14 FEBRUARY 20, 2004
www.houstonvoice.com HOUSTON VOICE
(ritonavir capsules) Soft Gelatin
(ritonavir oral solution)
ALERT: Find out about medicines that should NOT
be taken with NORVIR. Please also read [tie section
MEDICINES YOU SHOULD NOT TAKE WITH NORVIR."
Generic Name: ritonavir
Please read this leaflet carefully before you Mart taking NORVIR.
Also, read il each time you get your NORVIR prescription refilled.
just in ease something has changed. Remember that ihis information
does nol take the place of careful discussions with your doctor when
you start this medication and at check ups.
You should remain under a doctor's care when taking NORVIR and you
should not change or slop treatment without first talking with your doctor.
You should tell your doctor about any medicine you are taking or
planning to take because taking NORVIR with some medication*,
can result in serious or life-threatening problems.
Talk to your doctor if you have any questions about NORVIR. Your
doctor or pharmacist can also give you more information about NORVIR.
What is NORVIR and how does it work?
NORVIR is in a class of medicines called the HIV protease iPRO-tee-
asej inhibitors. NORVIR is used in combination with other anti-HIV
medicines to treat people with human immunodeficiency virus (HiV)
infection. NORVIR is for adults and for children age 2 years and older.
HIV infection leads to the destruction of CD4 (T> cells, which arc
important lo the immune system. After a large number of CD4 (T)
cells have been destroyed, acquired immune deficiency syndrome
NORVIR blocks HIV protease, a chemical which is needed tor HIV
to multiply. NORVIR reduces the amount of HIV in your blood and
incn-ases ihe number of CD4 (T) cells. Palients who took NORVIR
in clinical studies had significant reductions in both death and AIDS
defining diseases; however NORVIR may not have these el
Does NORVIR cure HIV or AIOS?
NORVIR does not cure HIV infection or AIDS. The long-term
effects of NORVIR are not known at this time. People taking
NORVIR may still get opportunistic infections or other
conditions lhat happen with HIV infection. Some of these
conditions are pneumonia, herpes virus infections, and
Mycobacterium avium complex (MAC) infections.
Does NORVIR reduce the risk of passing HIV to others?
NORVIR does noi reduce the risk of passing HIV to others through
sexual contact or blood contamination. Continue to practice safe sex
and do not use or share dirty needles.
How should I take NORVIR?
• You should stay under a doctor's care when taking NORVIR. Do
not change your treatment or stop treatment without first talking
with your doctor.
• It is very important that you take NORVIR every day exactly as
your doctor prescribed it.
• The usual dose for adults is six 100 mg capsules or 7.5 mL of the
oral solution twice a day I morning and night), in combination with
other anti-HIV medicines.
• The dosing of NORVIR may be different for you than for other
patienis. Follow the directions from your doctor, exactly as written
on the label
• Children from 2 to 16 years of age can aha take NORVIR. The
child's doctor will decide the right dose based on the child's height
• Take NORVIR with food if possible.
• NORVIR Oral Solution is peppermint/caramel flavored. You can
take it alone, or improve the taste by mixing il with 8 ounces of
chocolate milk. Ensure®, or Advera®. NORVIR Oral Solution
should be taken within I hour if mixed with theae items. Ask your
doctor, nurse or pharmacist about other ways to improve the taste
of NORVIR Oral Solution.
• Do not change or stop taking NORVIR without first talking with
your health care pro\ idee
• When your NORVIR supply starts to run low. get more from your
doctor or pharmacy. This is very important because the amount of
sims in your blood may increase if the medicine is stopped for
even a short time. The virus may develop resistance lo NORVIR
and become harder to treat.
• Be sure to set up a schedule and follow il carefully.
• Only take medicine lhat has been prescribed specifically for you.
Do not give NORVIR to others or lake medicine prescribed for
What should I do if I miss a dose of NORVIR?
It is important that you do not miss any doses. If you miss a dose of
NORVIR, take it as soon as possible and then take your next scheduled
dose at its regular time. If it is almost time for your nexl dose, wait and
take the next dose at the regular time. Do not double the next dose.
What happens if I take too much NORVIR?
