazon 30 mg + Insulin N=345 | Glustazon 45 mg + Insulin N=345 | |
| At least one congestive heart failure event | 0 | 2 (1.0%) | 2 (1.1%) | 3 (0.9%) | 5 (1.4%) |
| Hospitalized | 0 | 2 (1.0%) | 1 (0.5%) | 1 (0.3%) | 3 (0.9%) |
| Patients Treated with Glustazon or Placebo Added on to Metformin | |||||
| Number (%) of Patients | |||||
| Placebo-Controlled Trial (16 weeks) | Non-Controlled Double-Blind Trial (24 weeks) | ||||
| Placebo + Metformin N=160 | Glustazon 30 mg + Metformin N=168 | Glustazon 30 mg + Metformin N=411 | Glustazon 45 mg + Metformin N=416 | ||
| At least one congestive heart failure event | 0 | 1 (0.6%) | 0 | 1 (0.2%) | |
| Hospitalized | 0 | 1 (0.6%) | 0 | 1 (0.2%) |
Patients with type 2 diabetes and NYHA class II or early class III congestive heart failure were randomized to receive 24 weeks of double-blind treatment with either Glustazon at daily doses of 30 mg to 45 mg (n=262) or glyburide at daily doses of 10 mg to 15 mg (n=256). A summary of the incidence of adverse events related to congestive heart failure reported in this study is provided in Table 7.
Table 7: Treatment-Emergent Adverse Events of Congestive Heart Failure (CHF) in Patients with NYHA Class II or III Congestive Heart Failure Treated with Glustazon or Glyburide
| Number (%) of Subjects | ||
| Glustazon N=262 | Glyburide N=256 | |
| Death due to cardiovascular causes (adjudicated) | 5 (1.9%) | 6 (2.3%) |
| Overnight hospitalization for worsening CHF (adjudicated) | 26 (9.9%) | 12 (4.7%) |
| Emergency room visit for CHF (adjudicated) | 4 (1.5%) | 3 (1.2%) |
| Patients experiencing CHF progression during study | 35 (13.4%) | 21 (8.2%) |
Congestive heart failure events leading to hospitalization that occurred during the PROactive trial are summarized in Table 8.
Table 8: Treatment-Emergent Adverse Events of Congestive Heart Failure (CHF) in PROactive Trial
| Number (%) of Patients | ||
| Placebo N=2633 | Glustazon N=2605 | |
| At least one hospitalized congestive heart failure event | 108 (4.1%) | 149 (5.7%) |
| Fatal | 22 (0.8%) | 25 (1.0%) |
| Hospitalized, nonfatal | 86 (3.3%) | 124 (4.7%) |
Cardiovascular Safety
In the PROactive trial, 5238 patients with type 2 diabetes and a history of macrovascular disease were randomized to Glustazon (N=2605), force-titrated up to 45 mg daily or placebo (N=2633) in addition to standard of care. Almost all patients (95%) were receiving cardiovascular medications (beta blockers, ACE inhibitors, angiotensin II receptor blockers, calcium channel blockers, nitrates, diuretics, aspirin, statins and fibrates). At baseline, patients had a mean age of 62 years, mean duration of diabetes of 9.5 years, and mean HbA1c of 8.1%. Mean duration of follow-up was 34.5 months.
The primary objective of this trial was to examine the effect of Glustazon on mortality and macrovascular morbidity in patients with type 2 diabetes mellitus who were at high risk for macrovascular events. The primary efficacy variable was the time to the first occurrence of any event in a cardiovascular composite endpoint that included all-cause mortality, nonfatal myocardial infarction (MI) including silent MI, stroke, acute coronary syndrome, cardiac intervention including coronary artery bypass grafting or percutaneous intervention, major leg amputation above the ankle, and bypass surgery or revascularization in the leg. A total of 514 (19.7%) patients treated with Glustazon and 572 (21.7%) placebo-treated patients experienced at least one event from the primary composite endpoint (hazard ratio 0.90; 95% Confidence Interval: 0.80, 1.02; p=0.10).
