Do initiate treatment in patients with active liver disease who have ALT levels >2.5 times the upper limit of normal (ULN); if ALT >3 times the ULN, stop treatment; if ALT is 1.5-3 times the ULN, retest qWeek until normal or until it reaches 3 times the ULN and treatment must be discontinued
Not recommended for patients with symptomatic heart failure; may cause or exacerbate congestive heart failure in some patients; monitor patients carefully after initiating therapy; observe for signs and symptoms of heart failure; if signs and symptoms develop, manage heart failure according to current standards of care; consider discontinuing therapy or reducing the dose
New onset or exacerbation of existing edema and dyspnea reported
Macular edema reported; patients should be seen by an ophthalmologist if any visual symptoms arise during therapy; all diabetic patients should have regular eye exams
Delayed related weight gain reported with use; likely associated with fluid retention and fat accumulation
Thiazolidinediones, which are peroxisome proliferator-activated receptor (PPAR) gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin
Risk of hypoglycemia, in combination with insulin or other oral agents
May result in ovulation in some premenopausal, anovulatory women; ensure adequate contraception
May decrease hemoglobin/hematocrit
Increased fracture risk in females
Use with caution in premenopausal/anovulatory females (patient may resume ovulation and increase the risk of pregnancy)
Discuss potential for unintended pregnancy with premenopausal women as therapy with Glitazon, like other thiazolidinediones, may result in ovulation in some anovulatory women
Increased risk of CHF; not recommended in symptomatic heart failure
8. Cautions with other medicines
Some medicines interfere with the way Glitazon works. Your doctor may need to adjust your dose of Glitazon. They may also recommend checking your blood sugar levels more often.
Tell your doctor if you're taking any of these medicines before starting on Glitazon:
- gemfibrozil, a medicine used to reduce cholesterol
- rifampicin, a medicine for treating tuberculosis
What Other Drugs Interact with Glitazon?
If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.
Glitazon has no known severe interactions with other drugs.
Serious interactions of Glitazon include:
Glitazon has moderate interactions with at least 78 different drugs.
Glitazon has minor interactions with at least 135 different drugs.
This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.
What should I avoid while taking Glitazon (Actos)?
Avoid drinking alcohol. It lowers blood sugar and may interfere with your diabetes treatment.
- Patients with type 2 diabetes cannot make enough insulin, and the cells of their body respond less to the insulin that is produced. Since insulin is the hormone that stimulates cells to remove glucose from the blood, the reduced amount of insulin and its reduced effect cause cells to take up less glucose from the blood and the level of glucose in the blood to rise. Glitazon often is referred to as an "insulin sensitizer" because it attaches to the insulin receptors on cells throughout the body and causes the cells to become more sensitive (more responsive) to insulin. As a result, more glucose is removed from the blood, and the level of glucose in the blood falls. At least some insulin must be produced by the pancreas in order for Glitazon to work. Glitazon also lowers the level of glucose in the blood by reducing the production and secretion of glucose into the blood by the liver. In addition, Glitazon may alter the blood concentrations of lipids (fats) in the blood. Specifically, it decreases triglycerides and increases the "good" (HDL) cholesterol.
What is Glitazon (Actos)?
Glitazon is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. Glitazon is not for treating type 1 diabetes.
Glitazon may also be used for purposes not listed in this medication guide.
Before taking Glitazon, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (such as congestive heart failure, chest pain), liver disease, fluid in your lungs, swelling (edema), anemia, a certain eye problem (macular edema), bladder cancer.
You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.
Limit alcohol while taking this medication because it can increase the risk of developing low blood sugar.
It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because increased stress may require a change in your treatment plan, medications, or blood sugar testing.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Glitazon may increase the risk of bone fracture in women (usually in the upper arm, hand, or foot). See also Notes section.
Glitazon can cause changes in the menstrual cycle (promote ovulation) and increase the risk of becoming pregnant. Consult your doctor or pharmacist about the use of reliable birth control while using this medication.
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Your doctor may substitute insulin for this drug during your pregnancy. Follow all instructions carefully.
It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
What are some other side effects of Glitazon?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
How should I take Glitazon (Actos)?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Glitazon is usually taken once daily, with or without food.
Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, and feeling shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.
Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.
Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.
Glitazon is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.
Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.
The US FDA has released results of its review of Glitazon and bladder cancer and concluded that the data suggests use of this drug may be linked to an increase risk of bladder cancer. A 10-year prospective cohort study in diabetic patients performed by the manufacturer (n=158,918 never users; n=34,181 ever users) identified 1075 newly diagnosed cases of bladder cancer in never users and 186 cases in ever users. The fully adjusted hazard ratio (HR) showed Glitazon use was not associated with an increased risk (HR 1.06 (95% confidence interval 0.89 to 1.26). And while a modest trend towards higher risk with increasing duration was observed, this trend was not statistically significant. Compared to the interim 5-year results, the 10-year results found weaker associations that were not statistically significant. However, there are studies that have shown a statistically significant association between exposure to this drug and bladder cancer and an association between cumulative dose or cumulative duration of exposure and bladder cancer. Overall, this drug may be associated with an increase in the risk of urinary bladder tumors, however there is insufficient data to determine whether this drug is a tumor promoter for urinary bladder tumors.
Uncommon (0.1% to 1%): Bladder cancer
What is Actos (Glitazon)?
- Glitazon is an oral drug that reduces the amount of glucose (sugar) in the blood. It is in a class of anti-diabetic drugs called thiazolidinediones that are used in the treatment of type 2 diabetes. The other member in this class is rosiglitazone (Avandia). (Another member of this class, troglitazone or Rezulin, was removed from the market because of liver toxicity.)
Oral route (Tablet)
Glitazon hydrochloride may cause or worsen congestive heart failure. Monitor patients for signs and symptoms of heart failure after initiation or dose increases. Should such signs and symptoms of congestive heart failure develop, manage according to current standards of care and consider discontinuing therapy or a dose reduction. Glitazon hydrochloride is not recommended in patients with symptomatic heart failure and is contraindicated in patients with established NYHA Class III or IV heart failure.
Along with its needed effects, Glitazon may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking Glitazon:
- Chest pain
- decreased urine output
- dilated neck veins
- extreme fatigue
- irregular breathing
- irregular heartbeat
- problems with teeth
- swelling of the face, fingers, feet, or lower legs
- tightness in the chest
- trouble breathing
- weight gain
- Pain or swelling in the arms or legs without an injury
- pale skin
- trouble with breathing when active
- unusual bleeding or bruising
- unusual tiredness or weakness
Incidence not known
- Dark urine
- loss of appetite
- nausea or vomiting
- stomach pain
- unexplained, rapid weight gain
- yellow eyes or skin
Some side effects of Glitazon may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- Blurred vision or other changes in vision
- dry mouth
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased thirst
- increased urination
- loss of consciousness
- muscle pain or soreness
- problems with your teeth
- runny or stuffy nose
- sore throat
- unexplained weight loss
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Is Actos (Glitazon) safe to use during pregnancy or while breastfeeding?
- There are no adequate studies of Actos in pregnant women. Actos may be used in pregnancy if the physician feels the potential risks are justified.
- It is unknown if Actos is secreted in breast milk. Therefore, the effect of Actos on the nursing infant whose mother is taking Actos is unknown.