If you think that you took more than the prescribed dose of this
medicine, contact your local poison control center or emergency
As with all prescription medicines, NORVIR should be kept out of
the reach of young children. NORVIR liquid contains a large amounl
of alcohol. If a toddler or young child accidentally drinks more than
the recommended dose of NORVIR, it could make him/her sick from
too much alcohol. Contact your local poison control center or
emergency room immediately if this happens.
Who should not take NORVIR?
Together with your doctor, you need to decide whether NORVIR is
right for you.
•Do not take NORVIR if you are taking certain medicines. These
could cause serious side effects lhat could cause death. Before you
take NORVIR. you must tell your doctor about all the medicines you
are taking or are planning lo take. These include other prescription
and nonprescription medicines and herbal supplement
For more information about medicines you should not lake wilh
NORVIR. please read the section "MEDICINES YOU SHOULD
NOT TAKE WITH NORVIR."
• Do not lake NORVIR if you have had a serious allergic reaction to
NORVIR or any of its ingredients.
Can I take NORVIR with other medications?*
NORVIR may interact with other medicines, including those you
take without a prescription. You must tell your doctor aboul all Ihe
medicines you are taking or are planning to take.
MEDICINES YOU SHOULD NOT TAKE WITH NORVIR.
• Do not take the following medicines with NORVIR because they can
cause serious or life-threatening problems such as irregular
heartbeat, breathing difficulties or excessive sleepiness could occur:
Ergotamine, ergonovine, methylcrgonov ine. and
dihydrocrizoi.immc such at Cafergot®,
Migranal®. D.H.E 45®, and others
Ouinidmc. also known as Oumagluic'". drdioquin®.
Quinidex®, and others
• Do not take NORVIR with St. John's wort (hypericum
perforatum), an herbal pnxluct sold as a dietary supplement or
products containing St. John's won. Talk with your doctor if you
are laking or are planning to take St. John's wort. Taking St. John's
won may decrease NORVIR levels and lead to increased viral load
and possible resistance to NORVIR or cross-resistance to other
• Do not take NORVIR with Ihe cholesterol-lowering medicines
Mevacor® (lovasiatin) or Zocor® (simvastatin I because of possible
serious reactions. There is also an increased risk of drug
interactions between NORVIR and Lipitor® (alorvastalini. talk lo
your doctor before you take anv of these cholesterol-reducing
medicines with NORVIR.
Medicines that may require dosage adjustments:
It is possible that your doctor may need 10 increase or decrease the dose
of other medicines when you are also taking NORVIR. Remember to
tell your doctor all medicines yon are taking or plan to take.
• The following medicines require dose reduction if taken with
If you are taking Viagra® (sildenafil), your doctor may
lower your dose of Viagra.
Before you take Viagra with NORVIR, talk to your doctor about
possible drug interactions and side effects. If you take Viagra
and NORVIR together, you may be at risk of side effects of
Viagra such as low blood pressure, visual changes, and penile
erection lasting more than 4 hours. If an erection lasts longer
than 4 hours, you should get medical help immediately to avoid
permanent damage to your penis. Your doctor can explain these
symptoms to you.
• If you are taking Oral contraceptives Cthe pill") to prevent
pregnancy, your doctor should increase the dose or you should use
a different type of contraception since NORVIR may reduce the
effectiveness of oral contraceptives.
• If you are taking Mycobutin® (rifabuiin), your doctor will lower
the dose of Mycobutin.
• Other Special Considerations:
NORVIR oral solution contains alcohol. Talk with your doctor if
you are taking or planning to take metronidazole or disulfiram.
Severe nausea and vomiling can occur
■ If you are taking both didanosine (Videx) and NORVIR:
Didanosine and NORVIR should be separated by at least 2.5 hours.
« Rifampin, also known as Rimactane®. Rifadin®, Rifater®, or
Rifamate®. may reduce blood levels of NORVIR. Be sure lo tell
your doctor if you are taking rifampin
What are the possible side effects of NORVIR?
• This list of side effects is nol complete If you have questions aboul
side effects, ask your doctor, nurse, or pharmacist. You should
report any new or continuing symptoms to your doctor nghl away.
Yimr doctor may be able to help you manage these side effects.
• The most commonly reported side effects are: feeling weak/tired.
nausea, vomiting, diarrhea, loss of appetite, abdominal pain,
changes in taste, tingling feeling or numbness in hands or feet or
around the lips, headache, and dizziness.
