Sustiva

DRUG DESCRIPTION

SUSTIVAź (efavirenz) is an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI). Efavirenz is chemically described as (S)-6-chloro-4-(cyclopropylethynyl)-l,4-dihydro-4-(trifluoromethyl)-2H-3,l-benzoxazin-2-one. Its empirical formula is C14H9ClF3NO2 and its structural formula is:

SUSTIVAź
  (efavirenz) Structural Formula Illustration

Efavirenz is a white to slightly pink crystalline powder with a molecular mass of 315.68. It is practically insoluble in water ( < 10 microgram/mL).

Capsules: SUSTIVA is available as capsules for oral administration containing either 50 mg or 200 mg of efavirenz and the following inactive ingredients: lactose monohydrate, magnesium stearate, sodium lauryl sulfate, and sodium starch glycolate. The capsule shell contains the following inactive ingredients and dyes: gelatin, sodium lauryl sulfate, titanium dioxide, and/or yellow iron oxide. The capsule shells may also contain silicon dioxide. The capsules are printed with ink containing carmine 40 blue, FD&C Blue No. 2, and titanium dioxide.

Tablets: SUSTIVA is available as film-coated tablets for oral administration containing 600 mg of efavirenz and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The film coating contains Opadry Yellow and Opadry Clear. The tablets are polished with carnauba wax and printed with purple ink, Opacode WB.

What are the possible side effects of efavirenz (Sustiva)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Efavirenz may cause serious psychiatric symptoms including confusion, severe depression, suicidal thoughts, aggression, extreme fear, hallucinations, or unusual behavior. Contact your doctor at once if you have any of these side effects, even if you have had them before.

Call your doctor at once if you have any of these serious side effects:

  • fever, sore throat,...

Read All Potential Side Effects and See Pictures of Sustiva »

What are the precautions when taking efavirenz (Sustiva)?

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...

Read All Potential Precautions of Sustiva »


Sustiva Consumer (continued)

SIDE EFFECTS: See also How to Use section.

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.

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. 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. 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.

To decrease your risk of spreading HIV disease to others, always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity. Consult your doctor or pharmacist for more details.

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. Efavirenz decreases the effectiveness of hormonal birth control products, so you must always use a barrier protection with these products. 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.


Sustiva Patient Information Including Side Effects

Brand Names: Sustiva

Generic Name: efavirenz (Pronunciation: e FAV ir enz)

  • What is efavirenz (Sustiva)?
  • What are the possible side effects of efavirenz (Sustiva)?
  • What is the most important information I should know about efavirenz (Sustiva)?
  • What should I discuss with my healthcare provider before taking efavirenz (Sustiva)?
  • How should I take efavirenz (Sustiva)?
  • What happens if I miss a dose (Sustiva)?
  • What happens if I overdose (Sustiva)?
  • What should I avoid while taking efavirenz (Sustiva)?
  • What other drugs will affect efavirenz (Sustiva)?
  • Where can I get more information?

What is efavirenz (Sustiva)?

Efavirenz is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Efavirenz is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Efavirenz is not a cure for HIV or AIDS.

Efavirenz may also be used for other purposes not listed in this medication guide.

What are the possible side effects of efavirenz (Sustiva)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Efavirenz may cause serious psychiatric symptoms including confusion, severe depression, suicidal thoughts, aggression, extreme fear, hallucinations, or unusual behavior. Contact your doctor at once if you have any of these side effects, even if you have had them before.

Call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • nausea, stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, chills, body aches, flu symptoms; or
  • any other signs of new infection.

Less serious side effects may include:

  • mild nausea, vomiting, or stomach pain, diarrhea or constipation;
  • cough;
  • blurred vision;
  • headache, dizziness, tired feeling;
  • trouble concentrating, problems with balance or coordination;
  • muscle or joint pain;
  • sleep problems (insomnia), unusual dreams; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about efavirenz (Sustiva)?

Efavirenz may cause serious psychiatric symptoms including confusion, severe depression, suicidal thoughts, aggression, extreme fear, hallucinations, or unusual behavior. Contact your doctor at once if you have any of these side effects, even if you have had them before.

Do not use this medication without telling your doctor if you are pregnant. It could harm the unborn baby. Use two forms of birth control, including a barrier form (such as a condom or diaphragm with spermicide gel) while you are taking efavirenz, and for at least 12 weeks after your treatment ends. Tell your doctor if you become pregnant during treatment.

Do not take efavirenz with cisapride (Propulsid), pimozide (Orap), midazolam (Versed), triazolam (Halcion), or ergot medicines such as dihydroergotamine (D.H.E. 45), ergonovine (Ergotrate), ergotamine (Ergomar, Cafergot, Wigraine), or methylergonovine (Methergine).

These drugs can cause life-threatening side effects if you use them while you are taking efavirenz.

There are many other medicines that can interact with efavirenz, or make it less effective. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

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