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 formulation for sublingual use. It treats opioid dependence and opioid use disorder in adults.

GNH India supplies Libroxar as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Heaton K.S.

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Indications & Clinical Uses

Libroxar is used in the management of opioid dependence and related disorders, acting on the opioid receptor system to reduce withdrawal and cravings.

  • Opioid dependence: helps maintain abstinence by reducing withdrawal symptoms and cravings.
  • Opioid use disorder: supports long‑term recovery and stabilisation in patients with opioid misuse.
  • Relapse prevention: lowers the risk of relapse by providing a controlled opioid effect while blocking full agonist activity.

How It Works

  • Buprenorphine binds with high affinity to the μ‑opioid receptor as a partial agonist, providing modest analgesia and attenuating withdrawal, while antagonising κ‑opioid receptors. Naloxone has poor sublingual absorption but acts as an opioid antagonist if the product is injected, blocking the effects of full agonists and deterring misuse.

Side Effects

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Constipation: reduced bowel movements.
  • Headache: transient cranial pain.
  • Sweating: increased perspiration, especially at night.
  • Insomnia: difficulty falling or staying asleep.
  • Dry mouth: reduced salivation.

Serious or Rare Side Effects

  • Respiratory depression: slowed breathing, potentially life‑threatening.
  • Severe hypotension: marked drop in blood pressure.
  • Hepatic injury: abnormal liver function tests.
  • QT interval prolongation: cardiac rhythm disturbance.
  • Anaphylaxis: severe allergic reaction with rash, swelling, or airway compromise.
  • Overdose: signs include extreme sedation, pinpoint pupils, and respiratory failure.

Precautions & Warnings

Libroxar should be prescribed after a thorough clinical assessment and patients should be monitored for safety.

  • Assess patient history: review prior opioid use, liver function, and psychiatric conditions.
  • Monitor respiratory status: watch for signs of depression, especially during initiation.
  • Avoid use in acute severe asthma: risk of bronchospasm.
  • Use caution with CNS depressants: combine only under close supervision.
  • Educate on sublingual administration: ensure tablet is placed under the tongue until fully dissolved.
  • Store at ambient temperature: keep in the original pack, protect from moisture.

Avoid Interactions

Libroxar can interact with several drug classes; some combinations should be avoided while others require close monitoring.

Major Interactions (Avoid)

  • Opioid analgesics: additive respiratory depression risk.
  • Benzodiazepines: heightened sedation and respiratory compromise.
  • Alcohol: increased central nervous system depression.
  • MAO inhibitors: potential for severe hypertension or serotonin syndrome.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inhibitors (e.g., ketoconazole): may raise buprenorphine levels.
  • CYP3A4 inducers (e.g., rifampicin): may reduce efficacy.
  • Other CNS depressants (e.g., antihistamines): monitor for enhanced sedation.

Frequently Asked Questions

Libroxar is indicated for the treatment of opioid dependence and opioid use disorder. It helps reduce withdrawal symptoms, cravings, and supports long‑term abstinence by providing a controlled opioid effect while blocking the actions of full opioid agonists.

Buprenorphine acts as a partial agonist at the μ‑opioid receptor, delivering modest analgesia and mitigating withdrawal, while antagonising κ‑opioid receptors. Naloxone is poorly absorbed sublingually but becomes active if injected, blocking opioid receptors and discouraging misuse.

The appropriate dose of Libroxar is determined by the prescribing clinician based on the individual’s clinical condition, prior opioid exposure, and response to therapy. Dosage adjustments are made according to treatment guidelines and patient monitoring.

Safety data for Libroxar in pregnancy and lactation are limited. Clinicians should weigh potential benefits against risks and consider alternative therapies. If used, close monitoring of the mother and infant is recommended.

To order Libroxar, submit an enquiry on the product page at gnhindia.com with 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 and any necessary import documentation.

Libroxar combines buprenorphine and naloxone, offering partial agonist activity with an abuse‑deterrent component. Compared with buprenorphine‑only formulations, the naloxone addition reduces the potential for intravenous misuse, while providing similar efficacy in withdrawal management.

Libroxar should be stored at ambient temperature, below 25 °C, in its original packaging. Keep the product away from moisture and direct sunlight to maintain stability.

Libroxar is administered sublingually. The tablet or film is placed under the tongue and allowed to dissolve completely without chewing or swallowing until the full dose is absorbed.

Serious risks include respiratory depression, severe hypotension, hepatic injury, QT‑interval prolongation, and rare allergic reactions such as anaphylaxis. Patients should be monitored closely, especially during treatment initiation and dose changes.

Libroxar is contraindicated in individuals with known hypersensitivity to buprenorphine, naloxone, or any excipients, and in patients with severe respiratory compromise, acute severe asthma, or uncontrolled severe hepatic impairment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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