is an anti-HIV medication. It is in a category
of HIV medications called nucleoside
reverse transcriptase inhibitors (NRTIs).
Retrovir prevents HIV from altering the genetic
material of healthy T-cells. This prevents the
cells from producing new virus and decreases
the amount of virus in the body.
Retrovir, manufactured by GlaxoSmithKline, was
the first drug approved for the treatment of
HIV, in 1987.
Generic versions of zidovudine for distribution
in the United States were approved in September
2005: zidovudine tablets (made by Ranbaxy Laboratories
of Gurgaon, India; Aurobindo Pharma of Hyderabad,
India; and Roxane Laboratories of Columbus,
Ohio) and zidovudine oral solution (made by
Aurobindo Pharma). A capsule version of zidovudine
(made by Aurobindo Pharma) was approved for
sale in the United States in March 2006.
Retrovir must be used in combination with at
least two other anti-HIV drugs.
There are actually five ways that Retrovir can
a syrup formula for babies and young children
who have a difficult time swallowing pills*;
2) as a tablet containing 300mg Retrovir
(used in combination with at least two other
3) as a tablet that combines a single
dose of Retrovir with a single dose of Epivir
(3TC) (sold as Combivir;
used in combination with at least one other
4) as a tablet that combines single
doses of Retrovir, Epivir,
and Ziagen (abacavir)
(sold as Trizivir;
can be used alone by some HIV-positive people
or used in combination with at least one other
5) as a liquid that can be administered
intravenously (though an IV line), used mostly
to treat babies and children who are hospitalized
or pregnant women at the time of delivery.
versions also available in the United States
like other HIV medicines, can cause a condition
called lactic acidosis and severe liver problems.
Lactic acidosis occurs when acid builds up in
the blood, which can affect how the body functions.
In some cases, lactic acidosis can cause death.
Nausea and tiredness that don't get better may
be symptoms of lactic acidosis
sure to see your doctor regularly because other
serious side effects can occur, such as muscle
damage and a decrease in red and/or white blood
cells, especially in patients with advanced
HIV or AIDS
of liver disease (sometimes resulting in death)
has occurred in patients infected with both
HIV and hepatitis C virus who are taking anti-HIV
medicines and are also being treated for hepatitis
C with interferon with or without ribavirin.
If you are taking RETROVIR as well as interferon
with or without ribavirin, and you experience
side effects, be sure to tell your doctor
you start taking HIV medicines, your immune
system may get stronger and may begin to fight
infections that have been hidden in your body,
such as pneumonia, herpes virus, or tuberculosis.
If you have new symptoms after starting your
HIV medicines, be sure to tell your doctor
in body fat may occur in some patients taking
antiretroviral therapy. These changes may include
an increased amount of fat in the upper back
and neck ("buffalo hump"), breast,
and around the trunk. Loss of fat from the legs,
arms, and face may also occur. The cause and
long-term health effects of these conditions
are not known at this time
most common side effects with RETROVIR were
headache, weakness or tiredness, nausea, loss
of appetite, and vomiting
are not all the side effects you could have
when taking this medicine. Your healthcare professional
can talk to you about these and other side effects
your doctor promptly about any side effects
or other unusual symptoms you may experience
is known about Retrovir?
HIV-positive adults, the Retrovir dose is 600mg
a day, taken by mouth. The usual dose is 300mg,
taken twice a day, combined with other anti-HIV
drugs. The manufacturer of Retrovir is conducting
studies to see if Retrovir can be taken once
a day, but these have not yet been completed.
can be taken either with or without food.
and children can also take Retrovir, using the
syrup formulation. The dose depends on a baby's
size or a child's weight. If you are caring
for a child who is HIV-positive and has been
prescribed Retrovir, be sure that you understand
the correct dose to give the child. As a child
grows, the dose of Retrovir will need to be
increased on a regular basis.
studies have demonstrated that Retrovir is effective
for the treatment of HIV when combined with
other anti-HIV drugs, usually at least one other
nucleoside reverse transcriptase inhibitor (NRTI)
and either a protease inhibitor or non-nucleoside
reverse transcriptase inhibitor (NNRTI). Retrovir
should not be taken alone (as monotherapy) or
with just one other anti-HIV drug.
