• Naltrexone Injection

    (nal trex' one)

    IMPORTANT WARNING:

    Naltrexone injection may cause liver damage when given in large doses. It is not likely that naltrexone injection will cause liver damage when given in recommended doses. Tell your doctor if you have or have ever had hepatitis or another liver disease. If you experience any of the following symptoms, call your doctor immediately: excessive tiredness, unusual bleeding or bruising, pain in the upper right part of your stomach that lasts more than a few days, light-colored bowel movements, dark urine, or yellowing of the skin or eyes. Your doctor will probably not give you naltrexone injection if you have liver disease or if you develop symptoms of liver disease during your treatment.
    Talk to your doctor about the risks of receiving naltrexone injection.
    Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with naltrexone injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website http://www.vivitrol.com to obtain the Medication Guide.

    WHY is this medicine prescribed?

    Naltrexone injection is used along with counseling and social support to help people who have stopped drinking large amounts of alcohol to avoid drinking again. Naltrexone injection is also used along with counseling and social support to help people who have stopped abusing opiate medications or street drugs to avoid abusing the medications or street drugs again. Naltrexone injection should not be used to treat people who are still drinking alcohol, people who are still using opiates or street drugs, or people who have used opiates within the past 10 days. Naltrexone is in a class of medications called opiate antagonists. It works by blocking activity in the limbic system, a part of the brain that is involved in alcohol and opiate dependence.

    HOW should this medicine be used?

    Naltrexone injection comes as a solution (liquid) to be given by injection into the muscle of the buttocks by a healthcare provider once every 4 weeks.
    Naltrexone injection will not prevent withdrawal symptoms that may occur when you stop drinking alcohol after drinking large amounts for a long time or when you stop using opiate medications or street drugs.

    Are there OTHER USES for this medicine?

    This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

    What SPECIAL PRECAUTIONS should I follow?

    Before receiving naltrexone injection,
    • tell your doctor and pharmacist if you are allergic to naltrexone, any other medications, carboxymethylcellulose (an ingredient in artificial tears and some medications), or polylactide-co-glycolide (PLG; an ingredient in some injected medications). Ask your doctor or pharmacist if you don't know if a medication you are allergic to contains carboxymethylcellulose or PLG.
    • tell your doctor if you have taken any opiate medications including certain medications for diarrhea, cough, or pain; methadone (Dolophine); or buprenorphine (Buprenex, Subutex, in Suboxone) within the last 7 to 10 days. Ask your doctor if you are not sure if a medication you have taken is an opiate Also tell your doctor if you have used any opiate street drugs such as heroin within the last 7 to 10 days. Your doctor may order certain tests to see if you have recently taken any opiate medications or used street drugs. Your doctor will not give you naltrexone injection if you have recently taken an opiate medication or used street drug.
    • do not take any opiate medications or use street drugs during your treatment with naltrexone injection. Naltrexone injection blocks the effects of opiate medications and street drugs. You may not feel the effects of these substances if you take or use them at low or normal doses at most times during your treatment. However, you may be more sensitive to the effects of these substances when it is almost time for you to receive a dose of naltrexone injection or if you miss a dose of naltrexone injection. You may experience an overdose if you take normal doses of opiate medications at these times, or if you take high doses of opiate medications or use street drugs at any time during your treatment with naltrexone. An opiate overdose may cause serious injury, coma (long-lasting unconscious state), or death. If you take or use opiate medications or street drugs during your treatment and you develop any of the following symptoms, call your doctor or seek emergency medical care immediately: difficulty breathing, slow, shallow breathing, faintness, dizziness, or confusion. Be sure that your family knows which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own.
    • you should know that you may be more sensitive to the effects of opiate medications or street drugs after you finish your treatment with naltrexone injection. After you finish your treatment, tell any doctor who may prescribe medication for you that you were previously treated with naltrexone injection.
    • tell your doctor what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
    • tell your doctor if you have stopped taking opiates or using street drugs and are experiencing withdrawal symptoms such as anxiety, sleeplessness, yawning, fever, sweating, teary eyes, runny nose, goose bumps, shakiness, hot or cold flushes, muscle aches, muscle twitches, restlessness, nausea and vomiting, diarrhea, or stomach cramps, and if you have or have ever had bleeding problems such as hemophilia (a bleeding disorder in which the blood does not clot normally), a low number of platelets in your blood, depression, or kidney disease.
    • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving naltrexone injection, call your doctor.
    • if you need medical treatment or surgery, including dental surgery, tell the doctor or dentist that you are receiving naltrexone injection. Wear or carry medical identification so that healthcare providers who treat you in an emergency will know that you are receiving naltrexone injection.
    • you should know that naltrexone injection may make you feel dizzy or drowsy. Do not drive a car or operate machinery or do other dangerous activities until you know how this medication affects you.
    • you should know that people who drink large amounts of alcohol or who use street drugs often become depressed and sometimes try to harm or kill themselves. Receiving naltrexone injection does not decrease the risk that you will try to harm yourself. You, your family, or your caregiver should call your doctor right away if you experience symptoms such as feelings of sadness, anxiousness, worthlessness, or helplessness, or thinking about harming or killing yourself or planning or trying to do so. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor right away if you are unable to seek treatment on your own.
    • you should know that naltrexone injection is only helpful when it is used as part of an addiction treatment program. It is important that you attend all counseling sessions, support group meetings, education programs or other treatments recommended by your doctor.
    • talk to your doctor about the risks and benefits of naltrexone injection before you receive your first dose. Naltrexone will remain in your body for about 1 month after you receive the injection and cannot be removed before this time.

