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Kaletra capsules

Pronunciation

Generic Name: lopinavir/ritonavir (loe-PIN-a-vir/rit-OH-na-vir)
Brand Name: Kaletra

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 taking alfuzosin, astemizole, atorvastatin, cisapride, dihydrolam, an ergot derivative (eg, ergotamine), ergonovine, flecainide, fluticasone, lovastatin, methylergonovine, midazolam, pimozide, propafenone, rifampin, simvastatin, St. John's wort (Hypericum perforatum), terfenadine, tipranavir, triazolam, or voriconazole

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

Slideshow: Flashback: FDA Drug Approvals 2013

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, used for infections, inflammation, aches and pains, high blood pressure, high cholesterol, seizures), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) may interact with Kaletra capsules, increasing the risk of their side effects
  • Voriconazole because its 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 by mouth with food.
  • Continue to take Kaletra capsules even if you feel well. Do not miss any doses.
  • 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 may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Kaletra capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • 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 (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 capsules. 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 capsules, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
  • Kaletra capsules 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 capsules 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 capsules. To prevent pregnancy, use an extra form of birth control (eg, condoms).
  • Hemophilia patients - Report all bleeding episodes to your doctor.
  • Diabetes patients - Kaletra capsules may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Kaletra capsules may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Kaletra capsules.
  • Kaletra capsules should not be used in CHILDREN younger than 14 days 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 capsules while you are pregnant. It is not known if Kaletra capsules is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Kaletra capsules to the baby.

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.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in stool; 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 about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, 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.

Proper storage of Kaletra capsules:

Store in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Avoid exposure to excessive heat. Store away from heat, moisture, and light. Do not store in the bathroom. 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.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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