naltrexone

Pronunciation

Generic Name: naltrexone (injection) (nal TREX own)
Brand Name: Vivitrol

What is naltrexone injection?

Naltrexone blocks the effects of narcotic medicines and alcohol.

Naltrexone injection is used to treat addiction to alcohol or narcotic drugs. It is also used to prevent narcotic addiction relapse.

Naltrexone injection may also be used for purposes not listed in this medication guide.

What is the most important information I should know about naltrexone injection?

You should not use naltrexone if you have an addiction to narcotics, drug or alcohol withdrawal symptoms, or a history of alcohol or narcotic drug use within the past 7-10 days.

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Naltrexone can cause liver damage, especially at high doses. You should not receive naltrexone injection if you have hepatitis or symptoms of liver failure.

Call your doctor at once if you have signs of liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

What should I discuss with my health care provider before receiving naltrexone injection?

You should not use naltrexone if you are allergic to it, or if you have:

  • an addiction to narcotics;

  • a history of alcohol or narcotic drug use within the past 7-10 days; or

  • drug or alcohol withdrawal symptoms.

Do not drink alcohol while you are receiving naltrexone injections.

Naltrexone can cause liver damage, especially at high doses. You should not receive naltrexone injection if you have hepatitis or symptoms of liver failure.

To make sure naltrexone is safe for you, tell your doctor if you have:

  • liver or kidney disease; or

  • a bleeding or blood-clotting disorder such as hemophilia.

FDA pregnancy category C. It is not known whether naltrexone injection will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Naltrexone can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

How is naltrexone injection used?

Naltrexone is injected into a muscle. This injection is usually given once a month (every 4 weeks) and can be given only by a doctor or nurse in a clinic.

It is important to receive your naltrexone injections regularly to get the most benefit.

You may notice pain, redness, bruising, swelling, or a hard lump where the medication was injected. Call your doctor if you have this type of reaction to the shot, especially if it does not clear up or gets worse within 2 weeks.

Wear a medical alert tag or carry an ID card stating that you use naltrexone injection. Any medical care provider who treats you should know that you are receiving this medication.

Additional forms of counseling and/or monitoring may be recommended during treatment with naltrexone injection.

After receiving naltrexone you may be more sensitive to the effects of narcotic pain medications, even those you have used before.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment to receive your naltrexone injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, stomach pain, dizziness, or drowsiness.

What should I avoid while using naltrexone injection?

Do not drink alcohol during your treatment with naltrexone.

Do not use narcotic medications, heroin, or other street drugs while you are receiving naltrexone injection. Doing so could result in dangerous effects, including coma and death.

Ask your doctor before using any prescription or over-the-counter medicine to treat a cold, cough, diarrhea, or pain while you are being treated with naltrexone injection. These medicines may contain narcotics or alcohol.

Naltrexone may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you.

Naltrexone injection side effects

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

Call your doctor at once if you have:

  • blurred vision or eye problems;

  • new or worsening cough, wheezing, trouble breathing;

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • pain, swelling, redness, itching, bruising, oozing, skin changes, or a hard painful lump where the medication was injected.

Common side effects may include:

  • nausea for a few days after an injection;

  • vomiting, diarrhea, mild stomach pain;

  • muscle or joint aches;

  • cold symptoms such as stuffy nose, sneezing, sore throat;

  • anxiety, depressed mood, sleep problems (insomnia);

  • dry mouth; or

  • mild tenderness or discomfort an the injection was given.

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.

See also: Side effects (in more detail)

Naltrexone dosing information

Usual Adult Dose for Alcohol Dependence:

Oral Tablets:
50 mg orally once a day

Extended-release injectable suspension:
380 mg every 4 weeks (or once a month) via intramuscular gluteal injection, alternating buttocks

Usual Adult Dose for Opiate Dependence:

Treatment should not be attempted unless the patient has remained free of opioids for at least 7 to 10 days. Opioid abstinence should be verified by analysis of urine for absence of opioids. The patient should not be manifesting withdrawal signs or reporting withdrawal symptoms. If there is any question of occult opioid dependence, perform a naloxone challenge test and do not initiate naltrexone therapy until the naloxone challenge is negative. The naloxone challenge test should not be performed in a patient showing clinical signs or symptoms of opioid withdrawal, or whose urine contains opioids. The naloxone challenge can be repeated in 24 hours.

Initial dose: 25 mg orally one time.
Maintenance dose: If no withdrawal signs occur, 50 mg orally once a day may be started.
Alternative dose schedules: (to improve compliance) 50 mg orally on week days and 100 mg orally on Saturday; or 100 mg orally every other day; or 150 mg orally every third day.

Extended-release injectable suspension: 380 mg every 4 weeks (or once a month) via intramuscular gluteal injection, alternating buttocks

What other drugs will affect naltrexone injection?

The pain-relieving effects of any narcotic pain medications you use will be blocked if you use them during your treatment with naltrexone injection. Harmful side effects could also occur.

Other drugs may interact with naltrexone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your doctor can provide more information about naltrexone injection.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.02. Revision Date: 2014-01-24, 3:05:03 PM.

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