Naltrexone for Alcoholism and Opioid Addiction

ReVia (naltrexone hydrochloride) for Narcotic and Alcohol Addiction: Uses, Dosage, Side Effects, Interactions, Warnings

Naltrexone for Alcoholism and Opioid Addiction

During two randomized, double-blind placebo-controlled 12-week trials to evaluate the efficacy of REVIA as an adjunctive treatment of alcohol dependence, most patients tolerated REVIA well.

In these studies, a total of 93 patients received REVIA at a dose of 50 mg once daily. Five of these patients discontinued REVIA because of nausea.

No serious adverse events were reported during these two trials.

While extensive clinical studies evaluating the use of REVIA in detoxified, formerly opioid-dependent individuals failed to identify any single, serious untoward risk of REVIA use, placebo-controlled studies employing up to fivefold higher doses of REVIA (up to 300 mg per day) than that recommended for use in opiate receptor blockade have shown that REVIA causes hepatocellular injury in a substantial proportion of patients exposed at higher doses (see WARNINGS and PRECAUTIONS, Laboratory Tests).

Aside from this finding, and the risk of precipitated opioid withdrawal, available evidence does not incriminate REVIA, used at any dose, as a cause of any other serious adverse reaction for the patient who is “opioid-free.” It is critical to recognize that REVIA can precipitate or exacerbate abstinence signs and symptoms in any individual who is not completely free of exogenous opioids.

Patients with addictive disorders, especially opioid addiction, are at risk for multiple numerous adverse events and abnormal laboratory findings, including liver function abnormalities. Data from both controlled and observational studies suggest that these abnormalities, other than the dose-related hepatotoxicity described above, are not related to the use of REVIA.

Among opioid-free individuals, REVIA administration at the recommended dose has not been associated with a predictable profile of serious adverse or untoward events. However, as mentioned above, among individuals using opioids, REVIA may cause serious withdrawal reactions (see CONTRAINDICATIONS, WARNINGS, DOSAGE AND ADMINISTRATION).

Reported Adverse Events

REVIA has not been shown to cause significant increases in complaints in placebo-controlled trials in patients known to be free of opioids for more than 7 to 10 days.

Studies in alcoholic populations and in volunteers in clinical pharmacology studies have suggested that a small fraction of patients may experience an opioid withdrawal- symptom complex consisting of tearfulness, mild nausea, abdominal cramps, restlessness, bone or joint pain, myalgia, and nasal symptoms.

This may represent the unmasking of occult opioid use, or it may represent symptoms attributable to naltrexone. A number of alternative dosing patterns have been recommended to try to reduce the frequency of these complaints.

Alcoholism

In an open label safety study with approximately 570 individuals with alcoholism receiving REVIA, the following new-onset adverse reactions occurred in 2% or more of the patients: nausea (10%), headache (7%), dizziness (4%), nervousness (4%), fatigue (4%), insomnia (3%), vomiting (3%), anxiety (2%) and somnolence (2%).

Depression, suicidal ideation, and suicidal attempts have been reported in all groups when comparing naltrexone, placebo, or controls undergoing treatment for alcoholism.

RATE RANGES OF NEW ONSET EVENTS

NaltrexonePlacebo
Depression0 to 15%0 to 17%
Suicide Attempt/Ideation0 to 1%0 to 3%

Although no causal relationship with REVIA is suspected, physicians should be aware that treatment with REVIA does not reduce the risk of suicide in these patients (see PRECAUTIONS).

Opioid Addiction

The following adverse reactions have been reported both at baseline and during the REVIA clinical trials in opioid addiction at an incidence rate of more than 10%:

Difficulty sleeping, anxiety, nervousness, abdominal pain/cramps, nausea and/or vomiting, low energy, joint and muscle pain, and headache.

The incidence was less than 10% for:

Loss of appetite, diarrhea, constipation, increased thirst, increased energy, feeling down, irritability, dizziness, skin rash, delayed ejaculation, decreased potency, and chills.

The following events occurred in less than 1% of subjects:

Respiratory

Nasal congestion, itching, rhinorrhea, sneezing, sore throat, excess mucus or phlegm, sinus trouble, heavy breathing, hoarseness, cough, shortness of breath.

