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Naltraccord

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Naltraccord

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

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Overview of Naltraccord

What is Naltraccord? Overview

Property Description
Active Ingredient Naltrexone hydrochloride
Form Oral tablet
Pharmacological Class Opioid antagonist
Common Use Support for alcohol and opioid dependence
Origin Synthetic organic compound

1. What Type of Medicine is Naltraccord?

Naltraccord is a non-addictive prescription medication classified as a pure \mu-opioid receptor antagonist, primarily used to support recovery from substance use disorders. The generic name for the active compound in Naltraccord is Naltrexone.

Naltrexone belongs to the pharmacological class of opioid antagonists. This means that unlike opioid pain relievers (agonists), which activate receptors in the brain, Naltraccord works by strictly blocking these receptors. Naltrexone works by blocking the effects of opioid medications and street drugs like heroin. Its action is clinically recognized for its ability to reduce reinforcement associated with substance consumption. As a synthetic organic compound, this classification is critical, ensuring the medication itself cannot be misused or create physical dependence, making it a foundational tool in medication-assisted treatment (MAT).


2. The Active Ingredient and Physical Form

The active ingredient in Naltraccord is Naltrexone hydrochloride, and it is most commonly prescribed as an oral tablet taken by mouth. It is a single-ingredient medicine, meaning Naltrexone is the only pharmaceutical compound responsible for its intended effects.

The most frequent dosage form is a standard tablet, which allows for daily oral administration. While a long-acting injectable formulation is also available, the oral tablet offers patients and doctors greater flexibility and control for daily management. Naltrexone is an authorized active substance intended for this use. This specific, orally-delivered formulation is often favored when the patient requires daily adherence accountability or needs the option for rapid cessation of treatment.


3. What is Naltraccord's General Purpose?

Naltraccord's general purpose is to reduce cravings and block the reinforcing effects of alcohol and opioids, supporting long-term recovery efforts. It is designed to be used as part of a comprehensive program that includes counseling and behavioral support.

The medicine achieves its purpose through its simple mechanism principle: it attaches to the brain's opioid receptors and physically prevents alcohol or illicit opioids from binding there. By breaking the neurobiological link between using a substance and experiencing a "reward" or euphoria, Naltraccord helps to diminish the urge and prevent relapse.

Regulatory References

  1. Naltrexone: MedlinePlus Drug Information
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What side effects are possible with Naltraccord?

Possible side effects and safety information for Naltraccord

The safety profile for Naltraccord (Naltrexone) is defined by regulatory documents, which categorize observed adverse reactions and state specific constraints on its use as an opioid antagonist. This summary is based exclusively on official government regulatory sources, such as the EMA SmPC and FDA Prescribing Information.

Category Description (Regulatory Terminology)
Key adverse reaction categories: Gastrointestinal disturbances, central nervous system effects, musculoskeletal pain, and liver-related effects.
Frequency classification: Very Common (ge10%): Nausea/Vomiting, Headache, Insomnia, Anxiety, Abdominal pain/cramps, Joint pain (Arthralgia), Fatigue. Common (1% to 10%): Dizziness, Depression, Diarrhoea, Constipation, Rash, Tachycardia. Uncommon (0.1% to 1%): Liver disorder/Hepatitis. Rare (le0.1%): Suicidal ideation/Attempted suicide [EMA/SmPC, FDA].
System-organ classes involved: Gastrointestinal Disorders, Nervous System Disorders, Psychiatric Disorders, Hepatobiliary Disorders, Musculoskeletal and Connective Tissue Disorders, Cardiac Disorders [FDA DailyMed].
Serious adverse reactions (as documented in regulatory sources): Hepatotoxicity (Liver Cell Injury/Hepatitis), potentially leading to liver failure (under excessive doses), is noted by the FDA. Precipitation of Severe Opioid Withdrawal Syndrome in patients with current opioid dependence. Increased Vulnerability to Opioid Overdose after treatment cessation due to diminished tolerance. Depression and Suicidality are monitored [FDA DailyMed].
Population-specific safety considerations: Contraindicated in Acute Hepatitis or Liver Failure. Caution is required in patients with moderate to severe renal impairment. Safety and efficacy have not been established in pediatric patients (under 18 years) [FDA DailyMed, NIH].
Safety-related restrictions or limitations: Contraindicated in any patient currently dependent on opioids, those in acute opioid withdrawal, or individuals who have failed a naloxone challenge test. Use is also contraindicated in cases of known hypersensitivity to the compound [FDA DailyMed].

