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 an oral tablet for oral use. It is indicated for the treatment of opioid dependence and helps manage withdrawal symptoms in adults.

GNH India supplies Libroxar as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides regulatory‑approved batches to meet global demand. Customers benefit from reliable logistics, comprehensive documentation, and responsive technical support throughout the supply chain.

Manufacturer / TM Owner

Rafarm Sa.

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Indications & Clinical Uses

Libroxar, containing buprenorphine and naloxone, is used in the management of opioid dependence and related withdrawal.

  • Opioid dependence: reduces cravings and stabilizes patients during maintenance therapy.
  • Opioid withdrawal: alleviates acute withdrawal symptoms during detoxification.
  • Opioid use disorder: supports long‑term relapse prevention as part of a comprehensive treatment program.

How It Works

  • Buprenorphine binds with high affinity to μ‑opioid receptors but activates them only partially, providing enough analgesia to suppress withdrawal while limiting respiratory depression. Naloxone has negligible oral bioavailability but acts as an antagonist if the formulation is injected, rapidly displacing opioids from μ‑receptors and precipitating withdrawal, thereby deterring intravenous misuse. The combination yields a ceiling effect for opioid effects and discourages abuse.

Side Effects

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

Common Side Effects

  • Nausea: mild to moderate upset stomach.
  • Constipation: reduced bowel movements.
  • Headache: transient cranial pain.

Serious or Rare Side Effects

  • Respiratory depression: slowed breathing that may be life‑threatening.
  • Severe hypotension: marked drop in blood pressure.
  • Allergic reactions: rash, itching, or anaphylaxis.

Precautions & Warnings

When prescribing Libroxar, clinicians should observe several safety considerations to minimize risks.

  • Assess liver function: evaluate hepatic status before initiating therapy.
  • Monitor respiratory status: watch for signs of respiratory depression, especially in opioid‑naïve patients.
  • Avoid abrupt discontinuation: taper the dose to prevent precipitated withdrawal.
  • Caution with CNS depressants: limit concurrent use of benzodiazepines or alcohol.
  • Pregnancy and lactation: weigh benefits against potential risks; use only if clearly needed.
  • Store at ambient temperature: keep below 25 °C in the original container, protected from moisture.

Avoid Interactions

Libroxar can interact with other medicines, altering its efficacy or safety profile.

Major Interactions (Avoid)

  • Benzodiazepines: combined use increases risk of severe 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.
  • CYP3A4 inducers (e.g., rifampin): may reduce buprenorphine effectiveness.

Frequently Asked Questions

Libroxar is prescribed to treat opioid dependence and to manage acute withdrawal symptoms in adults. It is part of a comprehensive opioid use disorder program that includes counseling and psychosocial support, helping patients achieve stable maintenance therapy and reduce the risk of relapse.

Buprenorphine binds tightly to μ‑opioid receptors but activates them only partially, providing enough opioid effect to relieve withdrawal while limiting the ceiling for respiratory depression. This partial agonism eases cravings and stabilizes patients without producing the full opioid high.

The dose of Libroxar is individualized. A qualified prescriber determines the appropriate strength and dosing schedule based on the patient’s clinical condition, prior opioid exposure, and response to therapy. Patients should follow the prescribing information provided by their healthcare professional.

Safety in pregnancy and lactation has not been fully established. The medication should be used only if the potential benefit justifies the potential risk to the fetus or infant. Clinicians must evaluate each case carefully and discuss alternatives when possible.

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.

Both Libroxar and methadone are used for opioid dependence, but Libroxar combines a partial agonist (buprenorphine) with an antagonist (naloxone) to reduce misuse potential, while methadone is a full agonist. Libroxar generally has a lower risk of respiratory depression and a ceiling effect, whereas methadone may require more intensive monitoring.

Libroxar should be stored at ambient temperature, preferably below 25 °C, in its original packaging to protect it from moisture and light. Keep the product out of reach of children and do not use it after the expiration date indicated on the label.

Libroxar is taken orally, usually as a tablet, under the supervision of a healthcare professional. The tablet should be swallowed whole with water and not chewed or crushed. Dosing frequency and timing are determined by the prescriber based on the individual treatment plan.

The most serious risks include respiratory depression, severe hypotension, and allergic reactions such as anaphylaxis. Patients should be monitored closely for signs of breathing difficulty, sudden drops in blood pressure, or skin manifestations, and medical attention should be sought immediately if these occur.

Libroxar is contraindicated in individuals with known hypersensitivity to buprenorphine, naloxone, or any excipients in the formulation. It should also be avoided in patients with severe respiratory compromise, acute severe asthma, or those currently using opioid antagonists for opioid overdose reversal.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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