Actos (pioglitazone) dosing, indications, interactions, adverse effects, and more

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Sections pioglitazone
Dosing & Uses
Interactions
Adverse Effects
Warnings
Pregnancy
Pharmacology
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Patient Handout
Formulary

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

15mg
30mg
45mg

Type 2 Diabetes Mellitus

Indicated as monotherapy or with insulin or insulin secretagogues

15-30 mg PO with meal qDay initial; may increase dose by 15 mg with careful monitoring to 45 mg qDay maximum

Monitor ALT at start of treatment, qMonth for 12 months, q3Months thereafter

Dosage Modification

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 pioglitazone dose to 15 mg qDay

X-Linked Adrenoleukodystrophy (Orphan)

Hydroxypioglitazone: Orphan designation for treatment of X-linked adrenoleukodystrophy

Sponsor

Minoryx Therapeutics S.L.; TecnoCampus Mataro-Maresme. TCM3 602, Av. Ernest Lluch, 32; Mataró, Spain

Hearing Loss (Orphan)

Orphan designation for treatment of sudden sensorinueural hearing loss

Sponsor

Strekin AG; 60C Hochbergerstrasse; Basel, Switzerland

Not recommended

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>10%

Edema when used in combination with sulfonylurea or insulin (<27%)

Hypoglycemia (<27%)

Upper respiratory infection (13%)

1-10%

Headache (9%)

Heart failure (up to 8%)

Sinusitis (6%)

Fracture of bone (5%)

Pharyngitis (5%)

Myalgia (5%)

Frequency Not Defined

Aggravated diabetes

Diabetic macular edema

Hepatic failure (rare)

Increased cholesterol

Decreased serum triglycerides

Hematocrit/hemoglobin

Bladder cancer

Decreased visual acuity

Dyspnea

Increased transaminases

Pharyngitis

Sinusitis

Weight gain

Black Box Warnings

Thiazolidinediones, including pioglitazone and rosiglitazone, cause or exacerbate congestive heart failure in some patients

After initiation of these drugs, as well as after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain; dyspnea; and/or edema); if these signs or symptoms develop, the heart failure should be managed according to the current standards of care; furthermore, discontinuation or dose reduction of these drugs must be considered.

These drugs are not recommended for patients with symptomatic heart failure; initiation of these drugs in patients with established NYHA class III or IV heart failure is contraindicated

Contraindications

Hypersensitivity to pioglitazone

Diabetic ketoacidosis

Moderate-severe hepatic impairment (ALT >2.5x ULN)

CHF (NYHA class III, IV)

Cautions

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 pioglitazone, like other thiazolidinediones, may result in ovulation in some anovulatory women

Increased risk of CHF; not recommended in symptomatic heart failure

Cancer risk

Bladder cancer
- Pioglitazone may be linked to an increased risk of bladder cancer
- Do not prescribe for patients with active bladder cancer
- Consider benefit:risk ratio before prescribing in patients with a history of bladder cancer
- Instruct patients to contact their physician if signs of bladder cancer observed after initiating therapy (eg, blood or red colored urine, new or worsening urinary urgency, pain on urination)
Prostate cancer
- 7/22/2015: Compared with nonuse, pioglitazone use was associated with increased risk for prostate cancer (453.3 vs. 449.3 per 100,000 person-years) [JAMA 2015 July 21;314(3):265-277]
Pancreatic cancer
- 7/22/2015: Compared with nonuse, pioglitazone use was associated with increased risk for pancreatic cancer (81.1 vs. 48.4 per 100,000 person-years)

Pregnancy & Lactation

Pregnancy: Limited data with pioglitazone in pregnant women are not sufficient to determine a drug- associated risk for major birth defects or miscarriage; there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy; poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, still birth and delivery complications; poorly controlled diabetes increases fetal risk for major birth defects, still birth, and macrosomia related morbidity

Lactation: There is no information regarding the presence of pioglitazone in human milk, the effects on the breastfed infant, or the effects on milk production; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for pioglitazone and any potential adverse effects on the breastfed infant from pioglitazone or from the underlying maternal condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Improves target-cell response to insulin; decreases hepatic gluconeogenesis; depends on the presence of insulin for activity

Absorption

Onset: Initial effect (delayed), max effect (several weeks)

Duration: 24 hr

Peak plasma time: 2-4 hr (delayed by food)

Distribution

Protein bound: >99%

Vd: 0.63 L/kg

Metabolism

Metabolized by hepatic CYP2C8 and CYP3A4 into active metabolites

Active metabolites: Metabolite II (hydroxy derivative), metabolite III (keto derivative), metabolite IV (active hydroxy derivative)

Elimination

Half-life: 3-7 hr

Excretion: Urine (15-30%)