The official safety information structures the understanding of the medicine's risk profile by formally categorizing expected adverse reactions and explicitly detailing the serious, yet infrequent, risks such as liver injury and the life-threatening consequences of attempted opioid use. The regulatory constraints, including clear contraindications related to liver status and opioid dependence, define the precise safety perimeter for the drug's approved use.

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Overdose and Emergency Response

Overdose and When to Seek Help: Regulatory Summary

Official regulatory documents emphasize that overdose is a serious risk associated with the use of this medication, particularly with higher doses and during long-term therapy. These risks are summarized based on study results that estimate the potential for both fatal and non-fatal overdoses.

Overdose can lead to a serious brain condition known as toxic leukoencephalopathy.


Risk Factors and Required Actions

Overdose Component Regulatory Statement
Dose-Related Risk Higher doses carry greater risks of serious harm, and these risks persist over time.
Compounding Risk Warnings are required for combining this drug with other central nervous system (CNS) depressants, now explicitly including gabapentinoids.
Emergency Protocol Immediate action and medical help are required. Clinicians must counsel patients and caregivers on the availability of opioid overdose reversal agents, such as naloxone and nalmefene, including when to use them and how to access them.
Overdose Manifestation Toxic leukoencephalopathy, a serious brain condition, may occur following an overdose.

If an overdose is suspected, immediate emergency medical attention is required to manage potential life-threatening effects.

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Therapeutic Uses of Naltraccord

Naltraccord (Naltrexone) is considered relevant in the management of substance use disorders. It helps by addressing the core symptomatic drivers of these conditions, specifically the intense urges and cravings that may interfere with functional stability. The medication is applied in the therapeutic domains of Alcohol Use Disorder (AUD) and Opioid Use Disorder (OUD).

Supporting Recovery from Alcohol Use Disorder (AUD)

This medication is applied in addressing compulsive cravings, which are symptom clusters that may become intense or disruptive in patients with AUD. The key therapeutic benefit contributes to improved comfort during periods of heightened symptoms and supports patients during difficult episodes by easing distress. It may assist with managing heavy drinking episodes, helping patients cope more steadily with chronic use patterns.

“Naltraccord supports patients by easing the reinforcing effect associated with opioid use, thereby assisting with abstinence maintenance in recovery programs.”

Preventing Relapse in Opioid Use Disorder (OUD)

For patients who have completed detoxification from opioids, Naltraccord is commonly used to help with the strong psychological urge to use and the risk of relapse. The medication is applied in addressing conditions involving episodic or fluctuating manifestations.

Quick Fact: Support for Compulsive Urges Naltraccord plays a role in managing symptom clusters linked to dependence, particularly the intense urges that interfere with daily comfort, and assists with maintaining functional stability.

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Eligibility and Restrictions for Use

The use of Naltraccord is strictly governed by its official classification as an opioid antagonist, which defines numerous absolute contraindications and population restrictions in governmental regulatory documents.

Eligibility Scope

Classification Population Status
Allowed Adults (age 18+) who are demonstrably opioid-free Use Permitted
Contraindicated Patients receiving opioid analgesics or those in acute opioid withdrawal Must Not Use
Contraindicated Individuals with current physiologic opioid dependence or a positive urine screen for opioids Must Not Use
Contraindicated Patients with acute hepatitis or existing liver failure Must Not Use

Age and Condition Restrictions

Age Group / Condition Official Regulatory Status
Pediatric Use (Under 18) Safety and efficacy not established; generally not recommended
Pregnancy / Lactation Not recommended unless potential benefits clearly outweigh potential risks
Renal Impairment Caution is advised; use with careful monitoring due to renal clearance
Active Liver Disease Caution is required; mandates frequent monitoring of liver function tests

These rules define the mandatory boundaries for use: eligibility is confirmed only after verified opioid abstinence, and the drug is prohibited in cases of severe liver compromise.

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What should I know about interactions with other medicines?

