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Methadone

(Methadone Hydrochloride Tablets, USP) 5 mg, 10 mg

 Forms: 5mg  tablets (Identified 54 162) 10mg tablets (Identified 54 549)
Manufacturer: Roxane Laboratories, Inc.

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Description About Methadone

Methadone Binds to opiate receptors in the CNS. Alters the perception of and response to painful stimuli, while producing generalized CNS depression. Therapeutic Effects: Decrease in severity of pain. Suppression of withdrawal symptoms during detoxification and maintenance from heroin and other opioids.

INDICATIONS AND USAGE

1. For the treatment of moderate to severe pain not responsive to non-narcotic analgesics.
2. For detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
3. For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with
appropriate social and medical services.

Acute Pain – Maintenance patients on a stable dose of methadone who experience physical trauma, postoperative
pain or other acute pain cannot be expected to derive analgesia from their existing dose of methadone. Such patients
should be administered analgesics, including opioids, in doses that would otherwise be indicated for nonmethadone-treated
patients with similar painful conditions. Due to the opioid tolerance induced by methadone, when
opioids are required for management of acute pain in methadone patients, somewhat higher and/or more frequent
doses will often be required than would be the case for non-tolerant patients.

CONTRAINDICATIONS

Methadone is contraindicated in patients with a known hypersensitivity to methadone hydrochloride or any other
ingredient in DOLOPHINE.
Methadone is contraindicated in any situation where opioids are contraindicated such as: patients with respiratory
depression (in the absence of resuscitative equipment or in unmonitored settings), and in patients with acute
bronchial asthma or hypercarbia.
Methadone is contraindicated in any patient who has or is suspected of having a paralytic ileus.

Methadone should be used during pregnancy only if the potential benefit justifies the potential risk to the
fetus. Pediatric Use Safety and effectiveness in pediatric patients below the age of 18 years have not been established. The major hazards of methadone are respiratory depression and, to a lesser degree, systemic hypotension.
Respiratory arrest, shock, cardiac arrest, and death have occurred.

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