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EFAVIRENZ tablet, film coated


  1. Important:
  2. Read This Patient Information Before You Start Taking Efavirenz Tablets And Each Time You Get A Refill. There May Be New Information. This Information Does Not Take The Place Of Talking With Your Doctor About Your Medical Condition Or Treatment.what Are Efavirenz Tablets?
  3. 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 Tablets?
  4. You Should Take Efavirenz Tablets On An Empty Stomach At Bedtime. Taking Efavirenz Tablets With Food Increases The Amount Of Medicine In Your Body. Some Side Effects May Bother You Less If You Take Efavirenz Tablets On An Empty Stomach And At Bedtime.your Child S Doctor Will Prescribe The Right Dose Of Efavirenz Tablets Based On Your Child S Weight.if You Have Difficulty Swallowing Tablets, Tell Your Doctor.do Not Miss A Dose Of Efavirenz Tablets. If You Forget To Take Efavirenz Tablets, 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 Tablets, Call Your Doctor Or Go To The Nearest Hospital Emergency Room Right Away.when Your Efavirenz Tablets Supply Starts To Run Low, Get More From Your Doctor Or Pharmacy. It Is Important Not To Run Out Of Efavirenz Tablets. 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 Tablets And Harder To Treat.what Are The Possible Side Effects Of Efavirenz Tablets?efavirenz Tablets May Cause Serious Side Effects, Including:
  5. Active Ingredient:
  6. Efavirenz Tablets:
  7. Patient Information

Important: 

Ask your doctor or pharmacist about medicines that should not be taken with efavirenz tablets.For more information,

Read This Patient Information Before You Start Taking Efavirenz Tablets And Each Time You Get A Refill. There May Be New Information. This Information Does Not Take The Place Of Talking With Your Doctor About Your Medical Condition Or Treatment.what Are Efavirenz Tablets? 


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

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 Tablets? 

Do not take efavirenz tablets if you are allergic to efavirenz or any of the ingredients in efavirenz tablets.
Take efavirenz tablets exactly as your doctor tells you to.
Do not change your dose or stop taking efavirenz tablets unless your doctor tells you to.
Stay under the care of your doctor during treatment with efavirenz tablets.
Efavirenz tablets must be used with other antiretroviral medicines.
Take efavirenz tablets 1 time each day.
Efavirenz comes as tablets.
Efavirenz tablets must not be broken.
Swallow efavirenz tablets whole with liquid.
How and when to take efavirenz tablets.

You Should Take Efavirenz Tablets On An Empty Stomach At Bedtime. Taking Efavirenz Tablets With Food Increases The Amount Of Medicine In Your Body. Some Side Effects May Bother You Less If You Take Efavirenz Tablets On An Empty Stomach And At Bedtime.your Child S Doctor Will Prescribe The Right Dose Of Efavirenz Tablets Based On Your Child S Weight.if You Have Difficulty Swallowing Tablets, Tell Your Doctor.do Not Miss A Dose Of Efavirenz Tablets. If You Forget To Take Efavirenz Tablets, 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 Tablets, Call Your Doctor Or Go To The Nearest Hospital Emergency Room Right Away.when Your Efavirenz Tablets Supply Starts To Run Low, Get More From Your Doctor Or Pharmacy. It Is Important Not To Run Out Of Efavirenz Tablets. 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 Tablets And Harder To Treat.what Are The Possible Side Effects Of Efavirenz Tablets?efavirenz Tablets May Cause Serious Side Effects, Including: 


Serious mental health problemscan happen in people who take efavirenz tablets. Tell your doctor right away if you have any of the following symptoms:
feel sad or hopeless do not trust other people
feel anxious or restless 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

Active Ingredient: 

efavirenz, USP

Efavirenz Tablets: 

microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate. The film coating contains OpadryYellow (hypromellose, titanium dioxide, iron oxide yellow and polyethylene glycol)
This Patient Information has been approved by the U.S. Food and Drug Administration.


Efavirenztabcamberlogo2

Manufactured for:
Camber Pharmaceuticals, Inc.
Piscataway, NJ 08854

Manufactured by
HETEROTM

HETERO LABS LIMITED
22-110, I.D.A., Jeedimetla,
Hyderabad 500 055, India.



Revised: February 2018

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Hetero Labs Limited.




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 tablets.
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 tablets are 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 tablets.
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 tablets every day as prescribed. If a patient forgets to take efavirenz tablets, 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 tablets must always be used in combination with other antiretroviral drugs. Patients should be advised to take efavirenz tablets on an empty stomach, preferably at bedtime. Taking efavirenz tablets 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 tablets dosing schedule for infants and young children.
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 tablets[see Warnings 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 tablets are 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 tablets[see Warnings 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[see Warnings 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 tablets and for 12 weeks after discontinuing efavirenz tablets. Advise patients to contact their healthcare provider if they plan to become pregnant, become pregnant, or if pregnancy is suspected during treatment with efavirenz tablets[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 tablets 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)].
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Hetero Labs Limited.




Efavirenztabcamberlogo1

Manufactured for:
Camber Pharmaceuticals, Inc.
Piscataway, NJ 08854.


Manufactured by:
HETEROTM

HETERO LABS LIMITED
22-110, I.D.A., Jeedimetla,
Hyderabad 500 055, India.

Barcode

Revised: February 2018





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