Actos
pioglitazone hydrochloride
Pharmacologic class: Thiazolidinedione
Therapeutic class: Hypoglycemic
Pregnancy risk category C
FDA Box Warning
• Drug may cause or exacerbate heart failure. After starting therapy or increasing dosage, observe patient carefully for signs and symptoms of heart failure. If these develop, manage patient according to current standards of care and consider discontinuing drug or reducing dosage.
• Drug isn't recommended in patients with symptomatic heart failure. In patients with established New York Heart Association Class III or IV heart failure, drug initiation is contraindicated.
Action
Enhances insulin sensitivity in muscle and adipose tissue; inhibits hepatic gluconeogenesis
Availability
Tablets: 15 mg, 30 mg, 45 mg
Indications and dosages
➣ Adjunct to diet and exercise to improve glycemic control in type 2 (non-insulin-dependent) diabetes mellitus
Adults: 15 to 30 mg/day; may increase to 45 mg/day if needed
Contraindications
• Hypersensitivity to drug, its components, or rosiglitazone
• Established New York Heart Association Class III or IV heart failure
Precautions
Use cautiously in:
• edema, hepatic impairment
• symptomatic heart failure (use not recommended)
• female patients of childbearing age
• pregnant or breastfeeding patients
• children (safety and efficacy not established).
Administration
• Give with or without food.
• Know that drug may be used with sulfonylureas, metformin, or insulin when combination of diet, exercise, and monotherapy doesn't achieve adequate glycemic control.
Adverse reactions
CNS: headache
CV: congestive heart failure (CHF) or exacerbation of CHF
EENT: sinusitis, pharyngitis
Hematologic: anemia
Metabolic: aggravation of diabetes mellitus, hypoglycemia, hyperglycemia
Musculoskeletal: myalgia
Respiratory: upper respiratory infection
Other: tooth disorders, pain, edema
Interactions
Drug-drug.
Hormonal contraceptives: decreased contraceptive efficacy
Ketoconazole: increased pioglitazone effects
Drug-diagnostic tests. Creatine kinase: transient increase
Hematocrit, hemoglobin: decreased values (usually during first 4 to 12 weeks of therapy)
Drug-herbs. Chromium, coenzyme Q10, fenugreek: additive hypoglycemic effects
Glucosamine: poor glycemic control
Patient monitoring
See Monitor patient carefully for signs and symptoms of heart failure (including excessive, rapid weight gain; dyspnea; and edema) after initiation and after dosage increases. Consider discontinuation or dosage reduction if these symptoms appear.
• Assess patient's weight and compliance with diet and exercise program.
• Monitor liver function tests before and during therapy.
• Monitor glycosylated hemoglobin, hemoglobin, hematocrit, and blood glucose levels.
• Assess for signs and symptoms of hypoglycemia or hyperglycemia.
Patient teaching
• Instruct patient to take exactly as prescribed. Tell him he may take drug without regard to food.
• Tell patient drug may increase his risk for EENT and respiratory infections. Instruct him to contact prescriber if symptoms occur.
See Advise patient to immediately report unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, dark urine, fever, trauma, infection, rapid weight gain, edema, or shortness of breath.
• Tell premenopausal anovulatory patient that drug may cause ovulation. Recommend use of reliable contraception.
• Advise female of childbearing age to contact prescriber promptly if pregnancy occurs.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.
