GENERIC NAME: lopinavir and ritonavir
BRAND NAME: Kaletra
DRUG CLASS AND MECHANISM: Kaletra is an oral medication that is a combination of lopinavir and ritonavir. It is used for treating infections with the
human immunodeficiency virus (HIV). It is in a class of drugs called protease inhibitors which also includes ritonavir
(Norvir),
nelfinavir (Viracept) and saquinavir (Invirase, Fortovase). Although both lopinavir and ritonavir inhibit the HIV virus, they are combined in
Kaletra because ritonavir increases the concentration of lopinavir in the body. In fact, the activity of
Kaletra against HIV is due to the lopinavir because the amount of ritonavir in Kaletra is not enough to inhibit the HIV virus. During infection with HIV, the HIV virus multiplies within the
body's cells. Viruses are released from the cells and spread throughout the body where they infect other cells. In this manner, HIV
infection is perpetuated among new cells that the body produces continually. During the production of the viruses, new proteins for the viruses are
made. Some of the proteins are structural proteins, that, is, proteins that form the body of the virus. Other proteins are enzymes which
manufacture DNA and other components for the new viruses. Protease is the enzyme that forms the new structural proteins and enzymes. The lopinavir in
Kaletra blocks the action of protease and results in the formation of defective viruses that are unable to infect the body's cells. As a result, the number of viruses in the body (the viral load) decreases. Nevertheless,
Kaletra does not prevent the
transmission of HIV among individuals, and it does not cure HIV infections or AIDS.
Kaletra was approved by the FDA in September, 2000.
GENERIC AVAILABLE: No
PRESCRIPTION: Yes
PREPARATIONS: Capsules containing 133.3 mg lopinavir and 33.3 mg ritonavir (133.3/33 mg).
Oral solution: 80 mg lopinavir and 20 mg ritonavir per ml (80/20 mg/ml)
STORAGE: Capsules and solution should be refrigerated at 2-8°C (36-46°F). If stored at room temperature, the capsules and solution should be used within 2 months.
PRESCRIBED FOR: Kaletra is used for the treatment of HIV infection.
DOSING: The recommended dose for adults is 3 capsules or 5 ml (400/100 mg) of the solution given twice daily with food. A once
daily dose also has been approved.
Pediatric patients between 6 months to 12 years of age and weighing 7-14 kg should receive 12/3 mg/kg twice daily with food. Those weighing 15-40 kg should receive 10/2.5 mg/kg twice daily with food. The maximum dose for pediatric patients is 400/100 mg twice daily.
DRUG INTERACTIONS: Kaletra interacts with many drugs. Some of the important interactions are mentioned
below. Viewers should consult their healthcare provider before combining any drug with
Kaletra.
Kaletra should not be used together with amiodarone
(Cordarone), quinidine (Quinaglute, Cardioquin), triazolam (Halcion), midazolam
(Versed), pimozide (Orap), ergotamine derivatives (e.g. Ergostat), propafenone
(Rythmol) and flecainide (Tambocor) because Kaletra increases the levels of these drugs in the body and as a result may lead to
serious adverse effects of these drugs
Kaletra may also prevent the break down of lovastatin
(Mevacor), simvastatin (Zocor), atorvastatin (Lipitor) and cerivastatin (Baycol) and cause their levels in the body to rise. This may increase the occurrence of muscle breakdown
(rhabdomyolysis) a side effect of these drugs.
The blood concentration of rifabutin (Mycobutin) and sildenafil (Viagra) can be increased by
Kaletra. Therefore, the doses of rifabutin and sildenafil should be reduced.
The oral solution contains alcohol, which causes severe side effects when combined with metronidazole
(Flagyl) or disulfiram (Antabuse).
Kaletra can reduce the effectiveness of oral contraceptives.
Rifampin (Rifadin), St. John's wort, efavirenz (Sustiva) and nevirapine (Viramune) decrease the blood levels of
Kaletra and this can reduce the effect of Kaletra.
PREGNANCY: Use of Kaletra during pregnancy has not been adequately evaluated.
NURSING MOTHERS: It is not known whether Kaletra is
excreted in breast milk. Nevertheless, HIV-infected mothers should not breast-feed because of the potential risk of transmitting HIV to an infant that is not infected.
SIDE EFFECTS: The most common side effects of
Kaletra are abdominal pain, weakness, nausea, diarrhea, vomiting, headache and insomnia.
Kaletra may cause liver failure and failure of the pancreas. Like other protease inhibitors use of
Kaletra may be associated with redistribution or accumulation of body fat, increased cholesterol and worsening of diabetes.
Last Editorial Review: 10/16/2005
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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