Revia

Name: Revia

Why is this medication prescribed?

Naltrexone is used along with counseling and social support to help people who have stopped drinking alcohol and using street drugs continue to avoid drinking or using drugs. Naltrexone should not be used to treat people who are still using street drugs or drinking large amounts of alcohol. Naltrexone is in a class of medications called opiate antagonists. It works by decreasing the craving for alcohol and blocking the effects of opiate medications and opioid street drugs.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What is the most important information I should know about ReVia (naltrexone)?

You should not use naltrexone if you are having drug or alcohol withdrawal symptoms, or if you have taken any opioid medicine within the past 2 weeks.

What should I discuss with my health care provider before taking ReVia (naltrexone)?

Do not take naltrexone if you still use opioid medicine, or you could have sudden and severe withdrawal symptoms.

You should not use naltrexone if you are allergic to it, or if:

  • you are having withdrawal symptoms from drug or alcohol addiction;

  • you have used any opioid medicine within the past 10 days (including fentanyl, Vicodin, OxyContin, and many others); or

  • you have used methadone or buprenorphine (Subutex, Butrans, Suboxone, Zubsolv) in the past 14 days.

To make sure naltrexone is safe for you, tell your doctor if you have:

  • kidney disease;

  • liver disease; or

  • a bleeding or blood-clotting disorder such as hemophilia.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Naltrexone can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Naltrexone is not approved for use by anyone younger than 18 years old.

What do I need to tell my doctor BEFORE I take ReVia?

  • If you have an allergy to naltrexone or any other part of ReVia (naltrexone tablets).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are taking an opioid drug on a regular basis, are addicted to an opioid drug, or are having withdrawal signs.
  • If you have taken a pain drug within the past 7 to 10 days.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take ReVia with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take ReVia (naltrexone tablets) or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to ReVia. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Indications and Usage for Revia

Revia (naltrexone hydrochloride tablets, USP) is indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids.

Revia has not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions.

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.

For the Consumer

Applies to naltrexone: oral tablet

Other dosage forms:

  • intramuscular powder for suspension extended release

Along with its needed effects, naltrexone (the active ingredient contained in Revia) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking naltrexone:

Less common
  • Skin rash
Rare
  • Abdominal or stomach pain (severe)
  • blurred vision, aching, burning, or swollen eyes
  • chest pain
  • confusion
  • discomfort while urinating or frequent urination
  • fever
  • hallucinations or seeing, hearing, or feeling things that are not there
  • itching
  • mental depression or other mood or mental changes
  • ringing or buzzing in the ears
  • shortness of breath
  • swelling of the face, feet, or lower legs
  • weight gain

Some side effects of naltrexone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Abdominal or stomach cramping or pain (mild or moderate)
  • anxiety, nervousness, restlessness or trouble sleeping
  • headache
  • joint or muscle pain
  • nausea or vomiting
  • unusual tiredness
Less common
  • Chills
  • constipation
  • cough, hoarseness, runny or stuffy nose, sinus problems, sneezing, or sore throat
  • diarrhea
  • dizziness
  • fast or pounding heartbeat
  • increased thirst
  • irritability
  • loss of appetite
  • sexual problems in males

For Healthcare Professionals

Applies to naltrexone: compounding powder, intramuscular powder for injection extended release, oral tablet

General

General side effects have rarely included an opioid withdrawal-like symptom complex. This has been known to occur in a small number of patients receiving naltrexone (the active ingredient contained in Revia) Symptoms include tearfulness, mild nausea, abdominal cramps, restlessness, bone or joint pain, myalgia, and nasal symptoms.[Ref]

In one study, few symptoms were reported following the first week. However, stomach cramps, inability to sleep, and frightening thoughts were reported by 30% or more of subjects through the third week of therapy.

The effects of an opiate may be attenuated during self-administration of small doses of an opioid drug. Patients taking naltrexone may not benefit from opioid-containing medications, such as cough and cold preparations, antidiarrheal preparations, and opioid analgesics. However, patients treated with naltrexone may respond to lower doses of opioids than previously used. Patients who self-administer large doses of an opioid drug could sustain serious injury (including coma) or die if high opiate plasma concentrations remain beyond the therapeutic effectiveness of naltrexone.