Cardiovascular

Nose bleeds, phlebitis, edema, increased blood pressure, non-specific ECG changes, palpitations, tachycardia.

Musculoskeletal

Painful shoulders, legs or knees; tremors, twitching.

Genitourinary

Increased frequency of, or discomfort during, urination; increased or decreased sexual interest.

Dermatologic

Oily skin, pruritus, acne, athlete's foot, cold sores, alopecia.

Psychiatric

Depression, paranoia, fatigue, restlessness, confusion, disorientation, hallucinations, nightmares, bad dreams.

Special senses

Eyes–blurred, burning, light sensitive, swollen, aching, strained; ears–“clogged,” aching, tinnitus.

General

Increased appetite, weight loss, weight gain, yawning, somnolence, fever, dry mouth, head “pounding,” inguinal pain, swollen glands, “side” pains, cold feet, “hot spells.”

Postmarketing Experience

Data collected from postmarketing use of REVIA show that most events usually occur early in the course of drug therapy and are transient. It is not always possible to distinguish these occurrences from those signs and symptoms that may result from a withdrawal syndrome.

Events that have been reported include anorexia, asthenia, chest pain, fatigue, headache, hot flushes, malaise, changes in blood pressure, agitation, dizziness, hyperkinesia, nausea, vomiting, tremor, abdominal pain, diarrhea, palpitations, myalgia, anxiety, confusion, euphoria, hallucinations, insomnia, nervousness, somnolence, abnormal thinking, dyspnea, rash, increased sweating, vision abnormalities, and idiopathic thrombocytopenic purpura.

In some individuals the use of opioid antagonists has been associated with a change in baseline levels of some hypothalamic, pituitary, adrenal, or gonadal hormones. The clinical significance of such changes is not fully understood.

Adverse events, including withdrawal symptoms and death, have been reported with the use of REVIA in ultra rapid opiate detoxification programs. The cause of death in these cases is not known (see WARNINGS).

Laboratory Tests

In a placebo controlled study in which REVIA was administered to obese subjects at a dose approximately five-fold that recommended for the blockade of opiate receptors (300 mg per day), 19% (5/26) of REVIA recipients and 0% (0/24) of placebo-treated patients developed elevations of serum transaminases (i.e.

, peak ALT values ranging from 121 to 532; or 3 to 19 times their baseline values) after three to eight weeks of treatment.

The patients involved were generally clinically asymptomatic, and the transaminase levels of all patients on whom follow-up was obtained returned to (or toward) baseline values in a matter of weeks.

Transaminase elevations were also observed in other placebo controlled studies in which exposure to REVIA at doses above the amount recommended for the treatment of alcoholism or opioid blockade consistently produced more numerous and more significant elevations of serum transaminases than did placebo. Transaminase elevations occurred in 3 of 9 patients with Alzheimer's Disease who received REVIA (at doses up to 300 mg/day) for 5 to 8 weeks in an open clinical trial.

Drug Abuse And Dependence

REVIA is a pure opioid antagonist. It does not lead to physical or psychological dependence. Tolerance to the opioid antagonist effect is not known to occur.

Источник: https://www.rxlist.com/revia-drug.htm

VIVITROL® (naltrexone for extended-release injectable suspension)

Naltrexone for Alcoholism and Opioid Addiction

  • Opioid blocker
  • Must be administered by a healthcare provider
  • Once-monthly injection
  • Used with counseling
  • Non-addictive and not a narcotic
  • Requires opioid detox of 7–14 days prior to start of treatment

Anyone who receives a VIVITROL injection must not use any type of opioid (must be opioid-free) including street drugs, prescription pain medicines, cough, cold, or diarrhea medicines that contain opioids, or opioid dependence treatments, buprenorphine or methadone, for at least 7 to 14 days before starting VIVITROL. Using opioids in the 7 to 14 days before you start receiving VIVITROL may cause you to suddenly have symptoms of opioid withdrawal when you get the VIVITROL injection.

Sudden opioid withdrawal can be severe, and you may need to go to the hospital.

You must be opioid-free before receiving VIVITROL, unless your healthcare provider decides that you don’t need to go through detox first. Instead, your doctor may decide to give your VIVITROL injection in a medical facility that can treat you for sudden opioid withdrawal.

