Ensudyne 30 mg

Pioglitazone 30 mg

Warnings
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
  1. Pioglitazone may be linked to an increased risk of bladder cancer
  2. Do not prescribe for patients with active bladder cancer
  3. Consider benefit:risk ratio before prescribing in patients with a history of bladder cancer
  4. 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
  1. 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
  1. 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)