Naltrexone

What is naltrexone injection?

Naltrexone injection is a special narcotic drug that blocks the effects of other narcotic medicines and alcohol.

Naltrexone injection is used to treat narcotic drug or alcohol addiction..

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

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

Do not use narcotic drugs or alcohol while you are being treated with naltrexone injection. Never try to overcome the effects of the medication by using large doses of narcotic drugs or alcohol. 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 during your treatment with naltrexone injection. These medicines may contain narcotics or alcohol. Naltrexone injection can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

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.

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

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

Do not receive this injection if you are allergic to naltrexone, 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.

Before receiving naltrexone, tell your doctor if you are allergic to any drugs, or if you have:

• kidney disease;
• liver disease; or
• a bleeding disorder such as hemophilia.

If you have any of these conditions, you may need a dose adjustment or special tests to safely receive a naltrexone injection.

How is naltrexone injection used?

Naltrexone injection (Vivitrol) is given as a shot 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.

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

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 if you think you have received too much of this medicine.

Overdose symptoms may include nausea, stomach pain, dizziness, or seizure (convulsions).

What should I avoid while using naltrexone injection?

Naltrexone injection can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Do not use narcotic drugs or alcohol while receiving naltrexone injection. Never try to overcome the effects of the medication by using large doses of narcotic drugs or alcohol. 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 injection side effects

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

• blurred vision or eye problems;

• fast heartbeat;

• wheezing, difficulty breathing;

• mood changes, hallucinations (seeing or hearing things), confusion, thoughts of hurting yourself;

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• ear pain, ringing in your ears;

• feeling light-headed, fainting;

• skin rash or itching; or

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

Less serious side effects may include:

• feeling anxious, nervous, restless, or irritable;

• increased thirst;

• muscle or joint aches;

• weakness or tiredness;

• sleep problems (insomnia); or

• decreased sex drive, impotence, or difficulty having an orgasm.

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.

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 opioid- free 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.

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.

Before receiving naltrexone injection, tell your doctor if you use any of the following drugs:

• buprenorphine (Buprenex, Subutex);

• butorphanol (Stadol);

• codeine (Tylenol with codeine);

• hydrocodone (Lortab, Vicodin);

• hydromorphone (Dilaudid);

• levorphanol (Levo-Dromoran);

• meperidine (Demerol);

• methadone (Dolophine, Methadose);

• morphine (Kadian, MS Contin, Roxanol);

• nalbuphine (Nubain);

• naloxone (Narcan);

• oxycodone (OxyContin, Roxicodone, Percocet);

• oxymorphone (Numorphan); or

• propoxyphene (Darvon, Darvocet).

This list is not complete and there may be other drugs that can interact with naltrexone injection. 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.

Where can I get more information?

• Your doctor can provide more information about naltrexone injection.

• 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.