Pronunciation:

loe-PIN-a-veer, ri-TOE-na-veer

Brand Names:

• Kaletra

Dosage Forms:

• Capsule, Liquid Filled
• Tablet
• Solution

Classifications:

Therapeutic—

Antiretroviral Agent

Pharmacologic—

Protease Inhibitor

Uses of This Medicine:

The combination of lopinavir and ritonavir 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.

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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 has 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.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Alfuzosin
• Amiodarone
• Astemizole
• Bepridil
• Cisapride
• Conivaptan
• Dihydroergotamine
• Encainide
• Eplerenone
• Ergoloid Mesylates
• Ergonovine
• Ergotamine
• Flecainide
• Lovastatin
• Methylergonovine
• Methysergide
• Midazolam
• Pimozide
• Propafenone
• Quinidine
• Ranolazine
• Rifampin
• Simvastatin
• St John's Wort
• Terfenadine
• Triazolam
• Voriconazole

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. 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 this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using 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—

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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.

Less common

Bloating

blurred vision

chills

constipation

darkened urine

dry mouth

fast heart beat

fatigue

fever

flushed, dry skin

fruit-like breath odor

increased hunger

increased thirst

increased urination

indigestion

loss of appetite

loss of consciousness

nausea

pains in stomach, side, or abdomen, possibly moving to the back

sweating

troubled breathing

unexplained weight loss

vomiting

yellow eyes or skin

Frequency not determined

chest pain or discomfort

lightheadedness, dizziness or fainting

shortness of breath

slow or irregular heartbeat

unusual tiredness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Diarrhea

Less common

Abnormal stools

acid or sour stomach

belching

headache

heartburn

lack or loss of strength

pain

skin rash

stomach discomfort, upset, or pain

trouble in sleeping

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

Frequency not determined

Redistribution of body fat

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