Naltraccord Interactions with Other Medicines and Products

Naltraccord's official interaction profile is characterized primarily by its action as an opioid antagonist, resulting in explicit restrictions with opioid-containing products. The interaction information is grounded solely in government regulatory documentation.


Documented Pharmacological Interactions

Classification Interacting Substance/Condition Regulatory Status (Example)
Absolute Contraindication Opioid Analgesics and Opioid-Containing Medicines (e.g., cough/cold, anti-diarrheal) Prohibited (Risk of precipitating acute withdrawal)
Use Not Ordinarily Recommended Disulfiram Safety unknown; increased risk of liver problems
Additive Effect Risk Thioridazine Reports of lethargy and somnolence
Caution Advised CNS Depressants (e.g., sedatives) Potential for additive central effects

Pharmacokinetic and Time-Based Constraints

The most significant pharmacokinetic and time-based constraints involve the initiation of Naltraccord to avoid precipitating acute opioid withdrawal:

  • Timing Requirement for Initiation: Patients must be free of short-acting opioids for a minimum of 7 days and long-acting opioids for at least 10 to 14 days prior to starting treatment.
  • Exposure Modification: Naltraccord significantly increases the plasma level of Acamprosate. Conversely, concomitant use with Bremelanotide is restricted due to a reduction in Naltrexone exposure.
  • Metabolic Pathway: Neither Naltraccord nor its main active metabolite, 6-ß-naltrexol, is documented to be metabolized by the CYP450 enzyme system; therefore, CYP-mediated drug interactions are not a documented risk pathway.

Further population-specific interaction constraints advise caution in patients with moderate to severe renal impairment or pre-existing impaired hepatic function.

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Mechanism of Action

Naltraccord (Naltrexone) is a non-selective opioid receptor antagonist that binds competitively to endogenous opioid receptors primarily located within the central nervous system. Its molecular targets are the mu-opioid receptor (MOR), with lower affinity for the kappa-opioid receptor (KOR) and delta-opioid receptor (DOR).

The drug and its active metabolite, 6-beta-naltrexol, function as competitive inhibitors at these G-protein coupled receptors. By occupying the orthosteric binding site, Naltraccord prevents the binding and subsequent activation of both exogenous opioids and endogenously released opioid peptides, such as endorphins and enkephalins.

This blockade inhibits the adenylyl cyclase/cAMP pathway modulation typically initiated by opioid-receptor agonist binding. Specifically, preventing agonist-mediated Gi protein activation of the MOR results in an upstream interruption of the mesolimbic dopamine pathway, which originates in the ventral tegmental area (VTA) and projects to the nucleus accumbens (NAc). The system-level physiological consequence is the prevention of opioid-induced signal transduction and the subsequent attenuation of overall opioid system output.

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Dosage and Administration Information

How Naltraccord is Used: Official Administration Guidelines

Naltraccord (Naltrexone oral tablet) is an adjunctive medication intended for use only as part of a comprehensive treatment program that includes psychosocial support and counseling. The official administration guidelines define the specific route, dosing, and procedural conditions for its use.

Feature Official Usage Guideline
Route & Preparation The medication is taken orally as a tablet, which must be swallowed whole with liquid. It may be taken with or after meals if necessary.
Dosing for AUD The standard recommended dose for alcohol use support is 50 mg once daily.
Dosing for OUD Treatment for opioid dependence requires a cautious approach: the starting dose is 25 mg (half a tablet) once daily for the first day, escalating to the 50 mg daily maintenance dose thereafter.
Frequency The standard regimen is once daily. Alternate schedules are authorized to promote patient adherence, such as 100 mg every other day, or 100 mg on Monday and Wednesday, and 150 mg on Friday.

This oral therapy establishes a structured, sequential protocol, defining its use as an adjunctive component of recovery management. The procedural rules strictly mandate a minimum of 7 to 10 days of confirmed opioid abstinence before treatment initiation for opioid dependence. If a scheduled dose is missed, the patient should not double the next dose, but instead continue the normal schedule. For specific populations, such as pediatric patients (under 18), the medication is not recommended because its safety and effectiveness have not been established in these age groups.

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Recent Clinical Evidence

Research Evidence Overview

The research base for Naltraccord (oral naltrexone) includes Randomized Controlled Trials (RCTs) and systematic reviews, in which researchers explore specific outcomes related to its use in adults. This overview describes the available research structure, what findings were described, and what aspects remain uncertain.