Although there was no statistically significant difference between Glustazon and placebo for the three-year incidence of a first event within this composite, there was no increase in mortality or in total macrovascular events with Glustazon. The number of first occurrences and total individual events contributing to the primary composite endpoint is shown in Table 9.
Table 9: PROactive: Number of First and Total Events for Each Component within the Cardiovascular Composite Endpoint
| Cardiovascular Events | Placebo N=2633 | Glustazon N=2605 | ||
| First Events n (%) | Total events n | First Events n (%) | Total events n | |
| Any event | 572 (21.7) | 900 | 514 (19.7) | 803 |
| All-cause mortality | 122 (4.6) | 186 | 110 (4.2) | 177 |
| Nonfatal myocardial infarction (MI) | 118 (4.5) | 157 | 105 (4.0) | 131 |
| Stroke | 96 (3.6) | 119 | 76 (2.9) | 92 |
| Acute coronary syndrome | 63 (2.4) | 78 | 42 (1.6) | 65 |
| Cardiac intervention (CABG/PCI) | 101 (3.8) | 240 | 101 (3.9) | 195 |
| Major leg amputation | 15 (0.6) | 28 | 9 (0.3) | 28 |
| Leg revascularization | 57 (2.2) | 92 | 71 (2.7) | 115 |
| CABG = coronary artery bypass grafting; PCI = percutaneous intervention |
Weight Gain
Dose-related weight gain occurs when Glustazon is used alone or in combination with other antidiabetic medications. The mechanism of weight gain is unclear but probably involves a combination of fluid retention and fat accumulation.
Tables 10 and 11 summarize the changes in body weight with Glustazon and placebo in the 16-to 26-week randomized, double-blind monotherapy and 16-to 24-week combination add-on therapy trials and in the PROactive trial.
Table 10: Weight Changes (kg) from Baseline During Randomized, Double-Blind Clinical Trials
| Control Group (Placebo) | Glustazon 15 mg | Glustazon 30 mg | Glustazon 45 mg | ||
| Median (25th/75th percentile) | Median (25th/75th percentile) | Median (25th/75th percentile) | Median (25th/75th percentile) | ||
| Monotherapy (16 to 26 weeks) | -1.4 (-2.7/0.0) N=256 | 0.9 (-0.5/3.4) N=79 | 1.0 (-0.9/3.4) N=188 | 2.6 (0.2/5.4) N=79 | |
| Combination Therapy (16 to 24 weeks) | Sulfonylurea | -0.5 (-1.8/0.7) N=187 | 2.0 (0.2/3.2) N=183 | 3.1 (1.1/5.4) N=528 | 4.1 (1.8/7.3) N=333 |
| Metformin | -1.4 (-3.2/0.3) N=160 | N/A | 0.9 (-1.3/3.2) N=567 | 1.8 (-0.9/5.0) N=407 | |
| Insulin | 0.2 (-1.4/1.4) N=182 | 2.3 (0.5/4.3) N=190 | 3.3 (0.9/6.3) N=522 | 4.1 (1.4/6.8) N=338 |
Table 11: Median Change in Body Weight in Patients Treated with Glustazon Versus Patients Treated with Placebo During the Double-Blind Treatment Period in the PROactive Trial
| Placebo | Glustazon | |
| Median (25th/75th percentile) | Median (25th/75th percentile) | |
| Change from baseline to final visit (kg) | -0.5 (-3.3, 2.0) N=2581 | +3.6 (0.0, 7.5) N=2560 |
| Note: Median exposure for both Glustazon and Placebo was 2.7 years. |
>
Edema
Edema induced from taking Glustazon is reversible when Glustazon is discontinued. The edema usually does not require hospitalization unless there is coexisting congestive heart failure. A summary of the frequency and types of edema adverse events occurring in clinical investigations of Glustazon is provided in Table 12.
