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 a partial opioid agonist / opioid antagonist combination presented as a sublingual tablet for sublingual use. It is indicated for the treatment of opioid dependence and helps manage withdrawal symptoms in adults, reducing cravings and supporting recovery.

GNH India supplies Libroxar as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, providing reliable sourcing for opioid dependence treatment programs. Our distribution network adheres to EU quality standards and ensures timely delivery across regions.

Manufacturer / TM Owner

Laboratoires Smb S.A.

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Indications & Clinical Uses

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

  • Opioid dependence: reduces cravings and stabilises patients during recovery.
  • Opioid withdrawal: alleviates withdrawal symptoms and facilitates transition to maintenance therapy.
  • Maintenance therapy for opioid use disorder: supports long‑term abstinence and reduces relapse risk.

How It Works

  • Buprenorphine binds with high affinity to μ‑opioid receptors as a partial agonist, providing modest analgesic and anti‑craving effects while limiting respiratory depression. It also antagonises κ‑opioid receptors. Naloxone, poorly absorbed sublingually, acts as an opioid antagonist if the formulation is injected, rapidly blocking μ‑receptors and deterring misuse.

Side Effects

Libroxar may cause a range of adverse reactions. Patients should be monitored for any new or worsening symptoms.

Common Side Effects

  • Nausea: mild to moderate upset stomach.
  • Constipation: reduced bowel movements.
  • Headache: transient cranial discomfort.
  • Dizziness: sensation of light‑headedness.
  • Sweating: increased perspiration.
  • Insomnia: difficulty falling or staying asleep.

Serious or Rare Side Effects

  • Respiratory depression: slowed breathing requiring medical attention.
  • Severe hypotension: marked drop in blood pressure.
  • Hepatic dysfunction: abnormal liver enzymes or jaundice.
  • Allergic reaction: rash, itching, swelling, or anaphylaxis.
  • QT interval prolongation: potential cardiac rhythm disturbance.

Precautions & Warnings

Before initiating Libroxar, clinicians should consider several safety measures.

  • Assess patient history: evaluate prior opioid use, dependence severity, and comorbid conditions.
  • Monitor respiratory status: watch for signs of respiratory depression, especially during induction.
  • Avoid in acute severe asthma: risk of bronchospasm may be heightened.
  • Use caution in hepatic impairment: dose adjustments may be required.
  • Educate on sublingual administration: ensure tablet is placed under the tongue and not swallowed.
  • Store at below 25°C: keep in the original pack, protect from moisture.

Avoid Interactions

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

Major Interactions (Avoid)

  • Benzodiazepines: increased risk of profound sedation and respiratory depression.
  • Other opioids: additive opioid effects may lead to overdose.
  • Alcohol: potentiates central nervous system depression.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inhibitors (e.g., ketoconazole): may raise buprenorphine levels.
  • Antidepressants (SSRIs, SNRIs): can enhance serotonergic activity.
  • Antihypertensives (e.g., clonidine): may cause additive hypotensive effects.

Frequently Asked Questions

Libroxar is prescribed to treat opioid dependence and to manage opioid withdrawal symptoms. It helps reduce cravings, stabilises patients during detoxification, and can be used as part of a maintenance programme for opioid use disorder.

Buprenorphine acts as a partial agonist at the μ‑opioid receptor, delivering enough activation to lessen cravings and withdrawal while limiting the risk of respiratory depression. It also blocks κ‑opioid receptors, contributing to its anti‑craving profile.

The appropriate dose of Libroxar is determined by the prescribing clinician based on the individual’s opioid use history, current condition, and treatment goals. Dosage may be adjusted during induction and maintenance phases.

Safety data for Libroxar in pregnancy and lactation are limited. It should only be used if the potential benefit justifies the potential risk to the fetus or infant, and the decision must be made by a qualified healthcare professional.

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 and any necessary import documentation.

Libroxar combines buprenorphine with naloxone, offering a lower abuse potential compared with pure buprenorphine formulations. The naloxone component deters injection misuse, while the partial agonist activity of buprenorphine provides effective craving control similar to methadone but with a more favourable safety profile.

Libroxar tablets should be stored at temperatures below 25 °C, in their original packaging, and protected from moisture and direct sunlight. Keep out of reach of children and do not use after the expiry date.

Libroxar is taken as a sublingual tablet. The tablet should be placed under the tongue and allowed to dissolve completely without swallowing. Patients should avoid eating or drinking for at least 30 minutes after administration to ensure proper absorption.

The most serious risks include respiratory depression, severe hypotension, hepatic dysfunction, allergic reactions such as anaphylaxis, and cardiac arrhythmias like QT prolongation. Immediate medical attention is required if any of these symptoms occur.

Libroxar is contraindicated in individuals with known hypersensitivity to buprenorphine, naloxone, or any tablet components, and in patients with severe respiratory compromise, acute severe asthma, or uncontrolled severe hepatic impairment. Clinicians should evaluate each patient’s medical history before prescribing.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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