GENERIC NAME: EFAVIRENZ - ORAL (eh-FAV-er-enz)
BRAND NAME(S): Sustiva
USES: This drug is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Efavirenz belongs to a class of drugs known as non-nucleoside reverse transcriptase inhibitors (NNRTIs).Efavirenz is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.OTHER This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.This medication may also be used in combination with other HIV medications to reduce the risk of getting HIV infection after contact with the virus. Consult your doctor for more details.
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking efavirenz and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.Take this medication by mouth on an empty stomach, without food, usually once daily at bedtime or as directed by your doctor. Taking efavirenz with food increases the blood level of this medication, which may increase your risk of certain side effects. See Side Effects section.Swallow this medication whole with water. If you have difficulty swallowing the capsule, it may be opened and the contents mixed gently in a small amount (1 to 2 teaspoons) of soft food such as applesauce, grape jelly, or yogurt. After taking the mixed medication, add 2 more teaspoons of food to the empty mixing container. Swallow the remaining mixture to make sure that you get the entire dose. Swallow within 30 minutes of mixing. Do not eat any food for 2 hours after taking this medication. For babies who cannot eat solid foods, the contents may be mixed in 2 teaspoons of infant formula and drawn up into an oral syringe to be given to the baby. (See Patient Information Leaflet.)The dosage is based on your medical condition and response to treatment. In children, the dosage is also based on weight.It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not skip any doses. Do not increase your dose, take this drug more often than prescribed, or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time each day.
SIDE EFFECTS: Dizziness, trouble sleeping, drowsiness, unusual dreams, and trouble concentrating may frequently occur. These side effects may begin 1-2 days after starting this medication and usually go away in 2-4 weeks. They are also reduced by taking efavirenz on an empty stomach at bedtime. Avoid alcohol and street drugs while taking efavirenz. They may worsen these side effects.Tiredness, headache, nausea, vomiting, and diarrhea may also occur.If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Some people may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/persistent headaches, signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech).Infrequently, serious psychiatric symptoms may occur during efavirenz treatment, although it is unclear if they are caused by efavirenz. These effects may be seen especially in people who have mental/mood conditions. Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as depression, rare thoughts of suicide, nervousness, angry behavior, hallucinations).Tell your doctor immediately if any of these rare but serious side effects occur: signs of liver problems (such as persistent nausea/vomiting, stomach/abdominal pain, severe tiredness, yellowing eyes/skin, dark urine).Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.Efavirenz can commonly cause a rash that is usually not serious. In adults, a rash may occur in the first 2 weeks after starting treatment and if it is not serious, it will usually resolve in 4 weeks. In children, a rash may occur in the first 4 weeks after starting treatment. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, seek immediate medical attention if you develop any rash.A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, blisters, peeling skin, fever, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking efavirenz, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: mental/mood conditions (such as depression, thoughts of suicide, psychosis), liver problems (such as hepatitis B or C, cirrhosis), drug/substance/alcohol abuse, seizures, high cholesterol/triglyceride levels.This drug may make you dizzy or drowsy or cause trouble concentrating. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.A rash may be more common and serious in children taking efavirenz. Report any rash immediately. The doctor may prescribe an antihistamine for your child to take before efavirenz is started. Consult the doctor for more information.This medication is not recommended for use during pregnancy. It may harm an unborn baby, especially if taken during the first 3 months of pregnancy. Women of childbearing age should have a pregnancy test before starting efavirenz. It is important to prevent pregnancy while taking this medication and for 3 months after treatment. Consult your doctor about using at least 2 reliable forms of birth control (such as condoms with birth control pills) during treatment and for 3 months after the end of treatment (see also Drug Interactions section). If you become pregnant or think you may be pregnant, tell your doctor immediately. Discuss the risks and benefits of HIV treatment and alternatives to efavirenz during pregnancy to decrease the risk of HIV transmission to the baby.It is not known if efavirenz passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Do not take this medication with other products that contain efavirenz unless specifically directed by your doctor.Other medications can affect the removal of efavirenz from your body, which may affect how efavirenz works. Examples include some drugs used to treat seizures (such as carbamazepine, phenobarbital, phenytoin), rifamycins (such as rifampin), St. John's wort, among others.Efavirenz can speed up or slow down the removal of many other medications from your body, which may affect how they work. Examples of affected drugs include some drugs for anxiety/sleep (such as alprazolam, midazolam, triazolam), azole antifungals (such as itraconazole, ketoconazole, voriconazole), calcium channel blockers (such as diltiazem, verapamil), cisapride, ergot drugs (such as ergotamine), macrolide antibiotics (such as clarithromycin), methadone, pimozide, rifabutin, sertraline, some cholesterol-lowering statins (such as atorvastatin, pravastatin, simvastatin), warfarin, among others.Some other drugs to treat HIV infection (such as other NNRTIs including etravirine/nevirapine/rilpivirine) may also interact with efavirenz. If you are taking atazanavir with this medication, you may need to also take another medication (ritonavir). Consult your doctor or pharmacist for more details.This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Talk to your doctor about additional or alternative reliable forms of birth control, and always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity to decrease the risk of spreading HIV to others. Tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your hormonal birth control is not working well. (See also Precautions section.)Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine).Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.This medication may interfere with certain laboratory tests (including urine cannabinoid tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
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OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as liver tests, viral load, T-cell counts, cholesterol and triglyceride levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.Keep all medical and laboratory appointments.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised May 2013. Copyright(c) 2013 First Databank, Inc.
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