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|Kaletra

LOPINAVIR AND RITONAVIR (Systemic)

Some commonly used brand names are:

In the U.S.—

• Kaletra

In Canada—

• Kaletra

Category

• Antiviral, systemic

Description

The combination of lopinavir and ritonavir (low-PIN-a-veer and ri-TOE-na-veer) is used in the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus responsible for acquired immune deficiency syndrome (AIDS). It is used to slow the progression of disease in patients infected with HIV who have advanced symptoms, early symptoms, or no symptoms at all.

Lopinavir and ritonavir will not cure or prevent HIV infection or AIDS; however, it helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems usually related to AIDS or HIV disease. Lopinavir and ritonavir will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV disease.

This medicine is available only with your doctor"s prescription, in the following dosage forms:

• Oral
• Capsules (U.S. and Canada)
• Oral solution (U.S. and Canada)
• Tablets (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For lopinavir and ritonavir, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to lopinavir or ritonavir. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Lopinavir and ritonavir has not been studied in pregnant women. However, it has been found to cause birth defects and other problems in animals at doses many times the human dose. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether lopinavir and ritonavir pass into breast milk. However, because of the possibility that this medicine could cause unwanted effects in nursing babies and the risk of passing HIV on to the infant, breast-feeding is usually not recommended.

Children—The twice-daily dose of this medicine has been tested in children 6 months of age and older and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

The once-daily dose of this medicine have been tested only in adult patients and there is no specific information comparing use in children with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of lopinavir and ritonavir in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking lopinavir and ritonavir, it is especially important that your health care professional knows if you are taking any of the following:

• Amiodarone (e.g., Cordarone) or
• Bepridil (e.g., Vascor) or
• Quinidine (e.g., Quinidex)—Levels of these medicines in the body may be increased and cause toxic effects to the heart.

• Amprenavir (e.g., Agenerase)—Amprenavir should not be used with the lopinavir and ritonavir once-daily dosing regimen

• Astemizole (e.g. Hismanal) or
• Cisapride (e.g., Propulsid) or
• Flecainide (e.g., Tambocor) or
• Pimozide (e.g., Orap) or
• Propafenone (e.g., Rythmol) or
• Terfenadine (e.g., Seldane)—These medicines should not be taken with lopinavir and ritonavir due to the chance of serious heart rhythm problems.

• Atorvastatin (e.g., Lipitor) or
• Lovastatin (e.g., Mevacor) or
• Simvastatin (e.g., Zocor)—Simvastatin and lovastatin should not be taken with lopinavir and ritonavir due to the risk of serious effects on muscle tissue; atorvastatin dose should be as low as possible to avoid adverse effects

• Carbamazepine (e.g., Tegretol) or
• Dexamethasone (e.g., Decadron) or
• Phenobarbital (e.g., Luminal) or
• Phenytoin (e.g., Dilantin)—These medicines may reduce the effectiveness of lopinavir and ritonavir by lowering the amount of lopinavir present in the body. Carbamazepine, phenobarbital, and phenytoin should not be used with the lopinavir and ritonavir once-daily dosing regimen.

• Clarithromycin (e.g., Biaxin)—Use of lopinavir and ritonavir may increase the amount of clarithromycin in the body; patients with abnormal kidney function may need to have their dose adjusted

• Cyclosporine (e.g., Sandimmune, Neoral) or
• Felodipine (e.g., Plendil) or
• Nelfinavir (e.g., Viracept) or
• Nicardipine (e.g., Cardene) or
• Nifedipine (e.g., Procardia) or
• Sirolimus (e.g., Rapamune) or
• Tacrolimus (e.g., Prograf) or
• Trazodone (e.g., Desyrel)—Use of lopinavir and ritonavir may increase the amount of these medicines in the body, which may lead to increased side effects. Nelfinavir should not be used with the lopinavir and ritonavir once-daily dosing regimen.

• Dihydroergotamine (e.g. D.H.E., Migranal) or
• Ergonovine (e.g., Ergotrate) or
• Ergotamine (e.g., Ergostat) or
• Methylergonovine (e.g., Methergine) or
• Midazolam (e.g., Versed) or
• Triazolam (e.g., Halcion)—These medicines should not be taken with lopinavir and ritonavir because serious side effects could occur.

• Efavirenz (e.g., Sustiva) or
• Nevirapine (e.g., Viramune)—The dose of lopinavir and ritonavir might need to be increased when taken with these medicines. Efavirenz and nevirapine should not be used with the lopinavir and ritonavir once-daily dosing regimen.