Table 12: Adverse Events of Edema in Patients Treated with Glustazon
| Number (%) of Patients | |||||
| Placebo | Glustazon 15 mg | Glustazon 30 mg | Glustazon 45 mg | ||
| Monotherapy (16 to 26 weeks) | 3 (1.2%) N=259 | 2 (2.5%) N= 81 | 13 (4.7%) N= 275 | 11 (6.5%) N=169 | |
| Combined Therapy (16 to 24 weeks) | Sulfonylurea | 4 (2.1%) N=187 | 3 (1.6%) N=184 | 61 (11.3%) N=540 | 81 (23.1%) N=351 |
| Metformin | 4 (2.5%) N=160 | N/A | 34 (5.9%) N=579 | 58 (13.9%) N=416 | |
| Insulin | 13 (7.0%) N=187 | 24 (12.6%) N=191 | 109 (20.5%) N=533 | 90 (26.1%) N=345 | |
| Note: The preferred terms of edema peripheral, generalized edema, pitting edema and fluid retention were combined to form the aggregate term of “edema.” |
Table 13: Adverse Events of Edema in Patients in the PROactive Trial
| Number (%) of Patients | |
| Placebo N=2633 | Glustazon N=2605 |
| 419 (15.9%) | 712 (27.3%) |
| Note: The preferred terms of edema peripheral, generalized edema, pitting edema and fluid retention were combined to form the aggregate term of “edema.” |
Hepatic Effects
There has been no evidence of induced hepatotoxicity with Glustazon in the Glustazon controlled clinical trial database to date. One randomized, double-blind 3-year trial comparing Glustazon to glyburide as add-on to metformin and insulin therapy was specifically designed to evaluate the incidence of serum ALT elevation to greater than three times the upper limit of the reference range, measured every eight weeks for the first 48 weeks of the trial then every 12 weeks thereafter. A total of 3/1051 (0.3%) patients treated with Glustazon and 9/1046 (0.9%) patients treated with glyburide developed ALT values greater than three times the upper limit of the reference range. None of the patients treated with Glustazon in the Glustazon controlled clinical trial database to date have had a serum ALT greater than three times the upper limit of the reference range and a corresponding total bilirubin greater than two times the upper limit of the reference range, a combination predictive of the potential for severe drug-induced liver injury.
Hypoglycemia
In the Glustazon clinical trials, adverse events of hypoglycemia were reported based on clinical judgment of the investigators and did not require confirmation with fingerstick glucose testing.
In the 16-week add-on to sulfonylurea trial, the incidence of reported hypoglycemia was 3.7% with Glustazon 30 mg and 0.5% with placebo. In the 16-week add-on to insulin trial, the incidence of reported hypoglycemia was 7.9% with Glustazon 15 mg, 15.4% with Glustazon 30 mg, and 4.8% with placebo.
The incidence of reported hypoglycemia was higher with Glustazon 45 mg compared to Glustazon 30 mg in both the 24-week add-on to sulfonylurea trial (15.7% vs. 13.4%) and in the 24-week add-on to insulin trial (47.8% vs. 43.5%).
Three patients in these four trials were hospitalized due to hypoglycemia. All three patients were receiving Glustazon 30 mg (0.9%) in the 24-week add-on to insulin trial. An additional 14 patients reported severe hypoglycemia (defined as causing considerable interference with patient's usual activities) that did not require hospitalization. These patients were receiving Glustazon 45 mg in combination with sulfonylurea (n=2) or Glustazon 30 mg or 45 mg in combination with insulin (n=12).
Urinary Bladder Tumors
Tumors were observed in the urinary bladder of male rats in the two-year carcinogenicity study. In two 3-year trials in which Glustazon was compared to placebo or glyburide, there were 16/3656 (0.44%) reports of bladder cancer in patients taking Glustazon compared to 5/3679 (0.14%) in patients not taking Glustazon. After excluding patients in whom exposure to study drug was less than one year at the time of diagnosis of bladder cancer, there were six (0.16%) cases on Glustazon and two (0.05%) cases on placebo. There are too few events of bladder cancer to establish causality.
Laboratory Abnormalities
Hematologic Effects
Glustazon may cause decreases in hemoglobin and hematocrit. In placebo-controlled monotherapy trials, mean hemoglobin values declined by 2% to 4% in patients treated with Glustazon compared with a mean change in hemoglobin of -1% to +1% in placebo-treated patients. These changes primarily occurred within the first 4 to 12 weeks of therapy and remained relatively constant thereafter. These changes may be related to increased plasma volume associated with Glustazon therapy and are not likely to be associated with any clinically significant hematologic effects.
