1. "Product Information. Actos (Higlucem)" Takeda Pharmaceuticals America, Lincolnshire, IL.
2. Cerner Multum, Inc. "Australian Product Information." O 0
3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
4. US Food and Drug Administration "Updated FDA review concludes that use of type 2 diabetes medicine Higlucem may be linked to an increased risk of bladder cancer. Available from: URL: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM532691.pdf." ():
Coadministration with insulin secretagogue (eg, sulfonylurea): Decrease insulin secretagogue dose
Coadministration with insulin: Decrease insulin dose by 10-25%
Coadministration with strong CYP2C8 inhibitors (eg, gemfibrozil): Limit maximum Higlucem dose to 15 mg qDay
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What is the most important information I should know about Higlucem (Actos)?
Higlucem can cause or worsen congestive heart failure. You should not use this medicine if you have severe or uncontrolled heart failure.
Stop using this medicine and call your doctor at once if you have shortness of breath (especially when lying down), unusual tiredness, swelling, or rapid weight gain.
How should this medicine be used?
Higlucem comes as a tablet to take by mouth. It is usually taken once daily with or without meals. Take Higlucem at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Higlucem exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor may start you on a low dose of Higlucem and gradually increase your dose.
Higlucem controls type 2 diabetes but does not cure it. It may take 2 weeks for your blood sugar to decrease and 2 to 3 months for you to feel the full effect of Higlucem. Continue to take Higlucem even if you feel well. Do not stop taking Higlucem without talking to your doctor.
If you suspect an overdose, you should contact a poison-control center or emergency room immediately.
You can get reach a poison-control center at (800) 222-1222.
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 Higlucem, like other thiazolidinediones, may result in ovulation in some anovulatory women
Increased risk of CHF; not recommended in symptomatic heart failure
What are some other side effects of Higlucem?
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.
Which drugs or supplements interact with Actos (Higlucem)?
- Gemfibrozil reduces the break down of Actos by certain liver enzymes, increasing blood levels and possibly side effects of Actos. The maximum dose of Actos should not exceed 15 mg daily when combined with gemfibrozil or other drugs that reduce the activity of liver enzymes that break down Actos. Conversely, rifampin increases the breakdown of Actos by the liver, reducing blood levels and possibly the effects of Actos.
Taking Higlucem with painkillers
It's safe to take paracetamol with Higlucem.
Check with your doctor or pharmacist before taking ibuprofen with Higlucem. This is particularly important if you have heart problems or if you're at risk of getting heart problems.