  • VIVITROL is injected by a healthcare provider, about 1 time each month.
  • VIVITROL must be injected by a healthcare provider. Do not attempt to inject yourself with VIVITROL. Serious reaction, some that may require hospitalization, might happen.
  • VIVITROL is given as an injection into a muscle in your buttocks using a special needle that comes with VIVITROL.

See Med Guide for more information.

TREATING ALCOHOL DEPENDENCE
WITH VIVITROL AND COUNSELING1-3

When used as part of a treatment plan that includes counseling, VIVITROL can help reduce heavy drinking days.

A 6-month, double-blind, placebo-controlled, randomized clinical study compared alcohol-dependent outpatients treated with VIVITROL and counseling (n=205) with patients who received placebo and counseling (n=209).2

*Heavy drinking was defined as a self-report of 5 or more standard drinks consumed on a given day for male patients and 4 or more drinks for female patients.

Is there a risk of opioid overdose with VIVITROL?

Yes. One serious side effect of VIVITROL is the risk of opioid overdose. Using opioids, even in amounts that you used before VIVITROL treatment, can lead to accidental overdose, serious injury, coma, or death.

  • Do not take large amounts of opioids or try to overcome the opioid-blocking effects of VIVITROL.
  • Do not use opioids in amounts that you used before VIVITROL treatment. You may even be more sensitive to lower amounts of opioids:
  • After detox
  • When your next VIVITROL dose is due
  • If you miss a dose of VIVITROL
  • After you stop VIVITROL treatment

Get emergency medical help right away if you:

  • have trouble breathing
  • become very drowsy with slowed breathing
  • have slow, shallow breathing (little chest movement with breathing)
  • feel faint, dizzy, confused or have other unusual symptoms.

It is important that you tell your family and the people closest to you of this increased sensitivity to opioids and the risk of overdose.

Is there a risk of severe reactions at the injection site with VIVITROL?

Yes. One serious side effect of VIVITROL is severe reactions at the site of the injection, including tissue death. Some injection site reactions have required surgery. Call your healthcare provider right away if you notice any of the following at your injection site:

  • Intense pain
  • The area feels hard
  • Swelling
  • An open wound
  • A dark scab

Tell your healthcare provider about any injection site reaction that concerns you, gets worse over time, or does not get better by two weeks after the injection.

Is there a risk of a sudden opioid withdrawal when starting VIVITROL?

Yes. One serious side effect of VIVITROL is sudden opioid withdrawal. You must stop taking any opioids or opioid-containing medications, including buprenorphine or methadone, for at least 7 to 14 days before starting VIVITROL.

If your healthcare provider decides that you don’t need to complete detox first, he or she may give you VIVITROL in a medical facility that can treat sudden opioid withdrawal. Sudden opioid withdrawal can be severe and may require hospitalization.

Can VIVITROL cause liver damage or hepatitis?

Yes. One serious side effect of VIVITROL is liver damage or hepatitis. Naltrexone, the active ingredient in VIVITROL, can cause liver damage or hepatitis. Tell your healthcare provider if you have any of the following symptoms of liver problems during VIVITROL treatment:

  • Stomach area pain lasting more than a few days
  • Yellowing of the whites of your eyes

Your healthcare provider may need to stop treating you with VIVITROL if you get signs or symptoms of a serious liver problem.

If my healthcare provider is considering VIVITROL treatment for my alcohol dependence, do I need to tell my healthcare provider that I take opioids?

Yes.

If you are being treated for alcohol dependence but also use or are addicted to opioid-containing medicines or illicit opioids, it is important that you tell your healthcare provider before starting VIVITROL to avoid having sudden opioid withdrawal symptoms when you start VIVITROL treatment. Know the medications you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

VIVITROL is not right for everyone. There are significant risks from VIVITROL treatment, including risk of opioid overdose, severe reaction at the injection site and sudden opioid withdrawal.
See Important Safety Information below. Discuss all benefits and risks with a healthcare provider. See Prescribing Information and Medication Guide.

Источник: https://www.vivitrol.com/alcohol-dependence/what-is-vivitrol

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