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|Kaletra Capsules

Kaletra Capsules

Kaletra Capsules is used for:

Managing HIV infection in combination with other medicines. Kaletra Capsules is not a cure for HIV infection or AIDS.

Kaletra Capsules is an HIV protease inhibitor. It works by blocking a chemical that HIV needs to multiply, which reduces the amount of HIV in the blood.

Do NOT use Kaletra Capsules if:

• you are allergic to any ingredient in Kaletra Capsules
• you are currently taking alfuzosin, astemizole, atorvastatin, cisapride, dihydrolam, ergot derivatives (eg, ergotamine), ergonovine, flecainide, fluticasone, lovastatin, methylergonovine, midazolam, pimozide, propafenone, rifampin, simvastatin, St. John"s wort (Hypericum perforatum), terfenadine, triazolam, or voriconazole

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

Before using Kaletra Capsules:

Some medical conditions may interact with Kaletra Capsules. 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 AIDS, pancreatitis (swelling or tenderness of the abdomen), diabetes or high blood sugar (hyperglycemia), high cholesterol or triglyceride levels, or hemophilia or other bleeding disorders

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

• Many prescription and nonprescription medicines (eg, medicines used for infections, asthma, high cholesterol, birth control, heart problems, HIV infection, mental or mood problems, migraine headaches, erectile dysfunction, seizures, blood thinning, or pain), herbal supplements (eg, St. John"s wort), herbal teas, multivitamin products, and dietary supplements may interact with Kaletra Capsules and increase the risk of side effects
• Voriconazole because the effectiveness may be decreased by Kaletra Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Kaletra Capsules 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 Capsules:

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

• Take Kaletra Capsules with food.
• Continue to take Kaletra Capsules even if you feel well.
• Kaletra Capsules must be taken with other HIV medicines to be effective.
• If you are also taking didanosine, take Kaletra Capsules 1 hour before or 2 hours after taking didanosine.
• Kaletra Capsules works best when there is a constant level of Kaletra Capsules in your body. It is important not to miss doses of Kaletra Capsules. If you miss a dose of Kaletra Capsules, take it as soon as you remember. If it is within 2 hours of 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 Kaletra Capsules.

Important safety information:

• Kaletra Capsules contains a large amount of alcohol and may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could potentially be dangerous until you know how you react to Kaletra Capsules.
• Before you begin taking any new medicine, either prescription or nonprescription, check with your doctor or pharmacist. Talk with your doctor about which medicines should not be taken with Kaletra Capsules.
• Kaletra Capsules may increase the cholesterol and triglyceride levels in your blood. Cholesterol and triglyceride testing should be done before and during treatment with Kaletra Capsules.
• Patients with hepatitis B or hepatitis C who take Kaletra Capsules may have worsening liver disease. Tell your doctor before taking Kaletra Capsules if you have liver problems.
• Changes in body fat have occurred in some patients taking this type of HIV medicine. These changes may include increased amount of fat in the upper back and neck, breast, and around the trunk. Loss of fat from the legs, arms, and face may also happen. The cause and long-term effects of this are unknown.
• When your medicine supply begins to run low, get more from your doctor or pharmacy as soon as possible. The virus may develop resistance to Kaletra Capsules if you stop taking it, even for a short period of time, and may become harder to treat.
• Kaletra Capsules is not a cure for HIV infection and patients may continue to acquire illnesses/infections associated with HIV infection. Remain under the care of your health care provider.
• Kaletra Capsules offers no protection against the passing of HIV to others through sexual contact or blood contamination. Use barrier forms of contraception (eg, condoms) and do not share needles if you are infected with HIV.
• Kaletra Capsules may affect certain lab test results. Make sure all your doctors and laboratory personnel know that you are taking Kaletra Capsules.
• If you are taking birth control pills, Kaletra Capsules may decrease the effectiveness of the pills. Use an additional form of birth control (eg, condoms) while you are taking Kaletra Capsules.
• Hemophilia patients - Report all bleeding episodes to your doctor.
• Diabetes patients - Kaletra Capsules may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
• LAB TESTS will be required to monitor your progress and to check for side effects. Be sure to keep all doctor and lab appointments.
• Kaletra Capsules is not recommended for use in CHILDREN younger than 6 months of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, talk with your health care provider about the benefits and risk of using Kaletra Capsules during pregnancy. It is unknown if Kaletra Capsules is excreted in breast milk. HIV-infected mothers should not breast-feed their infants because of the risk of transmitting the HIV infection or Kaletra Capsules.

Possible side effects of Kaletra Capsules:

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:

Abnormal stools; chills; depression; diarrhea; fever; gas; headache; indigestion; loss of appetite; muscle pain; nausea; pain; prickling or tingling sensation on the skin; shift in body fat to stomach and upper body; sleeplessness; stomach pain; tiredness; vomiting; weakness; weight loss.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in stools; dark urine; drowsiness; fatigue; flushed face; increased blood sugar; increased thirst or urination; persistent fever; severe stomach pain with nausea and vomiting; unusual bleeding or bruising; unusual hunger; vision changes; 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. Symptoms may include change in the amount of urine; loss of consciousness; numbness or tingling in the arms, legs, hands, or feet; shallow breathing.

Store in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Avoid exposure to excessive heat. Throw away any unused medicine after the expiration date printed on label. Use within 2 months if stored at room temperature up to 77 degrees F (25 degrees C). Keep Kaletra Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Kaletra Capsules, please talk with your doctor, pharmacist, or other health care provider.
• Kaletra Capsules 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 Capsules. 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.