BRAND	FORM.	UNIT PRICE	PILL IMAGE
pioglitazone oral -	45 mg tablet
pioglitazone oral -	30 mg tablet
pioglitazone oral -	15 mg tablet
pioglitazone oral -	15 mg tablet
pioglitazone oral -	15 mg tablet
pioglitazone oral -	15 mg tablet
pioglitazone oral -	45 mg tablet
pioglitazone oral -	30 mg tablet
pioglitazone oral -	45 mg tablet
pioglitazone oral -	30 mg tablet
pioglitazone oral -	30 mg tablet
pioglitazone oral -	15 mg tablet
pioglitazone oral -	45 mg tablet
pioglitazone oral -	45 mg tablet
pioglitazone oral -	30 mg tablet
pioglitazone oral -	15 mg tablet
pioglitazone oral -	45 mg tablet
pioglitazone oral -	30 mg tablet
pioglitazone oral -	30 mg tablet
pioglitazone oral -	15 mg tablet
pioglitazone oral -	45 mg tablet
pioglitazone oral -	45 mg tablet
pioglitazone oral -	15 mg tablet
pioglitazone oral -	30 mg tablet
pioglitazone oral -	45 mg tablet
pioglitazone oral -	30 mg tablet
pioglitazone oral -	30 mg tablet
pioglitazone oral -	15 mg tablet
pioglitazone oral -	15 mg tablet
pioglitazone oral -	45 mg tablet
pioglitazone oral -	30 mg tablet
Actos oral -	45 mg tablet
Actos oral -	30 mg tablet
Actos oral -	15 mg tablet

Patient Handout

PIOGLITAZONE - ORAL

(PYE-oh-GLI-ta-zone)

COMMON BRAND NAME(S): Actos

WARNING: Pioglitazone may rarely cause or worsen a certain heart problem (heart failure). Tell your doctor right away if you notice any symptoms of heart failure, including: shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain.This medication is not recommended for people with certain types of heart failure. Before using this medication, tell your doctor if you have heart failure.

USES: Pioglitazone is a diabetes drug (thiazolidinedione-type, also called "glitazones") used along with a proper diet and exercise program to control high blood sugar in patients with type 2 diabetes. It works by helping to restore your body's proper response to insulin, thereby lowering your blood sugar.Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.Pioglitazone is used either alone or in combination with other diabetes medications (such as metformin or a sulfonylurea such as glyburide).Talk to your doctor about the risks and benefits of pioglitazone.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using pioglitazone and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once daily. Dosage is based on your medical condition, response to treatment, and if you are taking other diabetes drugs. Your doctor will adjust your dose based on your blood sugar to find the best dose for you. Follow your doctor's directions carefully.Take this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day.If you are already taking another diabetes drug (such as metformin or a sulfonylurea), follow your doctor's directions carefully for stopping/continuing the old drug and starting this medication. Carefully follow the medication treatment plan, meal plan, and exercise program your doctor has recommended.Check your blood sugar regularly as directed by your doctor. Keep track of the results, and share them with your doctor. Tell your doctor if your blood sugar measurements are too high or too low. Your dosage/treatment may need to be changed. It may take up to 2 to 3 months before the full benefit of this drug takes effect.

SIDE EFFECTS: See also Warning section.Sore throat, muscle pain, weight gain, or tooth problems may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: new/worsening vision problems (such as blurred vision), bone fracture, reddish-colored urine, urgent need to urinate, pain while urinating.Pioglitazone may rarely cause liver disease. Tell your doctor right away if you develop symptoms of liver disease, including: nausea/vomiting that doesn't stop, dark urine, yellowing of eyes/skin, stomach/abdominal pain.Pioglitazone does not usually cause low blood sugar (hypoglycemia). Low blood sugar may occur if this drug is prescribed with other diabetes medications (such as insulin or a sulfonylurea). Low blood sugar is more likely if you drink large amounts of alcohol, do unusually heavy exercise, or do not consume enough calories from food. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product.Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. If these symptoms occur, tell your doctor right away. Your dosage may need to be increased.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking pioglitazone, 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).Pioglitazone may increase the risk of bone fracture in women (usually in the upper arm, hand, or foot). See also Notes section.Pioglitazone 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.During pregnancy, this medication should be used only when clearly needed. 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.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Other medications can affect the removal of pioglitazone from your body, which may affect how pioglitazone works. Examples include gemfibrozil, rifamycins including rifampin, among others.Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness, hunger, or sweating, are unaffected by these drugs.Many drugs can affect your blood sugar, making it harder to control. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.Attend a diabetes education program to learn more about how to manage your diabetes with medications, diet, exercise, and regular medical exams.Learn the symptoms of high and low blood sugar and how to treat low blood sugar. Check your blood sugar regularly as directed and share the results with your doctor.Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, eating well-balanced meals containing adequate calcium and vitamin D, stopping smoking, and limiting alcohol. Consult your doctor to see if you need to take calcium/vitamin D supplements and discuss lifestyle changes that might benefit you.Lab and/or medical tests (such as liver function tests, blood glucose, hemoglobin A1c, complete blood counts, eye exams) should be done while you are taking this medication. Keep all medical and lab appointments.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Formulary

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View explanations for tiers and restrictions

Tier	Description
1	This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2	This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC	NOT COVERED – Drugs that are not covered by the plan.

Code	Definition
PA	Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL	Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST	Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR	Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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