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EFAVIRENZ tablet


  1. When Used With Other Antiretroviral Medicines To Treat Hiv-1 Infection, Efavirenz May Help:
  2. Avoid Doing Things That Can Spread Hiv-1 Infection To Others:
  3. , Tell Your Doctor If You Have Any Medical Conditions And In Particular, If You:
  4. May Cause Serious Side Effects, Including:
  5. Active Ingredient:
  6. Efavirenz Tablets:
  7. Manufactured By:
  8. Distributed By:
  9. Patient Information

When Used With Other Antiretroviral Medicines To Treat Hiv-1 Infection, Efavirenz 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).

Efavirenztabletsdoes 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 takeEfavirenz tablets?

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

Before takingEfavirenztablets

, 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 may harm your unborn baby. If you are able to become pregnant your healthcare provider should do a pregnancy test before you start efavirenz. You should not become pregnant while taking Efavirenz and for 12 weeks after stopping treatment with Efavirenz.Females who are able to become pregnant should use 2 effective forms of birth control during treatment and for 12 weeks after stopping treatment with Efavirenz tablets. A barrier form of birth control should 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 tablets.
  • Talk to your doctor about forms of birth control that may be used during treatment with Efavirenz.
  • 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 Efavirenztablets.
  • 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.

Efavirenztabletsmay affect the way other medicines work, and other medicines may affect how Efavirenztabletswork, and may cause serious side effects. If you take certain medicines with Efavirenz, 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 tabletsif 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.

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.
  • Do not start taking a new medicine without telling your doctor.Your doctor can tell you if it is safe to take Efavirenz tablets with other medicines.

How should I takeEfavirenz tablets?

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

How and when to take Efavirenz tablets?

  • You should take Efavirenz on an empty stomach at bedtime. Taking Efavirenz with food increases the amount of medicine in your body. Some side effects may bother you less if you take Efavirenz on an empty stomach and at bedtime.
  • Your child's doctor will prescribe the right dose of Efavirenz based on your child's weight.
  • If you have difficulty swallowing tablets, tell your doctor. Your doctor may recommend opening the efavirenz capsule and mixing the contents with food or infant formula.
  • Adults and children who take efavirenz using the capsule sprinkle method should not eat for 2 hours after taking a dose of efavirenz.
  • Babies should not be given infant formula for 2 hours after taking a dose of efavirenz using the capsule sprinkle method.
  • Do not miss a dose of Efavirenz. If you forget to take Efavirenz, take the missed dose right away, unless it is almost time for your next dose. Do not take 2 doses at one time. Just take your next dose at your regularly scheduled time. If you need help in planning the best times to take your medicine, ask your doctor or pharmacist.
  • If you take too much Efavirenz, call your doctor or go to the nearest hospital emergency room right away.
  • When your efavirenz supply starts to run low, get more from your doctor or pharmacy. It is important not to run out of Efavirenz. The amount of HIV-1 in your blood may increase if the medicine is stopped for even a short time. The virus may become resistant to Efavirenz and harder to treat.

What are the possible side effects of Efavirenztablets?

Efavirenztablets

May Cause Serious Side Effects, Including: 

  • Serious mental health problemscan happen in people who take Efavirenz. 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 tablets at room temperature between 68 F to 77 F (20 C to 25 C).

      Keep Efavirenz tablets and all medicines out of the reach of children.

      General information about Efavirenz tablets

      Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Efavirenz for a condition for which it was not prescribed. Do not give Efavirenz 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 that is written for health professionals. For more information, you can contact Strides Pharma Inc. at 1-877-244-9825

Active Ingredient: 

efavirenz

Efavirenz Tablets: 

croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The tablet film coating contains Instacoat Universal. Instacoat Universal contains HPMC 2910/Hypromellose, titanium dioxide, polyethylene glycol, red iron oxide, black iron oxide and yellow iron oxide. Opacode black ink contains propylene glycol, shellac glaze and ferrosoferric oxide.

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

Manufactured By: 

Strides Pharma Science Ltd.

Bengaluru-562106, India.

Distributed By: 

Strides Pharma Inc.

East Brunswick, NJ 08816.

Revision: 05/2019

Trademarks are the property of their respective owners.

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions 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.

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 safe 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[see Dosage and Administration (2) and Adverse 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 or tablets, 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 [see Dosage and Administration(2.3) and FDA-approved patient labeling(Patient Information and Instructions 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, and psychosis-like symptoms 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[see Warnings and Precautions (5.9) and Adverse 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, or if pregnancy is suspected during treatment with Efavirenz[see Warnings and Precautions (5.7)and Use 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 [see Use 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[see Warnings and Precautions (5.13)].



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