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What should I avoid while taking SUSTIVA (efavirenz)?
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Women taking SUSTIVA should not become pregnant. Serious birth defects have been seen in the
offspring of animals and women treated with SUSTIVA during pregnancy. It is not known whether
SUSTIVA caused these defects. Tell your doctor right away if you are pregnant. Also talk with your
doctor if you want to become pregnant.
Women should not rely only on hormone-based birth control, such as pills, injections, or implants,because SUSTIVA may make these contraceptives ineffective. Women must use a reliable form of capsules and tablets
barrier contraception, such as a condom or diaphragm, even if they also use other methods of birthcontrol.
ALERT: Find out about medicines that should NOT be taken with SUSTIVA.
Do not breast-feed if you are taking SUSTIVA. The Centers for Disease Control and Prevention rec-
Please also read the section "MEDICINES YOU SHOULD NOT TAKE WITH SUSTIVA."
ommend that mothers with HIV not breast-feed because they can pass the HIV through their milk to Read this information before you start taking SUSTIVA. Read it again each time you refill your the baby. Also, SUSTIVA may pass through breast milk and cause serious harm to the baby. Talk with prescription, in case there is any new information. This leaflet provides a summary about SUSTIVA and your doctor if you are breast-feeding. You may need to stop breast-feeding or use a different does not include everything there is to know about your medicine. This information is not meant to take the place of talking with your doctor.
Taking SUSTIVA with alcohol or other medicines causing similar side effects as SUSTIVA, such as What is SUSTIVA?
drowsiness, may increase those side effects.
SUSTIVA is a medicine used in combination with other medicines to help treat infection with Human Do not take any other medicines without checking with your doctor. These medicines include Immunodeficiency Virus type 1 (HIV-1), the virus that causes AIDS (acquired immune deficiency prescription and nonprescription medicines and herbal products, especially St. John's wort.
syndrome). SUSTIVA is a type of anti-HIV drug called a "non-nucleoside reverse transcriptase inhibitor"(NNRTI). NNRTIs are not used in the treatment of Human Immunodeficiency Virus type 2 (HIV-2) Before using SUSTIVA, tell your doctor if you
have problems with your liver or have hepatitis. Your doctor may want to do tests to check your
SUSTIVA works by lowering the amount of HIV-1 in the blood (viral load). SUSTIVA must be taken liver while you take SUSTIVA.
with other anti-HIV medicines. When taken with other anti-HIV medicines, SUSTIVA has been shown to have ever had mental illness or are using drugs or alcohol.
reduce viral load and increase the number of CD4+ cells, a type of immune cell in blood. SUSTIVA maynot have these effects in every patient.
have ever had seizures or are taking medicine for seizures [for example, Dilantin® (phenytoin),
SUSTIVA does not cure HIV or AIDS. People taking SUSTIVA may still develop other infections and Tegretol® (carbamazepine), or phenobarbital]. Your doctor may want to check drug levels in your blood complications. Therefore, it is very important that you stay under the care of your doctor.
from time to time.
SUSTIVA has not been shown to reduce the risk of passing HIV to others. Therefore, continue to What important information should I know about taking other medicines with SUSTIVA?
practice safe sex, and do not use or share dirty needles.
SUSTIVA may change the effect of other medicines, including ones for HIV, and cause serious side
What are the possible side effects of SUSTIVA?
effects. Your doctor may change your other medicines or change their doses. Other medicines, includ-
Serious psychiatric problems. A small number of patients experience severe depression, strange
ing herbal products, may affect SUSTIVA. For this reason, it is very important to:
thoughts, or angry behavior while taking SUSTIVA. Some patients have thoughts of suicide and a few let all your doctors and pharmacists know that you take SUSTIVA.
have actually committed suicide. These problems tend to occur more often in patients who have had tell your doctors and pharmacists about all medicines you take. This includes those you buy over-the- mental illness. Contact your doctor right away if you think you are having these psychiatric symptoms, counter and herbal or natural remedies.
so your doctor can decide if you should continue to take SUSTIVA.
Common side effects. Many patients have dizziness, trouble sleeping, drowsiness, trouble concen-
Bring all your prescription and nonprescription medicines as well as any herbal remedies that you are trating, and/or unusual dreams during treatment with SUSTIVA. These side effects may be reduced if you taking when you see a doctor, or make a list of their names, how much you take, and how often you take take SUSTIVA at bedtime on an empty stomach. They also tend to go away after you have taken the med- them. This will give your doctor a complete picture of the medicines you use. Then he or she can decide icine for a few weeks. If you have these common side effects, such as dizziness, it does not mean that you the best approach for your situation.
will also have serious psychiatric problems, such as severe depression, strange thoughts, or angry Taking SUSTIVA with St. John's wort (Hypericum perforatum), an herbal product sold as a dietary behavior. Tell your doctor right away if any of these side effects continue or if they bother you. It is supplement, or products containing St. John's wort is not recommended. Talk with your doctor if you possible that these symptoms may be more severe if SUSTIVA is used with alcohol or mood altering are taking or are planning to take St. John's wort. Taking St. John's wort may decrease SUSTIVA levels and lead to increased viral load and possible resistance to SUSTIVA or cross-resistance to other anti-HIV If you are dizzy, have trouble concentrating, or are drowsy, avoid activities that may be dangerous, such as driving or operating machinery.
