Brand
name: DUOVIR
(Combivir, Lamivudine/Zidovudine)
Generic name: Zidovudine
Why is DUOVIR (Combivir, Lamivudine/Zidovudine) prescribed?
DUOVIR (Combivir, Lamivudine/Zidovudine) is prescribed for adults infected with human immunodeficiency
virus (HIV). HIV causes the immune system to break down so that it
can no longer respond effectively to infection, leading to the fatal
disease known as acquired immune deficiency syndrome (AIDS). DUOVIR (Combivir, Lamivudine/Zidovudine) slows down the progress of HIV. Combining DUOVIR (Combivir, Lamivudine/Zidovudine) with other
drugs such as Epivir and Crixivan can help slow the progression.
DUOVIR (Combivir, Lamivudine/Zidovudine) is also prescribed for HIV-infected children over 3 months
of age who have symptoms of HIV or who have no symptoms but, through
testing, have shown evidence of impaired immunity.
DUOVIR (Combivir, Lamivudine/Zidovudine) taken during pregnancy often prevents transmission of HIV
from mother to child.
Signs and symptoms of HIV disease are significant weight loss, fever,
diarrhea, infections, and problems with the nervous system.
Most important fact about DUOVIR (Combivir, Lamivudine/Zidovudine)
The long-term effects of treatment with zidovudine are unknown. However,
treatment with DUOVIR (Combivir, Lamivudine/Zidovudine) may lead to blood diseases, including granulocytopenia
(a severe blood disorder characterized by a sharp decrease of certain
types of white blood cells called granulocytes) and severe anemia requiring
blood transfusions. This is especially true in women, individuals who
are overweight, people who have been using DUOVIR (Combivir, Lamivudine/Zidovudine) for a long time,
people with more advanced HIV, and those who start treatment later
in the course of their infection.
Also, because DUOVIR (Combivir, Lamivudine/Zidovudine) is not a cure for HIV infections or AIDS,
those who are infected may continue to develop complications, including
opportunistic infections (exotic infections that develop when the immune
system falters). Therefore, frequent blood counts by your doctor are
strongly advised. Notify your doctor immediately of any changes in
your general health.
How should you take DUOVIR (Combivir, Lamivudine/Zidovudine)?
Take DUOVIR (Combivir, Lamivudine/Zidovudine) exactly as prescribed by your doctor. Do not share
DUOVIR (Combivir, Lamivudine/Zidovudine) with anyone and do not exceed your recommended dosage. Take
it at even intervals every 4 hours around the clock (children every
6 hours).
If you are pregnant, take the drug 5 times a day.
If you miss a dose...
Take it as soon as you remember. If it is almost time for your next
dose, skip the one you missed and go back to your regular schedule.
Do not take 2 doses at once.
Storage instructions...
Tablets, capsules, and syrup should be stored at room temperature;
keep capsules away from moisture.
DUOVIR (Combivir, Lamivudine/Zidovudine) side effects
Side effects cannot be anticipated. If any develop or change in intensity,
inform your doctor as soon as possible. Only your doctor can determine
if it is safe for you to continue taking DUOVIR (Combivir, Lamivudine/Zidovudine).
The frequency and severity of side effects associated with the use
of DUOVIR (Combivir, Lamivudine/Zidovudine) are greater in people whose infection is more advanced
when treatment is started. Sometimes it is difficult to distinguish
side effects from the underlying signs of HIV disease or the infections
caused by HIV.
* Side effects may include:
Cough, diarrhea, difficult or labored breathing, ear pain, discharge
or swelling, enlarged liver, enlarged spleen, fever, general feeling
of illness, headache, loss of appetite, mouth sores, nausea, nasal
discharge or congestion, rash, swollen lymph nodes, vomiting
Why should DUOVIR (Combivir, Lamivudine/Zidovudine) not be prescribed?
If you have ever had a life-threatening allergic reaction to DUOVIR (Combivir, Lamivudine/Zidovudine) or any of its ingredients, you should not take DUOVIR (Combivir, Lamivudine/Zidovudine).
