Vivitrol

DRUG DESCRIPTION

VIVITROL® (naltrexone for extended-release injectable suspension) is supplied as a microsphere formulation of naltrexone for suspension, to be administered by intramuscular injection. Naltrexone is an opioid antagonist with little, if any, opioid agonist activity.

Naltrexone is designated chemically as morphinan-6-one, 17 (cyclopropylmethyl) 4,5-epoxy-3,14-dihydroxy-(5?) (CAS Registry # 16590-41-3). The molecular formula is C20H23NO4 and its molecular weight is 341.41 in the anhydrous form (i.e., < 1% maximum water content). The structural formula is:

VIVITROL®
  (naltrexone) Structural Formula Illustration

Naltrexone base anhydrous is an off-white to a light tan powder with a melting point of 168-170° C (334-338° F). It is insoluble in water and is soluble in ethanol.

VIVITROL (naltrexone xr inj) is provided as a carton containing a vial each of VIVITROL (naltrexone xr inj) microspheres and diluent, one 5-mL syringe, one 1-inch 20-gauge preparation needle, two 1.5-inch 20-gauge and two 2-inch 20-gauge administration needles with needle protection device.

VIVITROL (naltrexone xr inj) microspheres consist of a sterile, off-white to light tan powder that is available in a dosage strength of 380 mg naltrexone per vial. Naltrexone is incorporated in 75:25 polylactide-co-glycolide (PLG) at a concentration of 337 mg of naltrexone per gram of microspheres.

The diluent is a clear, colorless solution. The composition of the diluent includes carboxymethylcellulose sodium salt, polysorbate 20, sodium chloride, and water for injection. The microspheres must be suspended in the diluent prior to injection.

What are the possible side effects of naltrexone injection (Vivitrol)?

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.

Call your doctor at once if you have any of these serious side effects:

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

Read All Potential Side Effects and See Pictures of Vivitrol »

What are the precautions when taking naltrexone xr inj (Vivitrol)?

Before using 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 (e.g., codeine, oxycodone, morphine) in the last 7 to 10 days, are currently withdrawing from or dependent on any opioid (including methadone maintenance), currently have liver disease/liver failure.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems (e.g., hemophilia, low...

Read All Potential Precautions of Vivitrol »


Vivitrol Consumer (continued)

SIDE EFFECTS: Nausea, headache, dizziness, drowsiness, anxiety, tiredness, and loss of appetite may occur. If you have been using opiate narcotics regularly, 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.

Pain/redness/swelling/itching/bruising at the injection site may also occur. If any of these effects steadily worsen, or if they persist longer than two weeks, tell your doctor or pharmacist immediately. Rarely, a severe injection site reaction can cause permanent injury if not treated.

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 using naltrexone if you are physically addicted to narcotics. Tell your doctor immediately if any of these withdrawal symptoms occur: vomiting, diarrhea, mental/mood changes (e.g., anxiety, confusion, extreme sleepiness, visual hallucinations).

Tell your doctor right away if you have any serious side effects, including: fast/irregular heartbeat, depression/rare thoughts of suicide, signs of a serious breathing problem/pneumonia (e.g., cough, shortness of breath, wheezing), blisters/sores at injection site.

Get medical help right away if this rare but very serious side effect occurs: chest pain.

Naltrexone has rarely caused serious liver disease. The risk is increased when larger doses are used. (See also Warning section.)

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), 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 using 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 (e.g., codeine, oxycodone, morphine) in the last 7 to 10 days, are currently withdrawing from or dependent on any opioid (including methadone maintenance), currently have liver disease/liver failure.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems (e.g., hemophilia, low platelets), kidney disease, liver problems.

You should carry or wear medical identification stating that you are using this drug so that appropriate treatment can be given in a medical emergency. See also Medical Alert section.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

After stopping naltrexone treatment, you may be more sensitive to lower doses of opioids, increasing your risk of serious, possibly fatal side effects from the narcotic (e.g., decreased breathing, loss of consciousness).

Before having surgery or any medical/dental treatment, tell your doctor or dentist that you are using this medication.

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.

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.


Vivitrol Patient Information Including Side Effects

Brand Names: Vivitrol

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

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

What is naltrexone injection (Vivitrol)?

Naltrexone injection is a special narcotic drug that blocks the effects of other narcotic medicines and alcohol.

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

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

What are the possible side effects of naltrexone injection (Vivitrol)?

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.

Call your doctor at once if you have any of these serious side effects:

  • blurred vision or eye problems;
  • fast heartbeat;
  • wheezing, difficulty breathing;
  • 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;
  • feeling light-headed, fainting;
  • skin rash or itching; or
  • pain, redness, bruising, itching, swelling, oozing, skin changes, or a hard lump where the medication was injected.

Less serious side effects may include:

  • feeling anxious, nervous, restless, or irritable;
  • 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

Do not use narcotic drugs or alcohol while you are being treated with naltrexone injection. Never try to overcome the effects of the medication by using 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 during your treatment with naltrexone injection. These medicines may contain narcotics or alcohol.

Naltrexone injection 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.

You may notice pain, redness, bruising, swelling, or a hard lump where the medication was injected. Call your doctor if you have this type of reaction to the shot, especially if it does not clear up or gets worse within 2 weeks.

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

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

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