• Ethinyl estradiol—Lopinavir and ritonavir may cause this medicine to be less effective; therefore, alternative or additional birth control methods should be used when birth control pills containing ethinyl estradiol are taken with lopinavir and ritonavir.

• Fluticasone, inhaled or nasal (e.g., Flonase, Flovent)—Lopinavir and ritonavir may increase the amount of this medicine in your body. They should not be used together, if possible.

• Indinavir (e.g., Crixivan) or
• Saquinavir (e.g., Fortovase)—Lopinavir and ritonavir may decrease the amount of these medicines in your body.

• Ketoconazole (e.g., Nizoral) or
• Itraconazole (e.g., Sporanox)—High doses are not recommended when taken with lopinavir and ritonavir

• Rifabutin (e.g., Mycobutin)—Doses of this medicine should be decreased and patients should be monitored more closely when this medicine is taken with lopinavir and ritonavir.

• Rifampin (e.g., Rifadin) or
• St. John"s wort—Lopinavir and ritonavir may not work properly if taken with these medicines.

• Sildenafil (e.g., Viagra) or
• Tadalafil (e.g., Cialis) or
• Vardenafil (e.g., Levitra)—Use of lopinavir and ritonavir may increase the amount of this medicine in the body, which may lead to increased side effects; your doctor may decrease your dose of these medicines.

• Warfarin (e.g., Coumadin)—The amount of warfarin in the blood may be affected; bleeding times should be closely watched by your doctor.

Other medical problems—The presence of other medical problems may affect the use of lopinavir and ritonavir. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetes mellitus (sugar diabetes)—Lopinavir and ritonavir may increase blood sugar; it may be necessary to adjust your dose of insulin or oral diabetes medicine.

• Hemophilia—Lopinavir and ritonavir may increase the risk of major bleeding.

• Liver problems or
• Hepatitis B or
• Hepatitis C—Effects of lopinavir and ritonavir may be increased because of slower removal of the medicines from the body.

• Pancreatitis (history of)—The chance that this condition will return is increased.

Proper Use of This Medicine

A paper with information about lopinavir and ritonavir will be given to you with your filled prescription. Read this paper carefully and ask your health care professional if you need additional information or explanation.

It is important that lopinavir and ritonavir capsules and oral solution be taken with food.

Lopinavir and ritonavir tablets may be taken with or without food.

For oral solution dosage form, use calibrated dosing syringe to measure dose.

For tablet dosage form, swallow whole and do not crush or chew.

Take this medicine exactly as directed by your doctor. Do not take it more often and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without checking with your doctor first.

Dosing—The dose of lopinavir and ritonavir will be different for different patients. Follow your doctor"s orders or the directions on the label. The following information includes only the average doses of lopinavir and ritonavir. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules, tablets, or milliliters (mL) of lopinavir and ritonavir that you take depends on the strength of the medicine.

• For oral dosage form (capsules):
  • For treatment of HIV infection:
    • Adults: 400 milligrams (mg) of lopinavir and 100 mg of ritonavir (3 capsules) twice a day with food or 800 mg of lopinavir and 200 mg of ritonavir (6 capsules) one time a day with food.
    • Children: This dosage form is usually not used for children. Please refer to the oral solution dosage form.
• For oral dosage form (oral solution):
  • For treatment of HIV infection:
    • Adults and adolescents: 400 mg of lopinavir and 100 mg of ritonavir (5 milliliters [mL]) twice a day with food or 800 mg of lopinavir and 200 mg of ritonavir (10 mL) one time a day with food.
    • Children 6 months to 12 years of age: Dose is based on body weight and must be determined by your doctor.
    • Children less than 6 months of age: Use and dose must be determined by your doctor.
    • Use and dose must be determined by a doctor for all children receiving the once-daily dose
• For oral dosage form (tablets):
  • For treatment of HIV infection:
    • Adults: 400 milligrams (mg) of lopinavir and 100 mg of ritonavir (2 tablets) twice a day with food or 800 mg of lopinavir and 200 mg of ritonavir (4 tablets) one time a day with or without food.
    • Children: This dosage form is usually not used for children. Please refer to the oral solution dosage form.

Missed dose—If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store in the refrigerator. However, keep the medicine from freezing.
• Avoid high heat.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

If you are taking the oral solution form of this medicine, you should limit the amount of alcohol you drink. The oral solution contains 42% alcohol.

It is very important that you use a second type of birth control if you are currently using an estrogen-containing form of birth control

If you are taking sildenafil, tadalafil, or vardenafil, it is very important to report any side effects, especially dizziness, fainting, or changes in your vision

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects may occur that do not require medical attention.

Frequency not determined

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 01/18/2001
Revised: 11/10/2005

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