HIV-positive adults beginning anti-HIV drug
therapy for the first time, Retrovir is listed
as a "preferred" NRTI optionused
in combination with either Epivir
(3TC) or Emtriva
(emtricitabine)by the United States
Department of Health and Human Services in its
is safe and effective when used during the second
and third trimesters of pregnancy (the last
six months), during the time of delivery, and
in babies born to HIV-positive mothers. HIV-positive
women who do not take anti-HIV medications while
they are pregnant or at the time of delivery
have a 30% chance of giving birth to an HIV-positive
baby. One important clinical trial conducted
by the U.S. government (ACTG 076) demonstrated
that AZT treatment during pregnancy can reduce
this risk to 8%. This requires taking Retrovir
by mouth during pregnancy, and receiving Retrovir
through an IV line at the time of delivery.
After delivery, the baby will take Retrovir
syrup, by mouth, four times a day for six weeks.
about drug interactions?
should not be combined with Zerit
(d4T). They are "antagonistic,"
which means that they do not work well together
and can cause additional side effects.
laboratory studies have suggested that Retrovir
should not be combined with either Rebetol
or Copegus, two brand-name versions of ribavirin.
Ribavirin is an oral medication used to treat
hepatitis C. In these studies, ribavirin appeared
to affect the way Retrovir is broken down by
the body into its active form. This can make
Retrovir less effective against HIV. However,
many doctors report that this hasn't been in
a problem in their patients taking both drugs.
can interact with some medications used to treat
TB, MAC and other bacterial infections. Rifadin
(rifampin) and Mycobutin (rifabutin) can lower
levels of Retrovir in the bloodstream, which
can cause the drug to be less effective against
HIV. If you need to take Rifadin or Mycobutin,
it might be necessary to switch your Retrovir
for another nucleoside reverse transcriptase
inhibitor (NRTI) that does not interact with
about side effects?
marrow problems, such as decreased production
of red blood cells and/or white blood cells,
can occur in people talking Retrovir. Contact
your doctor immediately if you develop unusual
fatigue, pale skin, sore throat, fever, or chills,
which may be signs of bone marrow problems.
These problems are more likely to occur if you
combine Retrovir with other drugs that cause
these same side effects. Examples of other drugs
that can cause bone marrow problems include
ganciclovir (Cytovene), SMX-TMP (Bactrim; Septra),
and various chemotherapy drugs used to treat
rare but potentially serious side effect of
Retrovir is myopathy (damage to the muscles,
including the heart). People who use Retrovir
for a long period of time, meaning several years,
are at the greatest risk for myopathy. General
symptoms of myopathy include weakness of limbs,
usually proximal (located close to the center
of the body).
acidosis, which can be fatal, and severe liver
problems (fatty liver) have been reported in
people taking nucleoside reverse transcriptase
inhibitors (NRTIs). Contact your doctor immediately
if you experience nausea, vomiting, or unusual
or unexpected stomach discomfort; weakness and
tiredness; shortness of breath; weakness in
the arms and legs; yellowing of the skin or
eyes; or pain in the upper stomach area. These
problems are more likely to occur in HIV-positive
people taking Zerit (d4T),
or Zerit in combination with Videx/Videx
EC (ddI). However, there have been some
reports of these potentially serious side effects
occurring in people taking Retrovir.
tired (fatigue), rash, trouble sleeping (insomnia),
nausea, and headache can also be caused by Retrovir.
pregnant women take Retrovir?
is classified by the FDA as a pregnancy category
C drug. Pregnancy category C means that animal
studies have shown an adverse effect on the
fetus and there are no adequate and well-controlled
studies in humans, but potential benefits may
warrant use of the drug in pregnant women despite
potential risks. HIV-positive women who become
pregnant should discuss the benefits and possible
side effects of anti-HIV treatment to help protect
their babies from HIV.
guidelines on treating pregnant women recommend
that Retrovir be used at least during the last
trimester of pregnancy no matter a woman's viral
load or what other antiretrovirals she may be
taking. This is to help prevent a woman from
passing on HIV to her newborn.
is not known whether Retrovir passes into breast
milk and what effects it may have on a nursing
baby. However, to prevent HIV transmission of
the virus to uninfected babies, it is recommended
that HIV-positive mothers not breast-feed.