It is important to instruct patients to adhere to dietary instructions and
to have blood glucose and glycosylated hemoglobin tested regularly. During
periods of stress such as
fever, trauma, infection, or surgery, medication requirements may change and
patients
should be reminded to seek medical advice promptly.
Patients who experience an unusually rapid increase in weight or edema or who
develop shortness of breath or other symptoms of heart failure while on ACTOS
should
immediately report these symptoms to their physician.
Patients should be told that blood tests for liver function will be performed
prior to the
start of therapy, every two months for the first year, and periodically thereafter.
Patients
should be told to seek immediate medical advice for unexplained nausea, vomiting,
abdominal pain, fatigue, anorexia, or dark urine.
Patients should be told to take ACTOS once daily. ACTOS can be taken with or
without
meals. If a dose is missed on one day, the dose should not be doubled the following
day.
When using combination therapy with insulin or oral hypoglycemic agents, the
risks of
hypoglycemia, its symptoms and treatment, and conditions that predispose to
its devel-
opment should be explained to patients and their family members.
Therapy with ACTOS, like other thiazolidinediones, may result in ovulation
in some
premenopausal anovulatory women. As a result, these patients may be at an increased
risk for pregnancy while taking ACTOS. Thus, adequate contraception in premenopausal
women should be recommended. This possible effect has not been investigated
in clinical studies so the frequency of this occurrence is not known.