The opioid withdrawal-like symptom complex may be attributable to naltrexone or may represent occult opioid usage.[Ref]

Nervous system

Nervous system side effects reported during treatment for alcohol dependence have included headache (7%), dizziness (4%), nervousness (4%), fatigue (4%), insomnia (3%), anxiety (2%), and somnolence (2%).

Nervous system side effects reported in greater than 10% of patients during treatment for opioid dependence have included headaches, nervousness, anxiety, difficulty sleeping, and low energy. Loss of appetite, increased energy, irritability, and dizziness have been reported in less than 10% of patients. Asthenia, agitation, hyperkinesia, nervousness, fatigue, restlessness, confusion, disorientation, and somnolence have been reported rarely.

Nervous system side effects associated with extended-release injectable solution have frequently included headache, dizziness, syncope, somnolence, insomnia, and sedation. Dysgeusia, attention disturbance, mental impairment, and convulsions have been reported rarely.[Ref]

Psychiatric

Psychiatric side effects reported during treatment of alcohol dependence have included depression (up to 15%), suicidal ideation (up to 1%), and suicide attempts.

Psychiatric side effects reported during treatment of opioid dependence have included feeling down (less than 10%). Depression, paranoia, hallucinations, bad dreams, and nightmares have been reported rarely. Anxiety and abnormal thinking have also been reported.

Psychiatric side effects associated with extended-release injectable suspension have frequently included anxiety, sleep disorder, and depression. Irritability, decreased libido, abnormal dreams, alcohol withdrawal syndrome, euphoric mood, and delirium have been reported rarely.[Ref]

Depression and suicidal ideation or attempts have occurred in all study groups receiving naltrexone for treatment of alcohol dependence. These conditions also have been reported in data collected from postmarketing experience during treatment of opioid dependence.[Ref]

Gastrointestinal

Gastrointestinal side effects reported during treatment for alcohol dependence have included nausea (10%) and vomiting (3%).

Gastrointestinal side effects reported in greater than 10% of patients during treatment for opioid dependence have included abdominal pain, abdominal cramps, nausea, and vomiting. Loss of appetite, diarrhea, constipation, and increased thirst have been reported in less than 10% of patients. Hemorrhoids, ulcer, diarrhea, excessive gas, increased appetite, and dry mouth have been reported rarely.

Gastrointestinal side effects associated with extended-release injectable solution have frequently included nausea, vomiting, diarrhea, abdominal pain, and dry mouth. Constipation, toothache, tooth abscess, flatulence, gastroesophageal reflux, hemorrhoids, colitis, gastrointestinal hemorrhage, paralytic ileus, gastroenteritis, and perirectal abscess have been reported rarely.[Ref]

Hepatic

Hepatic side effects have included hepatocellular injury, hepatitis, and elevated liver transaminases and bilirubin.

Hepatic side effects associated with extended-release injectable suspension have rarely included cholelithiasis, increased aspartate aminotransferase (AST) level, increased alanine aminotransferase (ALT) level, and acute cholecystitis.[Ref]

In clinical studies, doses greater than 50 mg a day consistently resulted in more frequent and more significant elevations of serum transaminase levels when compared to placebo.

Patients who develop liver disease from other cause or who take naltrexone in excess may be more prone to hepatocellular injury.[Ref]

Musculoskeletal

Musculoskeletal side effects reported in greater than 10% of patients during treatment for opioid dependence have included joint and muscle pain. Tremors, twitching, and painful shoulders, legs or knees have been reported rarely.

Musculoskeletal side effects associated with extended-release injectable suspension have frequently included arthralgia, arthritis, joint stiffness, and muscle cramps. Limb pain, muscle spasms, and joint stiffness have been reported rarely.[Ref]

Respiratory

Respiratory side effects, during treatment of opioid dependence, have rarely included: nasal congestion, itching, rhinorrhea, sneezing, sore throat, excess mucous, sinus trouble, heavy breathing, hoarseness, cough, and shortness of breath.

