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 agonist presented as an oral dosage form for oral use. It is used in the treatment of opioid dependence and chronic pain in adult patients, including those requiring opioid substitution therapy and individuals with severe, refractory pain where other treatments are insufficient.

GNH India supplies Lefisyo as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to EU GMP standards and provides full regulatory documentation, ensuring reliable sourcing for health‑care providers across multiple continents.

Manufacturer / TM Owner

Alkaloid-Int D.O.O.

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Indications & Clinical Uses

  • Levomethadone Hydrochloride is used in opioid dependence management and chronic pain control.
  • Opioid dependence: reduces withdrawal symptoms, cravings, and stabilizes opioid tolerance during maintenance therapy.
  • Chronic pain: provides long‑acting analgesia for severe pain conditions unresponsive to non‑opioid agents.
  • Opioid substitution therapy: facilitates safe transition from heroin or other opioids to a regulated medication under medical supervision.
  • Post‑operative pain: offers effective analgesia for patients after major surgery.
  • Cancer pain: can be used as part of multimodal pain management in advanced malignancy.

How It Works

  • Levomethadone Hydrochloride acts as a full agonist at the μ‑opioid receptors, producing analgesia and suppressing opioid withdrawal by activating the same pathways as endogenous endorphins. In addition, it antagonizes N‑methyl‑D‑aspartate (NMDA) receptors, which may reduce opioid tolerance and hyperalgesia. The combined μ‑opioid activation and NMDA antagonism underlie its efficacy in opioid dependence treatment and chronic pain management, and contributes to overall opioid‑sparing effects.

Side Effects

Levomethadone Hydrochloride may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects

  • Nausea
  • Constipation
  • Dizziness
  • Drowsiness
  • Sweating

Serious or Rare Side Effects

  • Respiratory depression
  • QT interval prolongation
  • Severe hypotension
  • Dependence or addiction potential

Precautions & Warnings

  • When prescribing Lefisyo, clinicians should consider several safety measures.
  • Assess patient history: evaluate prior opioid use and tolerance.
  • Monitor respiratory function: watch for depression especially during initiation.
  • Avoid concurrent CNS depressants: limit use with benzodiazepines or alcohol.
  • Adjust dose in renal/hepatic impairment: consider reduced dosing.
  • Educate patient on signs of overdose: instruct to seek immediate help if breathing slows.
  • Store at ambient temperature below 25°C: keep in original container, protect from moisture and light.

Avoid Interactions

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

Major Interactions (Avoid)

  • Concomitant use with other full opioid agonists: risk of additive respiratory depression.
  • Benzodiazepines or barbiturates: increased CNS depression.
  • Monoamine oxidase inhibitors (MAOIs): potential for severe hypotension.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inhibitors (e.g., ketoconazole): may increase levomethadone levels.
  • CYP3A4 inducers (e.g., rifampin): may reduce efficacy.
  • Serotonergic agents: risk of serotonin syndrome.

Frequently Asked Questions

Lefisyo contains levomethadone hydrochloride and is prescribed for the management of opioid dependence and for the treatment of moderate to severe chronic pain in adult patients. It is used as part of opioid substitution programs and may also be employed when other analgesics are insufficient.

Levomethadone Hydrochloride works by fully activating μ‑opioid receptors, which produces analgesia and reduces cravings in opioid‑dependent individuals. It also blocks NMDA receptors, a mechanism that can lessen the development of opioid tolerance and may improve pain control.

The specific dose of Lefisyo is determined by the prescribing clinician based on the patient’s medical condition, prior opioid exposure, and response to therapy. Dosing regimens are individualized and should follow local prescribing guidelines and the prescriber’s judgment.

Safety data for levomethadone hydrochloride in pregnancy and lactation are limited. Healthcare providers should weigh potential benefits against possible risks and discuss any concerns with the patient. Use during pregnancy or while breastfeeding should only occur under direct medical supervision.

To request 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, and any necessary import documentation.

Compared with methadone, levomethadone is the levorotatory isomer and may have a slightly different side‑effect profile, while still providing full μ‑opioid agonism. Unlike buprenorphine, it is a full agonist rather than a partial agonist, which can result in stronger analgesia but also a higher risk of respiratory depression if not carefully monitored.

Lefisyo should be stored at ambient temperature below 25 °C, in its original packaging, protected from moisture, light, and excessive heat. Keep the product out of reach of children and do not use it after the expiration date.

Lefisyo is taken orally as directed by a qualified prescriber. The tablet (or other oral dosage form) is swallowed whole with water, and dosing intervals are determined by the treating clinician based on the individual’s therapeutic needs.

The most serious risks include respiratory depression, especially when therapy is initiated or when combined with other CNS depressants, QT‑interval prolongation that can lead to cardiac arrhythmias, severe hypotension, and the potential for physical dependence or addiction if misused.

Lefisyo is contraindicated in patients with known hypersensitivity to levomethadone or any component of the formulation, in individuals with severe respiratory insufficiency, uncontrolled asthma, or acute narrow‑angle glaucoma, and in patients currently taking monoamine oxidase inhibitors without an appropriate wash‑out period.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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