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Composition
(abacavir sulfate and
lamivudine)
Each tablet contains
abacavir sulfate.... 600mg
lamivudine................300 mg
Indication and Usage
* COPAID, in combination with
other antiretroviral agents, is
indicated for the treatment of
HIV-1 infection in adults.
* COPAID is one of 3 medicines
containing abacavir. Before
starting COPAID, your healthcare
professional will review your
medical history in order to
avoid the use of abacavir if you
have experienced a
hypersensitivity reaction to
abacavir in the past.
* In one study, more patients
had a severe hypersensitivity
reaction in the abacavir
once-daily group than in the
abacavir twice-daily group.
* COPAID should not be used as
part of a triple-nucleoside
regimen.
* COPAID does not cure HIV
infection/AIDS or prevent
passing HIV to others.
Important Safety Information
COPAID contains abacavir, which
is also contained in ZIAVIR® (abacavir
sulfate) and TRIIVIR® (abacavir
sulfate, lamivudine, and
zidovudine). Patients taking
COPAID may have a serious
allergic reaction
(hypersensitivity reaction) that
can cause death.
If you get a symptom from 2 or
more of the following groups
while taking COPAID, stop taking
COPAID and call your doctor
right away.
Abacavir and lamivudine,
two medications that have been
used for years to treat HIV
infection, are available as
COPAID. Take one COPAID Tablet
once a day as part of your HIV
combination regimen. COPAID has
no food or fluid requirements.
Information contained within
this Web site does not cover all
possible uses, actions,
warnings, precautions, side
effects, or interactions of
COPAID™ (which contains abacavir
sulfate and lamivudine) with
other medicines you may take.
If you have questions about the
information provided, ask your
healthcare professional. More
information, written in
technical medical language for
healthcare professionals, is
available. You can request this
information from your healthcare
professional.
COPAID, in combination with
other antiretroviral agents, is
indicated for the treatment of
HIV-1 infection in adults.
COPAID is one of 3 medicines
containing abacavir. Before
starting COPAID, your healthcare
professional will review your
medical history in order to
avoid the use of abacavir if you
have experienced a
hypersensitivity reaction to
abacavir in the past. In one
study, more patients had a
severe hypersensitivity reaction
in the abacavir once-daily group
than in the abacavir twice-daily
group.
COPAID should not be used as
part of a triple nucleoside
regimen.
COPAID does not cure HIV
infection/AIDS or prevent
passing HIV to others.
What’s the
most important information I
should know about taking COPAID?
COPAID contains abacavir,
which is also contained in
ZIAGEN® (abacavir
sulfate) and TRIZIVIR® (abacavir
sulfate, lamivudine, and
zidovudine). Patients taking
COPAID may have a serious
allergic reaction
(hypersensitivity reaction) that
can cause death.
If you get a symptom from 2
or more of the following groups
while taking COPAID, stop taking
COPAID and call your doctor
right away.
|
|
Symptom(s) |
|
Group 1 |
Fever |
|
Group 2 |
Rash |
|
Group 3 |
Nausea,
vomiting, diarrhea, or
abdominal (stomach area)
pain |
|
Group 4 |
Generally
ill feeling, extreme
tiredness, or achiness |
|
Group 5 |
Shortness
of breath, or sore throat |
Read the list of problems that
can happen on the Warning Card
that your pharmacist gives you.
Carry the Warning Card with you.
If you stop COPAID because
you have had an allergic
reaction to abacavir, NEVER take
COPAID or another abacavir-containing
medicine (ZIAVIR® and
TRIIVIR®) again.
If you take COPAID or another
abacavir-containing medicine
again after you have had an
allergic reaction, WITHIN
HOURS you may get
life-threatening symptoms
that may include very low
blood pressure or death.
If you stop COPAID for any
other reason, even for a few
days, and you are not allergic
to COPAID, talk with your
healthcare professional before
taking it again. Taking COPAID
again can cause a serious or
life-threatening reaction, even
if you never had an allergic
reaction before. If your
healthcare professional tells
you that you can take COPAID
again, start taking it when
you are around medical help or
people who can call a doctor if
you need one.
What other
safety information should I know
about COPAID™ (abacavir sulfate
and lamivudine)?
- COPAID, 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. Women are
more likely than men to get
this serious side effect.
- Patients with hepatitis B
virus (HBV) infection, who
take COPAID and then stop it,
may get "flare-ups" of their
hepatitis. A "flare-up" is
when the disease suddenly
returns in a worse way than
before. If you have HBV
infection, your doctor should
closely monitor your liver
function for several months
after stopping COPAID. You may
need to take anti-HBV
medicines.
- Worsening 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 COPAID as well
as interferon with or without
ribavirin and you experienc
side effects, be sure to tell
your doctor.
- When you start taking HIV
medicine, your immune system
may get stronger and could
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 medicine, be
sure to tell your doctor.
- Changes 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.
- The most common side
effects seen with COPAID were
allergic reaction, trouble
sleeping, depression,
headache, tiredness,
dizziness, nausea, diarrhea,
rash, fever, stomach pain,
abnormal dreams, and anxiety.
Most of these side effects did
not cause people to stop
taking this combination of
medicines in clinical studies.
These are not all the side
effects you could have when
taking this medicine. Your
healthcare professional can
discuss a full list of side
effects with COPAID.
Presentation
COPAID
KIT
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© Taj
Pharmaceuticals Limited. 2003-2008
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