naltrexone ER 380 mg intramuscular suspension,extended release

Generic name:
Naltrexone suspension - injection

Pronunciation
(nal-TREX-own)

Brand name(s)
Vivitrol

This medication is used to treat alcohol abuse. It is used only in people who have been able to stop drinking for some time before starting treatment with naltrexone. You should not be drinking when you start naltrexone. It can help people drink less alcohol or stop drinking altogether. Naltrexone works in the brain to decrease the desire to drink. It does not work like some other treatments for alcohol abuse (such as disulfiram). It will not make you sick when taken with alcohol.

This medication is also used to prevent relapse to opioid abuse, after opioid detoxification. It works by blocking the action of opioids. This medication must not be used in people currently taking opiates, including methadone. Doing so can cause sudden withdrawal symptoms.

Naltrexone belongs to a class of drugs known as opiate antagonists. It is used as part of a complete treatment program for alcohol or opioid abuse (such as counseling, 12-step program, lifestyle changes).

Ask your doctor or pharmacist if you should have naloxone available to treat opioid overdose. Teach your family or household members about the signs of an opioid overdose and how to treat it.

Read the Medication Guide provided by your pharmacist before you start using naltrexone and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Before you receive this medication, you should have a urine test to check for recent opiate drug use. Your doctor may give you another medication (naloxone challenge test) to check for opiate use. Do not use alcohol/any opiates for at least 7 days before starting naltrexone. You may need to stop certain opiate drugs (such as methadone) 10 to 14 days before starting naltrexone.

This medication is injected into a muscle in the buttock by a health care professional. It is given as directed by your doctor, usually once a month.

The dosage is based on your medical condition and response to treatment. Your doctor may start you at a lower dose and monitor you for any side effects or withdrawal symptoms before increasing your dose.

Continue your treatment program and use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

Tell your doctor if you start drinking alcohol again or start using drugs.

Nausea, headache, dizziness, drowsiness, anxiety, tiredness, and loss of appetite may occur. If you have been using opiates regularly, mild opiate withdrawal symptoms may occur, including abdominal cramps, restlessness, bone/joint pain, muscle aches, and runny nose. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Pain/redness/swelling/itching/bruising at the injection site may also occur. If any of these effects steadily worsen, or if they last longer than two weeks, tell your doctor or pharmacist right away. Rarely, a severe injection site reaction can cause permanent injury if not treated.

Remember that this medication has been prescribed because your doctor 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.

Sudden opiate withdrawal symptoms can occur within minutes after using naltrexone if you are physically addicted to opiates. Tell your doctor right away if any of these withdrawal symptoms occur:

• vomiting
• diarrhea
• mental/mood changes (such as anxiety, confusion, extreme sleepiness, visual hallucinations)

Tell your doctor right away if you have any serious side effects, including:

• fast/irregular heartbeat
• depression/rare thoughts of suicide
• signs of a serious breathing problem/pneumonia (such as cough, shortness of breath, wheezing)
• blisters/sores at injection site

Get medical help right away if you have any very serious side effects, including:

• chest pain

Naltrexone may rarely cause serious liver disease. The risk is increased when larger doses are used. Stop using this medication and get medical help right away if you have any symptoms of liver damage, including:

• dark urine
• nausea/vomiting that doesn't stop
• loss of appetite
• stomach/abdominal pain
• yellowing eyes/skin

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• 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 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using naltrexone, 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:

• current or recent use (in the last 7 to 14 days) of any type of opioid drug (such as morphine, methadone, buprenorphine)
• bleeding problems (such as hemophilia, low platelets)
• kidney disease
• liver problems

You should carry or wear medical identification stating that you are using this drug so that appropriate treatment can be given in a medical emergency.

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

After stopping naltrexone treatment or missing a dose of naltrexone, you may be more sensitive to lower doses of opioids, increasing your risk of serious, possibly fatal side effects from the opioid (such as decreased breathing, loss of consciousness). You may also be more sensitive to lower doses of opioids near the end of the month that you received naltrexone treatment.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication blocks the effects of opiate drugs (including heroin) and similar drugs (opioids). However, large doses of heroin or opioids can overcome this block. Trying to overcome this block is very dangerous and may cause serious injury, loss of consciousness, and death. Make sure you completely understand and accept the risks and benefits of using this medication. Follow your doctor's instructions closely.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. Consult your doctor before breastfeeding.

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.

Some products that may interact with this drug include:

• "blood thinners" (such as warfarin, enoxaparin)
• dextromethorphan
• diarrhea medication (such as diphenoxylate)
• opioid pain or cough relievers (such as codeine, hydrocodone)

This medication may interfere with certain lab tests (such as drug tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as liver function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

See also Precautions section.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a clinic or doctor's office and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.