Special warnings about DUOVIR (Combivir, Lamivudine/Zidovudine)
This drug has been studied for only a limited period of time. Long-term
safety and effectiveness are not known, especially for people who are
in a less advanced stage of AIDS or AIDS-related complex (the condition
that precedes AIDS), and for those using the drug over a prolonged
period of time.
DUOVIR (Combivir, Lamivudine/Zidovudine) can cause an enlarged liver and the chemical imbalance
known as lactic acidosis. This serious and sometimes fatal side effect
is more likely in women, people who are overweight, and those who have
been taking drugs such as DUOVIR (Combivir, Lamivudine/Zidovudine) for an extended period. Signs
of lactic acidosis include fatigue, nausea, abdominal pain, and a feeling
of unwellness. Contact your doctor if you experience any of these symptoms.
Treatment with DUOVIR (Combivir, Lamivudine/Zidovudine) may have to be discontinued.
If you develop a blood disease, you may require a blood transfusion,
and your doctor may reduce your dose or take you off the drug altogether.
Make sure your doctor monitors your blood count on a regular basis.
The use of DUOVIR (Combivir, Lamivudine/Zidovudine) has not been shown to reduce the risk of transmission
of HIV to others through sexual contact or blood contamination or to
nursing infants.
DUOVIR (Combivir, Lamivudine/Zidovudine) should be used with extreme caution by people who have
a bone marrow disease.
Some people taking DUOVIR (Combivir, Lamivudine/Zidovudine) develop a sensitization reaction, often
signaled by a rash. If you notice a rash developing, notify your doctor.
Contact your doctor immediately if you develop shortness of breath,
muscle weakness, abdominal pain, or any unexpected problems while being
treated with DUOVIR (Combivir, Lamivudine/Zidovudine).
Because little data are available concerning the use of DUOVIR (Combivir, Lamivudine/Zidovudine)
in people with impaired kidney or liver function, check with your doctor
before using DUOVIR (Combivir, Lamivudine/Zidovudine) if you have either problem.
Like other HIV drugs, DUOVIR (Combivir, Lamivudine/Zidovudine) sometimes causes a redistribution
of body fat, resulting in added weight around the waist, a "buffalo
hump" of fat on the upper back, breast enlargement, and wasting
of the face, arms, and legs. It's not known why this occurs, or what
long-term effects it might have.
Possible food and drug interactions when
taking DUOVIR (Combivir, Lamivudine/Zidovudine)
If DUOVIR (Combivir, Lamivudine/Zidovudine) is taken with certain other drugs, the effects of either
could be increased, decreased, or altered. It is especially important
to check with your doctor before combining DUOVIR (Combivir, Lamivudine/Zidovudine) with the following:
Atovaquone (Mepron)
Doxorubicin (Adriamycin, a cancer drug)
Fluconazole (Diflucan)
Ganciclovir (Cytovene)
Interferon (Intron A, Roferon-A)
Methadone
Nelfinavir (Viracept)
Phenytoin (Dilantin, a seizure medication)
Probenecid (Benemid, an antigout drug)
Ribavirin (Virazole)
Rifampin (Rifadin)
Ritonavir (Norvir)
Stavudine (Zerit)
Valproic acid (Depakene, a seizure medication)
Do not take DUOVIR (Combivir, Lamivudine/Zidovudine) with Combivir or Trizivir, which contain the
same active ingredient.
Special information if you are pregnant
or breastfeeding
The effects of DUOVIR (Combivir, Lamivudine/Zidovudine) during pregnancy are under study. Use during
pregnancy has been shown to protect the developing baby from contracting
HIV. If you are pregnant or plan to become pregnant, inform your doctor
immediately.
Since HIV can be passed on through breast milk to a nursing infant,
do not breastfeed your baby.
Recommended dosage for DUOVIR (Combivir, Lamivudine/Zidovudine)
ADULTS
Overdosage
Any medication taken in excess can have serious consequences. If you
suspect an overdose, seek emergency medical treatment immediately.
