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KALETRA
(lopinavir/ritonavir)

DRUG DESCRIPTION

KALETRA (lopinavir/ritonavir) is a co-formulation of lopinavir and ritonavir. Lopinavir is an inhibitor of the HIV-1 protease. As co-formulated in KALETRA, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir.

Lopinavir is chemically designated as [1S-[1R*,(R*), 3R*, 4R*]]-N-[4-[[(2,6-dimethylphenoxy)acetyl]amino]3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2H)pyrimidineacetamide. Its molecular formula is C37H48N4O5, and its molecular weight is 628.80. Lopinavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Lopinavir has the following structural formula:

Lopinavir Structural Formula Illustration

Ritonavir is chemically designated as 10-hydroxy-2-methyl-5-(1-methylethyl)-1- [2-(1-methylethyl)-4thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13-oic acid, 5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C37H48N6O5S2, and its molecular weight is 720.95. Ritonavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Ritonavir has the following structural formula:

Ritonavir Structural Formula Illustration

KALETRA capsules are available for oral administration in a strength of 133.3 mg lopinavir and 33.3 mg ritonavir with the following inactive ingredients: FD&C Yellow No. 6, gelatin, glycerin, oleic acid, polyoxyl 35 castor oil, propylene glycol, sorbitol special, titanium dioxide, and water.

What are the possible side effects of lopinavir and ritonavir (Kaletra)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking lopinavir and ritonavir and call your doctor at once if you have any of these serious side effects:

  • dizziness, fainting, fast or pounding heartbeats;
  • vision changes;
  • increased urination or extreme thirst;
  • penis erection that is painful or lasts longer than 4 hours;
  • signs of a new infection, such as fever or chills, cough, or flu symptoms;
  • severe...

Read All Potential Side Effects and See Pictures of Kaletra Capsules »

What are the precautions when taking lopinavir, ritonavir capsules (Kaletra Capsules)?

Before taking this product, tell your doctor or pharmacist if you are allergic to either lopinavir or ritonavir; or to other HIV protease inhibitors such as amprenavir, indinavir or saquinavir; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, diabetes, pancreatitis, high blood fat levels (cholesterol/triglycerides), heart problems (coronary artery disease, heart attack), bleeding problems (e.g., hemophilia), previous infection with certain diseases (e.g., hepatitis B infection, hepatitis C infection, tuberculosis).

Lopinavir/ritonavir...

Read All Potential Precautions of Kaletra Capsules »

Last reviewed on RxList: 7/5/2012
This monograph has been modified to include the generic and brand name in many instances.