pioglitazone hydrochloride
Actos
Pregnancy Risk Category C
How supplied
Tablets: 15 mg, 30 mg, 45 mg
Action
Lowers blood glucose levels by decreasing insulin resistance. Improves sensitivity of insulin in muscle and adipose tissue.
Indication & dosage
Adjunct to diet and exercise to improve glycemic control in patients with type 2 non-insulin-dependent diabetes mellitus; or when diet, exercise, and either a sulfonylurea, metformin, or insulin doesn't result in adequate glycemic control--
Adults: initially, 15 or 30 mg P.O. once daily. For patients who respond inadequately to initial dose, dosage may be increased in increments; maximum dose is 45 mg/day. If used in combination therapy, maximum dose shouldn't exceed 30 mg/day.
Adverse reactions
CNS: headache.
CV: edema.
EENT: sinusitis, pharyngitis.
Hematologic: anemia.
Metabolic: hypoglycemia with combination therapy, aggravated diabetes mellitus, weight gain.
Musculoskeletal: myalgia.
Respiratory: upper respiratory tract infection.
Other: tooth disorder, decreased triglyceride levels, increased high-density lipoprotein cholesterol levels.
Interactions
Drug-drug. Ketoconazole: may inhibit metabolism of pioglitazone. Monitor patient's blood glucose levels more frequently.
Oral contraceptives: may reduce plasma levels of oral contraceptives, resulting in less effective contraception. Advise patients taking drug and oral contraceptives to consider additional birth control measures.
Effects on diagnostic tests
None reported.
Contraindications
Contraindicated in patients with hypersensitivity to drug or its components and in those with type 1 insulin-dependent diabetes mellitus, clinical evidence of active liver disease, serum ALT level greater than 21/2 times the upper limit of normal, or New York Heart Association class III or IV heart failure; also contraindicated in patients who experienced jaundice while taking troglitazone and in the treatment of diabetic ketoacidosis.
Nursing considerations
- Use cautiously in patients with edema or heart failure.
- Alert:
Measure liver enzymes at start of therapy, every 2 months for first year of therapy, and periodically thereafter. Liver function tests also should be done in patients who develop signs and symptoms of liver dysfunction, such as nausea, vomiting, abdominal pain, fatigue, anorexia, or dark urine. Discontinue drug if patient develops jaundice or if results of liver functions tests show elevations in ALT levels greater than three times upper limit of normal.
- Because ovulation may resume in premenopausal, anovulatory women with insulin resistance, recommend use of additional contraceptive measures.
- Drug should be used in pregnancy only if the benefit justifies risk to fetus. Insulin is the preferred antidiabetic for use during pregnancy.
- Monitor patients with heart failure for increased edema.
- Hemoglobin level and hematocrit may decrease, usually during first 4 to 12 weeks of therapy.
- Patients with normal liver enzyme levels who are switched from troglitazone therapy should undergo a 1-week washout period before starting pioglitazone.
- Management of type 2 diabetes should include diet control. Because caloric restrictions, weight loss, and exercise help improve insulin sensitivity and help make drug therapy effective, these measures are essential for proper diabetes management.
- Watch for hypoglycemia in patients receiving pioglitazone with insulin or a sulfonylurea. Dosage adjustments of these drugs may be needed.
- Monitor blood glucose levels regularly, especially during situations of increased stress, such as infection, fever, surgery, and trauma.
- Blood glucose and glycosylated hemoglobin levels should be checked periodically, as ordered, to evaluate therapeutic response to drug.
- Safety and efficacy of drug in children haven't been evaluated.
- Alert:
Don't confuse pioglitazone with troglitazone or rosiglitazone.
Patient teaching
- Instruct patient to adhere to dietary instructions and to have blood glucose and glycosylated hemoglobin levels tested regularly.
- Inform patient taking pioglitazone with insulin or oral antidiabetics of signs and symptoms of hypoglycemia.
- Advise patient to notify doctor during periods of stress, such as fever, trauma, infection, or surgery, because dosage may have to be changed.
- Notify patient that blood tests for liver function will be performed before start of therapy, every 2 months for first year, and periodically thereafter.
- Tell patient to report unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or dark urine immediately because these signs and symptoms may indicate potential liver problems.
- Inform patient that drug can be taken with or without meals. If a dose is missed, it shouldn't be doubled the following day.
- Advise anovulatory, premenopausal women with insulin resistance that therapy may cause resumption of ovulation; recommend use of contraceptive measures.
*Liquid contains alcohol. **May contain tartrazine. †Canada ‡Australia §U.K. OTCOver the counter
Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE-THREATENING