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

Metadonijev Klorid Alkaloid-Int

Active Ingredient:
Methadone Hydrochloride
Origin:
EU

Metadonijev Klorid Alkaloid-Int (Methadone Hydrochloride)

Methadone Hydrochloride, the active ingredient in Metadonijev Klorid Alkaloid-Int, is an opioid analgesic presented as an oral formulation for systemic use. It is employed in the treatment of opioid dependence and for management of severe chronic pain in adult patients.

GNH India supplies Metadonijev Klorid Alkaloid-Int as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides regulatory‑compliant documentation for import and distribution across multiple regions, and ensures timely delivery.

Manufacturer / TM Owner

Alkaloid-Int D.O.O.

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Indications & Clinical Uses

Methadone Hydrochloride is used in opioid‑related pathways for dependence management and long‑term pain control.

  • Opioid dependence (maintenance therapy): stabilizes opioid receptors, reduces cravings and withdrawal symptoms in individuals undergoing maintenance treatment.
  • Opioid dependence (detoxification): facilitates gradual tapering of opioid use during supervised detox programs.
  • Severe chronic pain: provides long‑acting analgesia for patients with persistent pain unresponsive to other opioids.

How It Works

  • Methadone Hydrochloride acts as a full agonist at the µ‑opioid receptor, producing analgesia and suppressing withdrawal by activating the same receptors targeted by endogenous opioids. In addition, it antagonizes N‑methyl‑D‑aspartate (NMDA) receptors and inhibits the reuptake of serotonin and norepinephrine, contributing to its efficacy in chronic pain and reducing tolerance development. These combined actions result in a prolonged half‑life that supports once‑daily dosing in maintenance regimens.

Side Effects

Methadone Hydrochloride may be associated with a range of adverse reactions, varying in frequency and severity.

Common Side Effects

  • Nausea: mild to moderate stomach upset often occurring at treatment initiation.
  • Constipation: reduced bowel movements that may require dietary or pharmacologic management.
  • Dizziness: transient light‑headedness, especially when standing quickly.
  • Sweating: increased perspiration, commonly observed during dose adjustments.

Serious or Rare Side Effects

  • Respiratory depression: slowed breathing that can be life‑threatening, particularly with overdose or concurrent depressants.
  • QT interval prolongation: cardiac electrical changes that may predispose to arrhythmias.
  • Anaphylaxis: severe allergic reaction with hives, swelling, and airway compromise.

Precautions & Warnings

When prescribing Methadone Hydrochloride, clinicians should observe several safety considerations.

  • Assess patient history: evaluate prior opioid use, respiratory disorders, and cardiac conditions before initiation.
  • Initiate low dose: start with the lowest effective dose and titrate slowly to minimize overdose risk.
  • Monitor cardiac function: obtain baseline ECG and repeat if dose exceeds 100 mg/day or if risk factors exist.
  • Avoid concurrent CNS depressants: limit use of benzodiazepines, alcohol, or other opioids to reduce respiratory depression.
  • Educate patients: inform about signs of overdose, proper storage, and the importance of adherence.
  • Store at ambient temperature: keep tablets in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Methadone Hydrochloride can interact with several medications, altering its plasma levels or enhancing adverse effects.

Major Interactions (Avoid)

  • CYP3A4 inhibitors (e.g., ketoconazole, erythromycin): may increase methadone concentrations, raising overdose risk.
  • CNS depressants (e.g., benzodiazepines, barbiturates): combined use can cause profound respiratory depression.
  • QT‑prolonging drugs (e.g., haloperidol, sotalol): additive effect on cardiac repolarization leading to arrhythmias.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce methadone levels, risking withdrawal.
  • Antidepressants (e.g., SSRIs, SNRIs): can affect methadone metabolism and serotonin levels.
  • Herbal supplements (e.g., St. John’s wort): may lower drug exposure and diminish therapeutic effect.

Frequently Asked Questions

Metadonijev Klorid Alkaloid-Int contains methadone hydrochloride and is prescribed for opioid dependence treatment, including maintenance and detoxification programs, as well as for the management of severe chronic pain when other analgesics are insufficient.

Methadone hydrochloride acts as a full agonist at the µ‑opioid receptor, providing analgesia and suppressing opioid withdrawal. It also blocks NMDA receptors and inhibits serotonin and norepinephrine reuptake, which contributes to its effectiveness in chronic pain and reduces the development of tolerance.

The appropriate dose of methadone hydrochloride is determined individually by a qualified prescriber based on the patient’s clinical condition, prior opioid exposure, and response to therapy. Dosing should always follow the prescriber’s instructions and local regulatory guidelines.

Methadone is classified as Pregnancy Category C, indicating that risk cannot be ruled out. It may be used during pregnancy when the benefits outweigh potential risks, but careful monitoring is required. Methadone does pass into breast milk, so clinicians should evaluate the risk‑benefit ratio for breastfeeding mothers.

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‑acting oral option that provides stable plasma levels, reducing cravings and withdrawal more consistently than short‑acting opioids such as buprenorphine. However, it requires careful dosing and monitoring due to its potential for respiratory depression and cardiac effects, whereas some alternatives have a more favorable safety profile but may be less potent.

Store the product at ambient temperature, preferably below 25 °C. Keep the tablets in the original packaging, protect them from moisture, heat, and direct sunlight to maintain potency and stability throughout its shelf life.

Metadonijev Klorid is taken orally, usually as a tablet, under the guidance of a healthcare professional. The exact administration schedule—such as once daily or divided doses—depends on the individual treatment plan prescribed by the clinician.

The most critical risks include respiratory depression, especially when combined with other central nervous system depressants, and cardiac arrhythmias due to QT interval prolongation. Patients should be monitored closely for signs of overdose, breathing difficulties, and heart rhythm changes.

Methadone is contraindicated in individuals with known hypersensitivity to methadone, severe respiratory insufficiency, uncontrolled cardiac arrhythmias, or those taking medications that strongly inhibit CYP3A4 without appropriate monitoring. Pregnant or breastfeeding patients should use it only when clearly indicated and under specialist supervision.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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