A drugs used in alcohol dependence - It blocks the 'high' that these substances can give you
FDA Alerts
Special Alerts:
[Posted 08/12/2008] FDA informed healthcare professionals of the risk of adverse injection site reactions in patients receiving naltrexone (Vivitrol). Naltrexone is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment. Naltrexone is administered as an intramuscular gluteal injection and should not be administered intravenously, subcutaneously, or inadvertently into fatty tissue. Physicians should instruct patients to monitor the injection site and contact them if they develop pain, swelling, tenderness, induration, bruising, pruritus, or redness at the injection site that does not improve or worsens within two weeks. Physicians should promptly refer patients with worsening injection site reactions to a surgeon. Read the FDA recommendations for healthcare professionals to consider regarding the use of Naltrexone injection. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#naltrexone, http://www.fda.gov/cder/drug/infopage/naltrexone/default.htm and http://www.fda.gov/cder/drug/InfoSheets/HCP/naltrexoneHCP.htm.
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.
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