Each tablet contains 5 mg methadone hydrochloride.
Methadone has an analgesic potency almost equivalent to that of morphine. In addition, it also exerts sedative, hypnotic and antitussive effects. Unlike morphine, it does not cause euphoria and the onset of toxicomania is rare. Furthermore, it affects the peristalsis of the intestine less than morphine and the respiratory depression is much less pronounced than following morphine administration. Methadone also exerts a spasmolytic action on smooth and skeletal musculature.
Methadone Tablets is indicated for the management of pain severe enough to require daily, around‐the-clock, long‐term opioid treatment and for which alternative treatment options are inadequate, for example, severe pain when other drugs provide no relief, i.e. in carcinoma and other malignant diseases, in burns, infarct of myocardium, neuritis and severe neuralgia, biliary and renal colics, vesical tenesmus, post‐operative and post‐traumatic pain.
Therapy should be initiated with 2.5 mg orally given every 8‐12 hours. Dosage must be carefully individualized according to patient response.
Pregnancy (since methadone enters blood flow of the fetus and the newborn); neurosurgical interventions (because methadone potentiates edema of the brain); shock; copious bleeding. Patients should be advised not to take Methadone 4 hours prior to driving a car or during driving.
Endeavours should be made not to increase the dose above that recommended, and to administer Methadone only for a limited period (except in cases of malignant processes), as tolerance and toxicomania are likely to develop.
Accidental Exposure: Accidental consumption of even one dose of Methadone Tablet, especially by children, can result in a fatal overdose of methadone.
Risks from concomitant use with benzodiazepines or other CNS depressants: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
Reserve concomitant prescribing of Methadone Tablet and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and sedation.
Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended‐release opioid formulations, reserve Methadone Tablets for use in patients for whom alternative treatment options (e.g., non‐opioid analgesics or immediate‐release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Methadone Tablets is not indicated as an as‐needed analgesic.
FDA notified healthcare professionals of reports of death and life‐threatening adverse events such as respiratory depression and cardiac arrhythmias in patients receiving methadone. These adverse events are the possible result of unintentional methadone overdoses, drug interactions, and methadone's cardiac toxicities (QT prolongation and Torsades de Pointes). The reports underscore the importance of knowing methadone's toxicities and unique pharmacological properties, including dosing and monitoring recommendations.
N07BC02 - methadone ; Belongs to the class of drugs used in the management of opioid dependence.