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Medications and Drugs

Brand Names: AccessPak for HIV PEP Expanded with Kaletra

Generic Name: emtricitabine, lopinavir, ritonavir, and tenofovir (Pronunciation: em trye SYE ta been, loe PIN a vir, ri TOE na vir, ten OF oh vir)

What is emtricitabine, lopinavir, ritonavir, and tenofovir (AccessPak for HIV PEP Expanded with Kaletra)?

Emtricitabine, lopinavir, ritonavir, and tenofovir are antiviral drugs that prevent HIV (human immunodeficiency virus) cells from multiplying in your body.

The combination of these medications is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). This medication is not a cure for HIV or AIDS.

Emtricitabine, lopinavir, ritonavir, and tenofovir may also be used for purposes not listed in this medication guide.

What are the possible side effects of emtricitabine, lopinavir, ritonavir, and tenofovir (AccessPak for HIV PEP Expanded with Kaletra)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Call your doctor at once if you have a serious side effect such as:

  • severe dizziness, fainting, fast or pounding heartbeats;
  • vision changes;
  • increased urination thirst or extreme thirst;
  • penis erection that is painful or lasts longer than 4 hours;
  • signs of new infection such as fever, chills, skin lesions, or cough with yellow or green mucus;
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • swelling, rapid weight gain, feeling short of breath, urinating less than usual or not at all; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • mild skin rash;
  • diarrhea, upset stomach;
  • headache, mild dizziness;
  • sleep problems (insomnia), strange dreams;
  • runny or stuffy nose; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about emtricitabine, lopinavir, ritonavir, and tenofovir (AccessPak for HIV PEP Expanded with Kaletra)?

You should not take this medication if you have severe liver or kidney disease, or if you are allergic to emtricitabine (Emtriva, Atripla), lopinavir (Kaletra), ritonavir (Norvir), or tenofovir (Viread). Do not take this medication with other medicines that also contain emtricitabine or tenofovir (Atripla, Emtriva, Viread).

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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