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

  • Moderate to severe pain: provides potent analgesia for patients requiring strong opioid relief.
  • Opioid dependence management: serves as a substitution therapy to reduce withdrawal symptoms and support maintenance treatment.

How It Works

  • Levomethadone Hydrochloride acts as a full agonist at the mu‑opioid receptors in the central nervous system. By binding to these receptors, it activates intracellular signaling pathways that inhibit nociceptive transmission, producing analgesia, and also mimics the effects of endogenous opioids, thereby reducing cravings and withdrawal in opioid‑dependent individuals.

Side Effects

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

Common Side Effects

  • Nausea: feeling of stomach upset or urge to vomit.
  • Constipation: reduced bowel movements and hard stools.
  • Dizziness: light‑headed sensation, especially when standing quickly.
  • Drowsiness: increased sleepiness or fatigue.

Serious or Rare Side Effects

  • Respiratory depression: slowed or shallow breathing that can be life‑threatening.
  • QT interval prolongation: cardiac rhythm disturbance that may lead to arrhythmia.
  • Severe hypotension: marked drop in blood pressure causing faintness or shock.

Precautions & Warnings

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

  • Assess respiratory function: monitor for signs of depression, especially after dose changes.
  • Evaluate liver function: adjust therapy if hepatic impairment is present.
  • Avoid use in acute asthma: risk of bronchospasm and worsening airway obstruction.
  • Use caution in elderly patients: increased sensitivity to opioid effects and higher fall risk.
  • Store at ambient temperature below 25°C: keep in the original pack, protect from moisture.

Avoid Interactions

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

Major Interactions (Avoid)

  • CNS depressants (e.g., benzodiazepines, alcohol): may cause profound sedation and respiratory depression.
  • Monoamine oxidase inhibitors (MAOIs): increase risk of serotonin syndrome and hypertensive crisis.
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, erythromycin): can raise levomethadone plasma levels, heightening toxicity.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce drug exposure, diminishing efficacy.
  • Other opioids: additive opioid effects can increase sedation and respiratory risk.
  • QT‑prolonging agents (e.g., certain antiarrhythmics, fluoroquinolones): may exacerbate cardiac rhythm disturbances.

Frequently Asked Questions

Lefisyo contains levomethadone hydrochloride and is prescribed to treat moderate to severe pain as well as to support opioid dependence management. It provides strong analgesic effects and helps reduce withdrawal symptoms in patients undergoing substitution therapy.

Levomethadone hydrochloride acts as a full agonist at the mu‑opioid receptors in the brain and spinal cord. Activation of these receptors blocks pain signals and produces analgesia, while also mimicking the effects of endogenous opioids to alleviate cravings and withdrawal in opioid‑dependent individuals.

The dosage of Lefisyo is individualized and determined by the prescribing clinician based on the patient’s condition, pain severity, and response to therapy. The prescriber will select the appropriate strength and dosing schedule to achieve optimal therapeutic effect while minimizing risk.

Safety data for levomethadone hydrochloride in pregnancy and lactation are limited. It should only be used if the potential benefit justifies the potential risk to the fetus or infant, and the decision must be made by a qualified healthcare professional after careful assessment.

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, and will request trade or institutional credentials before providing pricing, availability, shipping details, and any necessary import documentation.

Levomethadone is the levo‑isomer of methadone, offering similar analgesic potency but with a potentially more favorable side‑effect profile. Compared with other opioids such as morphine or oxycodone, levomethadone has a longer half‑life, which may allow less frequent dosing in chronic pain or maintenance therapy.

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

Lefisyo is administered orally, typically as a tablet or capsule taken with water. The exact route (with or without food) and dosing interval are determined by the prescribing clinician based on the individual’s therapeutic needs.

The most serious risks include respiratory depression, which can be life‑threatening, and cardiac arrhythmias due to QT interval prolongation. Patients should be monitored closely for signs of slowed breathing, severe dizziness, or abnormal heart rhythms, especially when initiating therapy or adjusting the dose.

Lefisyo is contraindicated in patients with known hypersensitivity to levomethadone or any component of the formulation, in individuals with severe respiratory insufficiency, acute asthma, or untreated severe sleep apnea, and in those 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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