Revia

DRUG DESCRIPTION

REVIA (naltrexone hydrochloride), an opioid antagonist, is a synthetic congener of oxymorphone with no opioid agonist properties. Naltrexone differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced by a cyclopropylmethyl group. REVIA (naltrexone) is also related to the potent opioid antagonist, naloxone, or n-allylnoroxymorphone.

REVIA (naltrexone) is a white, crystalline compound. The hydrochloride salt is soluble in water to the extent of about 100 mg/mL. REVIA (naltrexone) is available in scored film-coated tablets containing 50 mg of naltrexone hydrochloride.

REVIA (naltrexone) Tablets also contain: lactose, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, polysorbate 80, yellow iron oxide and red iron oxide.

What are the possible side effects of naltrexone oral (ReVia)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using naltrexone oral and call your doctor at once if you have any of these serious side effects:

  • blurred vision or eye problems;
  • fast heartbeat;
  • mood changes, hallucinations (seeing or hearing things), confusion, thoughts of hurting yourself;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools,...

Read All Potential Side Effects and See Pictures of Revia

What are the precautions when taking naltrexone (Revia)?

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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: taken any type of opioid drugs in the last 7 to 10 days, current opioid dependence (including methadone maintenance), active liver disease/liver failure.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver problems.

You should carry or wear medical identification stating that you are taking...

Read All Potential Precautions of Revia


Revia Consumer (continued)

SIDE EFFECTS: 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 immediately 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. This increased risk is balanced by improved likelihood of taking this drug as directed and ease of use when this drug is taken less often (e.g., every other day). Discuss the risks and benefits with your doctor. (See also Warning section.)

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: taken any type of opioid drugs in the last 7 to 10 days, current opioid dependence (including methadone maintenance), active liver disease/liver failure.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver problems.

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.

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.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Revia Patient Information Including Side Effects

Brand Names: ReVia

Generic Name: naltrexone (oral) (Pronunciation: nal TREX own)

  • What is naltrexone oral (Revia)?
  • What are the possible side effects of naltrexone oral (Revia)?
  • What is the most important information I should know about naltrexone oral (Revia)?
  • What should I discuss with my health care provider before using naltrexone oral (Revia)?
  • How should I use naltrexone oral (Revia)?
  • What happens if I miss a dose (Revia)?
  • What happens if I overdose (Revia)?
  • What should I avoid while using naltrexone oral (Revia)?
  • What other drugs will affect naltrexone oral (Revia)?
  • Where can I get more information?

What is naltrexone oral (Revia)?

Naltrexone oral is an special narcotic drug that blocks the effects of other narcotic medicines and alcohol.

Naltrexone oral is used to treat narcotic drug or alcohol addiction..

Naltrexone oral may also be used for other purposes not listed in this medication guide.

What are the possible side effects of naltrexone oral (Revia)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using naltrexone oral and call your doctor at once if you have any of these serious side effects:

  • blurred vision or eye problems;
  • fast heartbeat;
  • mood changes, hallucinations (seeing or hearing things), confusion, thoughts of hurting yourself;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • ear pain, ringing in your ears;
  • skin rash or itching; or
  • wheezing, difficulty breathing.

Less serious side effects may include:

  • feeling anxious, nervous, restless, or irritable;
  • feeling light-headed, fainting;
  • increased thirst;
  • muscle or joint aches;
  • weakness or tiredness;
  • sleep problems (insomnia); or
  • decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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

Your doctor may recommend that naltrexone oral be given to you by a family member or other caregiver. This is to make sure you are using the medicine as it was prescribed as part of your treatment.

Do not use narcotic drugs or alcohol while taking naltrexone oral. Never try to overcome the effects of the medication by taking large doses of narcotic drugs or alcohol. Doing so could result in dangerous effects, including coma and death. Ask your doctor before using any prescription or over-the-counter medicine to treat a cold, cough, diarrhea, or pain while taking naltrexone oral. These medicines may contain narcotics or alcohol.

Naltrexone oral can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Carry an ID card or wear a medical alert bracelet stating that you are using naltrexone, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are using this medication.

Additional forms of counseling and/or monitoring may be recommended during treatment with naltrexone oral.

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