Respiratory side effects associated with extended-release injectable solution have frequently included upper respiratory infection and pharyngitis. Pharyngolaryngeal pain, dyspnea, sinus congestion, bronchitis, pneumonia, and chronic obstructive airways disease have been reported rarely.[Ref]

Cardiovascular

Cardiovascular side effects reported during treatment of opioid dependence have rarely included nose bleeds, phlebitis, edema, increased blood pressure, EKG changes, palpitations and tachycardia.

Cardiovascular side effects associated with extended release injectable suspension have rarely included palpitations, atrial fibrillation, myocardial infarction, angina pectoris, unstable angina, congestive cardiac failure, ischemic stroke, cerebral arterial aneurysm, hypertension, deep venous thrombosis, pulmonary embolism, hot flushes, and coronary artery atherosclerosis.[Ref]

Genitourinary

Genitourinary side effects reported in greater than 10% of patients during treatment of opioid dependence have included delayed ejaculation and decreased potency. Increased frequency of or discomfort during urination and increased or decreased sexual interest has been reported rarely.

Genitourinary side effects associated with extended-release injectable solution have rarely included urinary tract infection.[Ref]

Dermatologic

Dermatologic side effects reported during treatment of opioid dependence have rarely included oily skin, pruritus, acne, athletes foot, cold sores, alopecia, and rash.

Dermatologic side effects associated with the extended-release injectable suspension have included pain, tenderness, induration, swelling, erythema, bruising, pruritus, abscess, sterile abscess, and necrosis. Some cases required surgical intervention, including debridement of necrotic tissue. Some cases resulted in significant scarring. The reported cases occurred primarily in female patients.[Ref]

Ocular

Ocular side effects reported during treatment of opioid dependence have rarely included blurred vision, burning, and increased sensitivity to light.

Ocular side effects associated with extended-release injectable suspension have rarely included conjunctivitis.[Ref]

Other

Other side effects associated with treatment of opioid dependence have rarely included feeling of "clogged" ears, aching, and tinnitus.

Other side effects reported during treatment of opioid dependence have rarely included chills, weight loss, weight gain, yawning, fever, head "pounding", inguinal pain, swollen glands, "side" pains, cold feet, and "hot spells".

Other side effects associated with extended-release injectable suspension have frequently included asthenia and back pain/stiffness. Pyrexia, lethargy, rigors, chest pain/tightness, influenza, seasonal allergy, missed abortion, and decreased weight have been reported rarely.[Ref]

Endocrine

Endocrine side effects associated with opioid antagonists have included a change in the baseline levels of hypothalamic, pituitary gland, and gonadal hormones. The clinical significance of these changes is unknown.[Ref]

Other

Other side effects reported during ultra-rapid opioid detoxification programs with naltrexone (the active ingredient contained in Revia) have included withdrawal signs and symptoms and fatalities. The cause of death is unknown.[Ref]

Hematologic

Hematologic side effects have included a single case report of idiopathic thrombocytopenic purpura. This patient may have been previously sensitized to naltrexone (the active ingredient contained in Revia)

Hematologic side effects associated with extended-release injectable suspension have rarely included increased white blood cell count.[Ref]

Local

Local side effects associated with extended-release injectable suspension have frequently included tenderness, pruritus, ecchymosis, nodules, swelling, and pain at injection site.

The FDA has received 196 reports of injection site reactions including cellulitis, induration, hematoma, abscess, sterile abscess, and necrosis. Sixteen patients required surgical intervention ranging from incision and drainage in the cases of abscesses to extensive surgical debridement in the cases that resulted in tissue necrosis.[Ref]

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.

Healthcare providers should ensure that the naltrexone injection is given correctly with the prepackaged 1½-inch needle that is specifically designed for this drug.

Data shows that there is a variable depth of subcutaneous tissue dependent on the gender and weight of the patient. Women may be physiologically at higher risk for injection site reactions due to typically higher gluteal fat thickness.[Ref]

Metabolic

Metabolic side effects associated with extended-release injectable suspension have frequently included anorexia, decreased appetite, and other appetite disorders. Increased appetite, heat exhaustion, dehydration, and hypercholesterolemia have been reported rarely.[Ref]

Hypersensitivity

Hypersensitivity side effects associated with extended-release injectable solution have rarely included reactions such as angioneurotic edema and urticaria.[Ref]

Some side effects of Revia may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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