Kaletra Capsules (Lopinavir, Ritonavir Capsules) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 9, 2012

Kaletra Capsules

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Kaletra Capsules

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KALETRA®
(lopinavir/ritonavir) Capsules
(lopinavir/ritonavir) Oral Solution

DRUG DESCRIPTION

KALETRA (lopinavir/ritonavir) is a co-formulation of lopinavir and ritonavir. Lopinavir is an inhibitor of the HIV protease. As co-formulated in KALETRA, ritonavir inhibits the CYP3Amediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir.

Lopinavir is chemically designated as [1S-[1R*,(R*), 3R*, 4R*]]-N-[4-[[(2,6dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydroalpha-(1-methylethyl)-2-oxo-1(2H)-pyrimidineacetamide. Its molecular formula is C₃₇H₄₈N₄O₅, and its molecular weight is 628.80. Lopinavir has the following structural formula:

Lopinavir Structural Formula Illustration

Ritonavir is chemically designated as 10-Hydroxy-2-methyl-5-(1-methylethyl)-1- [2-(1methylethyl)-4-thiazolyl]-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 has the following structural formula:

Ritonavir Structural Formula Illustration

	Proprietary name:		Kaletra
	Established name:		lopinavir and ritonavir
	Route of administration:		ORAL (C38288)
	Active ingredients (moiety):		Lopinavir (Lopinavir), Ritonavir (Ritonavir)
#	Strength	Form	Inactive ingredients
1	133.3 MILLIGRAM, 33.3 MILLIGRAM	CAPSULE, LIQUID FILLED (C42954)	FD&C Yellow No. 6, gelatin, glycerin, oleic acid, polyoxyl 35 castor oil, propylene glycol, sorbitol special, titanium dioxide, water
2	80 MILLIGRAM, 20 MILLIGRAM	SOLUTION (C42986)	Acesulfame potassium, alcohol, artificial cotton candy flavor, citric acid ,glycerin, high fructose corn syrup, Magnasweet-110 flavor, menthol, natural & artificial vanilla flavor, peppermint oil, polyoxyl 40 hydrogenated castor oil, povidone, propylene glycol, saccharin sodium, sodium chloride, sodium citrate, water

Lopinavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water.

KALETRA capsules (lopinavir, ritonavir 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.

KALETRA oral solution is available for oral administration as 80 mg lopinavir and 20 mg ritonavir per milliliter with the following inactive ingredients: Acesulfame potassium, alcohol, artificial cotton candy flavor, citric acid, glycerin, high fructose corn syrup, Magnasweet-110 flavor, menthol, natural & 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).

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

fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
increased urination or extreme thirst;
easy bruising or bleeding;
signs of a new infection, such as fever or chills, cough, or flu...

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...

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Last reviewed on RxList: 5/25/2010
This monograph has been modified to include the generic and brand name in many instances.