Product image of Libroxar (Buprenorphine, Naloxone) supplied by GNH India

Libroxar

Active Ingredient:
Buprenorphine, Naloxone
Origin:
EU

Libroxar (Buprenorphine, Naloxone)

Buprenorphine/Naloxone, the active ingredient in Libroxar, is a partial opioid agonist / opioid antagonist combination presented as a sublingual tablet for sublingual use. It is indicated for the management of opioid dependence and opioid use disorder, helping to reduce withdrawal symptoms and curb misuse in adult patients.

GNH India supplies Libroxar as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, providing reliable sourcing for regulated markets.

Manufacturer / TM Owner

Laboratoires Smb S.A.

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Indications & Clinical Uses

Libroxar (buprenorphine/naloxone) is used in the opioid dependence treatment pathway to manage opioid use disorder.

  • Opioid dependence: reduces withdrawal symptoms and cravings, supporting stable maintenance.
  • Opioid use disorder: facilitates relapse prevention and transition to opioid‑free status.
  • Opioid addiction: aids in long‑term recovery by providing controlled opioid receptor activity.

How It Works

  • Buprenorphine binds with high affinity to the μ‑opioid receptor as a partial agonist, delivering modest analgesia while limiting maximal respiratory depression, and antagonizes κ‑receptors, reducing dysphoria. Naloxone, poorly absorbed sublingually, acts as an opioid antagonist if the product is injected, blocking μ‑receptors and deterring misuse. Together they modulate opioid pathways to alleviate withdrawal and curb illicit opioid effects.

Side Effects

Common Side Effects

  • Nausea
  • Constipation
  • Headache
  • Sweating
  • Dry mouth
  • Dizziness

Serious or Rare Side Effects

  • Respiratory depression
  • Severe hypotension
  • Allergic reactions (including anaphylaxis)
  • Liver enzyme elevation
  • Seizures
  • QT interval prolongation

Precautions & Warnings

Libroxar requires careful clinical monitoring due to its opioid activity and formulation.

  • Assess patient history: evaluate prior opioid use, dependence severity, and comorbid conditions.
  • Monitor for respiratory depression: especially during induction and dose adjustments.
  • Avoid use in severe hepatic impairment: consider alternative therapy or dose modification.
  • Caution with concomitant CNS depressants: increased risk of sedation and respiratory effects.
  • Pregnancy and breastfeeding: weigh benefits against potential risks; consult specialist.
  • Store at ambient temperature: keep below 25°C in the original packaging, protect from moisture.

Avoid Interactions

Libroxar may interact with several drug classes that affect opioid pathways or central nervous system function.

Major Interactions (Avoid)

  • Full opioid agonists (e.g., morphine, heroin): risk of precipitated withdrawal.
  • Benzodiazepines: additive CNS depression and respiratory risk.
  • Alcohol: increased sedation and respiratory depression.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inhibitors (e.g., ketoconazole): may raise buprenorphine levels.
  • CYP3A4 inducers (e.g., rifampin): may reduce therapeutic effect.
  • Antidepressants (e.g., SSRIs, SNRIs): monitor for serotonin syndrome.

Frequently Asked Questions

Libroxar is prescribed for the treatment of opioid dependence and opioid use disorder. It helps reduce withdrawal symptoms, cravings, and the risk of relapse by providing a controlled, partial activation of opioid receptors while deterring misuse through its naloxone component.

Buprenorphine acts as a partial agonist at the μ‑opioid receptor, delivering enough activation to ease withdrawal without full opioid effects, and blocks κ‑receptors to reduce dysphoria. Naloxone is an opioid antagonist that is minimally absorbed when taken sublingually but becomes active if the product is injected, blocking the receptors and discouraging injection misuse.

The specific dose of Libroxar is determined by the prescribing clinician based on the individual’s opioid use history, severity of dependence, and response to therapy. Dosing regimens are tailored to each patient and should follow the prescriber’s instructions and local regulatory guidelines.

The safety of Libroxar in pregnancy and lactation has not been definitively established. Healthcare providers must weigh the potential benefits of treating opioid dependence against any possible risks to the fetus or infant, and decisions should be made on a case‑by‑case basis with specialist input.

To order Libroxar, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements), and necessary import documentation.

Libroxar combines buprenorphine with naloxone, offering partial opioid agonism while deterring injection misuse, a profile distinct from pure agonists like methadone. Compared with buprenorphine‑only products, the naloxone component adds an abuse‑deterrent safeguard, making Libroxar a preferred option in settings where injection misuse is a concern.

Libroxar should be stored at ambient temperature, preferably below 25 °C. Keep the tablets in their original packaging, protect them from moisture and direct sunlight, and ensure they are out of reach of children and unauthorized personnel.

Libroxar is administered sublingually. The tablet is placed under the tongue and allowed to dissolve completely without chewing or swallowing, ensuring optimal absorption of buprenorphine while minimizing naloxone uptake. Patients should follow the prescriber’s instructions regarding timing and food intake.

Serious risks include respiratory depression, especially during induction or when combined with other central nervous system depressants, severe hypotension, allergic reactions such as anaphylaxis, and rare hepatic toxicity. Patients should be monitored closely for these events, and any signs of severe side effects require immediate medical attention.

Libroxar is contraindicated in individuals with known hypersensitivity to buprenorphine, naloxone, or any formulation components, in patients receiving full opioid agonists for acute pain, and in those with severe respiratory insufficiency. Caution is also advised for patients with significant hepatic impairment or uncontrolled psychiatric conditions.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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