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Atripla (Generic Efavirenz, Emtricitabine, and Tenofovir)

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WARNING

Hepatitis B virus infection should not be treated with efavirenz, emtricitabine, or tenofovir (HBV; an ongoing liver infection). If you suspect you may have HBV, let your doctor know. Before you start your efavirenz, emtricitabine, and tenofovir treatment, your doctor may do a test to determine whether you have HBV. When you stop taking efavirenz, emtricitabine, and tenofovir if you have HBV, your condition could abruptly get worse. For several months after you stop using this medicine, your doctor will check on you and place lab testing to see if your HBV has gotten worse.

Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to efavirenz, emtricitabine, and tenofovir, your doctor will prescribe specific tests both before and during your therapy.

The dangers of taking efavirenz, emtricitabine, and tenofovir should be discussed with your doctor.

Why is this medication prescribed?

For the treatment of human immunodeficiency virus (HIV) infection in adults and children weighing more than 40 kg, the combination of efavirenz, emtricitabine, and tenofovir may be used alone or in conjunction with additional drugs (88 lb). A group of drugs known as non-nucleoside reverse transcriptase inhibitors includes efavirenz (NNRTIs). Nucleoside reverse transcriptase inhibitors are a class of medicines that includes emtricitabine and tenofovir (NRTIs). They function by lowering the body’s HIV concentration. Despite the fact that efavirenz, emtricitabine, and tenofovir do not treat HIV, they may lessen your risk of getting AIDS and other HIV-related conditions including serious infections or cancer. The risk of contracting or spreading the HIV virus to others may be reduced by taking these medications, engaging in safer sexual behaviour, and changing other aspects of one’s lifestyle.

How should this medicine be used?

Efavirenz, Emtricitabine, and Tenofovir are available as a tablet for oral use. Typically, it is taken once daily with water and first thing in the morning (at least 1 hour before or 2 hours after a meal). Efavirenz, emtricitabine, and tenofovir should be taken every day at roughly the same time. It may be less irritating to experience some side effects if you take efavirenz, emtricitabine, and tenofovir right before bed. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Follow the directions on the label for efavirenz, emtricitabine, and tenofovir. Never take it in larger or less amounts or more frequently than directed by your doctor.

Even if you feel good, keep taking efavirenz, emtricitabine, and tenofovir. Without consulting your doctor, do not discontinue taking efavirenz, emtricitabine, or tenofovir. It is possible for the virus to develop drug resistance and become more difficult to treat if you stop taking efavirenz, emtricitabine, and tenofovir for even a brief period of time or skip doses.

For a copy of the manufacturer’s information for the patient, ask your pharmacist or doctor.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking efavirenz, emtricitabine, and tenofovir,

