KALETRA- lopinavir and ritonavir tablet, film coated 
Rebel Distributors Corp



KALETRA® (kuh-LEE-tra)



KALETRA® (kuh-LEE-tra)


Oral Solution

Read the Medication Guide that comes with KALETRA before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment. You and your doctor should talk about your treatment with KALETRA before you start taking it and at regular check-ups. You should stay under your doctor’s care when taking KALETRA.

What is the most important information I should know about KALETRA?

KALETRA may cause serious side effects, including:

Tell your doctor right away if you have any of these symptoms while taking KALETRA:

See the section below “What are the possible side effects of KALETRA?” for more information about serious side effects.

What is KALETRA?

KALETRA is a prescription anti-HIV medicine that contains two medicines: lopinavir and ritonavir. KALETRA is called a protease inhibitor that is used with other anti-HIV-1 medicines to treat people with human immunodeficiency virus (HIV-1) infection. HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

It is not known if KALETRA is safe and effective in children under 14 days old.

Who should not take KALETRA?

What should I tell my doctor before taking KALETRA?

KALETRA may not be right for you. Tell your doctor about all your medical conditions, including if you:

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Many medicines interact with KALETRA. Do not start taking a new medicine without telling your doctor or pharmacist. Your doctor can tell you if it is safe to take KALETRA with other medicines. Your doctor may need to change the dose of other medicines while you take KALETRA.

Medicines you should not take with KALETRA.

Serious problems or death can happen if you take these medicines with KALETRA:

Medicines that you should not take with KALETRA since they may make KALETRA not work as well:

Medicines that may need changes:

If you are not sure if you are taking a medicine above, ask your doctor.

How should I take KALETRA?

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.

What are the possible side effects of KALETRA?

KALETRA can cause serious side effects.

Common side effects of KALETRA include:

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:

KALETRA oral solution:

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 children.

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 may 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 (MAC) 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 E172.

KALETRA oral solution: acesulfame potassium, alcohol, artificial 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?”.

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.

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Revised: 12/2010
Rebel Distributors Corp