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Used as an aid in relapse prevention in alcohol and/or opiate dependence; has been used as part of rapid and ultrarapid detoxification techniques.
Better bioavailability and longer duration of action than naloxone; will not prevent opiate withdrawal
This medication is used to prevent people who have been addicted to certain drugs (opiates) from taking them again. It is used as part of a complete treatment program for drug abuse (e.g., compliance monitoring, counseling, behavioral contract, lifestyle changes). This medication must not be used in people currently taking opiates, including methadone. Doing so can cause sudden withdrawal symptoms.
Naltrexone belongs to a class of drugs known as opiate antagonists. It works in the brain to prevent opiate effects (e.g., feelings of well-being, pain relief). It also decreases the desire to take opiates.
This medication is also used to treat alcohol abuse. It can help people drink less alcohol or stop drinking altogether. It also decreases the desire to drink alcohol when used with a treatment program that includes counseling, support, and lifestyle changes.
Take this medication by mouth with or without food, usually 50 milligrams once daily or as directed by your doctor. This medication may be given as part of a program where a health care professional will watch you take the medication. In this case, your doctor may order a higher dose (100-150 milligrams) to be taken every 2-3 days to make it easier to schedule clinic visits. Naltrexone may be taken with food or antacids if stomach upset occurs.
A urine test should be done to check for recent opiate drug use. Your doctor may give you another medication (naloxone challenge test) to check for opiate use. Do not use any opiates for at least 7 days before starting naltrexone. You may need to stop certain opiate drugs (such as methadone) 10 to 14 days before starting naltrexone.
Dosage is based on your medical condition and response to treatment. Your doctor may start you at a lower dose and monitor you for any side effects or withdrawal symptoms before increasing your dose. Take this medication as directed. Do not increase your dose, take it more often, or stop taking it without your doctor’s approval.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.
Tell your doctor if you start using drugs or alcohol again.
Before taking naltrexone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: current or recent use (in the last 7 to 14 days) of any type of opioid drug (such as morphine, methadone, buprenorphine), kidney disease, liver disease.
You should carry or wear medical identification stating that you are taking this drug so that appropriate treatment can be given in a medical emergency.
This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana.
After stopping naltrexone treatment, you may be more sensitive to lower doses of opioids, increasing your risk of possibly life-threatening side effects from the narcotic (e.g., decreased breathing, loss of consciousness).
This medication blocks the effects of opiate drugs (including heroin) and similar drugs (opioids). However, large doses of heroin or narcotics can overcome this block. Trying to overcome this block is very dangerous and may cause serious injury, loss of consciousness, and death. Make sure you completely understand and accept the risks and benefits of using this medication. Follow your doctor’s instructions closely.
Before having surgery or any medical treatment, tell your doctor or dentist that you are taking this medication.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.
Some products that may interact with this drug include: cough medication (e.g., dextromethorphan), disulfiram, diarrhea medication (e.g., diphenoxylate), narcotic medication (e.g., codeine, hydrocodone, propoxyphene), thioridazine.
This medication may interfere with certain laboratory tests (including drug tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
DOSAGE AND INDICATION
For the maintenance treatment of alcohol dependence.
50 mg PO once daily with food for 12 weeks has been shown to be effective. Other regimens or durations have not been evaluated in placebo-controlled trials, but include 50 mg PO once daily on weekdays and 100 mg PO on Saturdays; 100 mg PO every other day; or 150 mg PO every third day. A consensus panel recommends naltrexone treatment be individualized to meet the patient’s needs. Some patients may require naltrexone doses of 100 mg/day PO. Initially, patients may require 3 to 6 months of naltrexone treatment. Certain patients may benefit from up to 1 year of treatment. To decrease gastrointestinal side effects, start with 12.5 mg to 25 mg PO once daily and gradually titrate the dose, split the daily dose, or adjust the administration times. Pharmacotherapy should be used as a part of a comprehensive management program that includes psychosocial support and treatment. Naltrexone does not eliminate or reduce alcohol withdrawal symptoms. If naltrexone is initiated early in the abstinence process, it will not prevent signs and symptoms that would be experienced if the drug had not been started.
380 mg IM every 4 weeks. Efficacy was established in clinical trials evaluating outpatients. Vivitrol is indicated in patients who are able to abstain from alcohol in an outpatient setting prior to treatment initiation. NOTE: Patients should not be actively drinking alcohol at the time of initial Vivitrol administration. Pretreatment with oral naltrexone is not required before using Vivitrol. There are no data to specifically address treatment re-initiation in patients who stopped, and there are no systematically collected data that specifically address the switch from oral naltrexone to IM naltrexone.
For relapse prevention following opioid detoxification in patients with opiate agonist dependence.
Initial dose of 25 mg PO with food. If no withdrawal signs occur, the patient may be started on 50 mg PO once daily therafter. NOTE: Naltrexone should be used as part of a comprehensive treatment plan that includes psychosocial support and medication compliance techniques. Patients must be opioid-free for a minimum of 7—10 days before starting naltrexone to avoid precipitation of opioid withdrawal.
