babies younger than 14 days of age unless your doctor thinks it is
right for your baby.
«if a young child drinks more than the recommended dose, it
could make them sick. Contact your local poison control center
or emergency room right away.
Talk with your doctor if you take or plan to take metronidazole
or disulfiram. You can have severe nausea and vomiting if you
take these medicines with KALETRA.
* When your KALETRA supply starts to run low, get more from your
doctor or pharmacy, it is important not to run out of KALETRA. The
amount of HiV-1 virus in your blood may increase if the medicine
is stopped for even a short time. The virus may become resistant
to KALETRA and become harder to treat.
* KALETRA can be taken with acid reducing agents used for
heartburn or reflux such as omeprazole (Prilosec®) and ranitidine
(Zantac®) with no dose adjustment.
«KALETRA should not be administered once daily in combination
with carbamazepine (Tegretol® and EpitoF), phenobarbital
(Luminal®), or phenytoin (Dilantin®).
Avoid doing things that can spread HIV infection. KALETRA does not
stop you from passing HIV infection to others. Do not share needles,
other injection equipment or personal items that can have blood
or body fluids on them, like toothbrushes and razor blades. Always
practice safer sex by using a latex or polyurethane condom to lower
the chance of sexual contact with semen, vaginal secretions, or
blood.
KALETRA can cause serious side effects.
«See “What is the most important information i should know
about KALETRA?”
• Liver problems. Liver problems, including death, can happen
in people who take KALETRA. Blood tests in people who take
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. Tell your healthcare provider
right away if you have^any of these signs and symptoms of liver
problems:
«loss of appetite
o yellow skin and whites of eyes (jaundice)
o dark-colored urine
o pale colored stools, itchy skin
o stomach area (abdominal) pain.
• Inflammation of the pancreas (pancreatitis). Some people
who take KALETRA get inflammation of the pancreas which may
be serious and cause death. You have a higher chance of getting
pancreatitis if you have had it before. Tell your doctor if you have
nausea, vomiting, or abdominal pain while taking KALETRA. These
may be signs of pancreatitis.
»increases in certain fat (triglycerides and cholesterol) levels
in your blood. Large increases of triglycerides and cholesterol
can be seen in blood test results of some people who take
KALETRA. 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). Some people
who take protease inhibitors including KALETRA get new or more
serious diabetes, or high blood sugar. Tell your doctor if you notice
an increase in thirst or urinate often while taking KALETRA.
• Changes In body fat. Changes in body fat in some people who
take 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.
Increased bleeding for hemophiliacs. Some people with
hemophilia have increased bleeding with protease inhibitors
including KALETRA.
* Increased risk of certain problems when you take medicines
used for the treatment of erectile problems such as sildenafil
(Viaora®). tadalafil (Cialis®1. or vardenafil (Levitra®) with
KALETRA;
o low blood pressure. If you get dizzv or faint, vou need to lie
. down. Tell your doctor if vou feel dizzv. or have fainting soells.
® vision changes. Tell vour doctor rioht awav if vou have vision
changes.
o penis erection lasting more than 4 hours. If vou are a male
and have an erection that lasts longer than 4 hours, get medical
help right awav to avoid permanent damage to vour penis. Your
doctor can explain these symptoms to vou.
® Allergic reactions. Skin rashes, some of them severe, can occur
in people who take KALETRA. Tell your healthcare provider if you
had a rash when you took another medicine for your HIV infection
or if you notice any skin rash when you take KALETRA.
• Babies taking KALETRA oral solution may have side effects.
KALETRA oral solution contains alcohol and propylene glycol. Call
your doctor right away if your baby appears too sleepy or their
breathing has changed.
Common side effects of KALETRA include:
♦ diarrhea
* nausea
* stomach area (abdominal) pain
•feeling weak
* vomiting
• headache
• upset stomach
These are not all of the possible side effects of KALETRA. For more
information, ask your doctor or pharmacist. Tell your doctor about
any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report
side effects to FDA at 1-800-FDA-1088.
How should I store KALETRA?
KALETRA tablets;
• Store KALETRA tablets at room temperature, between 59°F to 86°F
(15°Cto30°C).
♦ Do not keep KALETRA tablets out of the container it comes in for
longer than 2 weeks, especially in areas where there is a lot of
humidity. Keep the container closed tightly.
KALETRA oral solution;
♦ Store KALETRA oral solution in a refrigerator, between 36“F to 46°F
(2°C to 8°C). KALETRA oral solution that is kept refrigerated may
be used until tae expiration date printed on the label.
* KALETRA oral solution that is stored at room temperature (less
than IT? or 25®C) should be used within 2 months.
• Keep KALETRA away from high heat.
Throw away any medicine that is out of date or that you no longer
need.
Keep KALETRA and all medicines out of the reach of chiidren.
General information about KALETRA
KALETRA does not cure HIV-1 or AIDS. The long-term effects of
KALETRA are not known at this time. People taking KALETRA mav
still get opportunistic infections or other conditions that happen
with HIV-1 infection. Some of these conditions are pneumonia-
herpes virus infections, and Mycobacterium avium complex fMACI
infections.
Medicines are sometimes prescribed for purposes other than those
listed in a Medication Guide. Do not use KALETRA for a condition for
which it was not prescribed. Do not give KALETRA to other people,
even if they have the same condition you have. It may harm them.
This Medication Guide summarizes the most important information
about KALETRA. If you would like more information, talk with your
doctor. You can ask your pharmacist or doctor for information
about KALETRA that is written for health professionals. For more
information about KALETRA call 1 -800-633-9110 or go to
www.KALETRA.com.
What are the Ingredients in KALETRA?
Active ingredient: lopinavir and ritonavir
Inactive ingredients:
KALETRA 200 mg lopinavir and 50 mg ritonavir tablets;
copovidone, sorbitan monolaurate, colloidal silicon dioxide, and
sodium stearyl fumarate. The film coating contains: hypromellose,
titanium dioxide, polyethylene glycol 400, hydroxypropyl cellulose,
talc, colloidal silicon dioxide, polyethylene glycol 3350, yellow ferric
oxide 172, and polysorbate 80.
KALETRA 100 mg lopinavir and 25 mg ritonavir tablets:
copovidone, sorbitan monolaurate, colloidal silicon dioxide, and
sodium stearyl fumarate. The film coating contains: polyvinyl
alcohol, titanium dioxide, talc, polytheylene glycol 3350, and yellow
ferric oxide El 72.
KALETRA oral solution; acesulfame potassium, alcohol, artjficial
cotton candy flavor, citric acid, glycerin, high fructose corn syrup,
Magnasweet-110 flavor, menthol, natural and artificial vanilla flavor,
peppermint oil, polyoxyl 40 hydrogenated castor oil, povidone,
propylene glycol, saccharin sodium, sodium chloride, sodium
citrate, and water.
KALETRA oral solution contains 42.4% alcohol (v/v). “See
How should I take KALETRA?”
2011,ALL RIGHTS RESERVED
* 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.
KALETRA Tablets, 200 mg lopinavir/50 mg ritonavir
Manufactured by Abbott Pharmaceuticals PR Ltd.,
Barceloneta, PR 00617
for Abbott Laboratories, North Chicago, IL 60064, U.S.A.
KALETRA Tablets, 100 mg lopinavir/25 mg ritonavir and KALETRA
Oral Solution
Abbott Laboratories, North Chicago, IL 60064, U.S.A.
Ref:03-A465-R10
Revised: February, 2011
036-553815 MASTER
El
039-665606
Abbott
May 1A-27.2011 qnotes 11