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EFAVIRENZ capsule


  1. Patient Information
  2. What Are Efavirenz Capsules?
  3. When Used With Other Antiretroviral Medicines To Treat Hiv-1 Infection, Efavirenz Capsules May Help:
  4. Avoid Doing Things That Can Spread Hiv-1 Infection To Others:
  5. Capsules?
  6. Capsules, Tell Your Doctor If You Have Any Medical Conditions And In Particular, If You:
  7. How Should I Take Efavirenz Capsules?
  8. Capsules May Cause Serious Side Effects, Including:
  9. Active Ingredient:
  10. Inactive Ingredients:
  11. Important Information:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient InformationandInstructions for Use).


Drug Interactions


A statement to patients and healthcare providers is included on the product s bottle labels:ALERT: Find out about medicines that should NOT be taken with Efavirenz Capsules.


Efavirenz may interact with some drugs; therefore, patients should be advised to report to their doctor the use of any other prescription or nonprescription medication.


General Information for Patients


Patients should be informed that efavirenz is not a cure for HIV-1 infection and patients may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. Patients should remain under the care of a physician while taking efavirenz.


Patients should be advised to avoid doing things that can spread HIV-1 infection to others.


  • Do not share or reuse needles or other injection equipment.
  • Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
  • Do not have any kind of sex without protection.Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.
  • Do not breastfeed.Mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in breast milk.

Dosing Instructions


Patients should be advised to take efavirenz every day as prescribed. If a patient forgets to take efavirenz, tell the patient to take the missed dose right away, unless it is almost time for the next dose. Advise the patient not to take 2 doses at one time and to take the next dose at the regularly scheduled time. Advise the patient to ask a healthcare provider if he/she needs help in planning the best times to take his/her medicine.


Efavirenz must always be used in combination with other antiretroviral drugs. Patients should be advised to take efavirenz on an empty stomach, preferably at bedtime. Taking efavirenz with food increases efavirenz concentrations and may increase the frequency of adverse reactions. Dosing at bedtime may improve the tolerability of nervous system symptoms[seeDosage and Administration (2)andAdverse Reactions (6.1)].Healthcare providers should assist parents or caregivers in determining the best efavirenz dosing schedule for infants and young children.

For adult and pediatric patients who cannot swallow capsules, patients or their caregivers should be advised to read and carefully follow the instructions for administering the capsule contents in a small amount of food or infant formula[seeDosage and Administration (2.3)andFDA-approved patient labeling (Patient InformationandInstructions for Use)]. Patients should call their healthcare provider or pharmacist if they have any questions.


Nervous System Symptoms


Patients should be informed that central nervous system symptoms (NSS) including dizziness, insomnia, impaired concentration, drowsiness, and abnormal dreams are commonly reported during the first weeks of therapy with efavirenz[seeWarnings and Precautions (5.6)].Dosing at bedtime may improve the tolerability of these symptoms, which are likely to improve with continued therapy. Patients should be alerted to the potential for additive effects when efavirenz is used concomitantly with alcohol or psychoactive drugs. Patients should be instructed that if they experience NSS they should avoid potentially hazardous tasks such as driving or operating machinery.


Psychiatric Symptoms


Patients should be informed that serious psychiatric symptoms including severe depression, suicide attempts, aggressive behavior, delusions, paranoia, psychosis-like symptoms and catatonia have been reported in patients receiving efavirenz[seeWarnings and Precautions (5.5)].If they experience severe psychiatric adverse experiences they should seek immediate medical evaluation. Patients should be advised to inform their physician of any history of mental illness or substance abuse.


Rash


Patients should be informed that a common side effect is rash[seeWarnings and Precautions (5.8)].Rashes usually go away without any change in treatment. However, since rash may be serious, patients should be advised to contact their physician promptly if rash occurs.

Hepatotoxicity

Inform patients to watch for early warning signs of liver inflammation or failure, such as fatigue, weakness, lack of appetite, nausea and vomiting, as well as later signs such as jaundice, confusion, abdominal swelling, and discolored feces, and to consult their health care professional without delay if such symptoms occur[seeWarnings and Precautions (5.9)andAdverse Reactions (6.1)].

