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

Libroxar

Active Ingredient:
Buprenorphine, Naloxone
Origin:
EU

Libroxar (Buprenorphine, Naloxone)

Buprenorphine, the active ingredient in Libroxar, is an opioid analgesic (partial agonist/antagonist combination) presented as a sublingual tablet 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

Rafarm Sa.

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Indications & Clinical Uses

Libroxar (buprenorphine/naloxone) is used in the management of opioid dependence, targeting the opioid receptor system.

  • Opioid dependence: reduces withdrawal symptoms and cravings during maintenance therapy.
  • Opioid use disorder: supports long‑term abstinence and prevents relapse.
  • Opioid detoxification: facilitates safe transition off full‑agonist opioids under medical supervision.

How It Works

  • Buprenorphine binds with high affinity to the μ‑opioid receptor as a partial agonist, providing sufficient receptor activation to relieve withdrawal while limiting maximal opioid effect; it also antagonizes κ‑opioid receptors. Naloxone, poorly absorbed sublingually, acts as an opioid antagonist that becomes active if the product is injected, blocking opioid effects and deterring misuse.

Side Effects

Libroxar may cause a range of adverse reactions, which are generally categorized by frequency.

Common Side Effects

  • Headache: mild to moderate head pain.
  • Nausea: feeling of queasiness.
  • Constipation: reduced bowel movements.
  • Sweating: increased perspiration.
  • Dizziness: light‑headed sensation.
  • Dry mouth: reduced salivation.

Serious or Rare Side Effects

  • Respiratory depression: severe slowing of breathing.
  • Severe hypotension: marked drop in blood pressure.
  • Allergic reactions: rash, itching, swelling, or anaphylaxis.
  • Liver enzyme elevation: abnormal liver function tests.

Precautions & Warnings

Before prescribing Libroxar, clinicians should consider several safety measures.

  • Assess dependence severity: evaluate opioid use history before initiating.
  • Monitor for withdrawal: watch for signs of precipitated withdrawal especially if recent opioid use.
  • Avoid concomitant CNS depressants: limit use with benzodiazepines or alcohol.
  • Pregnancy and lactation: weigh benefits against potential risks.
  • Renal or hepatic impairment: adjust therapy as clinically indicated.
  • Store at ambient temperature: keep below 25°C in the original pack, protect from moisture.

Avoid Interactions

Libroxar can interact with other medicines; some combinations should be avoided while others require monitoring.

Major Interactions (Avoid)

  • Benzodiazepines: combined use can cause profound respiratory depression.
  • Other opioids: may precipitate withdrawal or increase toxicity.
  • CYP3A4 inhibitors (e.g., ketoconazole): raise buprenorphine levels.
  • Alcohol: additive central nervous system depression.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampin): may reduce effectiveness.
  • Antidepressants (e.g., SSRIs): monitor for serotonin syndrome.
  • Antihistamines: may increase sedation.
  • Anticonvulsants (e.g., carbamazepine): may lower plasma levels.

Frequently Asked Questions

Libroxar is indicated for the treatment of opioid dependence and opioid use disorder. It helps reduce withdrawal symptoms, cravings, and supports maintenance therapy to prevent relapse in patients who are dependent on opioids.

Buprenorphine binds tightly to the μ‑opioid receptor as a partial agonist, providing enough activation to relieve withdrawal while limiting the maximal opioid effect. It also blocks κ‑opioid receptors, which contributes to its analgesic and anti‑withdrawal properties.

The dose of Libroxar is individualized. The prescribing clinician determines the appropriate strength and frequency based on the patient’s opioid use history, clinical response, and any co‑existing conditions.

Safety data for Libroxar in pregnancy and lactation are limited. Clinicians should weigh the potential benefits against possible risks and consider alternative therapies when treating pregnant or nursing individuals.

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

Both Libroxar and methadone are used for opioid dependence, but Libroxar combines buprenorphine (a partial μ‑opioid agonist) with naloxone to deter injection misuse, whereas methadone is a full agonist. Libroxar generally has a ceiling effect on respiratory depression, offering a safety advantage in overdose risk.

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

Libroxar is administered sublingually. The tablet is placed under the tongue and allowed to dissolve completely without swallowing, ensuring optimal absorption of buprenorphine while minimizing naloxone activity.

Serious risks include respiratory depression, severe hypotension, allergic reactions such as anaphylaxis, and significant liver enzyme elevations. Patients should be monitored closely for these events, especially during treatment initiation or dose changes.

Libroxar is contraindicated in individuals with known hypersensitivity to buprenorphine, naloxone, or any formulation components, and in patients receiving opioid antagonists for acute opioid overdose. Caution is advised for those with severe respiratory compromise or uncontrolled severe asthma.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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