Evidence for Use in Alcohol Use Disorder (AUD)

Naltraccord was studied for its use in managing symptoms of Alcohol Use Disorder, a condition characterized by fluctuating or episodic manifestations. Research examined outcomes related to drinking frequency and quantity. Findings indicate that the group receiving the medicine had data show patterns related to heavy drinking frequency compared to the placebo group. Despite this, findings were mixed across all trials, and the consistency of these findings subgroup findings are uncertain. The results apply only to the populations studied under the trial conditions.


Evidence for Use in Opioid Use Disorder (OUD)

The use of Naltraccord was evaluated in individuals with Opioid Use Disorder (OUD) who had already completed full detoxification. Research explored the medication's use in individuals with OUD to monitor outcomes related to relapse. Research describes a key reported pattern of low adherence to the daily oral regimen across many trial settings, which is linked to evidence quality varies across studies. Conclusions regarding sustained abstinence are limited because certainty remains low.


Research Gaps and Long-Term Data

The majority of primary research involves follow-up durations were limited, typically 12 to 24 weeks. Long-term effects are not fully established. Data for certain groups remain insufficient, particularly for older adults or children, as these groups are often excluded from primary trials. For OUD, the problem of low patient adherence to the daily tablet is associated with data for certain groups remain insufficient and comparative evidence is lacking in some analyses. The research is ongoing to address these evidence gaps and contributes to understanding the medicine’s long-term role.

Key Studies & References

  1. The effects of naltrexone on retention in treatment and being opioid-free in opioid-dependent people: A systematic review and meta-analysis
  2. ASAM National Practice Guideline for the Treatment of Opioid Use Disorder (Used for treatment setting context and adherence issues)
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Frequently Asked Questions (FAQ)

Common questions about Naltraccord (FAQ)

Q: Is it common to experience nausea or stomach upset when first starting Naltraccord?

A: According to regulatory documents, nausea and vomiting are listed as Very Common adverse reactions, meaning they are reported by ge10% of patients. Some product information notes that patients who are abstinent from alcohol at the start of treatment may report fewer episodes of nausea.


Q: How does Naltraccord relate to the need for counseling or support programs?

A: Official administration guidelines classify Naltraccord as an adjunctive medication. This means it is intended to be used only as part of a comprehensive treatment program that includes psychosocial support and counseling, and not as a standalone treatment.


Q: Is there a common recommendation on whether to take oral Naltraccord with or without food?

A: Official usage guidelines state that the oral tablet must be swallowed whole. If necessary, the medication may be taken with or after meals, as described in official usage guidelines.


Q: What is the general non-directive guidance for a missed dose of Naltraccord?

A: Regulatory documentation specifies that if a scheduled dose is missed, the patient should not double the next dose. Instead, the regulatory guidance is to continue the normal dosing schedule.


Q: Are there any known allergic reactions associated with Naltraccord use?

A: Regulatory documentation lists a contraindication for individuals with a known hypersensitivity to the compound. Regulatory documents mention that symptoms indicative of an allergic reaction may include swelling of the face, lips, or tongue, rash, or difficulty breathing.


Q: Can a person become physically dependent on Naltraccord?

A: Naltraccord is classified as a pure μ-opioid receptor antagonist and is described as a non-addictive prescription medication. Its pharmacological mechanism, which involves blocking receptors, indicates the medication itself cannot create physical dependence.


Q: Is Naltraccord a 'cure' for the conditions it treats?

A: Naltraccord is classified as an adjunctive medication and is intended to be used as part of a comprehensive program. While research explores specific outcomes related to its use, it is not classified in official documents as a cure for the conditions it treats.


Q: Does Naltraccord cause an immediate, unpleasant physical reaction if alcohol is consumed?

A: Official pharmacological information states that Naltraccord is not aversive therapy. It is described as not causing a disulfiram-like reaction as a result of alcohol consumption.


Q: How does Naltraccord affect the feeling of reward associated with alcohol use?

A: Naltraccord's mechanism principle is to reduce cravings and block the reinforcing effects associated with alcohol. It attaches to opioid receptors, preventing the neurobiological link between using a substance and experiencing a reward or euphoria.


Q: What are the considerations for using Naltraccord during pregnancy?