pioglitazone
(pi-o-glit-a-zone) pioglitazone,Actos
(trade name)Classification
Therapeutic: antidiabeticsPharmacologic: thiazolidinediones
Indications
Action
Therapeutic effects
Pharmacokinetics
Time/action profile (effects on blood glucose)
| ROUTE | ONSET | PEAK | DURATION |
|---|---|---|---|
| PO | 30 min | 2–4 hr | 24 hr |
Contraindications/Precautions
Adverse Reactions/Side Effects
Cardiovascular
- chf (life-threatening)
- edema
Ear, Eye, Nose, Throat
- macular edema
Gastrointestinal
- liver failure (life-threatening)
- ↑ liver enzymes
Genitourinary
- bladder cancer (especially after >1 yr) (life-threatening)
Hematologic
- anemia
Musculoskeletal
- rhabdomylolysis (life-threatening)
Miscellaneous
- fractures (arm, hand, foot) in female patients
Interactions
Drug-Drug interaction
May ↓ efficacy of hormonal contraceptives.Strong CYP2C8 inhibitors, including gemfibrozil may ↑ levels.Ketoconazole may ↑ effects of pioglitazone.Concurrent use with insulin may ↑ risk of fluid retention and worsening HF.Glucosamine may worsen blood glucose control.Chromium, and coenzyme Q-10 may produce ↑ hypoglycemic effects.Route/Dosage
Availability (generic available)
Nursing implications
Nursing assessment
- Observe patient taking concurrent insulin for signs and symptoms of hypoglycemic reactions (sweating, hunger, weakness, dizziness, tremor, tachycardia, anxiety).
- Assess for signs and symptoms of heart failure (edema, dyspnea, rapid weight gain, unusual tiredness) after initiation and with dose increases.
- Lab Test Considerations: Monitor serum glucose and Hb A1c periodically during therapy to evaluate effectiveness.
- Monitor CBC with differential periodically during therapy. May cause ↓ in hemoglobin and hematocrit, usually during the first 4–12 wk of therapy; then levels stabilize.
- Monitor serum AST, ALT, alkaline phosphatase, and total bilirubin levels before starting therapy and periodically thereafter or if jaundice or symptoms of hepatic dysfunction occur. Pioglitazone should not be started in patients with active liver disease or ALT levels >2.5 times the upper limit of normal. Patients with mild ALT ↑ should have more frequent monitoring. If ALT ↑ to >3 times the upper limit of normal, recheck ALT promptly. Discontinue pioglitazone if ALT remains >3 times normal.
- May cause transient ↑ in CPK levels.
Potential Nursing Diagnoses
Imbalanced nutrition: more than body requirements (Indications)Noncompliance (Patient/Family Teaching)
Implementation
- Do not confuse Actos (pioglitazone) with Actonel (risedronate).
- Patients stabilized on a diabetic regimen who are exposed to stress, fever, trauma, infection, or surgery may require administration of insulin.
- Oral: May be administered with or without meals.
Patient/Family Teaching
- Instruct patient to take medication as directed. If dose for 1 day is missed, do not double dose the next day.
- Explain to patient that this medication controls hyperglycemia but does not cure diabetes. Therapy is long-term.
- Review signs of hypoglycemia and hyperglycemia with patient. If hypoglycemia occurs, advise patient to take a glass of orange juice or 2–3 tsp of sugar, honey, or corn syrup dissolved in water and notify health care professional.
- Encourage patient to follow prescribed diet, medication, and exercise regimen to prevent hypoglycemic or hyperglycemic episodes.
- Instruct patient in proper testing of serum glucose and ketones. These tests should be closely monitored during periods of stress or illness, and health care professional should be notified if significant changes occur.
- Advise patient to notify health care professional immediately if signs of hepatic dysfunction (nausea, vomiting, upper right abdominal pain, fatigue, anorexia, dark urine, jaundice), bladder cancer (hematuria, dysuria, urinary urgency), or HF (edema, shortness of breath, rapid weight gain, tiredness) occur.
- Advise patient to inform health care professional of medication regimen before treatment or surgery.
- Insulin is the preferred method of controlling blood glucose during pregnancy. Counsel female patients that higher doses of oral contraceptives or a form of contraception other than oral contraceptives may be required and to notify health care professional promptly if pregnancy is planned or suspected.
- Advise patient to carry a form of sugar (sugar packets, candy) and identification describing disease process and medication regimen at all times.
- Emphasize the importance of routine follow-up exams.
Evaluation/Desired Outcomes
- Control of blood glucose levels.