Naltrexone blocks the effects of opioid medication, including pain relief or feelings of well-being that can lead to opioid abuse.

Naltrexone injection is used to prevent relapse in adults who became dependent on opioid medicine and then stopped using it. Naltrexone can help keep you from feeling a "need" to use the opioid.

Naltrexone injection is also used to treat alcoholism by reducing your urge to drink alcohol. This may help you drink less or stop drinking altogether. You should not be drinking at the time you receive your first naltrexone injection.

Naltrexone is not a permanent cure for drug addiction or alcoholism.

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

You should be treated with naltrexone only if you have not recently used: any opioid medicine, buprenorphine, methadone, or medicine to treat a cold, cough, diarrhea, or pain. Using these medicines in the 7 to 14 days before starting naltrexone can cause sudden opioid withdrawal symptoms.

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

Call your doctor if you have ongoing or worsening pain, redness, itching, bruising, swelling, or a hard lump where the medicine was injected.

Naltrexone can harm your liver. Tell your doctor if you have upper stomach pain, dark urine, or yellowing in the whites of your eyes.

After receiving naltrexone, your body will be more sensitive to opioids if you use an opioid medicine in the future. Using the same amount you used before could lead to overdose or death.

Naltrexone is injected into a muscle. This injection is usually given once a month (every 4 weeks) and can be given only by a healthcare professional. Get your naltrexone injection regularly to get the most benefit.

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

Naltrexone injections are only part of a complete treatment program that may also include additional forms of counseling and/or monitoring. Follow your doctor's instructions very closely.

In case of emergency, wear or carry medical identification to let others know you are using naltrexone.

After using naltrexone, your body will be more sensitive to opioids. If you use an opioid medicine in the future, you will need to use less than before naltrexone treatment. Using the same amount you used before could lead to overdose or death.

Usual Adult Dose for Alcohol Dependence:

Oral:
Average dose: 50 mg orally once a day
Duration of therapy: 12 weeks

Intramuscular:
380 mg intramuscularly every 4 weeks/once a month

Comments:
-There is no data specifically addressing switching from buprenorphine or methadone to naltrexone, however some patients have reported severe manifestations of precipitated withdrawal when switched from an opioid agonist to opioid antagonist therapy.
-Patients switching from buprenorphine or methadone may be vulnerable to precipitated withdrawal for up to 2 weeks.
-Be prepared to manage withdrawal symptomatically with non-opioid medications.
-To achieve best possible results, implement compliance-enhancing techniques, especially medication compliance

Usual Adult Dose for Opiate Dependence:

Oral:
Initial dose: 25 mg orally once a day
Maintenance dose: 50 mg orally once a day (if no withdrawals on 25 mg/day)

Intramuscular:
380 mg intramuscularly every 4 weeks/once a month

Comments:
-There is no data specifically addressing switching from buprenorphine or methadone to naltrexone, however some patients have reported severe manifestations of precipitated withdrawal when switched from an opioid agonist to opioid antagonist therapy.
-Patients switching from buprenorphine or methadone may be vulnerable to precipitated withdrawal for up to 2 weeks.
-Be prepared to manage withdrawal symptomatically with non-opioid medications.
-This drug is of value only as a part of a comprehensive management plan that includes measures to ensure the patient takes this medication.


Use(s): Blockade of the effects of exogenously administered opioids

You should not receive a naltrexone injection if you still use opioid medicine, or you could have sudden and severe withdrawal symptoms.

You should not be treated with naltrexone if you are allergic to it, or if:

• you are currently addicted to opioids;

• you are having withdrawal symptoms from opioid addiction;

• you have used any opioid medicine within the past 7 to 14 days (including fentanyl, Vicodin, OxyContin, and many others);

• you have used methadone or buprenorphine (Subutex, Butrans, Suboxone, Zubsolv) in the past 14 days; or

• you have used any medicine to treat a cold, cough, diarrhea, or pain in the past 7 to 14 days.

Tell your doctor if you have ever had:

• liver disease;

• kidney disease; or

• bleeding problems such as hemophilia.

Tell your doctor if you are pregnant or breastfeeding.

It is not known whether naltrexone will harm an unborn baby. However, if you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

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

Since naltrexone is given by a healthcare professional in a medical setting, an overdose is unlikely to occur. However, overdose symptoms may include nausea, stomach pain, drowsiness, dizziness, or a reaction where an injection was given (such as severe pain or skin changes).

Do not use opioid medication, heroin, or other street drugs while you are receiving naltrexone. Once naltrexone is injected, it cannot be removed from your body. Never try to overcome the effects of naltrexone by taking large doses of opioids. Doing so could result in dangerous effects, including coma and death.

Ask your doctor before using any medicine to treat a cold, cough, diarrhea, or pain. These medicines may contain opioids and may not work as well while you are using naltrexone.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Get emergency medical help if you have signs of an allergic reaction: hives; chest pain, wheezing, difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Using opioid medicine while you are receiving naltrexone injections could stimulate opioid withdrawal symptoms. Common withdrawal symptoms are yawning, sweating, fever, stomach pain, vomiting, diarrhea, watery eyes, runny nose, goose bumps, body aches, shaking, muscle twitching, trouble sleeping, and feeling restless or anxious.

Naltrexone may cause serious side effects. Call your doctor at once if you have:

• weak or shallow breathing;

• new or worsening cough, wheezing, trouble breathing;

• severe pain, swelling, blistering, skin changes, a dark scab, or a hard lump where the medicine was injected;

• liver problems--stomach pain (upper right side), dark urine, tiredness, jaundice (yellowing of the skin or eyes); or

• symptoms of depression--unusual mood or behavior changes, loss of interest in things you once enjoyed, crying, new sleep problems, thoughts about hurting yourself.

You may feel nauseated the first time you receive a naltrexone injection. You may also have a headache, tiredness, joint and muscle pain, loss of appetite, and vomiting.

Common side effects of naltrexone may include:

• nausea, vomiting, loss of appetite;

• joint pain, muscle cramps;

• dizziness, drowsiness;

• sleep problems (insomnia);

• tooth pain; or

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

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.

Other drugs may affect naltrexone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.