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 oral use. It is employed in the management of moderate to severe pain and in the treatment of opioid dependence in adult patients.

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

Manufacturer / TM Owner

Alkaloid-Int D.O.O.

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Indications & Clinical Uses

Levomethadone Hydrochloride acts on the mu‑opioid receptor pathway to provide analgesia and support opioid substitution therapy.

  • Pain management: reduces moderate to severe chronic pain when other analgesics are insufficient.
  • Opioid dependence treatment: facilitates withdrawal management and maintenance therapy in individuals with opioid use disorder.
  • Post‑operative analgesia: provides short‑term pain relief following surgical procedures.

How It Works

  • Levomethadone Hydrochloride binds selectively to mu‑opioid receptors in the central nervous system, acting as a full agonist. This activation inhibits nociceptive neurotransmission, producing analgesia, and also mitigates withdrawal symptoms by substituting for other opioids, thereby stabilizing receptor activity and reducing cravings.

Side Effects

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

Common Side Effects

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

Serious or Rare Side Effects

  • Respiratory depression: slowed breathing, potentially life‑threatening.
  • Cardiac arrhythmia: irregular heart rhythm, including QT prolongation.
  • Severe hypotension: marked drop in blood pressure.
  • Seizures: convulsive episodes.
  • Allergic reactions: rash, itching, swelling, or anaphylaxis.

Precautions & Warnings

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

  • Assess respiratory function: monitor for signs of respiratory depression, especially in opioid‑naïve patients.
  • Evaluate cardiac risk: obtain baseline ECG to detect QT interval prolongation.
  • Review concomitant CNS depressants: avoid or adjust doses when combined with benzodiazepines or alcohol.
  • Monitor liver function: adjust dosing in hepatic impairment.
  • Educate patients on dependence: discuss risks of tolerance and addiction.
  • Store at ambient temperature: keep below 25 °C in the original container, protect from moisture and direct sunlight.

Avoid Interactions

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

Major Interactions (Avoid)

  • Other opioids: additive respiratory depression.
  • CNS depressants (e.g., benzodiazepines, barbiturates): heightened sedation and respiratory risk.
  • QT‑prolonging agents (e.g., certain antiarrhythmics, macrolide antibiotics): increased risk of cardiac arrhythmia.

Moderate Interactions (Monitor Closely):\n- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin): may raise levomethadone plasma levels.

  • CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce drug concentration.
  • Anticholinergic drugs: may exacerbate constipation.

Frequently Asked Questions

Lefisyo contains levomethadone hydrochloride and is prescribed for the management of moderate to severe chronic pain as well as for opioid dependence treatment, helping to reduce withdrawal symptoms and support maintenance therapy in adults.

Levomethadone hydrochloride acts as a full agonist at the mu‑opioid receptors in the central nervous system. By activating these receptors, it blocks pain signals and mimics the effects of other opioids, thereby alleviating pain and reducing cravings in individuals with opioid use disorder.

The dosage of Lefisyo is individualized and must be determined by a qualified prescriber based on the patient’s clinical condition, prior opioid exposure, and response to therapy. Physicians set the appropriate dose and titration schedule.

Safety of levomethadone hydrochloride in pregnancy or while breastfeeding has not been fully established. Healthcare providers should weigh the potential benefits against possible risks to the fetus or infant and consider alternative therapies when appropriate.

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

Levomethadone hydrochloride is the levo‑isomer of methadone, offering similar analgesic potency with a potentially more favorable side‑effect profile. Compared with racemic methadone, it may require lower doses for equivalent pain relief, but clinical decisions should consider individual patient response and safety.

Lefisyo should be stored at ambient temperature, below 25 °C, in its original packaging. Keep the product away from moisture, direct sunlight, and sources of heat to maintain its stability and potency.

Lefisyo is administered orally, typically as a tablet or capsule taken with water. The exact route and timing are directed by the prescribing clinician, who may advise on whether to take the medication with or without food.

The most serious risks include respiratory depression, which can be life‑threatening, and cardiac arrhythmias such as QT interval prolongation. Patients should be monitored closely for signs of slowed breathing or irregular heart rhythms, especially when initiating therapy.

Lefisyo is contraindicated in individuals with known hypersensitivity to levomethadone or other opioids, those with severe respiratory insufficiency, uncontrolled asthma, or significant cardiac conduction abnormalities. It should also be avoided in patients taking other strong CNS depressants without careful medical supervision.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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