Efavirenz, emtricitabine, and tenofovir

Name: Efavirenz, emtricitabine, and tenofovir

How should this medicine be used?

The combination of efavirenz, emtricitabine, and tenofovir comes as a tablet to take by mouth. It is usually taken once a day with water on an empty stomach (at least 1 hour before or 2 hours after a meal). Take efavirenz, emtricitabine, and tenofovir at around the same time every day. Taking efavirenz emtricitabine, and tenofovir at bedtime may make certain side effects less bothersome. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take efavirenz, emtricitabine, and tenofovir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Continue to take efavirenz, emtricitabine, and tenofovir even if you feel well. Do not stop taking efavirenz, emtricitabine, and tenofovir without talking to your doctor. If you stop taking efavirenz, emtricitabine, and tenofovir even for a short time, or skip doses, the virus may become resistant to medications and may be harder to treat.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Atripla side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult 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:

  • unusual thoughts or behavior, anger, severe depression, thoughts of hurting yourself or others, hallucinations;

  • a seizure (convulsions);

  • kidney problems--increased thirst and urination, muscle pain or weakness;

  • liver problems--nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); 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.

Atripla may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with Atripla. Tell your doctor if you have:

  • signs of a new infection--fever, night sweats, swollen glands, mouth sores, cold sores, sores on your genital or anal area, diarrhea, stomach pain, weight loss;

  • chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

  • rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

  • trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or

  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common side effects may include:

  • dizziness, drowsiness, tired feeling;

  • nausea, diarrhea;

  • headache, depressed mood, trouble concentrating;

  • sleep problems (insomnia), strange dreams;

  • 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.

Efavirenz, emtricitabine, and tenofovir dosing information

Usual Adult Dose for HIV Infection:

1 tablet orally once a day

Use: As a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection

Usual Adult Dose for Nonoccupational Exposure:

US CDC recommendations: 1 tablet orally once a day
Duration of therapy: 28 days

Comments:
-The components of this drug are recommended as a preferred NNRTI-based regimen for nonoccupational postexposure prophylaxis of HIV infection.
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.
-Current guidelines should be consulted for additional information.

Usual Adult Dose for Occupational Exposure:

US Public Health Service working group recommendations: 1 tablet orally once a day
Duration of therapy: 28 days, if tolerated

Comments:
-Only with expert consultation, an alternative regimen for use as HIV postexposure prophylaxis
-Prophylaxis should be started as soon as possible, preferably within hours after exposure.
-The optimal duration of prophylaxis is unknown and may differ based on institution protocol.
-Current guidelines should be consulted for additional information.

Usual Pediatric Dose for HIV Infection:

12 years or older weighing at least 40 kg: 1 tablet orally once a day

Use: As a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection

Commonly used brand name(s)

In the U.S.

  • Atripla

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Non-Nucleoside Reverse Transcriptase Inhibitor

Before Using efavirenz, emtricitabine, and tenofovir

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For efavirenz, emtricitabine, and tenofovir, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to efavirenz, emtricitabine, and tenofovir or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of efavirenz, emtricitabine, and tenofovir combination in children 12 years of age and older with a body weight of at least 40 kg. However, safety and efficacy have not been established in children younger than 12 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of efavirenz, emtricitabine, and tenofovir combination in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution in patients receiving efavirenz, emtricitabine, and tenofovir combination.

Pregnancy

Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking efavirenz, emtricitabine, and tenofovir, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using efavirenz, emtricitabine, and tenofovir with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Amifampridine
  • Amisulpride
  • Bepridil
  • Carbamazepine
  • Cisapride
  • Dasabuvir
  • Dronedarone
  • Elbasvir
  • Grazoprevir
  • Mesoridazine
  • Paritaprevir
  • Pimozide
  • Piperaquine
  • Ritonavir
  • Saquinavir
  • Sparfloxacin
  • St John's Wort
  • Terfenadine
  • Thioridazine
  • Voriconazole
  • Ziprasidone

