Product image of Methadone Hydrochloride Alkaloid-Int (Methadone Hydrochloride) supplied by GNH India

Methadone Hydrochloride Alkaloid-Int

Active Ingredient:
Methadone Hydrochloride
Origin:
EU

Methadone Hydrochloride Alkaloid-Int (Methadone Hydrochloride)

Methadone Hydrochloride, the active ingredient in Methadone Hydrochloride Alkaloid-Int, is a synthetic opioid agonist presented as an oral formulation for oral use. It is employed in the management of opioid dependence and in the treatment of chronic pain for adult patients.
GNH India supplies Methadone Hydrochloride Alkaloid-Int 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

Methadone Hydrochloride is used within the opioid dependence and pain management pathways.

  • Opioid dependence treatment: stabilises patients and reduces cravings during maintenance therapy.
  • Chronic pain management: provides long‑acting analgesia for severe, persistent pain.
  • Opioid withdrawal management: alleviates withdrawal symptoms during detoxification programs.

How It Works

  • Methadone Hydrochloride acts as a full agonist at the μ‑opioid receptor, producing analgesia and suppressing withdrawal symptoms. It also blocks N‑methyl‑D‑aspartate (NMDA) receptors and inhibits the reuptake of serotonin and norepinephrine, contributing to its efficacy in both pain control and opioid substitution therapy.

Side Effects

Methadone Hydrochloride may cause a range of adverse reactions.

Common Side Effects

  • Constipation: reduced bowel motility leading to hard stools.
  • Nausea: feeling of queasiness, sometimes with vomiting.
  • Drowsiness: increased sleepiness or fatigue.
  • Sweating: excessive perspiration, especially at night.

Serious or Rare Side Effects

  • Respiratory depression: slowed or shallow breathing that can be life‑threatening.
  • QT interval prolongation: cardiac electrical disturbance that may cause arrhythmia.
  • Severe hypotension: marked drop in blood pressure leading to dizziness or fainting.
  • Adrenal insufficiency: inadequate cortisol production causing fatigue and weakness.

Precautions & Warnings

Before initiating therapy, clinicians should consider several safety measures.

  • Assess patient history: evaluate prior opioid use, comorbidities, and substance abuse.
  • Monitor respiratory function: watch for signs of hypoventilation, especially during dose titration.
  • Evaluate cardiac status: obtain baseline ECG to detect QT prolongation risk.
  • Avoid use in severe hepatic impairment: liver dysfunction can increase drug levels.
  • Use caution in pregnancy: weigh benefits against potential fetal risks.
  • Store at ambient temperature: keep in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Methadone Hydrochloride interacts with several medication classes that may alter its safety profile.

Major Interactions (Avoid)

  • Central nervous system depressants: combined use can cause profound sedation or respiratory depression.
  • Monoamine oxidase inhibitors (MAOIs): may precipitate serotonin syndrome.
  • QT‑prolonging drugs: increase risk of cardiac arrhythmias.

Moderate Interactions (Monitor Closely)

  • Potent CYP3A4 inhibitors (e.g., ketoconazole): can raise methadone plasma concentrations.
  • CYP3A4 inducers (e.g., rifampin): may reduce methadone effectiveness.

Frequently Asked Questions

Methadone Hydrochloride Alkaloid-Int is prescribed for opioid dependence treatment, including maintenance therapy and withdrawal management, as well as for the long‑term management of severe chronic pain in adult patients.

Methadone acts as a full agonist at the μ‑opioid receptor, providing analgesia and reducing withdrawal symptoms. It also blocks NMDA receptors and inhibits serotonin and norepinephrine reuptake, which contributes to its effectiveness in both pain control and opioid substitution.

The appropriate dose of methadone hydrochloride is determined individually by the prescribing clinician based on the patient’s clinical condition, prior opioid exposure, and response to therapy. Dosage adjustments are made according to therapeutic goals and safety monitoring.

Methadone is classified as Pregnancy Category C, indicating that risk to the fetus cannot be ruled out. It may be used when the benefits outweigh potential risks, and dosing should be closely monitored. Methadone does pass into breast milk, so breastfeeding decisions should be made in consultation with a healthcare professional.

To place an order, 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.

Methadone offers a long half‑life and strong μ‑opioid receptor activity, allowing once‑daily dosing for many patients. Compared with buprenorphine, methadone has a higher risk of respiratory depression but may provide more robust suppression of cravings for individuals with high opioid tolerance.

Methadone Hydrochloride Alkaloid-Int should be stored at ambient temperature, below 25 °C, in its original packaging. Protect the product from moisture, direct sunlight, and extreme temperature fluctuations to maintain potency.

The medication is administered orally, typically as a tablet or solution, and should be taken exactly as prescribed. Patients should swallow tablets whole with water and avoid crushing or chewing unless specifically instructed by a healthcare provider.

The most serious risks include respiratory depression, especially during dose escalation or when combined with other CNS depressants, and cardiac arrhythmias due to QT interval prolongation. Regular monitoring of respiratory function and ECG is essential to mitigate these hazards.

Methadone is contraindicated in patients with known hypersensitivity to methadone, those taking monoamine oxidase inhibitors, and individuals with severe respiratory insufficiency or uncontrolled cardiac arrhythmias. Caution is also advised for patients with significant hepatic impairment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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