  • If you have any allergies to efavirenz, emtricitabine, tenofovir, other drugs, or any of the substances in efavirenz, emtricitabine, and tenofovir tablets, let your doctor and pharmacist know right away. Request a list of the components from your pharmacist.
  • Inform your physician if you are taking elbasvir plus grazoprevir or voriconazole (Vfend) (Zepatier). If you are taking one or more of these drugs, your doctor will probably advise you not to take efavirenz, emtricitabine, and tenofovir.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, or dietary supplements you are currently taking or intend to take. Incorporate any of the following: Antidepressants, adefovir (Hepsera), atazanavir (Reyataz), atorvastatin (Lipitor, in Caduet), atovaquone and proguanil (Malarone), boceprevir (Victrelis), bupropion (Wellbutrin, Zyban, etc); acyclovir (Sitavig, Zovirax); lumefantrine (Coartem); atova; etonogestrel (Nexplanon, in Nuvaring); etravirine (Intelence); felodipine; fosamprenavir (Lyrica); carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril); clarithromycin (Biaxin, in Prevpac); cidofovir; cyclosporine (Gengraf, Neoral, Sandimmune); daruna; Drugs for anxiety, mental illness, and seizures include itraconazole (Onmel, Sporanox), ketoconazole, lamivudine (Epivir, Epivir HBV, in Combivir, Epzicom, Triumeq, Trizivir), ledipasvir and sofosbuvir (Harvoni), lopinavir and ritonavir (Kaletra), maraviroc (Selzentry), methadone; Other HIV medications include efavirenz, emtricitabine, and tenofovir (Complera, Descovy, Genvoya, Odefsey, Stribild, Truvada, Sustiva, Emtriva, and Viread); posaconazole (Noxafil); pravastatin (Pravachol); raltegravir (Isentress); rifabutin (Mycobutin), rifampin (Rifadin, Rimactane, in Rifamate, Rifater), ritonavir (Norvir, in Kaletra, Technivie, Viekira Pak), saquinavir (Invirase), sedatives, sertraline (Zoloft), sleeping pills, simeprevir (Olysio), simvastatin; tranquillizers, warfarin, verapamil (Calan, Covera, Tarka, Verelan), valacyclovir (Valtrex), valganciclovir (Valcyte), and valganciclovir (Coumadin, Jantoven). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects. Be important to inform your doctor about all of the medications you are taking, including any that do not appear on this list, as many other drugs may interact with efavirenz, emtricitabine, and tenofovir or may raise your risk of developing liver damage while receiving therapy with these drugs.
  • Please let your doctor know if you are taking any herbal supplements, especially St. John’s wort.
  • Inform your doctor if you have ever consumed significant amounts of alcohol, used illegal drugs, overused prescription drugs, or presently have a prolonged QT interval (a rare heart condition that can result in irregular heartbeat, fainting, or sudden death). Additionally, let your doctor know if you suffer from or have ever suffered from any of the disorders listed in the IMPORTANT WARNING section, such as depression or another mental illness, bone issues like osteoporosis or bone fractures, seizures, liver disease, or renal disease.
  • If you are pregnant or plan to become pregnant, let your doctor know. Throughout your therapy and for 12 weeks following your last dose, you shouldn’t get pregnant. Before starting this medicine, you must have a negative pregnancy test. You must also use reliable birth control while undergoing therapy if you are capable of getting pregnant. You shouldn’t use efavirenz, emtricitabine, or tenofovir as your sole method of birth control while you are receiving therapy since they may interfere with the function of hormonal contraceptives (birth control pills, patches, rings, implants, or injections). Along with any other method of birth control you choose, you must utilise a barrier method of contraception (device that prevents sperm from entering the uterus, such as a condom or a diaphragm). Ask your doctor to assist you in selecting a birth control technique that will be effective for you. Call your doctor right away if you became pregnant while taking efavirenz, emtricitabine, or tenofovir.
  • If you have HIV or are taking efavirenz, emtricitabine, or tenofovir, you shouldn’t breastfeed.
  • You need to be aware that your body fat may expand or shift to several regions, including your upper back, neck (the “buffalo hump”), breasts, and the area surrounding your abdomen. Your face, legs, and arms may show a reduction of body fat.
  • You should be aware that while you use medications to treat your HIV infection, your immune system could become stronger and start to fight other infections you previously have in your body or trigger the development of other illnesses. You might start to exhibit signs of certain illnesses as a result of this. Tell your doctor right away if you experience any new or worsening symptoms while taking efavirenz, emtricitabine, or tenofovir.
  • You need to be aware that efavirenz, emtricitabine, and tenofovir may cause you to feel sleepy, lightheaded, or unable to focus. Prior to understanding how this drug affects you, avoid using machinery or driving a car.
  • You should be aware that the antivirals efavirenz, emtricitabine, and tenofovir may alter your mood or mental state. If you have any of the following side effects while taking efavirenz: depression, suicidal thoughts, plans, or attempts, irrational anger or aggressive behaviour, hallucinations (hearing voices or seeing things that are not there), unusual ideas, or loss of awareness. Make sure your family is aware of any potentially critical symptoms so they can contact your doctor on your behalf if you are unable to get help on your own.
  • Ask your doctor if drinking alcohol is safe for you to do so while taking efavirenz, emtricitabine, and tenofovir. The negative effects of efavirenz, emtricitabine, and tenofovir can be exacerbated by alcohol.
  • You should be aware that months or years after taking efavirenz, emtricitabine, and tenofovir for the first time, efavirenz may still result in very serious nervous system issues, including encephalopathy (a serious and potentially deadly brain illness). It is crucial for you and your doctor to understand that efavirenz may be the source of any nervous system issues you experience, even if they may not manifest until after you have taken efavirenz, emtricitabine, and tenofovir for a while. Anytime during your efavirenz, emtricitabine, and tenofovir treatment, if you develop balance and coordination issues, confusion, memory issues, or any other issues brought on by aberrant brain function, call your doctor immediately away. Your physician might advise discontinuing your use of efavirenz, emtricitabine, and tenofovir.

What special dietary instructions should I follow?

If you plan to consume grapefruits or grapefruit juice while taking this medication, consult your doctor.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Emtricitabine, tenofovir, and efavirenz all have potential adverse effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Headache
  • Diarrhea
  • Gas
  • Indigestion
  • Skin colour fading, particularly on the hands’ or feet’s soles or the palms
  • Light skin
  • Having trouble falling or staying asleep
  • Confusion
  • Forgetfulness
  • Feeling disturbed, anxious, or uneasy
  • Unusual level of happiness
  • Strange dreams
  • Back or joint pain
  • Itching

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you develop any of these signs or any of the ones detailed in the IMPORTANT WARNING section:

  • Less urinations
  • Making a lot of urine
  • Heightened thirst
  • Persistent or escalating bone pain
  • Broken bones
  • Pain in the hands, feet, legs, arms, or other body parts
  • Aching or weakened muscles
  • Rash
  • Skin that is flaking, blistering, or peeling
  • Hands, arms, feet, or legs that are numb, burning, or tingly
  • Swelling of the legs, ankles, feet, cheeks, throat, tongue, lips, and eyes
  • Breathing or swallowing challenges
  • Hoarseness
  • Seizures
  • Flu-like signs
  • Nausea
  • Vomiting
  • Extreme fatigue
  • Loss of appetite, pain in the upper right side of the stomach, unusual bleeding, or bruises, as well as yellowing of the skin or eyes, light-colored stools, dark yellow or brown urine, and loss of appetite
  • Weakness, muscle discomfort, fast or irregular heartbeat, cold or blue hands and feet, shortness of breath, rapid breathing, stomach pain with nausea, and vomiting

Other adverse effects could be brought on by efavirenz, emtricitabine, and tenofovir. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Store it away from excessive heat and moisture at room temperature (not in the bathroom).

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose signs could include the following:

  • Physical movements that are out of your control
  • Dizziness
  • Difficulty paying attention
  • Nervousness
  • Confusion
  • Forgetfulness
  • Having trouble falling or staying asleep
  • Strange dreams
  • Drowsiness
  • Hallucinations (seeing things or hearing sounds and voices that do not exist)
  • Unusual level of happiness
  • Strange ideas

What other information should I know?

Inform the lab staff and your doctor that you are taking efavirenz, emtricitabine, and tenofovir prior to any laboratory test.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

Efavirenz, emtricitabine, and tenofovir should always be available. Do not put off getting a refill on your prescription until you are out of medicine.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Atripla® (as a combination product containing Efavirenz, Emtricitabine, Tenofovir)
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