Vivitrol (naltrexone) blocks the effects of narcotic medicines and alcohol.
Vivitrol injection is used to treat addiction to alcohol or narcotic drugs. It is also used to prevent narcotic addiction relapse.
Vivitrol injection may also be used for purposes not listed in this medication guide.
Important information
You should not use Vivitrol 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.
Vivitrol can cause liver damage, especially at high doses. You should not receive Vivitrol 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).
Before receiving Vivitrol
You should not use Vivitrol if you are allergic to naltrexone, or if you have:
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an addiction to narcotics;
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a history of alcohol or narcotic drug use within the past 7-10 days; or
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drug or alcohol withdrawal symptoms.
Do not drink alcohol while you are receiving Vivitrols.
Vivitrol can cause liver damage, especially at high doses. You should not receive Vivitrol if you have hepatitis or symptoms of liver failure.
To make sure Vivitrol is safe for you, tell your doctor if you have:
FDA pregnancy category C. It is not known whether Vivitrol will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
See also: Pregnancy and breastfeeding warnings (in more detail)
Naltrexone can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.
How is Vivitrol injection used?
Vivitrol 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 Vivitrol 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 Vivitrol. 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 Vivitrol.
After receiving Vivitrol 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 Vivitrol 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?
Do not drink alcohol during your treatment with Vivitrol.
Do not use narcotic medications, heroin, or other street drugs while you are receiving Vivitrol. 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 Vivitrol. These medicines may contain narcotics or alcohol.
Vivitrol may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you.
Vivitrol side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Vivitrol: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
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blurred vision or eye problems;
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new or worsening cough, wheezing, trouble breathing;
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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
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pain, swelling, redness, itching, bruising, oozing, skin changes, or a hard painful lump where the medication was injected.
Common Vivitrol side effects may include:
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nausea for a few days after an injection;
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vomiting, diarrhea, mild stomach pain;
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muscle or joint aches;
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cold symptoms such as stuffy nose, sneezing, sore throat;
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anxiety, depressed mood, sleep problems (insomnia);
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dry mouth; or
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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)
Vivitrol 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 Vivitrol?
The pain-relieving effects of any narcotic pain medications you use will be blocked if you use them during your treatment with Vivitrol. Harmful side effects could also occur.
Other drugs may interact with Vivitrol, 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.
