Drug Notebook

FDA Alerts

    Hepatic Effects
  • Possible dose-related hepatotoxicity. Margin between therapeutic and hepatotoxic dosages may be less than fivefold; hepatotoxicity not apparent at usual dosages. (See Hepatic Effects under Cautions.)
  • Contraindicated in patients with acute hepatitis or liver failure; carefully weigh potential benefits against possible hepatotoxic risks in patients with active liver disease.
  • Instruct patients to discontinue naltrexone and contact a clinician if manifestations of acute hepatitis occur. (See Advice to Patients.)

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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. Carry an ID card or wear a medical alert bracelet stating that you are being treated with naltrexone, in case of emergency. Any doctor, dentist, or emergency 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.

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 purposes other than those listed in this medication guide.

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:

If you have any of these conditions, you may not be able to receive naltrexone injection or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether naltrexone injection passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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.

Carry an ID card or wear a medical alert bracelet stating that you are being treated with naltrexone, in case of emergency. Any doctor, dentist, or emergency 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.

What happens if I miss a dose?

If you miss an appointment to have your naltrexone injection, make another appointment as soon as possible.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine.

Symptoms of a naltrexone injection overdose may include nausea, stomach pain, dizziness, or seizure (convulsions).

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