Vivitrol

Generic Name: naltrexone (nal-TREX-one)
Brand Name: Vivitrol

Vivitrol is used for:

Treating alcohol addiction in certain patients. It is also used to prevent opioid (narcotic) pain medicine use in opioid-dependent patients following detoxication treatment. Vivitrol is used along with a complete management program. It may also be used for other conditions as determined by your doctor.

Vivitrol is a narcotic antagonist. Exactly how Vivitrol works to decrease alcohol use is not known. It is thought to decrease opioid use by blocking their effects. Vivitrol does not decrease alcohol or opioid withdrawal symptoms.

Do NOT use Vivitrol if:

• you are allergic to any ingredient in Vivitrol or to the solution used to mix Vivitrol
• you are taking a narcotic pain medicine (eg, codeine), a narcotic cough/cold medicine (eg, hydrocodone), or certain medicines used for diarrhea (eg, diphenoxylate), or you have taken any narcotic within the past 7 to 10 days
• you are dependent on narcotics, have had a positive urine test for narcotics, or are having withdrawal symptoms from narcotics
• you have hepatitis or liver failure

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Vivitrol:

Some medical conditions may interact with Vivitrol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of kidney or liver problems, blood or bleeding problems (eg, hemophilia, low blood platelets), mental or mood problems, or suicidal thoughts or actions
• if you have recently had an alcoholic drink

Some MEDICINES MAY INTERACT with Vivitrol. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Certain medicines used for diarrhea (eg, diphenoxylate), narcotic cough/cold medicines (eg, hydrocodone), or narcotic pain medicines (eg, codeine) because their effectiveness may be decreased by Vivitrol

This may not be a complete list of all interactions that may occur. Ask your health care provider if Vivitrol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Vivitrol:

Use Vivitrol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Vivitrol comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Vivitrol refilled.
• Vivitrol is usually given as an injection at your doctor's office, hospital, or clinic.
• Vivitrol should be given every 4 weeks (once a month).
• If you miss a dose of Vivitrol, contact your doctor as soon as possible to reschedule your dose.

Ask your health care provider any questions you may have about how to use Vivitrol.

Important safety information:

• Vivitrol may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Vivitrol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Vivitrol has only been shown to decrease alcohol or opioid use as part of a complete treatment program. Be sure to follow the program given to you by your doctor or health care provider.
• Do not begin to use Vivitrol if you are actively drinking. Tell your doctor if you have recently had an alcoholic drink.
• Carry an ID card at all times that says you use Vivitrol.
• Mild pain, redness, swelling, itching, bruising, tenderness, or hardness of the skin around the injection site may occur with Vivitrol. Tell your doctor if you experience any skin problems that bother you, do not get better, or get worse within 2 weeks after your injection. Contact your doctor right away if you notice symptoms of a severe injection-site reaction (eg, severe pain, severe swelling or hardness of the skin, lumps, blisters, skin color changes, dark scabbing, an open wound at the injection site).
• Tell your doctor or dentist that you take Vivitrol before you receive any medical or dental care, emergency care, or surgery.
• Family and caregivers must closely observe patients who take Vivitrol. Tell the doctor right away if the patient has symptoms like depression or suicidal thoughts or actions.
• Do not use any narcotics (eg, codeine, heroin) while you are using Vivitrol. Using large doses of narcotics while you are using Vivitrol could cause a serious injury, coma, or death.
• After you stop using Vivitrol, you may be more sensitive to narcotics. Even very low doses of narcotics may cause serious and sometimes life-threatening breathing or circulation problems after you stop using Vivitrol.
• Lab tests, including liver function and complete blood cell counts, may be performed while you use Vivitrol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Vivitrol should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Vivitrol while you are pregnant. Vivitrol is found in breast milk. Do not breast-feed while taking Vivitrol.

If you are addicted to narcotics and you use Vivitrol, you may experience WITHDRAWAL symptoms. These may include anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Vivitrol:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; drowsiness; headache; joint pain or stiffness; loss of appetite; mild nausea; mild pain, redness, swelling, itching, bruising, tenderness, or hardness of the skin around the injection site; muscle cramps; sore throat; stomach pain; tiredness; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; chest, jaw, or left arm pain; confusion; cough; dark urine; fainting; fast or irregular heartbeat; fever; new or worsening mental or mood problems (eg, depression); numbness of an arm or leg; one-sided weakness; pain, redness, or swelling in the legs; pale stools; seizures; severe or persistent constipation or stomach pain; shortness of breath; slurred speech; sudden, severe headache or vomiting; suicidal thoughts or actions; symptoms of a severe injection-site reaction (eg, severe pain, severe swelling or hardness of the skin, lumps, blisters, skin color changes, dark scabbing, an open wound at the injection site); vision changes; wheezing; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include severe drowsiness, dizziness, nausea, or stomach pain.

Vivitrol is usually handled and stored by a health care provider. If you are using Vivitrol at home, store Vivitrol as directed by your pharmacist or health care provider. Keep Vivitrol out of the reach of children and away from pets.

General information:

• If you have any questions about Vivitrol, please talk with your doctor, pharmacist, or other health care provider.
• Vivitrol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.
• Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Vivitrol or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. 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 Vivitrol. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Vivitrol. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Vivitrol.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. 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 this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.