Using efavirenz, emtricitabine, and tenofovir with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alfuzosin
  • Amiodarone
  • Amitriptyline
  • Amprenavir
  • Anagrelide
  • Apomorphine
  • Aripiprazole
  • Aripiprazole Lauroxil
  • Arsenic Trioxide
  • Artemether
  • Asenapine
  • Astemizole
  • Atazanavir
  • Atovaquone
  • Avanafil
  • Axitinib
  • Azithromycin
  • Bedaquiline
  • Bexarotene
  • Boceprevir
  • Bosutinib
  • Bupropion
  • Buserelin
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clozapine
  • Cobimetinib
  • Crizotinib
  • Cyclobenzaprine
  • Cyclosporine
  • Dabrafenib
  • Daclatasvir
  • Darunavir
  • Dasatinib
  • Deflazacort
  • Degarelix
  • Delamanid
  • Desipramine
  • Deslorelin
  • Deutetrabenazine
  • Dexamethasone
  • Didanosine
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Dolutegravir
  • Domperidone
  • Donepezil
  • Doxepin
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Droperidol
  • Ebastine
  • Efavirenz
  • Enzalutamide
  • Eribulin
  • Erythromycin
  • Escitalopram
  • Etravirine
  • Famotidine
  • Felbamate
  • Fingolimod
  • Flecainide
  • Fluconazole
  • Fluoxetine
  • Formoterol
  • Fosamprenavir
  • Foscarnet
  • Fosphenytoin
  • Galantamine
  • Gatifloxacin
  • Gemifloxacin
  • Ginkgo Biloba
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Histrelin
  • Hydroquinidine
  • Hydroxychloroquine
  • Hydroxyzine
  • Ibutilide
  • Idelalisib
  • Ifosfamide
  • Iloperidone
  • Imipramine
  • Itraconazole
  • Ivabradine
  • Ketoconazole
  • Lapatinib
  • Ledipasvir
  • Leuprolide
  • Levofloxacin
  • Levonorgestrel
  • Linagliptin
  • Lumefantrine
  • Maraviroc
  • Mefloquine
  • Methadone
  • Methotrimeprazine
  • Metronidazole
  • Mifepristone
  • Mizolastine
  • Moricizine
  • Moxifloxacin
  • Nafarelin
  • Naloxegol
  • Nelfinavir
  • Netupitant
  • Nevirapine
  • Nifedipine
  • Nilotinib
  • Norfloxacin
  • Octreotide
  • Ofloxacin
  • Olanzapine
  • Olaparib
  • Ondansetron
  • Orlistat
  • Paliperidone
  • Panobinostat
  • Papaverine
  • Paroxetine
  • Pasireotide
  • Pazopanib
  • Pentamidine
  • Perphenazine
  • Pimavanserin
  • Pipamperone
  • Pitolisant
  • Ponatinib
  • Posaconazole
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Proguanil
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Ribociclib
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Rilpivirine
  • Risperidone
  • Sertindole
  • Sevoflurane
  • Simeprevir
  • Sirolimus
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sonidegib
  • Sorafenib
  • Sotalol
  • Sulpiride
  • Sultopride
  • Sunitinib
  • Tacrolimus
  • Tamoxifen
  • Telavancin
  • Telithromycin
  • Tetrabenazine
  • Tizanidine
  • Tolterodine
  • Tolvaptan
  • Toremifene
  • Trazodone
  • Trimipramine
  • Triptorelin
  • Ulipristal
  • Vandetanib
  • Vardenafil
  • Velpatasvir
  • Vemurafenib
  • Venetoclax
  • Venlafaxine
  • Vilanterol
  • Vilazodone
  • Vinflunine
  • Vorinostat
  • Warfarin
  • Zotepine
  • Zuclopenthixol

Using efavirenz, emtricitabine, and tenofovir with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Atorvastatin
  • Caspofungin
  • Darunavir
  • Dienogest
  • Diltiazem
  • Estradiol
  • Ethinyl Estradiol
  • Ethynodiol
  • Etonogestrel
  • Indinavir
  • Lopinavir
  • Medroxyprogesterone
  • Mestranol
  • Norgestimate
  • Ospemifene
  • Pravastatin
  • Ritonavir
  • Sertraline
  • Simvastatin
  • Telaprevir
  • Tipranavir

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of efavirenz, emtricitabine, and tenofovir. Make sure you tell your doctor if you have any other medical problems, especially:

  • Allergic reaction to efavirenz (eg, Stevens-Johnson syndrome, erythema multiforme, toxic skin eruptions), history of—Should not be used in patients with this condition.
  • Bone problems (eg, osteopenia), history of or
  • Depression, history of or
  • Fanconi syndrome (kidney disease), history of or
  • Hepatitis B infection, history of or
  • Heart rhythm problem (eg, QT prolongation) or
  • Kidney failure, acute or
  • Liver disease, mild or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Kidney disease, moderate or severe or
  • Liver disease, moderate or severe—Use is not recommended in patients with these conditions.

Proper Use of efavirenz, emtricitabine, and tenofovir

Take efavirenz, emtricitabine, and tenofovir exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

efavirenz, emtricitabine, and tenofovir comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Do not change the dose or stop using efavirenz, emtricitabine, and tenofovir without checking first with your doctor. When your supply of efavirenz, emtricitabine, and tenofovir is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of efavirenz, emtricitabine, and tenofovir.

Take efavirenz, emtricitabine, and tenofovir on an empty stomach, at the same time each day, preferably at bedtime.

Keep taking efavirenz, emtricitabine, and tenofovir for the full time of treatment even if you begin to feel better. It is also important that you continue taking all of the medicines that your doctor has given you for HIV infection.

Dosing

The dose of efavirenz, emtricitabine, and tenofovir will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of efavirenz, emtricitabine, and tenofovir. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For treatment of HIV infection:
      • Adults and children 12 years of age and older and weighs at least 40 kilograms (kg)—One tablet once a day.
      • Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of efavirenz, emtricitabine, and tenofovir, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the bottle tightly closed. Keep the medicine in the original bottle that you were given at the pharmacy.

Usual Adult Dose for HIV Infection

1 tablet orally once a day

Use: As a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection

Usual Adult Dose for Occupational Exposure

US Public Health Service working group recommendations: 1 tablet orally once a day
Duration of therapy: 28 days, if tolerated

Comments:
-Only with expert consultation, an alternative regimen for use as HIV postexposure prophylaxis
-Prophylaxis should be started as soon as possible, preferably within hours after exposure.
-The optimal duration of prophylaxis is unknown and may differ based on institution protocol.
-Current guidelines should be consulted for additional information.

Usual Pediatric Dose for HIV Infection

12 years or older weighing at least 40 kg: 1 tablet orally once a day

Use: As a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection

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