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ACCEL Pioglitazone; ACH-Pioglitazone; ACT Pioglitazone; Actos [DSC]; APO-Pioglitazone; Auro-Pioglitazone [DSC]; DOM-Pioglitazone; JAMP-Pioglitazone; MINT-Pioglitazone; MYLAN-Pioglitazone [DSC]; PHL-Pioglitazone [DSC]; PMS-Pioglitazone; PRO-Pioglitazone; RAN-Pioglitazone; RATIO-Pioglitazone [DSC]; SANDOZ Pioglitazone; TEVA-Pioglitazone; VAN-Pioglitazone
Diabetes mellitus, type 2: Oral:
Initial: 15 to 30 mg once daily; patients with heart failure (NYHA Class I or II) should initiate therapy with 15 mg once daily. Note: Not recommended in patients with symptomatic heart failure
Dosage titration: Based on HbA1c, the dosage may be increased in 15 mg increments up to a maximum of 45 mg once daily; monitor closely during titration for adverse effects (eg, weight gain, edema, signs/symptoms of heart failure)
Dosage adjustment for hypoglycemia with combination therapy:
With an insulin secretagogue (eg, sulfonylurea): Decrease the insulin secretagogue dose.
With insulin: Decrease insulin dose by 10% to 25%; individualize further adjustments per glycemic response
Dosage adjustment with strong CYP2C8 inhibitors (eg, gemfibrozil): Maximum recommended dose: 15 mg once daily
Refer to adult dosing.
No dosage adjustment necessary.
Hepatic impairment prior to initiation: No dosage adjustment necessary; use with caution if baseline liver tests are abnormal
Hepatic impairment during therapy: If liver injury is suspected (eg, fatigue, jaundice, dark urine): Interrupt therapy, measure serum liver tests, and investigate possible etiologies:
If an alternative etiology is not identified and ALT >3 x ULN: Do not reinitiate therapy.
If an alternative etiology is identified and ALT elevated (but <3 x ULN) or total bilirubin elevated (but <2 x ULN): May reinitiate with caution.
Diabetes mellitus, type 2: As an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus
American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE), “Consensus Statement on the Comprehensive Type 2 Diabetes Management Algorithm – 2018 Executive Summary,” January 2018
American Diabetes Association, “Standards of Medical Care in Diabetes – 2018,” January 2018
Diabetes Canada, “Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada,” 2018
May be administered without regard to meals.
Individualized medical nutrition therapy (MNT) is an integral part of therapy
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light, moisture, and humidity.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience headache, common cold symptoms, sinus pain, pharyngitis, muscle pain, or flatulence. Have patient report immediately to prescriber signs of heart problems (cough or shortness of breath that is new or worse, swelling of the ankles or legs, abnormal heartbeat, weight gain of more than five pounds in 24 hours, dizziness, or passing out), bone pain, severe loss of strength and energy, angina, vision changes, painful urination, hematuria, polyuria, signs of low blood sugar (dizziness, headache, fatigue, feeling weak, shaking, tachycardia, confusion, increased hunger, or sweating), or signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice) (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021073s049lbl.pdf#page=35, must be dispensed with this medication.
Hypersensitivity to pioglitazone or any component of the formulation; NYHA Class III/IV heart failure (initiation of therapy)
Canadian labeling: Additional contraindications (not is U.S. labeling): Any stage of heart failure (eg, NYHA Class I, II, III, IV); serious hepatic impairment; active bladder cancer; history of bladder cancer; uninvestigated macroscopic hematuria; pregnancy
Concerns related to adverse effects:
• Bladder cancer: An FDA review concluded that although clinical trial data are inconsistent regarding the risk of bladder cancer in patients exposed to pioglitazone, there is still the potential for an increased risk and package labeling has been updated to reflect this. Avoid use of pioglitazone in patients with active bladder cancer and consider risks versus benefits prior to initiating therapy in patients with a history of bladder cancer.
• Edema: Dose-related edema, including new-onset or exacerbation of existing edema, has been reported; use with caution in patients with edema. Monitor for signs/symptoms of heart failure.