    What SPECIAL DIETARY instructions should I follow?

    Unless your doctor tells you otherwise, continue your normal diet.

    What should I do IF I FORGET to take a dose?

    If you miss an appointment to receive naltrexone injection, schedule another appointment as soon as possible.

    What SIDE EFFECTS can this medicine cause?

    Naltrexone injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
    • nausea
    • vomiting
    • diarrhea
    • stomach pain
    • decreased appetite
    • dry mouth
    • headache
    • difficulty falling asleep or staying asleep
    • dizziness
    • tiredness
    • anxiety
    • joint pain or stiffness
    • muscle cramps
    • weakness
    • tenderness, redness, bruising, or itching at the injection site
    Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:
    • pain, hardness, swelling, lumps, blisters, open wounds, or a dark scab at the injection site
    • coughing
    • wheezing
    • shortness of breath
    • hives
    • rash
    • swelling of the eyes, face, mouth, lips, tongue, or throat
    • hoarseness
    • difficulty swallowing
    • chest pain
    Naltrexone injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.
    If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch ] or by phone [1-800-332-1088].

    What should I do in case of OVERDOSE?

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
    Symptoms of overdose may include:
    • nausea
    • stomach pain
    • drowsiness
    • dizziness

    What OTHER INFORMATION should I know?

    Keep all appointments with your doctor.
    Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving naltrexone injection.
    Ask your doctor or pharmacist any questions you have about naltrexone injection.
    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

    Brand Names

    • Vivitrol®

    Naltrexone

    (nal trex' one)

    IMPORTANT WARNING:

    Naltrexone may cause liver damage when taken in large doses. It is not likely that naltrexone will cause liver damage when taken in recommended doses. Tell your doctor if you have or have ever had hepatitis or liver disease. If you experience any of the following symptoms, stop taking naltrexone and call your doctor immediately: excessive tiredness,unusual bleeding or bruising, loss of appetite, pain in the upper right part of your stomach that lasts more than a few days, light-colored bowel movements,dark urine, or yellowing of the skin or eyes.
    Keep all appointments with your doctor and the laboratory. Your doctor may order certain laboratory tests to check your body's response to naltrexone.
    Talk to your doctor about the risks of taking naltrexone.

    WHY is this medicine prescribed?

    Naltrexone is used along with counseling and social support to help people who have stopped drinking alcohol and using street drugs continue to avoid drinking or using drugs. Naltrexone should not be used to treat people who are still using street drugs or drinking large amounts of alcohol. Naltrexone is in a class of medications called opiate antagonists. It works by decreasing the craving for alcohol and blocking the effects of opioid medications and opioid street drugs.

    HOW should this medicine be used?

