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 to manage moderate to severe pain and to support treatment of opioid dependence in appropriate patients, and is marketed within the European Union.

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

Manufacturer / TM Owner

Alkaloid-Int D.O.O.

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Indications & Clinical Uses

Levomethadone Hydrochloride is used in the management of pain and opioid dependence, acting on the mu‑opioid receptor pathway.

  • Moderate to severe pain: provides analgesia for acute or chronic pain conditions where strong opioid therapy is indicated.
  • Opioid dependence treatment: assists in detoxification and maintenance therapy for individuals with opioid use disorder.
  • Post‑surgical pain: helps control pain following major surgical procedures when other analgesics are insufficient.

How It Works

  • Levomethadone Hydrochloride acts as a potent agonist at the mu‑opioid receptors in the central nervous system. By binding to these receptors, it inhibits the transmission of nociceptive signals and alters the perception of pain. The drug also modulates reward pathways, which contributes to its utility in opioid dependence treatment by reducing withdrawal symptoms and cravings.

Side Effects

Levomethadone Hydrochloride may cause a range of adverse reactions, from mild to severe, depending on individual sensitivity and dosage.

Common Side Effects

  • Nausea or vomiting
  • Constipation
  • Drowsiness or sedation
  • Dizziness or light‑headedness
  • Dry mouth
  • Sweating

Serious or Rare Side Effects

  • Respiratory depression, which can be life‑threatening
  • Severe hypotension or cardiac arrhythmias
  • Allergic reactions such as rash, itching, or anaphylaxis

Precautions & Warnings

When prescribing Lefisyo, clinicians should consider several safety measures to minimize risks.

  • Assess patient history: evaluate prior opioid use, respiratory conditions, and hepatic or renal impairment.
  • Monitor for sedation: advise patients to avoid operating machinery or driving until they know how the drug affects them.
  • Avoid abrupt discontinuation: taper the dose gradually to prevent withdrawal symptoms.
  • Use caution in the elderly: start with the lowest effective dose and monitor closely for adverse effects.
  • Store at ambient temperature: keep below 25°C in the original packaging, protected from moisture and direct sunlight.

Avoid Interactions

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

Major Interactions (Avoid)

  • Concurrent use with other central nervous system depressants (e.g., benzodiazepines, barbiturates) may cause profound respiratory depression.
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, erythromycin) can increase levomethadone plasma levels, raising toxicity risk.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampin, carbamazepine) may reduce drug concentrations, diminishing analgesic effect.
  • Serotonergic agents (e.g., SSRIs, tramadol) could increase the risk of serotonin syndrome.
  • Anticholinergic drugs may exacerbate constipation, requiring proactive bowel regimen.

Frequently Asked Questions

Lefisyo contains levomethadone hydrochloride and is indicated for the management of moderate to severe pain as well as for the treatment of opioid dependence. It is prescribed when strong opioid analgesia is required or when patients need assistance with detoxification and maintenance therapy for opioid use disorder.

Levomethadone is a mu‑opioid receptor agonist. By binding to these receptors in the brain and spinal cord, it blocks the transmission of pain signals and modifies the brain’s reward pathways, which helps relieve pain and reduces cravings and withdrawal symptoms in individuals with opioid dependence.

The dose 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. No standard dosing regimen is provided here; the prescribing clinician will set the appropriate dosage and titration schedule.

Safety data for levomethadone during pregnancy and lactation are limited. It should only be used if the potential benefit justifies the potential risk to the fetus or infant. Healthcare professionals should discuss the risks and benefits with the patient and consider alternative therapies when possible.

To place an order, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies hospitals, pharmacies and procurement teams across international markets. After the enquiry, the sales team will verify trade or institutional credentials and respond with pricing, availability, shipping details (including any cold‑chain requirements) and the necessary import documentation.

Levomethadone is the levorotatory enantiomer of methadone and generally provides similar analgesic and anti‑withdrawal effects with a potentially more favorable side‑effect profile. Both act on mu‑opioid receptors, but levomethadone may exhibit less cardiotoxicity and a more predictable pharmacokinetic profile, making it a preferred option for some clinicians.

Lefisyo should be stored at ambient temperature, preferably below 25 °C. Keep the product in its original packaging, protect it from moisture, direct sunlight and extreme heat. Do not store in the bathroom or near a kitchen sink to maintain its stability.

Lefisyo is administered orally, typically as a tablet or capsule taken with water. The exact form and dosing schedule are determined by the prescribing physician. Patients should follow the prescriber’s instructions regarding timing, food intake, and any required dose adjustments.

The most serious risks include respiratory depression, which can be life‑threatening, especially when combined with other central nervous system depressants. Severe hypotension, cardiac arrhythmias, and allergic reactions such as anaphylaxis are also possible. Patients should be monitored closely for signs of these adverse events, particularly during initiation and dose changes.

Lefisyo is contraindicated in individuals with known hypersensitivity to levomethadone or any component of the formulation, in patients with severe respiratory insufficiency, acute or severe asthma, and in those taking monoamine oxidase inhibitors (MAOIs) within 14 days. Caution is also advised for patients with significant hepatic or renal impairment, and it should be avoided in pregnant women unless clearly justified.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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