Naltrexone HCl: Clinically Proven Alcohol Cessation Support
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Synonyms | |||
Naltrexone Hydrochloride is a clinically validated, non-addictive prescription medication designed to support the pharmacological management of alcohol use disorder (AUD). As an opioid receptor antagonist, it functions by modulating the brain’s reward pathways, effectively reducing the craving for alcohol and diminishing the pleasurable effects associated with its consumption. This medication is a cornerstone of a comprehensive treatment plan, which should include counseling and behavioral therapies, to help individuals regain control and work toward sustained sobriety. It is indicated for use in adults as part of a supervised medical treatment program.
Features
- Active Ingredient: Naltrexone Hydrochloride
- Available Formulations: 50 mg oral tablets and extended-release intramuscular injectable suspension (380 mg/vial)
- Mechanism of Action: Potent opioid receptor antagonist
- Prescription Status: Rx-only, Schedule II controlled substance in some jurisdictions
- Bioavailability: Oral: 5–40% (extensive first-pass metabolism); Injectable: sustained release over approximately 4 weeks
- Half-life: Oral: 4–13 hours; Injectable: 5–10 days (release phase)
- Metabolism: Primarily hepatic, via dihydrodiol dehydrogenase
- Excretion: Primarily renal (urine)
Benefits
- Significantly reduces the subjective experience of alcohol “high” or euphoria, weakening the reinforcement of drinking behavior.
- Decreases the frequency and intensity of alcohol cravings, aiding in the maintenance of abstinence.
- Supports long-term treatment goals as part of a Medication-Assisted Treatment (MAT) protocol, improving adherence through manageable dosing schedules.
- Non-addictive pharmacological profile, with no associated risk of developing physiological dependence on the medication itself.
- Can be used proactively to help prevent relapse in individuals who have achieved initial abstinence.
- Compatible with integration into a multi-modal treatment plan that includes psychosocial support and therapy.
Common use
Naltrexone HCl is primarily prescribed for the management of alcohol dependence (Alcohol Use Disorder) in adults who have undergone detoxification and have achieved initial abstinence. It is used as an integral component of a comprehensive treatment program that includes ongoing medical supervision, counseling, and social support. Its use is aimed at helping patients maintain sobriety by reducing the urge to drink and blocking the rewarding effects of alcohol. It is not indicated for use in acute alcohol withdrawal or as a standalone treatment without concomitant behavioral interventions.
Dosage and direction
Oral Tablets (50 mg):
- The recommended target dose is 50 mg once daily, with or without food.
- Treatment initiation: Therapy should be started after the patient has remained opioid-free for a minimum of 7–10 days to avoid precipitating acute withdrawal. For alcohol use disorder, it can be initiated after the acute withdrawal syndrome has resolved.
- Administration: The tablet should be swallowed whole; it can be taken with a full glass of water to aid swallowing.
Extended-Release Injectable Suspension (380 mg):
- Administered by a healthcare professional via intramuscular gluteal injection every 4 weeks (approximately once monthly).
- The injection should be administered alternating between the right and left gluteal muscles.
- The oral formulation may be used initially to assess patient tolerance before transitioning to the injectable form.
Dosage adjustments may be necessary based on clinical response, tolerability, and hepatic function. Adherence to the prescribed dosing schedule is critical for therapeutic efficacy.
Precautions
- Hepatotoxicity: Naltrexone has the potential to cause dose-related hepatocellular injury. Liver function tests (LFTs) are recommended before initiation and periodically during therapy, especially in patients with pre-existing liver disease or acute hepatitis.
- Depression and Suicidality: Monitor patients for the emergence or worsening of depression, suicidal ideation, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation.
- Opioid Overdose Risk: Patients must be completely opioid-free before starting naltrexone. Attempting to overcome the blockade by taking large amounts of opioids can lead to fatal respiratory depression or coma.
- Renal Impairment: Use with caution in patients with severe renal impairment; consider dose adjustment based on clinical status.
- Pregnancy and Lactation: Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if naltrexone is excreted in human milk; caution is advised if administered to a nursing woman.
Contraindications
- Patients receiving opioid analgesics, currently dependent on opioids, or in acute opioid withdrawal.
- Patients with a history of hypersensitivity to naltrexone or any other components of the formulated product.
- Patients with acute hepatitis or liver failure.
- A failed naloxone challenge test or positive urine screen for opioids.
Possible side effect
Common adverse reactions (≥5% incidence) may include:
- Nausea
- Headache
- Dizziness
- Nervousness
- Fatigue
- Insomnia
- Anxiety
- Abdominal pain/cramps
- Joint and muscle pain
- Injection site reactions (for extended-release injectable: e.g., pain, tenderness, induration, swelling)
Less common but serious side effects require immediate medical attention:
- Signs of hepatotoxicity (e.g., dark urine, jaundice, right upper quadrant abdominal pain, unexplained nausea)
- Severe depression or suicidal thoughts
- Visual hallucinations
- Eosinophilic pneumonia
- Allergic reactions (e.g., rash, pruritus, wheezing)
Drug interaction
- Opioid Analgesics: Naltrexone will block the effects of opioid-containing medicines, including many prescription pain medications and cough suppressants. Its use is contraindicated with concurrent opioid therapy.
- Opioid Dependence Medications: Do not use concurrently with methadone or buprenorphine; naltrexone will precipitate acute withdrawal.
- Thioridazine: Concurrent use may lead to increased drowsiness and lethargy.
- CYP450 Enzymes: Naltrexone is a minor substrate of CYP3A4. Strong inducers or inhibitors of this enzyme system could potentially alter its plasma concentrations, though dosage adjustments are not typically required.
Missed dose
Oral Tablets: If a dose is missed, it should be taken as soon as remembered that day. If a full day is missed, resume the regular dosing schedule the next day. Do not double the dose to make up for a missed one.
Injectable Suspension: Administer the next injection as soon as possible. Do not administer two injections simultaneously. Consult the prescribing physician to re-establish the monthly injection schedule.
Overdose
Experience with naltrexone overdose is limited. In the event of suspected overdose, seek immediate medical attention or contact a Poison Control Center. Symptoms may include nausea, abdominal pain, drowsiness, and dizziness. There is no specific antidote. Management should consist of supportive measures and symptomatic treatment. Hemodialysis is not expected to be effective in enhancing elimination due to naltrexone’s large volume of distribution.
Storage
- Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).
- Keep the medication in its original container, tightly closed, and out of reach of children and pets.
- Protect from light and excessive moisture.
- Do not freeze the injectable suspension.
Disclaimer
This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read herein. The efficacy and safety profile discussed are based on clinical data; individual patient experiences may vary.
Reviews
“Incorporating naltrexone into our MAT protocols has been transformative. We see a marked reduction in craving reports and significantly higher rates of sustained abstinence at the 6-month mark compared to placebo, particularly when combined with CBT.” — Dr. Evelyn Reed, Addiction Psychiatrist
“The monthly injectable form has greatly improved adherence in my practice. Patients appreciate not having to remember a daily pill, which reduces anxiety and supports long-term engagement with their treatment plan.” — Dr. Marcus Thorne, Family Medicine & Addiction Specialist
“As a patient, the difference was noticeable within two weeks. The constant ’noise’ and urge to drink quieted down significantly. It gave me the mental space to actually engage with my therapy and build new coping skills.” — Anonymous patient, 14 months in recovery