    Naltrexone comes as a tablet to take by mouth either at home or under supervision in a clinic or treatment center. When naltrexone is taken at home, it is usually taken once a day with or without food. When naltrexone is taken in a clinic or treatment center, it may be taken once a day, once every other day, once every third day, or once every day except Sunday. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take naltrexone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
    Naltrexone is only helpful when it is used as part of an addiction treatment program. It is important that you attend all counseling sessions, support group meetings, education programs, or other treatments recommended by your doctor.
    Naltrexone will help you avoid using drugs and alcohol, but it will not prevent or relieve the withdrawal symptoms that may occur when you stop using these substances. Instead, naltrexone may cause or worsen withdrawal symptoms. You should not take naltrexone if you have recently stopped using opioid medications or opioid street drugs and are now experiencing withdrawal symptoms.
    Naltrexone will help you avoid drugs and alcohol only as long as you are taking it. Continue to take naltrexone even if you feel well. Do not stop taking naltrexone without talking to your doctor.

    Are there OTHER USES for this medicine?

    This medication may be sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

    What SPECIAL PRECAUTIONS should I follow?

    Before taking naltrexone,
    • tell your doctor and pharmacist if you are allergic to naltrexone naloxone, other opioid medications, or any other medications.
    • tell your doctor if you are taking any opioid (narcotic) medications or street drugs including levomethadyl acetate (LAAM, ORLAAM) (not available in the US), or methadone (Dolophine, Methadose); and certain medications for diarrhea, cough, or pain. Also tell your doctor if you have taken any of these medications in the past 7 to 10 days. Ask your doctor if you are not sure if a medication you have taken is an opioid. Your doctor may order certain tests to see if you have taken any opioid medications or used any opioid street drugs during the past 7 to 10 days. Your doctor will tell you not to take naltrexone if you have taken or used opioids in the past 7 to 10 days.
    • do not take any opioid medications or use opioid street drugs during your treatment with naltrexone. Naltrexone blocks the effects of opioid medications and opioid street drugs. You may not feel the effects of these substances if you take or use them at low or normal doses. If you take or use higher doses of opioid medications or drugs during your treatment with naltrexone, it may cause serious injury, coma (long-lasting unconscious state), or death.
    • you should know that if you took opioid medications before your treatment with naltrexone, you may be more sensitive to the effects of these medications after you finish your treatment. After you finish your treatment, tell any doctor who may prescribe medications for you that you were previously treated with naltrexone.
    • tell your doctor what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention disulfiram (Antabuse) and thioridazine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
    • tell your doctor if you have or have ever had depression or kidney disease.
    • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking naltrexone, call your doctor.
    • if you need medical treatment or surgery, including dental surgery, tell the doctor or dentist that you are taking naltrexone. Wear or carry medical identification so that healthcare providers who treat you in an emergency will know that you are taking naltrexone.
    • you should know that people who overuse drugs or alcohol often become depressed and sometimes try to harm or kill themselves. Receiving naltrexone does not decrease the risk that you will try to harm yourself. You or your family should call the doctor right away if you experience symptoms of depression such as feelings of sadness, anxiousness, hopelessness, guilt, worthlessness, or helplessness, or thinking about harming or killing yourself or planning or trying to do so. Be sure that your family knows which symptoms may be serious so they can call the doctor right away if you are unable to seek treatment on your own.

    What SPECIAL DIETARY instructions should I follow?

    Unless your doctor tells you otherwise, continue your normal diet.

    What should I do IF I FORGET to take a dose?

    Take the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

    What SIDE EFFECTS can this medicine cause?

    Naltrexone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
    • nausea
    • vomiting
    • stomach pain or cramping
    • diarrhea
    • constipation
    • loss of appetite
    • headache
    • dizziness
    • anxiety
    • nervousness
    • irritability
    • tearfulness
    • difficulty falling or staying asleep
    • increased or decreased energy
    • drowsiness
    • muscle or joint pain
    • rash
    Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:
    • confusion
    • hallucinations (seeing things or hearing voices that do not exist)
    • blurred vision
    • severe vomiting and/or diarrhea
    Naltrexone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
    If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch ] or by phone [1-800-332-1088].

    What should I know about STORAGE and DISPOSAL of this medication?

    Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

    What should I do in case of OVERDOSE?

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

    What OTHER INFORMATION should I know?

    Before having any laboratory tests, tell your doctor and the laboratory personnel that you are taking naltrexone.
    Ask your doctor or pharmacist any questions you have about naltrexone.
    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

    Brand Names

    • ReVia®
    • Also available generically
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