Creatine Phosphokinase
During protocol-specified measurement of serum creatine phosphokinase (CPK) in Glustazon clinical trials, an isolated elevation in CPK to greater than 10 times the upper limit of the reference range was noted in nine (0.2%) patients treated with Glustazon (values of 2150 to 11400 IU/L) and in no comparator-treated patients. Six of these nine patients continued to receive Glustazon, two patients were noted to have the CPK elevation on the last day of dosing and one patient discontinued Glustazon due to the elevation. These elevations resolved without any apparent clinical sequelae. The relationship of these events to Glustazon therapy is unknown.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Glustazon. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- New onset or worsening diabetic macular edema with decreased visual acuity.
- Fatal and nonfatal hepatic failure.
Postmarketing reports of congestive heart failure have been reported in patients treated with Glustazon, both with and without previously known heart disease and both with and without concomitant insulin administration.
In postmarketing experience, there have been reports of unusually rapid increases in weight and increases in excess of that generally observed in clinical trials. Patients who experience such increases should be assessed for fluid accumulation and volume-related events such as excessive edema and congestive heart failure.
What is the most important information I should know about Glustazon?
- Carry an ID card at all times that says you have diabetes.
- Proper diet, regular exercise, and regular blood sugar testing are important for best results with Glustazon. Follow the diet and exercise program given to you by your health care provider.
- Check your blood sugar levels as directed by your doctor. If they are often higher than they should be and you take Glustazon exactly as prescribed, tell your doctor.
- It may be harder to control your blood sugar during times of stress such as fever, infection, injury, or surgery. Talk with your doctor about how to control your blood sugar if any of these occur. Do not change the dose of your medicine without checking with your doctor.
- It may take 2 to 3 months to get the full effect from Glustazon. Do NOT take more than the recommended dose without checking with your doctor.
- Glustazon may cause low blood sugar levels when it is used along with insulin or other oral diabetic medicines. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
- Glustazon may cause ovulation in women who have not reached menopause but do not ovulate. Be sure to use effective birth control while using Glustazon.
- Tell your doctor or dentist that you take Glustazon before you receive any medical or dental care, emergency care, or surgery.
- Glustazon may be associated with an increased risk of bladder cancer. Tell your doctor right away if you notice symptoms that could be associated with bladder cancer (eg, a red color or blood in the urine, difficult or painful urination, an increased need to urinate). Discuss any questions or concerns with your doctor.
- An increased incidence of bone fracture has been reported in women who take Glustazon. Tell your doctor if you have a history of bone fracture, low calcium intake, or weak bones (eg, osteoporosis). Tell your doctor right away if you experience any unusual bone pain.
- Lab tests, including fasting blood sugar, hemoglobin A, eye examinations, and liver function, may be performed while you use Glustazon. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Glustazon should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Glustazon while you are pregnant. It is not known if Glustazon is found in breast milk. Do not breast-feed while taking Glustazon.
Glustazon contraindications
You should not use this medication if you are allergic to Glustazon, if you have severe heart failure, if you have active bladder cancer, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).
Do not take Glustazon for longer than recommended. Taking this medication for longer than 1 year (12 months) may increase your risk of developing bladder cancer. Talk with your doctor about your specific risk.
Before taking Glustazon, tell your doctor if you have congestive heart failure or heart disease, fluid retention, a history of bladder cancer, a history of heart attack or stroke, or liver disease.
Take care not to let your blood sugar get too low. Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Other sugar sources include orange juice and milk. Be sure your family and close friends know how to help you in an emergency.
Some women using Glustazon have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control.
Women may also be more likely than men to have bone fractures in the upper arm, hand, or foot while taking Glustazon. Talk with your doctor if you are concerned about this possibility.
Certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes with Glustazon.
References
- DTP/NCI. "pioglitazone hydrochloride: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "5-[4-[2-(5-Ethyl-2-pyridyl)ethoxy]benzyl]thiazolidine-2,4-dione: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
- HSDB. "PIOGLITAZONE". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Glustazon are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Glustazon. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported side effects
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Information checked by Dr. Sachin Kumar, MD Pharmacology
