Emtricitabine, lopinavir, ritonavir and tenofovir

Emtricitabine, lopinavir, ritonavir and tenofovir

Emtricitabine, lopinavir, ritonavir and tenofovir

What is emtricitabine, lopinavir, ritonavir and tenofovir?

Emtricitabine, lopinavir, ritonavir, and tenofovir are combination medications used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Emtricitabine, lopinavir, ritonavir and tenofovir are not a cure for HIV or AIDS.

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

Side effects of emtricitabine, lopinavir, ritonavir and tenofovir

If necessary, get emergency medical helpSigns of an allergic reaction:hives; difficulty breathing; Swelling of your face, lips, tongue, or throat.

Early symptoms of lactic acidosiscan worsen over time and this condition can be fatal. Get medical help right away if you have even mild symptoms: muscle pain or weakness, numbness or coldness in your arms and legs, difficulty breathing, stomach pain, nausea with vomiting, fast or uneven heartbeat, dizziness, or feeling very weak or tired.

Emtricitabine, lopinavir, ritonavir, and tenofovir can cause serious side effects. Call your doctor immediately if you have:

• severe dizziness, fainting, fast or rapid heartbeat;

• visual disturbances;

• increased urination or extreme thirst;

• severe pain in the upper abdomen spreading to the back, nausea and vomiting, fast heartbeat;

• easy bruising, unusual bleeding (nose, mouth, vagina or rectum), purple or red dot-like spots under the skin;

• Penile erection that is painful or lasts longer than 4 hours;

• Signs of a new infection – fever, chills, skin lesions, or cough with yellow or green mucus;

• Liver problems - nausea, upper abdominal 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 of the feet or ankles, tiredness or shortness of breath; or

• severe skin reaction - fever, sore throat, swelling of the face or tongue, burning in the eyes, skin pain, followed by a red or purple rash that spreads (especially on the face or upper body) and causes blistering and peeling.

Common side effects of emtricitabine, lopinavir, ritonavir, and tenofovir may include:

• diarrhea, nausea, vomiting, stomach pain;

• headache, dizziness, fatigue;

• depressive mood, sleep problems (insomnia), strange dreams;

• mild rash; or

• Changes in the shape or location of body fat (especially on the 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 can report side effects to FDA at 1-800-FDA-1088.

Warnings

You should not take emtricitabine, lopinavir, ritonavir, and tenofovir 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 may cause unwanted or dangerous effects when used at the same time as emtricitabine, lopinavir, ritonavir and tenofovir. Your doctor may need to change your treatment plan if you are taking certain medicines.

Get medical help immediately if you have even mild symptoms, such as:Muscle pain or weakness, numbness or coldness in the arms and legs, difficulty breathing, stomach pain, nausea with vomiting, fast or uneven heartbeat, dizziness, or severe weakness or tiredness.

Before you take this medicine

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 may 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 are taking any of the following medicines:

• 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 DHE 45, Ergomar, Cafergot, Ergotrate, Methergine, Migergot or Migranal.

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

• liver or kidney disease;

• heart disease or cardiac arrhythmia;

• low levels of potassium in your blood;

• a bleeding disorder such as hemophilia;

• osteopenia (low bone mineral density); or

• Pancreatic problems, diabetes or high cholesterol.

Some people taking this medicine develop a serious condition calledLactic acidosis.This may be more likely in women, people who are overweight or have liver disease, and people who have taken HIV/AIDS medication for a long time. Talk to 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 planning to become pregnant. HIV can be passed on to your baby if you are not treated properly during pregnancy. Take all your HIV medications as prescribed to control your infection.

Women with HIV or AIDS should not breastfeed their babies. Even if your baby is born without HIV, the virus can be passed to the baby through breast milk.

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

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

Follow all instructions on your prescription label. Do not take emtricitabine, lopinavir, ritonavir, and tenofovir in larger or smaller amounts or for longer than recommended.

Your doctor may need frequent blood tests while you are using this medicine. Your kidney and liver function or bone density may also need to be tested.

HIV/AIDS is usually treated with a combination of medications. Use all medications as directed by your doctor. Read the Medication Guide or Patient Instructions included with each medication. Do not change your dosage or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under medical care.

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

If you have hepatitis B, you may experience liver problems after stopping this medicine, even months after stopping it. 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 the next scheduled dose. Do not take extra medicine to make up for a missed dose.

What happens if I overdose?

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

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

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

Taking emtricitabine, lopinavir, ritonavir and tenofovir will not prevent you from passing HIV to other people. Don't have unprotected sex or share razors or toothbrushes. Talk to your doctor about safe ways to prevent HIV transmission during sex. Sharing medicine or medication needles is never safe, even for a healthy person.

What other medicines affect emtricitabine, lopinavir, ritonavir and tenofovir?

This medicine can damage your kidneys. This effect is increased if you also take certain other medicines, including antiviral medicines, chemotherapy, injected antibiotics, medicines for intestinal disorders, medicines to prevent organ transplant rejection, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve). . Dosage adjustments or special testing may be necessary when taking these other medicines.

Many medications can interact with emtricitabine, lopinavir, ritonavir, and tenofovir. Not all possible interactions are listed here. Tell your doctor about all medications you are currently taking and any medications you are taking or stopping, especially:

• any other HIV or AIDS medications;

• ADHD medications;

• antibiotics or antifungals;

• an antidepressant;

• anti-malarial drugs;

• antiviral medications to treat herpes, HIV, or cytomegalovirus (CMV);

• asthma or allergy medications;

• cholesterol-lowering medicines;

• Erectile dysfunction medications (Viagra, Cialis, Levitra);

• heart or blood pressure medications, heart rhythm medications;

• insulin or oral diabetes medications;

• anti-leukemia drugs;

• medicines for treating a psychiatric disorder;

• anti-migraine medicines;

• narcotic painkillers;

• a sedative;

• anti-seizure medications; or

• Steroid medications (prednisone and others).

This list is not exhaustive and many other medications may interact with emtricitabine, lopinavir, ritonavir, and tenofovir. This includes prescription and over-the-counter medications, vitamins and herbal products. Give any doctor who treats you a list of all your medications.

More information

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