Kaletra Solution

Kaletra Solution is used for:

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Treating HIV infection. It is used along with other medicines for HIV.

Kaletra Solution is a combination of 2 HIV protease inhibitors. It works by stopping the HIV virus from multiplying.

Do NOT use Kaletra Solution if:

• you are allergic to any ingredient in Kaletra Solution
• you are taking alfuzosin, amiodarone, astemizole, bepridil, certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), cisapride, conivaptan, disulfiram, eletriptan, an ergot derivative (eg, ergotamine, methylergonovine), flecainide, meperidine, metronidazole, midazolam, pimozide, propafenone, quinidine, rifampin, St. John's wort, terfenadine, tipranavir, or triazolam

Contact your doctor or health care provider right away if any of these apply to you.

Before using Kaletra Solution:

Some medical conditions may interact with Kaletra Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have hepatitis, liver problems, or abnormal liver function tests
• if you have pancreas problems (eg, pancreatitis), diabetes or high blood sugar (hyperglycemia), high cholesterol or triglyceride levels, or hemophilia or another bleeding disorder
• if you have a history of alcohol abuse

Some MEDICINES MAY INTERACT with Kaletra Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Amiodarone, astemizole, bepridil, cisapride, flecainide, meperidine, pimozide, propafenone, quinidine, or terfenadine because serious side effects such as seizures, blood problems, or heart problems (eg, irregular heartbeat) may occur
• Midazolam or triazolam because serious side effects such as prolonged sedation or breathing problems may occur
• Ergot derivatives (eg, ergotamine, methylergonovine) because serious blood flow problems may occur
• Rifampin or St. John's wort because they may decrease Kaletra Solution's effectiveness
• Alfuzosin, certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), conivaptan, or eletriptan because the risk of their side effects may be increased by Kaletra Solution
• Disulfiram or metronidazole because severe nausea and vomiting may occur
• Many prescription and nonprescription medicines (eg, used for infections, HIV, inflammation, allergic reactions, breathing problems, pain, birth control, blood thinning, irregular heartbeat, other heart problems, high blood pressure, high cholesterol, immune suppression, erectile dysfunction, seizures, sleep disorders, depression, other mood or mental problems, alcoholism), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) because they may interact with Kaletra Solution, increasing the risk of side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Kaletra Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Kaletra Solution:

Use Kaletra Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Kaletra Solution. Talk to your pharmacist if you have questions about this information.
• Take Kaletra Solution by mouth with food.
• Use the dosing cup that comes with Kaletra Solution to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
• Kaletra Solution must be taken with other HIV medicines to be effective.
• If you are also taking didanosine, take it at least 1 hour before or 2 hours after you take Kaletra Solution.
• Continue to take Kaletra Solution even if you feel well. Do not miss any doses. Do not stop taking Kaletra Solution without checking with your doctor.
• If you miss a dose of Kaletra Solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use this medicine.

Important safety information:

• Kaletra Solution may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start Kaletra Solution.
• Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Kaletra Solution. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
• When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Kaletra Solution, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
• Kaletra Solution is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
• Kaletra Solution does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.
• Hormonal birth control (eg, birth control pills) may not work as well while you are using Kaletra Solution. To prevent pregnancy, use an extra form of birth control (eg, condoms).
• Hemophilia patients - Report all bleeding episodes to your doctor.
• Kaletra Solution may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
• Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Lab tests, including cholesterol and triglyceride levels, viral load, and liver function, may be performed while you use Kaletra Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Caution is advised when using Kaletra Solution in CHILDREN; they may be more sensitive to its effects, especially skin rash.
• Kaletra Solution should be used with extreme caution in CHILDREN younger than 6 months old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Kaletra Solution while you are pregnant. It is not known if Kaletra Solution is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or this medicine to the baby.

Possible side effects of Kaletra Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; headache; nausea; stomach pain; tiredness; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; fever, chills, or sore throat; pale stools; severe or persistent nausea or stomach pain; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; confusion; unusual drowsiness; flushed face; fruit-like breath odor); vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Kaletra Solution in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. If stored in the refrigerator, Kaletra Solution may be used until the expiration date printed on the label. Kaletra Solution may also be stored at room temperature up to 77 degrees F (25 degrees C). If stored at room temperature, throw away any medicine that is left after 2 months. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Kaletra Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Kaletra Solution, please talk with your doctor, pharmacist, or other health care provider.
• Kaletra Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Kaletra Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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