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.)
REMS:
FDA approved a REMS for naltrexone to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of naltrexone and consists of the following: medication guide and communication plan. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
The medicine is for injection into a muscle. It is given by a health care professional in a hospital or clinic setting.
A patient information sheet for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Your condition will be monitored carefully while you are receiving this medicine.
Visit your doctor or health care professional regularly. It is important to attend any counseling or support groups that your doctor or health care professional recommends. Attending these sessions while you are taking this medicine will help you not drink alcohol. Never try to overcome the effects of the medicine by taking large amounts of narcotics (opioids) because this can cause severe problems including death. Also, you may be more sensitive to lower doses of opioids after you stop taking this medicine.
If you are going to have surgery, tell your doctor or health care professional that you are taking this medicine.
Do not treat yourself for coughs, colds, pain, or diarrhea. Ask your doctor or health care professional for advice. Some of the ingredients may interact with this medicine and cause side effects.
Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medicine and dosage times.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
irritation, pain, or redness at the injection site
loss of appetite
nausea
tiredness
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
This drug is given in a hospital or clinic and will not be stored at home.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
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.
