Dallas Voice (Dallas, Tex.), Vol. 19, No. 14, Ed. 1 Friday, August 2, 2002 Page: 20 of 68
sixty eight pages : ill. 14 x 12View a full description of this newspaper.
Extracted Text
The following text was automatically extracted from the image on this page using optical character recognition software:
KALETRA™
(lopinavir/ritonavir) capsules
(lopinavir/ritonavir) oral solution
ALERT: Find out about medicines that should NOT be
taken with KALETRA. Please also read the section
“MEDICINES YOU SHOULD NOT TAKE WITH KALETRA.”
Patient Information
KALETRA™
(kuh-LEE-tra)
Generic Name: lopinavir/ritonavir
(lop-IN-uh-veer/rit-ON-uh-veer)
Read this leaflet carefully before you start taking KALETRA. Also, read it
each time you get your KALETRA prescription refilled, in case something
has changed. This information does not take the place of talking with your
doctor when you start this medicine and at check ups. Ask your doctor if
you have any questions about KALETRA.
What is KALETRA and how does it work?
KALETRA is a combination of two medicines. They are lopinavir and
ritonavir. KALETRA is a type of medicine called an HIV (human
immunodeficiency virus) protease (PRO-tee-ase) inhibitor. KALETRA is
always'used in combination with other anti-HIV medicines to treat people
with human immunodeficiency virus (HIV) infection. KALETRA is for adults
and for children age 6 months and older.
HIV infection destroys CD4 (T) cells, which are important to the immune
system. After a large number of T cells are destroyed, acquired immune
deficiency syndrome (AIDS) develops.
KALETRA blocks HIV protease, a chemical which is needed for HIV to
multiply. KALETRA reduces the amount of HIV in your blood and increases
the number of T cells. Reducing the amount of HIV in the blood reduces
the chance of death or infections that happen when your immune system
is weak (opportunistic infections).
Does KALETRA cure HIV or AIDS?
KALETRA does not cure HIV infection or AIDS. The long-term effects of
KALETRA are not known at this time. People taking KALETRA may still
get opportunistic infections or other conditions that happen with HIV
infection. Some of these conditions are pneumonia, herpes virus
infections, and Mycobacterium avium complex (MAC) infections.
Does KALETRA reduce the risk of passing HIV to others?
KALETRA does not 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 KALETRA?
• You should stay under a doctor's care when taking KALETRA. Do not change
your treatment or stop treatment without first talking with your doctor.
• You must take KALETRA every day exactly as your doctor prescribed it.
The dose of KALETRA may be different for you than for other patients.
Follow the directions from your doctor, exactly as written on the label.
• Dosing in adults (including children 12 years of age and older): The usual dose
for adults is 3 capsules (400/100 mg) or 5.0 mL of the oral solution twice a
day (morning and night), in combination with other anti-HIV medicines.
• Dosing in children from 6 months to 12 years of age: Children from 6 months
to 12 years of age can also take KALETRA. The child’s doctor will decide the
right dose based on the child's weight.
• Take KALETRA with food to help it work better.
• Do not change your dose or stop taking KALETRA without first talking
with your doctor.
• When your KALETRA supply starts to run low, get more from your doctor
or pharmacy. This is very important because the amount of virus in your
blood may increase if the medicine is stopped for even a short time. The
virus may develop resistance to KALETRA and become harder to treat.
• Be sure to set up a schedule and follow it carefully.
• Only take medicine that has been prescribed specifically for you. Do not
give KALETRA to others or take medicine prescribed for someone else.
What should I do if I miss a dose of KALETRA?
It is important that you do not miss any doses. If you miss a dose of KALETRA.
take it as soon as possible and then take your next scheduled dose at its regular
time. If it is almost time for your next dose, do not take the missed dose. Wait
and take the next dose at the regular time. Do not double the next dose.
What happens if I take too much KALETRA?
If you suspect that you took more than the prescribed dose of this medicine,
contact your local poison control center or emergency room immediately.
As with all prescription medicines, KALETRA should be kept out of the reach
of young children. KALETRA liquid contains a large amount of alcohol. If a
toddler or young child accidentally drinks more than the recommended dose
of KALETRA, 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 KALETRA?
