Naltrexone Hydrochloride is a non-addictive, opioid antagonist medication approved by the FDA for the management of alcohol dependence in adults. It is scientifically formulated to reduce alcohol cravings and diminish the rewarding effects of alcohol consumption. When used as part of a comprehensive treatment plan that includes counseling and support, Naltrexone HCl supports sustained abstinence and helps restore neurochemical balance. This prescription medication offers a pharmacological approach to assist individuals committed to reducing or ceasing alcohol intake.

Features

• Contains 50 mg Naltrexone Hydrochloride per tablet
• White, round, film-coated oral tablet, debossed with product identification code
• Opioid receptor antagonist mechanism of action
• Manufactured under cGMP (current Good Manufacturing Practices) standards
• Available in 30-count and 90-count bottles with child-resistant caps
• Requires prescription and medical supervision

Benefits

• Reduces the frequency and intensity of alcohol cravings
• Diminishes the pleasurable effects of alcohol, supporting reduced consumption
• Supports long-term abstinence when combined with behavioral therapy
• Non-addictive with no potential for abuse or dependence
• Helps restore normal neurotransmitter function in reward pathways
• Enables patients to maintain daily functioning without sedation or impairment

Common use

Naltrexone HCl is primarily prescribed for the management of alcohol dependence in adults who have undergone detoxification and are committed to maintaining abstinence. It is used as part of a comprehensive treatment program that includes psychosocial support, counseling, and monitoring. The medication is typically initiated after a minimum of 7-10 days of alcohol-free status to ensure complete elimination of alcohol from the system. Healthcare providers may prescribe Naltrexone for both complete abstinence goals and reduced drinking approaches, depending on individual patient circumstances and treatment objectives.

Dosage and direction

The recommended dosage for alcohol dependence is 50 mg once daily, with or without food. Treatment should be initiated under medical supervision after ensuring the patient is opioid-free for at7-10 days. Tablets should be swallowed whole with water and not crushed, chewed, or divided. The optimal duration of treatment varies individually but typically ranges from 3 to 12 months based on treatment response and patient goals. Dosage adjustments are not typically required for hepatic impairment, but caution is advised in patients with moderate to severe hepatic disease. Treatment should be monitored regularly by a healthcare provider to assess efficacy and tolerability.

Precautions

Patients should be advised that Naltrexone may cause hepatocellular injury when given in excessive doses. Liver function tests are recommended before initiation and periodically during treatment. Patients should carry identification noting they are taking Naltrexone in case of emergency requiring opioid analgesia. Use with caution in patients with renal impairment (creatinine clearance <30 mL/min). May cause drowsiness or dizziness; patients should avoid driving or operating machinery until they know how the medication affects them. Not recommended for use during acute alcohol withdrawal. Patients should continue to avoid alcohol consumption while taking Naltrexone.

Contraindications

Naltrexone HCl is contraindicated in patients receiving opioid analgesics, currently dependent on opioids, including those maintained on agonists/partial agonists like methadone or buprenorphine, or in acute opioid withdrawal. Contraindicated in patients with acute hepatitis or liver failure. Should not be used in patients who have failed the naloxone challenge test or have a positive urine screen for opioids. Hypersensitivity to Naltrexone or any component of the product formulation constitutes a contraindication. Not recommended for use in patients with uncontrolled bleeding disorders.

Possible side effects

Common side effects (≥10% incidence) include nausea, headache, dizziness, nervousness, fatigue, and insomnia. Less common effects (1-10% incidence) may include vomiting, decreased appetite, joint/muscle pain, sleep disturbance, anxiety, and increased thirst. Rare but serious side effects (<1% incidence) include hepatotoxicity, depression, suicidal ideation, eosinophilic pneumonia, and hypersensitivity reactions. Most side effects are mild to moderate and tend to diminish within the first few weeks of treatment. Patients should report persistent or severe side effects to their healthcare provider promptly.

Drug interaction

Naltrexone may precipitate acute withdrawal in patients dependent on opioids. Concomitant use with opioid-containing medications (including cough/cold preparations and antidiarrheal medications) is contraindicated. May enhance hepatotoxicity of other drugs metabolized by the liver. Use with caution with hepatotoxic drugs including NSAIDs, anticonvulsants, and certain antibiotics. May interact with medications affecting central nervous system function, including sedatives, tranquilizers, and other psychotropic agents. No clinically significant interactions with disulfiram have been observed. Healthcare providers should review all concomitant medications, including over-the-counter products and herbal supplements.

Missed dose

If a dose is missed, it should be taken as soon as remembered unless it is almost time for the next scheduled dose. In that case, the missed dose should be skipped and the regular dosing schedule resumed. Patients should not take double or extra doses to make up for a missed dose. If multiple doses are missed, patients should contact their healthcare provider before resuming treatment, as retitration may be necessary. Consistent daily dosing is important for maintaining therapeutic efficacy in reducing alcohol cravings.

Overdose

In the event of overdose, supportive measures should be instituted with attention to preventing self-injury. There is no specific antidote for Naltrexone overdose. Symptoms may include nausea, vomiting, abdominal pain, dizziness, and lethargy. In severe cases, hepatic enzyme elevations or acute liver injury may occur. Management includes gastric lavage if presented early, followed by supportive care with monitoring of vital signs and hepatic function. Hemodialysis is not expected to be helpful due to Naltrexone’s large volume of distribution. Patients experiencing suspected overdose should seek immediate medical attention or contact a poison control center.

Storage

Store at controlled room temperature 20°-25°C (68°-77°F) with excursions permitted between 15°-30°C (59°-86°F). Keep container tightly closed and protect from light and moisture. Dispense in original container with child-resistant closure. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging. Properly dispose of unused medication through drug take-back programs or according to FDA-recommended disposal methods if no take-back program is available.

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. Naltrexone HCl is a prescription medication that should be used only under the supervision of a qualified healthcare provider. Individual results may vary. Patients should consult with their healthcare provider before starting, stopping, or changing any medication regimen. The manufacturer and distributors are not liable for any adverse effects resulting from the use or misuse of this product.

Reviews

Clinical studies demonstrate that Naltrexone significantly improves abstinence rates compared to placebo, with meta-analyses showing a number needed to treat of 12 to prevent return to any drinking. Patients report reduced alcohol cravings within the first week of treatment, with maximal effects typically observed after 4-8 weeks of consistent use. Healthcare providers note improved treatment adherence when combined with comprehensive behavioral support. Long-term follow-up studies indicate maintained benefits for up to one year post-treatment in responsive patients. Real-world evidence supports the effectiveness of Naltrexone in both abstinence and reduced drinking goals when properly prescribed and monitored.