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 formulation for systemic use. It is employed to manage severe chronic pain in adult patients requiring strong opioid therapy.

GNH India supplies Lefisyo as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring quality and regulatory compliance across all markets. The company provides reliable sourcing, documentation and logistics support for global healthcare providers.

Manufacturer / TM Owner

Alkaloid-Int D.O.O.

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Indications & Clinical Uses

Levomethadone Hydrochloride acts as a potent opioid analgesic and is used in the management of severe pain conditions.

  • Severe chronic pain: provides potent analgesia for patients with high pain intensity.
  • Cancer‑related pain: helps control breakthrough and persistent pain in oncology patients.
  • Opioid dependence: used in maintenance therapy to reduce withdrawal symptoms and support recovery.

How It Works

  • Levomethadone Hydrochloride binds to mu‑opioid receptors in the central nervous system, activating them to inhibit nociceptive neurotransmission. This receptor activation reduces the perception of pain, alters emotional response to pain, and can suppress withdrawal symptoms in opioid‑dependent individuals. The drug’s high affinity for the mu‑receptor contributes to its strong analgesic potency.

Side Effects

Levomethadone Hydrochloride may cause a range of adverse reactions, which vary in frequency and severity.

Common Side Effects

  • Nausea: feeling of sickness or urge to vomit.
  • Constipation: reduced bowel movements and hard stools.
  • Drowsiness: increased sleepiness or fatigue.
  • Dry mouth: reduced salivation leading to a parched feeling.

Serious or Rare Side Effects

  • Respiratory depression: slowed or shallow breathing that can be life‑threatening.
  • Hypotension: significant drop in blood pressure causing dizziness.
  • QT interval prolongation: cardiac rhythm changes that may lead to arrhythmias.
  • Severe allergic reaction: rash, swelling, or anaphylaxis requiring immediate medical attention.

Precautions & Warnings

When prescribing or dispensing Levomethadone Hydrochloride, several safety measures should be observed.

  • Assess pain level: confirm that opioid therapy is appropriate for the patient’s condition.
  • Monitor for respiratory depression: observe breathing especially after dose adjustments.
  • Evaluate for signs of dependence: use caution in patients with a history of substance abuse.
  • Avoid concurrent CNS depressants: limit use with benzodiazepines, alcohol, or other sedatives.
  • Store at ambient temperature: keep below 25°C, in the original packaging, and protect from moisture.

Avoid Interactions

Levomethadone Hydrochloride can interact with other medicines, requiring careful management.

Major Interactions (Avoid)

  • Benzodiazepines: increased risk of respiratory depression.
  • Other opioids: additive central nervous system depression.
  • CYP3A4 inhibitors (e.g., ketoconazole): may raise levomethadone plasma levels.
  • MAO inhibitors: risk of severe hypotension.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampin): may reduce levomethadone efficacy.
  • Serotonergic drugs: potential for serotonin syndrome.
  • Alcohol: enhances sedative effects and may increase respiratory risk.

Frequently Asked Questions

Lefisyo contains levomethadone hydrochloride, an opioid analgesic prescribed for the management of severe chronic pain, including cancer‑related pain, and for maintenance therapy in patients with opioid dependence. It is intended for adult patients who require strong opioid treatment under medical supervision.

Levomethadone works by binding to mu‑opioid receptors in the brain and spinal cord, activating them to inhibit the transmission of pain signals. This receptor activation also reduces the emotional response to pain and can alleviate withdrawal symptoms in individuals dependent on opioids.

The appropriate dose of Lefisyo is determined by the prescribing healthcare professional based on the patient’s pain severity, prior opioid exposure, and individual health status. Dosage may be adjusted over time to achieve adequate pain control while minimizing side effects.

Safety data for levomethadone during pregnancy and lactation are limited. Because opioids can cross the placenta and appear in breast milk, the drug should be used only if the potential benefit justifies the potential risk to the fetus or infant. Consultation with a specialist is recommended.

To order Lefisyo, 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 (including any cold‑chain requirements), and necessary import documentation.

Levomethadone is the levo‑isomer of methadone, offering similar analgesic potency with potentially fewer cardiac side effects at equivalent doses. Compared with morphine or oxycodone, levomethadone has a longer half‑life, which may allow less frequent dosing but requires careful monitoring for accumulation and QT‑interval prolongation.

Lefisyo should be stored at ambient temperature, preferably below 25 °C. Keep the product in its original packaging, protect it from moisture and direct sunlight, and ensure it is out of reach of children and unauthorized personnel.

Lefisyo is administered orally, typically as a tablet or capsule taken with water. The exact route (e.g., with or without food) should follow the prescribing clinician’s instructions to optimize absorption and reduce gastrointestinal side effects.

The most serious risks include respiratory depression, which can be life‑threatening, especially when combined with other CNS depressants; severe hypotension; QT‑interval prolongation leading to cardiac arrhythmias; and the potential for dependence or abuse. Patients should be monitored closely, particularly during dose initiation and adjustments.

Lefisyo should not be used by individuals with known hypersensitivity to levomethadone or any component of the formulation, patients with severe respiratory insufficiency, uncontrolled asthma, or significant obstructive sleep apnea. It is also contraindicated in patients taking monoamine oxidase inhibitors within 14 days of starting therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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