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 presented as an oral formulation for oral use. It is employed in the management of opioid dependence and for the relief of moderate to severe pain in appropriate patients.

GNH India supplies Lefisyo as a licensed, GDP‑compliant international pharmaceutical supplier, providing the product to hospitals, pharmacies and clinics worldwide across multiple regulatory jurisdictions. Our distribution network ensures reliable access and adherence to quality standards for healthcare providers seeking opioid dependence treatment solutions.

Manufacturer / TM Owner

Alkaloid-Int D.O.O.

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Indications & Clinical Uses

Levomethadone Hydrochloride is used in opioid dependence treatment and pain management.

  • Opioid dependence: helps reduce withdrawal symptoms and cravings during maintenance therapy.
  • Moderate to severe pain: provides analgesia for patients requiring strong opioid analgesics.
  • Opioid detoxification: assists in transitioning patients off other opioids under medical supervision.

How It Works

  • Levomethadone Hydrochloride acts as a selective mu‑opioid receptor agonist. By binding to these receptors in the central nervous system, it inhibits the release of neurotransmitters that transmit pain signals and modulates reward pathways, thereby reducing the perception of pain and diminishing cravings associated with opioid dependence.

Side Effects

Levomethadone Hydrochloride may cause a range of adverse reactions.

Common Side Effects

  • Nausea: feeling of sickness or urge to vomit.
  • Constipation: reduced bowel movements and hard stools.
  • Drowsiness: increased sleepiness or fatigue.
  • Dizziness: sensation of light‑headedness or imbalance.
  • Dry mouth: reduced salivation leading to a parched feeling.
  • Sweating: excessive perspiration unrelated to temperature.

Serious or Rare Side Effects

  • Respiratory depression: slowed or shallow breathing that can be life‑threatening.
  • QT interval prolongation: potential cardiac rhythm disturbances.
  • Severe hypotension: marked drop in blood pressure causing faintness.
  • Seizures: uncontrolled electrical activity in the brain.
  • Anaphylaxis: acute allergic reaction with airway compromise.
  • Hepatotoxicity: liver injury indicated by abnormal enzymes.

Precautions & Warnings

When prescribing or dispensing Levomethadone Hydrochloride, consider the following precautions.

  • Assess patient history: evaluate for respiratory disorders, head injury, or severe hepatic impairment.
  • Monitor for dependence: watch for signs of tolerance, misuse, or addiction.
  • Avoid concurrent CNS depressants: co‑administration with benzodiazepines or alcohol can increase sedation.
  • Caution in renal impairment: dose adjustments may be required in reduced kidney function.
  • Educate on overdose risk: inform patients about signs of respiratory depression and emergency measures.
  • Store at ambient temperature: keep in the original container, protect from moisture and heat.

Avoid Interactions

Levomethadone Hydrochloride can interact with several drug classes.

Major Interactions (Avoid)

  • Other opioids: additive risk of respiratory depression and profound sedation.
  • Benzodiazepines: combined CNS depression may be life‑threatening.
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): increase levomethadone plasma levels, heightening toxicity.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce therapeutic effect.
  • Alcohol: enhances sedative effects and impairs judgment.
  • Certain antidepressants (e.g., SSRIs, SNRIs): potential for serotonin syndrome when combined with opioids.

Frequently Asked Questions

Lefisyo contains levomethadone hydrochloride and is indicated for the treatment of opioid dependence as part of a maintenance program, as well as for the management of moderate to severe pain when a strong opioid analgesic is required.

Levomethadone hydrochloride is a mu‑opioid receptor agonist. By binding to these receptors in the brain and spinal cord, it blocks pain transmission and reduces the rewarding effects of other opioids, helping to control cravings and alleviate pain.

The dosage of Lefisyo is individualized. A qualified prescriber determines the appropriate amount based on the patient’s clinical condition, response to therapy, and any relevant safety considerations.

Safety data for levomethadone in pregnancy and lactation are limited. Use only if the potential benefit justifies the potential risk to the fetus or infant, and discuss any concerns with a healthcare professional.

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 racemic methadone, levomethadone is the levo‑enantiomer, offering similar efficacy with potentially different pharmacokinetic properties. It may provide a more predictable response in some patients, but selection depends on individual clinical factors and prescriber preference.

Lefisyo should be stored at ambient temperature, below 25 °C, in its original packaging to protect it from moisture and light. Keep the product out of reach of children and do not use if the packaging is damaged.

Lefisyo is taken orally as directed by the prescribing clinician. The tablet (or other oral form) should be swallowed whole with water and not chewed, crushed, or dissolved unless specifically instructed.

The most serious risks include respiratory depression, especially when combined with other CNS depressants, severe hypotension, QT‑interval prolongation leading to cardiac arrhythmias, and the potential for dependence or misuse. Immediate medical attention is required if any of these occur.

Lefisyo is contraindicated in patients with known hypersensitivity to levomethadone, those with severe respiratory insufficiency, uncontrolled asthma, or significant paralytic ileus. Caution is also advised for individuals with severe hepatic impairment or a history of substance misuse.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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