A: Official regulatory status indicates Naltraccord is not recommended during pregnancy. This is unless the potential benefit is determined to clearly outweigh the potential risk to the fetus.


Q: What are the considerations for using Naltraccord while breastfeeding?

A: Naltraccord is not recommended while breastfeeding. Official documentation notes that in animal studies, the compound and its metabolite were excreted in milk, and official information notes caution is required.


Q: Are joint or muscle pain known concerns for people using Naltraccord?

A: Yes, Joint pain (Arthralgia) is listed in regulatory sources as a Very Common (ge10%) adverse reaction. Official product information also lists muscle pain as a commonly reported effect.


Q: Is a loss of appetite a known or common effect of Naltraccord?

A: Lack of appetite is listed in product information as a Common (1% to 10%) side effect. Loss of appetite is also noted as a symptom associated with potential liver injury that requires monitoring.


Q: Are non-physical side effects, like increased anxiety or nervousness, associated with Naltraccord?

A: Yes, regulatory documents list Anxiety as a Very Common (ge10%) adverse reaction. Official product information notes that nervousness is also listed among the frequently reported adverse effects.


Q: Does Naltraccord carry a warning regarding depression or suicidal thoughts?

A: Regulatory documents note that Depression is a Common side effect and Suicidal ideation/Attempted suicide is a Rare serious adverse reaction. Official labeling states that the risk of suicide is known to be increased in patients with substance use disorders and is not reduced by treatment with this medication.


Q: What non-opioid medications are described in official documents as potentially interacting with Naltraccord?

A: Documented non-opioid interactions include substances like Disulfiram and Thioridazine, with caution advised for CNS Depressants (e.g., sedatives). Acamprosate and Bremelanotide are also noted due to pharmacokinetic effects.


Q: Is it possible to use Naltraccord in combination with other approved non-opioid treatments for the same condition?

A: Naltraccord is classified as an adjunctive medication to be used as part of a comprehensive program. Pharmacokinetic constraints in official labeling mention co-administration with other non-opioid medications approved for the same conditions, such as Acamprosate.


Q: What is the purpose of carrying a medical identification card while using Naltraccord?

A: Regulatory guidance recommends carrying identification stating that you are taking Naltraccord. This is recommended to help healthcare providers, dentists, and pharmacists remain aware of the opioid antagonist's presence and potential for interactions, particularly with opioid analgesics.


Q: What is the advice regarding driving or operating machinery when first starting Naltraccord?

A: Official product information advises that Naltraccord may impair the mental and/or physical abilities required for performing potentially hazardous tasks, such as driving a car or operating machinery. The labeling indicates that patients should determine how the medicine affects them before attempting these activities.


Q: What is the typical range of time people use Naltraccord for its intended purpose?

A: Regulatory documentation does not specify a mandatory treatment duration. However, primary research used to evaluate the medication typically involves follow-up periods of 12 to 24 weeks (approximately 3 to 6 months) to assess outcomes.


Q: Is there a risk of liver damage when Naltraccord is used at recommended levels?

A: Official documents indicate that Naltraccord does not appear to be a hepatotoxin at the recommended doses. However, the drug is contraindicated (prohibited) in patients with acute hepatitis or liver failure, and the official warnings mention the risk of hepatic injury if excessive doses are taken.

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How should Naltraccord be stored and disposed of?

Storage and Security Requirements

Naltraccord (naltrexone oral tablets) must be stored according to official regulatory specifications to maintain the medication’s stability.

  • Required Temperature: Store at 25 C (77 F), with permitted excursions between 15 C to 30 C (59 F to 86 F) (USP Controlled Room Temperature).
  • Protection: Keep the bottle tightly closed in its original, light-resistant container and store away from excess heat and moisture. The product must be kept from freezing.
  • Child Safety: It is a mandatory requirement to keep this and all medication out of the sight and reach of children.

Disposal Instructions

Discarding unused or expired Naltraccord must follow specific safety guidelines.

  • Unused Product: The FDA recommends using a drug take-back program or mail-back service where available.
  • Household Disposal: If no take-back option is available, unused tablets should be mixed with an unappealing substance (like used coffee grounds or dirt), placed in a sealed container, and thrown into the household trash. All personal information on the label must be scratched out prior to disposal.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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