■ Blood tests in patients taking NORVIR may show possible liver
problems. People with liver disease such as Hepatitis 8 and
Hepatitis C who take NORVIR may have worsening liver disease.
Liver problems including rare cases of death have occurred in
patients taking NORVIR. It is unclear if NORVIR caused these
liver problems because some patients had other illnesses or were
taking other medicines.
• Some patienis taking NORVIR can develop serious problems with
their pancreas 1 pancreatitis) which may cause death. Tell your
doctor if you have nausea, vomiting, or abdominal pain luese
may be signs ol pancreatitis.
• Some patients have large increases m triglycerides and cholesterol.
The long-term chance of getting complications such as heart
attacks or stroke due to increases in triglycerides and cholesterol
caused by protease inhibitors is nol known at this lime.
■ Diabetes and high hlixxl sugar (hyperglycemia) have occurred in
patients taking protease inhibitors. Some patienis had diabetes
before starting protease inhibitors, others did not. Some patients
need changes in their diabetes medication Others needed new
• Changes in body fat have been seen in some patients taking
antiretroviral therapy. These changes may include increased
amounl of fat in the upper back and neck ("'buffalo luimp"). breast
and around the trunk. Loss of fat from the legs, arms and lace DM)
also happen. The cause and long tenn health effects of these
conditions are not known .it this lime
• Some patients with hemophilia have increased bleeding with
• Allergic reactions ranging from mild 10 severe have occurred in
palients laking NORVIR.
There have been other side effects noted in patienis receiving
NORVIR; however, ihese side effects ma) have been due to other
medicines thai patients were laking or lo the illness itself Some ot
these side effects can be serious. If you have questions aboul side
effects, ask your doctor, nurse, or pharmacist. You should report any
new or persistent svmptoms to your doctor immediately.
What should I tell my doctor before taking NORVIR?
• If you are pregnant or planning to become pregnant: The effecis of
NORVIR on pregnant women or their unborn babies are not known.
• // \1111 are breast-feeding: Do not breast-Iced if you are taking
NORVIR You should not breast-feed if you have HIV. If you are a
woman who has or will have a baby, talk with your doctor about the
best way to feed your baby. You should be aware that if your baby
does not already have HIV. there is a chanee that HIV can be
transmuted through breast-feeding
• If you have liver problems II you have liver problems or are
infected with Hepatitis B or Hepatitis ('. you should tell your
docior before taking NORVIR.
• If you have diabetes: Some people taking protease inhibitors
develop new or more serious diabetes or high blood sugar. Be sure
to tell your doctor if you have diabetes or .111 increase in thirst
and/or frequent urination.
'If you have hemophilia: Some people with hemophilia have had
increased bleeding. Il is not known whether the protease inhibitors
caused these problems. Be sure 10 tell your doctor it you have
hemophilia types A and B.
How do I store NORVIR?
• Keep NORVIR and all other medicines out of the reach of
• Store NORVIR Oral Solution al room lempcrature. Do not
refrigerate NORVIR Oral Solution. Avoid exposing NORVIR (>i.d
Solution to excessive heat or cold
• Refrigeration of NORVIR soft gelatin capsules by the patient is
recommended, but not required if used within M) days and stored
below 77 F (25 C|. Avoid exposing NORVIR soil gelatin capsules
to excessive heat or cold.
• Store NORVIR soft gelalin capsules and NORVIR Oral Solution
in the original container.
• Shake NORVIR Oral Solution well before cash use
• Use NORVIR Oral Solution by the expiraiion date on the bottle
Do not keep medicine that is out of dale or thai you no longer need. Be
sure thai if you throw any medicine away, il is oul of the reach of children.
General advice about prescription medicines:
Talk to your doctor or other health care provider if you have any
questions about this medicine or your condition. Medicines are
sometimes prescribed for purposes other than ihose listed in a Patient
Information Leaflet. If you have any concerns about this medicine.
ask your doctor. Your doctor or pharmacist can give you information
about this medicine thai was written for health care professionals. Do
nol use this medicine for a condition for which it was not prescribed.
Do not share ihis medicine wilh other people,
• The brands lisied are trademarks of their respective owners and are not
trademarks of Abbott Laboratories. The makers of these1 brands are noi
affiliated with and do not endorse Abbott Laboratories or its products.
Revised: October, 2003