emtricitabine, lopinavir, ritonavir, and tenofovir

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Pronunciation: em trye SYE ta been, loe PIN a vir, ri TOE na vir, ten OF oh vir

Brand: AccessPak for HIV PEP Expanded with Kaletra

What is the most important information I should know about emtricitabine, lopinavir, ritonavir, and tenofovir?

You should not take this medicine 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 medicine with other medicines that also contain emtricitabine or tenofovir (Atripla, Emtriva, Viread).

Some medicines can cause unwanted or dangerous effects when used with emtricitabine, lopinavir, ritonavir, and tenofovir. Your doctor may need to change your treatment plan if you use certain medicines.

Get emergency medical help if you have even mild symptoms 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.

What is emtricitabine, lopinavir, ritonavir, and tenofovir?

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

Emtricitabine, lopinavir, ritonavir, and tenofovir is a combination medicine used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). This medicine 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 should I discuss with my healthcare provider before taking emtricitabine, lopinavir, ritonavir, and tenofovir?

You should not take this medicine 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 medicine with other medicines that also contain emtricitabine or tenofovir (Atripla, Emtriva, Viread).

Some medicines can interact with emtricitabine, lopinavir, ritonavir, and tenofovir and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs:

  • alfuzosin;
  • lovastatin or simvastatin;
  • St. John's wort;
  • pimozide;
  • midazolam or triazolam;
  • rifampin;
  • sildenafil, Viagra (or Revatio for pulmonary arterial hypertension); or
  • an ergot medicine such as D.H.E. 45, Ergomar, Cafergot, Ergotrate, Methergine, Migergot, or Migranal.

To make sure emtricitabine, lopinavir, ritonavir, and tenofovir is safe for you, tell your doctor if you have:

  • liver or kidney disease;
  • heart disease or heart rhythm disorder;
  • low levels of potassium in your blood;
  • a bleeding disorder such as hemophilia;
  • osteopenia (low bone mineral density); or
  • pancreas problems, diabetes, or high cholesterol.

Some people taking this medicine develop a serious condition called lactic acidosis. This may be more likely in women, in people who are overweight or have liver disease, and in people who have taken HIV/AIDS medication for a long time. Talk with your doctor about your risk.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Do not give this medicine to a child without medical advice.

How should I take emtricitabine, lopinavir, ritonavir, and tenofovir?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

While using this medicine, you may need frequent blood tests at your doctor's office. Your kidney and liver function or bone density may also need to be tested.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

Store at room temperature away from moisture and heat. Do not freeze.

If you have hepatitis B you may develop liver symptoms after you stop taking this medicine, even months after stopping. Your doctor may want to check your liver function for several months after you stop using emtricitabine, lopinavir, ritonavir, and tenofovir.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking emtricitabine, lopinavir, ritonavir, and tenofovir?

If you also take didanosine (Videx), take it 1 hour before or 2 hours after you take emtricitabine, lopinavir, ritonavir, and tenofovir.

Taking this medicine will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

What are the possible side effects of emtricitabine, lopinavir, ritonavir, and tenofovir?

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

Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: 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:

  • severe dizziness, fainting, fast or pounding heartbeats;
  • vision changes;
  • increased urination or extreme thirst;
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • penis erection that is painful or lasts longer than 4 hours;
  • signs of new infection --fever, chills, skin lesions, or cough with yellow or green mucus;
  • liver problems --nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • kidney problems --little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; 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.

Common side effects may include:

  • diarrhea, nausea, vomiting, stomach pain;
  • headache, dizziness, feeling tired;
  • depressed mood, sleep problems (insomnia), strange dreams;
  • mild skin rash; 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 other drugs will affect emtricitabine, lopinavir, ritonavir, and tenofovir?

This medicine can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve). You may need dose adjustments or special tests when taking any of these other medications.

Many drugs can interact with emtricitabine, lopinavir, ritonavir, and tenofovir. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

  • any other HIV or AIDS medications;
  • ADHD medication;
  • antibiotic or antifungal medicine;
  • an antidepressant;
  • anti-malaria medication;
  • antiviral medications to treat herpes, HIV, or cytomegalovirus (CMV);
  • asthma or allergy medication;
  • cholesterol-lowering medicine;
  • erectile dysfunction medication (Viagra, Cialis, Levitra);
  • heart or blood pressure medication, heart rhythm medication;
  • insulin or oral diabetes medication;
  • leukemia medication;
  • medicine to treat a psychiatric disorder;
  • migraine headache medicines;
  • narcotic pain medicine;
  • a sedative;
  • seizure medication; or
  • steroid medication (prednisone and others).

This list is not complete and many other drugs can interact with emtricitabine, lopinavir, ritonavir, and tenofovir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about emtricitabine, lopinavir, ritonavir, and tenofovir.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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