Product image of Lefisyo (Levomethadone Hydrochloride) supplied by GNH India

Lefisyo

Active Ingredient:
Levomethadone Hydrochloride
Origin:
EU

Lefisyo (Levomethadone Hydrochloride)

Levomethadone Hydrochloride, the active ingredient in Lefisyo, is an opioid analgesic presented as an oral tablet for oral use. It is indicated for the treatment of opioid dependence and severe chronic pain in appropriate patients.

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

Manufacturer / TM Owner

Inn-Farm D.O.O.

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Indications & Clinical Uses

Levomethadone Hydrochloride acts on the opioid system to manage dependence and pain.

  • Opioid dependence: reduces withdrawal symptoms and cravings in individuals undergoing detoxification.
  • Severe chronic pain: provides long‑acting analgesia for patients with persistent, high‑intensity pain.
  • Opioid substitution therapy: serves as a maintenance option for patients requiring stable opioid receptor activation.

How It Works

  • Levomethadone Hydrochloride is a potent mu‑opioid receptor agonist that produces analgesia and suppresses opioid withdrawal by activating central opioid pathways. It also antagonizes NMDA receptors, which may reduce opioid tolerance and modulate pain signaling. The combined actions result in effective pain control and stabilization of opioid dependence.

Side Effects

Levomethadone Hydrochloride may cause a range of adverse reactions.

Common Side Effects

  • Nausea: mild to moderate upset stomach.
  • Constipation: reduced bowel motility.
  • Drowsiness: increased sleepiness.
  • Dry mouth: reduced salivation.
  • Sweating: excessive perspiration.
  • Dizziness: light‑headed sensation.

Serious or Rare Side Effects

  • Respiratory depression: slowed breathing, potentially life‑threatening.
  • QT interval prolongation: cardiac rhythm disturbance.
  • Severe hypotension: marked drop in blood pressure.
  • Seizures: convulsive episodes.
  • Allergic reactions: rash, angioedema, or anaphylaxis.
  • Adrenal insufficiency: impaired stress response.

Precautions & Warnings

When prescribing Levomethadone Hydrochloride, clinicians should consider several safety measures.

  • Assess opioid tolerance: confirm patient’s prior exposure before initiating therapy.
  • Monitor respiratory function: especially during dose titration or in patients with pulmonary disease.
  • Evaluate cardiac risk: baseline ECG recommended due to QT prolongation potential.
  • Screen for hepatic impairment: adjust dosing if liver function is compromised.
  • Avoid abrupt discontinuation: taper gradually to prevent withdrawal.
  • Store at ambient temperature below 25°C: keep in the original pack, protect from moisture and light.

Avoid Interactions

Levomethadone Hydrochloride can interact with various medications, requiring careful management.

Major Interactions (Avoid)

  • Concomitant CNS depressants: additive respiratory depression risk.
  • Monoamine oxidase inhibitors (MAOIs): may cause hypertensive crisis.
  • Other strong opioids: increase overdose potential.

Moderate Interactions (Monitor Closely)

  • Benzodiazepines: enhanced sedation, monitor respiratory status.
  • Selective serotonin reuptake inhibitors (SSRIs): potential for serotonin syndrome.
  • CYP3A4 inhibitors/inducers: may alter levomethadone plasma levels, requiring dose adjustment.

Frequently Asked Questions

Lefisyo contains levomethadone hydrochloride and is used to manage opioid dependence and to provide analgesia for severe chronic pain. It helps reduce withdrawal symptoms in patients undergoing detoxification and offers long‑acting pain relief for those with persistent high‑intensity pain.

Levomethadone works by strongly activating mu‑opioid receptors, which produces analgesia and suppresses opioid cravings. It also blocks NMDA receptors, a mechanism that may limit the development of tolerance and modulate pain pathways, resulting in effective pain control and stabilization of opioid dependence.

The appropriate dose of Lefisyo is determined by the prescribing clinician based on the individual’s medical condition, opioid tolerance, and treatment goals. Patients should follow the dosage instructions provided by their healthcare professional and not adjust the dose on their own.

Safety data for levomethadone during pregnancy and lactation are limited. It should only be used if the potential benefit to the mother outweighs any possible risk to the fetus or infant. Healthcare providers must evaluate each case individually and discuss potential risks with the patient.

To order Lefisyo, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams worldwide. After submission, the sales team will verify trade or institutional credentials, then provide pricing, availability, shipping details, and any necessary import documentation.

Levomethadone is the levo‑enantiomer of methadone, offering similar opioid receptor activity with potentially reduced side‑effect burden. Both are used for opioid dependence and chronic pain, but levomethadone may provide a more predictable pharmacokinetic profile and lower risk of certain adverse cardiac effects compared with racemic methadone.

Lefisyo should be stored at ambient temperature below 25 °C. Keep the product in its original packaging, protect it from moisture and direct light, and ensure the container is tightly closed when not in use to maintain stability.

Lefisyo is administered orally, typically as a tablet taken with water. The exact dosing schedule and whether it should be taken with food are determined by the prescribing clinician based on the patient’s therapeutic needs.

The most serious risks include respiratory depression, which can be life‑threatening, and cardiac arrhythmias such as QT interval prolongation. Other severe concerns are severe hypotension, seizures, and allergic reactions like anaphylaxis. Patients should be monitored closely, especially during initiation and dose changes.

Lefisyo should be avoided in individuals with known hypersensitivity to levomethadone or any component of the formulation, those with severe respiratory insufficiency, uncontrolled cardiac arrhythmias, or significant hepatic impairment. It is also contraindicated in patients concurrently using monoamine oxidase inhibitors.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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