Together with your doctor, you need to decide whether KALETRA is right
for you.
• Do not take KALETRA if you are taking certain medicines. These could
cause serious side effects that could cause death. Before you take
KALETRA, you must tell your doctor about all the medicines you are
taking or are planning to take. These include other prescription and non-
prescription medicines and herbal supplements.
For more information about medicines you should not take with KALETRA, please
read the section titled “MEDICINES YOU SHOULD NOT TAKE WITH KALETRA."
• Do not take KALETRA if you have an allergy to KALETRA or any of its
ingredients, including ritonavir or lopinavir.
Can I take KALETRA with other medications?*
KALETRA may interact with other medicines, including those you take
without a prescription. You must tell your doctor about all the medicines
you are taking or planning to take before you take KALETRA.
MEDICINES YOU SHOULD NOT TAKE WITH KALETRA:
• Do not take the following medicines with KALETRA because they can
cause serious problems or death if taken with KALETRA.
- Dihydroergotamine, ergonovine, ergotamine and methylergonovine
such as Cafergot®, Migranal®, D.H.E. 45®, Ergotrate Maleate,
Methergine, and others
- Halcion® (triazolam)
- Hismanal® (astemizole)
- Orap® (pimozide)
- Propulsid® (cisapride)
- Rythmol® (propafenone)
- Seldane® (terfenadine)
- Tambocor™ (flecainide)
-Versed® (midazolam)
• Do not take KALETRA with rifampin, also known as Rimactane®,
Rifadin®, Rifater®, or Rifamate®. Rifampin may lower the amount of
KALETRA in your blood and make it less effective.
• Do not take KALETRA with St. John's wort (hypericum perforatum), an
herbal product sold as a dietary supplement, or products containing St.
John's wort. Talk with your doctor if you are taking or planning to take St.
John’s wort. Taking St. John's wort may decrease KALETRA levels and
lead to increased viral load and possible resistance to KALETRA. or cross-
resistance to other anti-HIV medicines.
• Do not take KALETRA with the cholesterol-lowering medicines Mevacor®
(lovastatin) or Zocor® (simvastatin) because of possible serious
reactions. There is also an increased risk of drug interactions between
KALETRA and Lipitor® (atorvastatin); talk to your doctor before you take
any of these cholesterol-reducing medicines with KALETRA.
Medicines that require dosage adjustments:
It is possible that your doctor may need to increase or decrease the dose
of other medicines when you are also taking KALETRA. Remember to tell
your doctor all medicines you are taking or plan to take.
Before you take Viagra® (sildenafil) with KALETRA, talk to your doctor
about problems these two medicines can cause when taken together.
You may get increased side effects of VIAGRA, such as low blood
pressure, vision changes, and penis erection lasting more than 4 hours.
If an erection lasts longer than 4 hours, get medical help right away to
avoid permanent damage to your penis. Your doctor can explain these
symptoms to you.
• If you are taking oral contraceptives ("the pill") to prevent pregnancy, you
should use an additional or different type of contraception since
KALETRA may reduce the effectiveness of oral contraceptives.
• Efavirenz (Sustiva™) or nevirapine (Viramune®) may lower the amount of
KALETRA in your blood. Your doctor may increase your dose of KALETRA
if you are also taking efavirenz or nevirapine.
• If you are taking Mycobutin® (rifabutin), your doctor will lower the dose
of Mycobutin.
• A change in therapy should be considered if you are taking KALETRA with:
Phenobarbital
Phenytoin (Dilantin® and others)
Carbamazepine (Tegretol® and others)
These medicines may lower the amount of KALETRA in your blood and
make it less effective.
• Other Special Considerations:
KALETRA oral solution contains alcohol. Talk with your doctor if you are
taking or planning to take metronidazole or disulfiram. Severe nausea
and vomiting can occur.
• If you are taking both didanosine (Videx®) and KALETRA:
Didanosine (Videx®) should be taken one hour before or two hours after
KALETRA.
What are the possible side effects of KALETRA?
