pioglitazone hydrochloride

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pioglitazone hydrochloride Warning - High-alert drug!

Actos
Pharmacologic class: Thiazolidinedione
Therapeutic class: Hypoglycemic
Pregnancy risk category C
FDA Boxed 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-insulindependent) 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.
Route

Onset

Peak

Duration

P.O.

30 min

2 hr

24 hr

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

 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.

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.

Lipid Screening

Measure fasting lipids at least annually in adults with diabetes

o Every 2 yrs for adults with low-risk lipid values (LDL-C <100 mg/dL, HDL-C
>50 mg/dL,
TG <150 mg/dL)

Goals

No overt CVD: LDL-C <100 mg/dL (2.6 mmol/L)

Overt CVD: <70 mg/dL (1.8 mmol/L) (using high-dose statin therapy)

Alternative goal if goals not achieved on maximal statin therapy: 3040% LDL-C
reduction from baseline

Lipid Treatment

Lifestyle modification, focusing on

o Reduce saturated fat, trans fat, cholesterol intake
o Increase omega-3 fatty acids, viscous fiber, plant stenols/sterols intake
o Weight loss (if indicated)
o Increased physical activity

Statin therapy* and lifestyle changes in patients with

o Overt CVD
o No CVD who are aged >40 yrs and have 1 CVD risk factor (family history of
CVD, hypertension, smoking, dyslipidemia, or albuminuria)
o Consider statins in lower-risk patients (no overt CVD, aged <40 yrs) if LDL-C
>100 mg/dL or in presence of multiple CVD risk factors

Source: American Diabetes Association. Standards of medical care in diabetes

2013. Diabetes Care. 2013;36(suppl 1):S11-S66.