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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.
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