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Takeda Submitted an Application for an Additional Indication of Alogliptin for Combination Therapy with Thiazolidinediones, and a New Drug Application of Fixed-Dose Combination of Alogliptin and Pioglitazone HCl in Japan Pharmalive.com/
... of fixed-dose combination (FDC) of alogliptin and pioglitazone HCl (generic name, tradename in Japan: Actos ) to the Ministry of Health, Labour and Welfare in Japan. An NDA for ...

Takeda Submitted an Application for an Additional Indication of Alogliptin The FINANCIAL
... of fixed-dose combination (FDC) of alogliptin and pioglitazone HCl (generic name, tradename in Japan: Actos) to the Ministry of Health, Labour and Welfare in Japan. ...

FDA wants additional data for Takeda's diabetes drug The Money Times
... Alogliptin to become a cash cow for the pharmaceutical giant. Takedas present diabetes treatment, Actos, a top seller, will lose patent protection in 2011. Alogliptin was expected to be ...

Click for the latest world news headlines from EIN News

Takeda's alogliptin rejected, little chance of launch before 2013 PharmaTimes
... to its future success as the company prepares for life after its diabetes blockbuster Actos (pioglitazone), which loses patent protection in the USA in 2011. Also the delay means ...

UPDATE 1-Takeda shares hurt by diabetes drug U.S. setback Reuters
... risks. Analysts said the delay in approval of the successor to Takeda's top-selling drug Actos by around two and a half years from the previously targeted deadline of Friday ...



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Actos (Pioglitazone)


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  Actos

Common uses

This medicine is used to treat type 2 diabetes by reducing the resistance your body has to insulin. It is used either alone or in combination with other anti-diabetes medicines, including metformin or insulin, as part of a diet and exercise program.

Before using

Additional monitoring of your dose or condition may be needed if you are taking ketoconazole, birth control pills, or other medicine for diabetes (such as insulin, glipizide, or glyburide).

Use of Actos is not recommended if you have newly diagnosed or worsening heart failure (acute congestive heart failure), type 1 diabetes, diabetic ketoacidosis, active liver disease, or experienced jaundice with troglitazone. Inform your doctor of any other medical conditions, including heart disease (e.g., chronic congestive heart failure), allergies, pregnancy, or breast-feeding.

Use of Actos in children under age 18 is not recommended. Discuss with your doctor the risks and benefits of giving Actos to your child. Contact your doctor or pharmacist if you have any questions or concerns about taking Actos.

Directions

Follow the directions for using Actos provided by your doctor. This medicine may be taken on an empty stomach or with food. Store Actos at room temperature at 77 degrees f (25 degrees c) in a tightly-closed container, away from heat, moisture, and light.

If you miss a dose of Actos, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Cautions

Do not stop using Actos or other diabetes medicine without first checking with your doctor. Check with your doctor before adjusting the dose of your diabetes medicine or changing your diet. If you are taking Actos with other diabetes medicine, you are at an increased risk of becoming hypoglycemic (low blood sugar). Signs of hypoglycemia include an increased heartbeat, headache, sweating, tremor, increased hunger, changes in vision, nervousness, or tiredness. Discuss with your doctor or nurse how to handle hypoglycemic reactions.

Keep all doctor and laboratory appointments while you are using this medicine. Laboratory and/or medical tests such as liver function tests and hba1c blood levels may be done to monitor your progress or to check for side effects. Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Actos.

Before you begin taking any new medicine, either prescription or over-the-counter, check with your doctor or pharmacist. For women taking birth control pills: Actos may decrease the effectiveness of your birth control pill. To prevent pregnancy, use an additional form of birth control.

For women: Actos may increase your chance of pregnancy by causing ovulation to resume in premenopausal women who have not been ovulating. If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Actos during pregnancy. It is unknown if Actos is excreted in breast milk. Do not breast-feed while taking Actos.

Possible side effects

A side effect that may occur while taking Actos is sore throat. If it continues or is bothersome, check with your doctor.

Contact your doctor immediately if you experience the following side effects: bloating or swelling of ankles, feet, or hands; chest pain; rapid weight gain; shortness of breath; fatigue; unexplained nausea or vomiting; stomach pain; loss of appetite; unusual thirst; unusual amount of urine; dark urine; or yellowing of the skin or eyes. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

If you take too much

If overdose is suspected, contact your local poison control center or emergency room immediately.

Additional information

Follow the dietary plan provided by your doctor. Carry an identification card at all times that says you are diabetic. Monitor your blood sugar levels regularly according to your doctor's directions. If your blood sugar level is often higher than it should be and you are taking Actos according to directions, check with your doctor.

Do not share Actos with others for whom it was not prescribed. Do not use Actos for other health conditions. Keep this product out of the reach of children. If using Actos for an extended period of time, obtain refills before your supply runs out.

Drug interactions

Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Some medicines or medical conditions may interact with Actos. Inform your doctor or pharmacist of all prescription and over-the-counter medicine that you are taking.

 
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