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]).
NALTREXONE (nal TREX one) helps you to remain free of your dependence on opiate drugs or alcohol. It blocks the 'high' that these substances can give you. This medicine is combined with counseling and support groups.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
if you have used drugs or alcohol within 7 to 10 days
Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. Do not take this medicine within 7 to 10 days of taking any opioid drugs. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.
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?
If you miss a dose and remember on the same day, take the missed dose. If you do not remember until the next day, ask your doctor or health care professional about rescheduling your doses. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
any prescription or street opioid drug like codiene, heroin, methadone
This medicine may also interact with 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?
Visit your doctor or health care professional regularly.
Never try to overcome this medicine by taking large amounts of opioid drugs. You may cause an overdose, coma and death.
Tell all of your doctors and health care providers that you are taking this medicine. For emergencies, carry a medication card. Or, wear a medical identification bracelet or chain to say that you take this medicine.
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:
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?
Keep out of the reach of children.
Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.
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.
