Vivitrol 380mg Inj, 1 Vial

Naltrexone is an opioid receptor antagonist. It competitively binds to mu, delta, and kappa opioid receptors in the central nervous system and periphery, with the highest affinity for the mu receptor. This binding blocks the effects of exogenous opioids and reduces alcohol craving, though the exact mechanism for reducing alcohol craving is not fully understood but is thought to involve modulation of the endogenous opioid system.

Serious Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
New or worsening behavioral or mood changes, including:
+ Depression
+ Thoughts of suicide
+ Confusion
Breathing difficulties, such as:
+ Slow breathing
+ Shallow breathing
Sexual problems in males
Signs of lung or breathing problems, including:
+ Shortness of breath
+ Trouble breathing
+ Cough
+ Fever
Severe skin irritation at the injection site, characterized by:
+ Hardness
+ Blisters
+ Dark scab
+ Lumps
+ Open wound
+ Pain
+ Swelling

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you notice any of the following:

Feeling nervous or excitable
Anxiety
Headache
Muscle cramps
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Excessive thirst
Sleep disturbances
Dizziness
Drowsiness
Fatigue
Weakness
Back pain
Muscle pain
Joint pain
Common cold symptoms
Tooth pain
Irritation at the injection site
Nose or throat irritation
Dry mouth

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you are currently taking or have recently taken an opioid medication, such as morphine or oxycodone, or if you have an opioid use disorder or are experiencing withdrawal symptoms.
* If you have taken a pain medication within the past 7 to 14 days.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing medications and health conditions.

Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor to ensure your safety.

Important Warnings and Precautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent potential interactions with other treatments.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and engaging in activities that require you to be alert. This will help prevent accidents and ensure your safety.

Monitoring and Lab Tests
Your doctor will schedule regular blood work and other lab tests to monitor your condition. It is crucial to keep these appointments and follow your doctor's instructions. Additionally, inform all your healthcare providers and lab workers that you are taking this medication, as it may affect certain lab test results.

Interactions with Other Substances
Do not consume alcohol while taking this medication. It is also essential to avoid taking opioid drugs, as they will not be effective and may cause severe harm, including coma or death, if taken in excess. If you have taken opioid drugs in the past, be aware that low doses or amounts you have used before may lead to overdose and death after receiving this medication.

Opioid Overdose Risk
After receiving a dose of this medication, its blocking effect on opioids will gradually decrease over time. If you miss a dose, stop treatment, or have completed treatment and are opioid-free, you may be at risk of overdose and death if you take opioid drugs. A medication called naloxone can be used to help treat an opioid overdose. Your doctor may prescribe naloxone for you to have on hand in case of an emergency. If you have questions about naloxone or suspect an opioid overdose, seek medical attention immediately, even if naloxone has been administered.

Opioid Withdrawal Symptoms
If you have opioid use disorder and are given this medication, you may experience symptoms of opioid withdrawal, such as sweating, shaking, fever, chills, diarrhea, stomach upset, vomiting, stomach cramps, goosebumps, body aches, anxiety, irritability, yawning, or rapid heartbeat.

Skin and Lung Infection Risks
In rare cases, severe skin problems can occur at the injection site, potentially requiring surgical intervention. Additionally, a type of lung infection caused by an allergic reaction has been reported with this medication, which may require hospitalization. Inform your doctor immediately if you experience any unusual symptoms.

Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is essential to discuss the benefits and risks of this medication to you and your baby.

• Opioid analgesics (e.g., morphine, oxycodone, hydrocodone, fentanyl, tramadol)
• Patients receiving opioid analgesics
• Patients in acute opioid withdrawal
• Patients who have failed the naloxone challenge test or have a positive urine screen for opioids

• Other hepatotoxic drugs (e.g., acetaminophen in high doses, isoniazid, amiodarone, methotrexate) - increased risk of liver injury
• Thioridazine (potential for increased somnolence and lethargy)

• Opioid-containing cough, cold, or antidiarrheal medications (e.g., codeine, loperamide) - naltrexone will block their effects
• Disulfiram (potential for additive hepatotoxicity, though not well-established)

• Signs/symptoms of liver injury (e.g., abdominal pain, dark urine, jaundice, fatigue, nausea, vomiting)
• Signs/symptoms of depression or suicidal ideation
• Severe injection site reactions (e.g., pain, swelling, induration, blistering, open wound, necrosis)
• Signs of opioid withdrawal (if patient attempts to use opioids while on naltrexone)
• Pneumonia (rare, but reported in clinical trials)

Category C. Vivitrol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Animal studies have shown adverse effects.

L3 (Moderately Safe). Naltrexone and its active metabolite are excreted into human milk. The effect on the breastfed infant is unknown. Weigh the developmental and health benefits of breastfeeding along with the mother’s clinical need for Vivitrol and any potential adverse effects on the breastfed infant from Vivitrol or from the underlying maternal condition.

Safety and effectiveness in pediatric patients (under 18 years of age) have not been established for alcohol or opioid dependence.

No specific dose adjustment is recommended based on age. However, elderly patients may have decreased renal or hepatic function, which should be considered. Monitor for adverse effects and comorbidities.

• Ensure a 7-14 day opioid-free period before initiating Vivitrol to prevent precipitated opioid withdrawal, which can be severe and require hospitalization.
• Administer Vivitrol as a deep intramuscular gluteal injection, alternating buttocks for subsequent injections. Do not administer intravenously or subcutaneously.
• Educate patients thoroughly about the risk of opioid overdose if they attempt to overcome the blockade, emphasizing that even after discontinuing Vivitrol, they may be more sensitive to opioids.
• Vivitrol does not eliminate cravings for all individuals; it is most effective when used as part of a comprehensive treatment program including counseling and psychosocial support.
• Monitor injection sites closely for severe reactions, which can include necrosis and require surgical intervention.
• Patients should be advised to carry identification indicating they are on naltrexone, especially in case of an emergency where opioid analgesia might be needed.

• Oral naltrexone (Revia, Depade) - for alcohol and opioid dependence
• Acamprosate (Campral) - for alcohol dependence
• Disulfiram (Antabuse) - for alcohol dependence
• Buprenorphine/naloxone (Suboxone, Zubsolv, Bunavail) - for opioid dependence
• Methadone - for opioid dependence

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.

Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications by checking with your pharmacist for guidance on the best disposal method. Unless instructed to do so, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities offer drug take-back programs, which provide a safe and responsible way to dispose of unwanted medications.

This medication is accompanied by a Medication Guide, which provides important information about its safe and effective use. Read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, consult with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will help healthcare professionals provide the best possible care.