• Fractures: An increased incidence of bone fractures in females treated with pioglitazone has been observed; majority of fractures occurred in the lower limb and distal upper limb. Consider risk of fracture prior to initiation and during use.
• Heart failure/cardiac effects: [US Boxed Warning]: Thiazolidinediones, including pioglitazone, may cause or exacerbate heart failure; closely monitor for signs and symptoms of heart failure (eg, rapid weight gain, dyspnea, edema), particularly after initiation or dose increases; if heart failure develops, treat accordingly and consider dose reduction or discontinuation of pioglitazone. Not recommended for use in any patient with symptomatic heart failure. Initiation of therapy is contraindicated in patients with NYHA class III or IV heart failure; if used in patients with NYHA class I or II (systolic) heart failure, initiate at lowest dosage and monitor closely.
• Hematologic effects: May decrease hemoglobin/hematocrit; effects may be related to increased plasma volume.
• Hepatic effects: Hepatic failure, including fatalities, has been reported. Monitor for signs/symptoms of liver
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
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- •This drug may cause or make heart failure worse in some people. Tell your doctor if you have ever had heart failure. Do not take this drug if you have moderate to very bad heart failure or if you have any signs of heart failure. You will be watched closely for signs of heart failure when you start this drug and if your dose is raised. Call your doctor right away if you have swelling in the arms or legs, shortness of breath or trouble breathing, sudden weight gain or weight gain that is not normal, or are feeling very tired. Talk with your doctor.
- •It is used to lower blood sugar in patients with high blood sugar (diabetes).
- •If you have an allergy to pioglitazone or any other part of this drug.
- •If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- •If you have any of these health problems: Acidic blood problem, bladder cancer, or type 1 diabetes.
- •If the patient is a child. Do not give this drug to a child.
- This is not a list of all drugs or health problems that interact with this drug.
- Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
- •Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
- •Do not drive if your blood sugar has been low. There is a greater chance of you having a crash.
- •The chance of getting bladder cancer may be raised when taking this drug. Talk with the doctor.
- •Check your blood sugar as you have been told by your doctor.
- •Have blood work checked as you have been told by the doctor. Talk with the doctor.
- •Talk with your doctor before you drink alcohol.
- •Follow the diet and workout plan that your doctor told you about.
- •It may be harder to control your blood sugar during times of stress like when you have a fever, an infection, an injury, or surgery. A change in level of physical activity or exercise and a change in diet may also affect your blood sugar. Talk with your doctor.
- •This drug may raise the chance of broken bones. The chance may be higher in women. Broken bones were seen after people took this drug for 1 year. Most of the broken bones happened in the upper arm, hand, or foot. Talk with your doctor about how to keep your bones healthy or if you have any questions.
- •If you are 65 or older, use this drug with care. You could have more side effects.
- •There is a chance of pregnancy in women of childbearing age who have not been ovulating. If you want to avoid pregnancy, use birth control that you can trust while taking this drug.
- •Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
- •Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
- WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- •Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- •Bone pain.
- •Feeling very tired or weak.
- •Change in eyesight.
- •Pain when passing urine or blood in urine.
- •Passing urine more often.
- •Low blood sugar can happen. The chance of low blood sugar may be raised when this drug is used with other drugs for high blood sugar (diabetes). Signs may be dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating. Call your doctor right away if you have any of these signs. Follow what you have been told to do if you get low blood sugar. This may include taking glucose tablets, liquid glucose, or some fruit juices.
- •Very bad and sometimes deadly liver problems have happened with this drug. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- 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:
- •Signs of a common cold.
- •Sinus pain.
- •Sore throat.
- •Muscle pain.
- 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 your national health agency.
- Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- •Take with or without food.
- •To gain the most benefit, do not miss doses.
- •Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
- •Skip the missed dose and go back to your normal time.
- •Do not take 2 doses at the same time or extra doses.
- •Store in the original container at room temperature.
- •Protect from light.
- •Store in a dry place. Do not store in a bathroom.
- •Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- •Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
- •If your symptoms or health problems do not get better or if they become worse, call your doctor.
- •Do not share your drugs with others and do not take anyone else’s drugs.
- •Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- •Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- •Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
- •If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.