• This list of side effects is not complete. If you have questions about side
effects, ask your doctor, nurse, or pharmacist. You should report any new
or continuing symptoms to your doctor right away. Your
doctor may be able to help you manage these side effects.
• The most commonly reported side effects of moderate severity that are
thought to be drug related are: abnormal stools (bowel movements),
diarrhea, feeling weak/tired, headache, and nausea. Children taking
KALETRA may sometimes get a skin rash.
•Blood tests in patients taking KALETRA may show possible liver
problems. People with liver disease such as Hepatitis B and Hepatitis C
who take KALETRA may have worsening liver disease. Liver problems
including death have occurred in patients taking KALETRA. In studies, it
is unclear if KALETRA caused these liver problems because some'
patients had other illnesses or were taking other medicines.
• Some patients taking KALETRA can develop serious problems with their
pancreas (pancreatitis), which may cause death. You have a higher chance
of having pancreatitis if you have had it before. Tell your doctor if you have
nausea, vomiting, or abdominal pain. These may be signs of pancreatitis.
• Some patients have large increases in 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 not known at this time.
• Diabetes and high blood sugar (hyperglycemia) occur in patients taking
protease inhibitors such as KALETRA. Some patients had diabetes before
starting protease inhibitors, others did not. Some patients need changes
in their diabetes medicine. Others needed new diabetes medicine.
• Changes in body fat have been seen in some patients taking antiretroviral
therapy. These changes may include 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 happen. The cause and long term
health effects of these conditions are not known at this time.
• Some patients with hemophilia have increased bleeding with protease inhibitors.
• There have been other side effects in patients taking KALETRA. However,
these side effects may have been due to other medicines that patients were
taking or to the illness itself. Some of these side effects can be serious.
What should I tell my doctor before taking KALETRA?
• if you are pregnant or planning to become pregnant: The effects of
KALETRA on pregnant women or their unborn babies are not known.
• If you are breast-feeding: Do not breast-feed if you are taking KALETRA.
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 chance that HIV can be transmitted through breast-feeding.
• If you have liver problems: If you have liver problems or are infected with
Hepatitis B or Hepatitis C, you should tell your doctor before taking KALETRA.
• If you have diabetes: Some people taking protease inhibitors develop new
or more serious diabetes or high blood sugar. Tell your doctor if you have
diabetes or an increase in thirst or frequent urination.
• If you have hemophilia: Patients taking KALETRA may have increased bleeding.
How do I store KALETRA?
• Keep KALETRA and all other medicines out of the reach of children.
• Refrigerated KALETRA capsules and oral solution remain stable until the
expiration date printed on the label. If stored at room temperature up to 77°F
(25°C), KALETRA capsules and oral solution should be used within 2 months.
• Avoid exposure to excessive heat.
Do not keep medicine that is out of date or that you no longer need. Be sure
that if you throw any medicine away, it is out 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 those 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 that was written for
health care professionals. Do not use this medicine for a condition for which
it was not prescribed. Do not share this medicine with other people.
• The brands listed are trademarks of their respective owners and are not
trademarks of Abbott Laboratories. The makers of these brands are not
affiliated with and do not endorse Abbott Laboratories or its products.
Ref.: 03-5177-R6
Revised: January,'2002
02E-036-3722-1 MASTER
ABBOTT LABORATORIES
NORTH CHICAGO, IL 60064, U.S.A.
02D-036-3550-1
PRINTED IN U.S.A.
20
AUGUST 2, 2002
DALLAS VOICE
Upcoming Pages
Here’s what’s next.
Search Inside
This issue can be searched. Note: Results may vary based on the legibility of text within the document.
Tools / Downloads
Get a copy of this page or view the extracted text.
Citing and Sharing
Basic information for referencing this web page. We also provide extended guidance on usage rights, references, copying or embedding.
Reference the current page of this Newspaper.
Vercher, Dennis. Dallas Voice (Dallas, Tex.), Vol. 19, No. 14, Ed. 1 Friday, August 2, 2002, newspaper, August 2, 2002; Dallas, Texas. (https://digital.library.unt.edu/ark:/67531/metapth616279/m1/20/: accessed July 17, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Special Collections.