Actos (pioglitazone): Diabetes Drug Side Effects & Dosage

Why is Actos (pioglitazone) prescribed to patients?

Actos is used for the treatment of type 2 diabetes
in adults. It is used along with a
healthy
diabetic diet,
regular
exercise,
weight control,
smoking reduction, and careful monitoring of
blood glucose.
Actos may be
used alone or in combination with
metformin (Glucophage,
Glucophage XR, Glumetza, Fortamet, Riomet), a drug in a different
class of anti-diabetic drugs, that also lowers blood glucose.
Actos requires
naturally-secreted insulin to be effective so it is not recommended in
type 1 diabetes where the amount of insulin is very low or absent.
Nevertheless, Actos is approved for treating type 2
diabetes in combination with
insulin as well as another class of
diabetes drugs, the sulfonylureas, that
increases the amount of insulin produced.

What is Actos (pioglitazone)?

Pioglitazone is an oral drug that reduces
the amount of
glucose (sugar) in the blood. It is in a class of anti-diabetic
drugs called thiazolidinediones that are used in the treatment of
type 2 diabetes. The other member in this class is
rosiglitazone (Avandia). (Another
member of this class, troglitazone or Rezulin, was removed from the market
because of
liver toxicity.)

Do I need a prescription for Actos (pioglitazone)?

Yes

Is Actos (pioglitazone) available as a generic drug?

Yes

What are the side effects of Actos (pioglitazone)?

ACTOS BLACK BOX WARNING

Actos and similar drugs can cause or women congestive heart failure in some patients.
Patients should be monitored for signs and symptoms of heart failure (for example, excessive, rapid weight gain, dyspnea, and/or edema) at the beginning of treatment and after dose increases.
Actos is not recommended for patients with symptomatic heart failure and patients with established New York Heart Association (NYHA) Class III or IV heart failure should not use
Actos.

Other side effects of Actos

The most common side effects of Actos alone or in combination with sulfonylureas, metformin, or insulin are:

Possible serious side effects of Actos include:

Dose related fluid
accumulation (edema) can occur especially when combined with insulin. Fluid
accumulation can worsen or lead to heart failure.
Actos should not be
used in patients with heart disease classified by the New York Heart Association
(NYHA) as Class III and IV heart failure or symptomatic heart failure.

Fluid
accumulation also may lead to macular edema, resulting in reduced vision. Actos also can reduce red blood cells.

There have been post-marketing reports of liver failure while taking
Actos.

Actos has been associated
with liver injury. Periodic monitoring of liver-related side effects and liver
tests should be conducted in patients taking Actos.

Symptoms of liver injury are:

Actos should be stopped if patients have symptoms of liver injury and liver function test results that are greater than three times the normal level. Liver blood tests are obtained before starting treatment. Monitoring liver tests during treatment is not recommended for patients without
liver disease.

Actos may cause ovulation in women who have stopped ovulating if they are
premenopausal and
insulin resistant. This may lead to pregnancy. For women (but not men) taking
Actos, there is an increased risk of
bone fractures of the distal bones
of the arm and leg. Patients taking Actos should maintain proper bone
health.

What is the dosage for Actos (pioglitazone)?

Actos is prescribed once daily in doses ranging from 15
to 45 mg.
The recommended starting dose for patients without heart failure is 15
or 30 mg and for those with heart failure it is 15 mg daily. The dose may be
increased in 15 mg intervals to a maximum dose of 45 mg daily if needed.
Actos may be
taken any time of the day, with or without meals.
If a dose is missed on one
day, two doses should not be taken the next day to make up for the missed dose.

Which drugs or supplements interact with Actos (pioglitazone)?

Gemfibrozil reduces the break down of
Actos
by certain liver enzymes, increasing blood levels and possibly side effects of
Actos. The maximum dose of Actos should not exceed 15 mg daily
when combined with gemfibrozil or other drugs that reduce the activity of liver
enzymes that break down Actos. Conversely, rifampin increases the
breakdown of Actos by the liver, reducing blood levels and possibly the
effects of Actos.

Is Actos (pioglitazone) safe to use during pregnancy or while breastfeeding?

There are no adequate studies of Actos in
pregnant
women. Actos may be used in pregnancy if the physician feels the
potential risks are justified.
It is unknown if Actos is secreted in
breast
milk. Therefore, the effect of Actos on the
nursing infant whose mother
is taking Actos is unknown.

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What else should I know about Actos (pioglitazone)?

What preparations of Actos (pioglitazone) are available?

Tablets: 15, 30 and 45 mg.

How should I keep Actos (pioglitazone) stored?

Tablets should be kept at room temperature, 15 C -30 C (59 F -86
F).

How does Actos (pioglitazone) work?

Patients with
type 2 diabetes cannot make enough
insulin, and the cells of their body respond less to the insulin that is
produced. Since insulin is the hormone that stimulates cells to remove glucose
from the blood, the reduced amount of insulin and its reduced effect cause cells
to take up less glucose from the blood and the level of glucose in the blood to
rise. Pioglitazone often is referred to as an "insulin sensitizer" because it
attaches to the insulin receptors on cells throughout the body and causes the
cells to become more sensitive (more responsive) to insulin. As a result, more
glucose is removed from the blood, and the level of glucose in the blood falls.
At least some insulin must be produced by the pancreas in order for pioglitazone
to work. Pioglitazone also lowers the level of glucose in the blood by reducing
the production and secretion of glucose into the blood by the liver. In
addition, pioglitazone may alter the blood concentrations of
lipids (fats) in
the blood. Specifically, it decreases
triglycerides and increases the "good" (HDL)
cholesterol.

When was Actos (pioglitazone) approved by the FDA?

Pioglitazone received FDA approval in July 1999.