MEDICINES YOU SHOULD NOT TAKE WITH SUSTIVA
Rash is common. Rashes usually go away without any change in treatment. In a small number of patients, rash may be serious. If you develop a rash, call your doctor right away. Rash may be a seri-
The following medicines may cause serious and life-threatening side effects when taken with SUSTIVA.
ous problem in some children. Tell your child's doctor right away if you notice rash or any other side
You should not take any of these medicines while taking SUSTIVA: effects while your child is taking SUSTIVA.
Hismanal® (astemizole) Other common side effects include tiredness, upset stomach, vomiting, and diarrhea.
Propulsid® (cisapride) Changes in body fat. Changes in body fat develop in some patients taking anti-HIV medicine. These
Versed® (midazolam) changes may include an increased amount of fat in the upper back and neck ("buffalo hump"), in the Halcion® (triazolam) breasts, and around the trunk. Loss of fat from the legs, arms, and face may also happen. The cause andlong-term health effects of these fat changes are not known.
Ergot medications (for example, Wigraine® and Cafergot®) Tell your doctor or healthcare provider if you notice any side effects while taking SUSTIVA.
The following medicine should not be taken with SUSTIVA since it may lose its effect or may increase Contact your doctor before stopping SUSTIVA because of side effects or for any other reason.
the chance of having side effects from SUSTIVA: This is not a complete list of side effects possible with SUSTIVA. Ask your doctor or pharmacist for • Vfend® (voriconazole) a more complete list of side effects of SUSTIVA and all the medicines you will take.
The following medicines may need to be replaced with another medicine when taken with SUSTIVA: How should I take SUSTIVA (efavirenz)?
Fortovase®, Invirase® (saquinavir) You should take SUSTIVA on an empty stomach, preferably at bedtime.
Swallow SUSTIVA with water.
The following medicines may need to have their dose changed when taken with SUSTIVA: Taking SUSTIVA with food increases the amount of medicine in your body, which may increase the Crixivan® (indinavir) frequency of side effects.
Taking SUSTIVA at bedtime may make some side effects less bothersome.
SUSTIVA must be taken in combination with other anti-HIV medicines. If you take only SUSTIVA, the Mycobutin® (rifabutin) medicine may stop working.
• REYATAZ® (atazanavir sulfate). If you are taking SUSTIVA and REYATAZ, you should also be taking Do not miss a dose of SUSTIVA. If you forget to take SUSTIVA, take the missed dose right away, unless it is almost time for your next dose. Do not double the next dose. Carry on with your Zoloft® (sertraline) regular dosing schedule. If you need help in planning the best times to take your medicine, ask yourdoctor or pharmacist.
These are not all the medicines that may cause problems if you take SUSTIVA. Be sure to tell
your doctor about all medicines that you take.
Take the exact amount of SUSTIVA your doctor prescribes. Never change the dose on your own. Donot stop this medicine unless your doctor tells you to stop.
General advice about SUSTIVA:
If you believe you took more than the prescribed amount of SUSTIVA, contact your local Poison Medicines are sometimes prescribed for conditions that are not mentioned in patient information
Control Center or emergency room right away.
leaflets. Do not use SUSTIVA for a condition for which it was not prescribed. Do not give SUSTIVA to
other people, even if they have the same symptoms you have. It may harm them.
Tell your doctor if you start any new medicine or change how you take old ones. Your doses mayneed adjustment.
Keep SUSTIVA at room temperature (77°F) in the bottle given to you by your pharmacist. The temperature can range from 59° to 86°F.
When your SUSTIVA supply starts to run low, get more from your doctor or pharmacy. This is veryimportant because the amount of virus in your blood may increase if the medicine is stopped for even Keep SUSTIVA out of the reach of children.
a short time. The virus may develop resistance to SUSTIVA and become harder to treat.
This leaflet summarizes the most important information about SUSTIVA. If you would like more Your doctor may want to do blood tests to check for certain side effects while you take SUSTIVA.
information, talk with your doctor. You can ask your pharmacist or doctor for the full prescribinginformation about SUSTIVA, or you can visit the SUSTIVA website at http://www.sustiva.com or call The dose of SUSTIVA capsules for adults is 600 mg (three 200-mg capsules, taken together) once a
day by mouth. The dose of SUSTIVA for children may be lower (see Can children take SUSTIVA?).
SUSTIVA® is a registered trademark of Bristol-Myers Squibb Pharma Company.
REYATAZ® is a registered trademark of Bristol-Myers Squibb Company.
The dose of SUSTIVA tablets for adults is 600 mg (one tablet) once a day by mouth.
Other brands listed are the trademarks of their respective owners and are not trademarks of Bristol-Myers Squibb Company.
Can children take SUSTIVA?
Yes, children who are able to swallow capsules can take SUSTIVA. Rash may be a serious problem in
some children. Tell your child's doctor right away if you notice rash or any other side effects while your
child is taking SUSTIVA. The dose of SUSTIVA for children may be lower than the dose for adults.
Capsules containing lower doses of SUSTIVA are available. Your child's doctor will determine the right dose based on your child's weight.
Princeton, NJ 08543 USA Who should not take SUSTIVA?
Do not take SUSTIVA if you are allergic to the active ingredient, efavirenz, or to any of the inactive ingre-
Revised April 2005 dients. Your doctor and pharmacist have a list of the inactive ingredients.
Based on package insert dated February 2005, 51-022486-06, 1187089

Source: http://www.healthyplace.com/images/stories/sex/hp-sustiva_pi.pdf