NOTE: Intramuscular naltrexone must be prepared and administered by a healthcare professional. Pretreatment with oral naltrexone is not required before using Vivitrol. There are no data to specifically address treatment re-initiation in patients who stopped therapy, and there are no systematically collected data that specifically address the switch from oral naltrexone to IM naltrexone or from buprenorphine, buprenorphine; naloxone or methadone. Some patients may experience severe manifestations of precipitated withdrawal when being switched from opioid agonist therapy to opioid antagonist therapy. Patients transitioning from buprenorphine or methadone may be vulnerable to precipitation of withdrawal symptoms for as long as 2 weeks. Be prepared to manage withdrawal symptomatically with non-opioid medications.
380 mg IM every 4 weeks or once a month. The drug should be administered as a gluteal injection, alternating buttocks for each subsequent injection, and using the carton components provided by the manufacturer, which include customized needles. Naltrexone must not be injected using any other needle. The body size of the patient should be assessed prior to each injection to ensure that the needle length is adequate. Alternate treatment should be considered in those whose body size precludes gluteal administration using the manufacturer-provided needles.
For the opiate agonist withdrawal induction† during detoxification.
NOTE: Rapid and ultrarapid opiate detoxification should only be done in a controlled setting under the supervision of a physician experienced in the management of opiate withdrawal. Severe withdrawal symptoms and death have been reported in patients undergoing ultrarapid opiate detoxification.
For rapid opiate detoxification†.
Various titration regimens leading up to a full dose of naltrexone 50 mg PO once daily have been used during rapid opiate detoxification. In some cases patients have been treated with naloxone prior to naltrexone. Many studies also use concomitant adjuvant medications to decrease withdrawal symptoms including phenothiazines, benzodiazepines, and non-opiate analgesics (NSAIDs).For ultrarapid opiate detoxification†.
Naltrexone with or without naloxone has been given during ultrarapid opiate detoxification. In a study using naltrexone alone, 50 mg PO was given prior to sedation with midazolam. Other medications used in ultrarapid detoxification include clonidine, benzodiazepines, antiemetic agents (e.g., metoclopramide and ondansetron), and general anesthesia.
For the treatment of pruritus†.
Due to cholestatic liver disease.
50 mg PO once daily for 7 days to 4 weeks resulted in significant improvement in itching and sleep in patients with pruritus resistant to cholestyramine or ursodiol. Nausea may be limited by using an initial dose of naltrexone 25 mg PO once daily, followed by subsequent titration.
Due to systemic or dermatologic disease.
Limited data suggest 50 mg PO once daily may be effective. In an open-label pilot study of 50 patients with severe pruritus, naltrexone for up to 20 months significantly reduced symptoms in 35 patients, with 13 patients experiencing complete resolution. Six patients experienced tachyphylaxis within 1—9 months of treatment; 2 patients with chronic prurigo nodularis overcame tachyphylaxis by administration of 50 mg twice a day. Adverse effects, including fatigue, dizziness, heartburn, and diarrhea were rare and were restricted to the first 2 weeks of treatment. Nausea, which occurred in 11 patients, was generally controlled by metoclopramide; however, 2 patients required discontinuation of therapy.
For uremic pruritus†.
Limited data suggest 50 mg PO once daily may be effective. In a randomized, double-blind, placebo-controlled crossover trial of 15 hemodialysis patients with severe resistant pruritus, treatment with naltrexone for 7 days resulted in a significant reduction in pruritus compared to placebo. Relief from pruritus occurred within the first 48 hours of treatment. Adverse reactions were reported by a total of 5 patients and included heartburn and upper abdominal discomfort.
For use as an adjunct to psychosocial interventions for tobacco cessation† (smoking cessation†).
Limited data are available. Naltrexone 50 mg PO once daily has been used alone or in combination with nicotine transdermal patches as a treatment or adjuvant therapy in patients attempting to stop smoking. In a trial comparing nicotine patches alone or with naltrexone, the results showed a decreased urge to smoke in response to smoking cues, a decrease in withdrawal scored, and reduced negative effects following exposure to smoking cues in patients treated with the combination. The conclusions of this study are considered preliminary and require more extensive follow-up.
†Indicates off-label use
150 mg/day PO; 380 mg/dose IM.
150 mg/day PO; 380 mg/dose IM.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Naltrexone undergoes significant liver metabolism. In patients with severe hepatic dysfunction, up to a 10-fold increase in naltrexone AUC may be observed. Dosage adjustment may be necessary in patients with hepatic impairment. However, specific guidelines for dosage adjustments in patients with hepatic dysfunction are not available.
Both naltrexone and its active metabolite are excreted renally, and naltrexone doses may need adjustment for patients with renal impairment. However, specific guidelines for dosage adjustment in patients with renal impairment are not available.
· Nausea, headache, dizziness, anxiety, tiredness, and trouble sleeping may occur. In a small number of people, mild opiate withdrawal symptoms may occur, including abdominal cramps, restlessness, bone/joint pain, muscle aches, and runny nose. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
· Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
· Sudden opiate withdrawal symptoms can occur within minutes after taking naltrexone. Tell your doctor right away if any of these withdrawal symptoms occur: abdominal cramps, nausea/vomiting, diarrhea, joint/bone/muscle aches, mental/mood changes (e.g., anxiety, confusion, extreme sleepiness, visual hallucinations), runny nose.
· Naltrexone has rarely caused serious liver disease. The risk is increased when larger doses are used. Discuss the risks and benefits with your doctor. Stop using this medication and tell your doctor right away if you develop symptoms of liver disease, including: persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.
· A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat),
· This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages and list of side effects as well as information on the drug. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you
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