Females of Reproductive Potential


Advise females of reproductive potential to use effective contraception as well as a barrier method during treatment with efavirenz and for 12 weeks after discontinuing efavirenz. Advise patients to contact their healthcare provider if they plan to become pregnant, become pregnant, or if pregnancy is suspected during treatment with efavirenz[seeWarnings and Precautions (5.7)andUse in Specific Populations (8.1,8.3)].


Pregnancy Exposure Registry


Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to efavirenz during pregnancy[seeUse in Specific Populations (8.1)].


Fat Redistribution


Patients should be informed that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy and that the cause and long-term health effects of these conditions are not known[seeWarnings and Precautions (5.13)].

Dispense with Patient Information available at:www.aurobindousa.com/product-medication-guides

What Are Efavirenz Capsules? 


Efavirenz capsules are a prescription HIV-1 (Human Immunodeficiency Virus type 1) medicine used with other antiretroviral medicines to treat HIV-1 infection in adults and in children who are at least 3 months old and who weigh at least 7 pounds 12 ounces (3.5 kg). HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).


It is not known if efavirenz capsules are safe and effective in children younger than 3 months of age or who weigh less than 7 pounds 12 ounces (3.5 kg).

When Used With Other Antiretroviral Medicines To Treat Hiv-1 Infection, Efavirenz Capsules May Help: 


  • reduce the amount of HIV-1 in your blood. This is called viral load.
  • increase the number of CD4+ (T) cells in your blood that help fight off other infections.

Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).


Efavirenz capsules do not cure HIV-1 infection or AIDS. You should keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses.

Avoid Doing Things That Can Spread Hiv-1 Infection To Others: 

  • Do not share or reuse needles or other injection equipment.
  • Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
  • Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood.

Ask your doctor if you have any questions about how to prevent passing HIV to other people.


Who should not take efavirenz

Capsules? 

Do not take efavirenz capsules if you are allergic to efavirenz or any of the ingredients in efavirenz capsules.

Before taking efavirenz

Capsules, Tell Your Doctor If You Have Any Medical Conditions And In Particular, If You: 

  • have a heart condition
  • have ever had a mental health problem
  • have ever used street drugs or large amounts of alcohol
  • have liver problems, including hepatitis B or C virus infection
  • have a history of seizures
  • are pregnant or plan to become pregnant. Efavirenz capsules may harm your unborn baby. If you are able to become pregnant your healthcare provider should do a pregnancy test before you start efavirenz capsules. You should not become pregnant while taking efavirenz capsules and for 12 weeks after stopping treatment with efavirenz capsules.

Females who are able to become pregnant should use 2 effective forms of birth control during treatment and for 12 weeks after stopping treatment withefavirenz capsules.A barrier form of birth control should always be used along with another type of birth control.


  • Barrier forms of birth control may include latex or polyurethane condom, contraceptive sponge, diaphragm with spermicide, and cervical cap.
  • Hormonal forms of birth control, such as birth control pills, injections, vaginal rings, or implants may not work during treatment with efavirenz capsules.
  • Talk to your doctor about forms of birth control that may be used during treatment with efavirenz capsules.
  • Pregnancy Registry.There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your doctor about how you can take part in this registry.
  • Do not breastfeed if you take efavirenz capsules.
  • You should not breastfeed if you have HIV because of the risk of passing HIV to your baby.

Tell your doctor and pharmacist about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.


Efavirenz capsules may affect the way other medicines work, and other medicines may affect how efavirenz capsules work, and may cause serious side effects. If you take certain medicines with efavirenz capsules, the amount of efavirenz in your body may be too low and it may not work to help control your HIV infection. The HIV virus in your body may become resistant to efavirenz or other HIV medicines that are like it.


You should not takeefavirenz capsules if you take ATRIPLA(efavirenz, emtricitabine, tenofovir disoproxil fumarate) unless your doctor tells you to.


Tell your doctor and pharmacist about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with efavirenz capsules.


Keep a list of your medicines to show your doctor and pharmacist.


  • You can ask your doctor or pharmacist for a list of medicines that interact with efavirenz capsules.
  • Do not start taking a new medicine without telling your doctor.Your doctor can tell you if it is safe to take efavirenz capsules with other medicines.

How Should I Take Efavirenz Capsules? 

  • Take efavirenz capsules exactly as your doctor tells you to.
  • Do not change your dose or stop taking efavirenz capsules unless your doctor tells you to.
  • Stay under the care of your doctor during treatment with efavirenz capsules.
  • Efavirenz capsules must be used with other antiretroviral medicines.
  • Take efavirenz capsules 1 time each day.
  • Efavirenz comes as capsules.
  • Swallow efavirenz capsules whole with liquid.

How and when to take efavirenz capsules.

  • You should take efavirenz capsules on an empty stomach at bedtime. Taking efavirenz capsules with food increases the amount of medicine in your body. Some side effects may bother you less if you take efavirenz capsules on an empty stomach and at bedtime.
  • Your child s doctor will prescribe the right dose of efavirenz capsules based on your child s weight.
  • If you have difficulty swallowing capsules, tell your doctor. Your doctor may recommend opening the efavirenzcapsule and mixing the contents with food or infant formula.

    Efavirenz

Capsules May Cause Serious Side Effects, Including: 

  • Serious mental health problemscan happen in people who take efavirenz capsules. Tell your doctor right away if you have any of the following symptoms:
    • feel sad or hopeless
    • feel anxious or restless
    • have thoughts of hurting yourself (suicide) or have tried to hurt yourself or others
    • are not able to tell the difference between what is true or real and what is false or unreal
    • do not trust other people
    • hear or

      • Store efavirenz capsules at room temperature between 68 to 77 F (20 to 25 C).

      Keep efavirenz capsules and all medicines out of the reach of children.


      General information about efavirenz capsules

      Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use efavirenz capsules for a condition for which it was not prescribed. Do not give efavirenz capsules to other people, even if they have the same symptoms that you have. It may harm them.


      If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about efavirenz capsules that is written for health professionals. For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.

Active Ingredient: 

efavirenz

Inactive Ingredients: 

lactose monohydrate, magnesium stearate, sodium lauryl sulfate and sodium starch glycolate (potato). The capsule shell contains gelatin, silicon dioxide and sodium lauryl sulfate. In addition 50 mg contains titanium dioxide and yellow iron oxide, 100 mg contains titanium dioxide and 200 mg contains yellow iron oxide. The capsules are printed with edible ink containing black iron oxide and shellac.


This Patient Information has been approved by the U.S. Food and Drug Administration.


Distributed by:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India


Issued: October 2017

ATRIPLA is a registered trademark of Bristol-Myers Squibb & Gilead Sciences, LLC.

ZEPATIER is a registered trademark of Merck Sharp & Dohme Corp.

Instructions for Use
Efavirenz Capsules USP

(eh-FAV-ir-enz)

Preparing a dose of efavirenz capsules using the capsule sprinkle method


Read this Instructions for Use before you prepare your first dose of efavirenz capsules mixed with food or infant formula using the capsule sprinkle method, each time you get a refill, and as needed. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment. Ask your doctor or pharmacist if you have any questions about how to mix or give a dose of efavirenz capsules using the capsule sprinkle method.

Important Information: 


  • For more information about efavirenz capsules,


    Store efavirenz capsules at room temperature between 68 to 77 F (20 to 25 C).

    Keep efavirenz capsules and all medicines out of the reach of children.

    This Instructions for Use has been approved by the U.S. Food and Drug Administration.

    Dispense with Patient Information available at:www.aurobindousa.com/product-medication-guides

    Distributed by:
    Aurobindo Pharma USA, Inc.
    2400 Route 130 North
    Dayton, NJ 08810

    Manufactured by:
    Aurobindo Pharma Limited
    Hyderabad-500 038, India

    Issued: October 2017



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