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Basic Drug Info
Drug Name:Methadone Hydrochloride
Manufacturer:Roxane
Other Info:Active Ingredient: methadone hydrochloride, USPInactive Ingredients: alcohol (8%), benzoic acid, citric acid, FD&C Red #40, FD&C Yellow #6, flavoring (lemon), glycerin, sorbitol, and water.4056301//02Revised February 2007© RLI, 2007



Clinical Trials:


Indications and Usage

For the treatment of moderate to severe pain not responsive to non-narcotic analgesics.

For detoxification treatment of opioid addiction (heroin or other morphine-like drugs).For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.NOTEOutpatient maintenance and outpatient detoxification treatment may be provided only by Opioid Treatment Programs (OTPs) certified by the Federal Substance Abuse and Mental Health Services Administration (SAMHSA) and registered by the Drug Enforcement Administration (DEA).

This does not preclude the maintenance treatment of a patient with concurrent opioid addiction who is hospitalized for conditions other than opioid addiction and who requires temporary maintenance during the critical period of his/her stay, or of a patient whose enrollment has been verified in a program which has been certified for maintenance treatment with methadone.
Contraindications
Methadone is contraindicated in patients with a known hypersensitivity to methadone hydrochloride or any other ingredient in Methadone Hydrochloride Oral Solution.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.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

LUNG FUNCTION DECREASED --

Asthma -- A form of bronchial disorder with three distinct components: airway hyper-responsiveness (RESPIRATORY HYPERSENSITIVITY), airway INFLAMMATION, and intermittent AIRWAY OBSTRUCTION. It is characterized by spasmodic contraction of airway smooth muscle, WHEEZING, and dyspnea (DYSPNEA, PAROXYSMAL).

Hypercapnia -- A clinical manifestation of abnormal increase in the amount of carbon dioxide in arterial blood.

Paralytic Ileus --

Warnings

Respiratory depression is the chief hazard associated with methadone hydrochloride administration.

Methadone’s peak respiratory depressant effects typically occur later, and persist longer than its peak analgesic effects, particularly during the initial dosing period.

These characteristics can contribute to cases of iatrogenic overdose, particularly during treatment initiation or dose titration.Patients tolerant to other opioids may be incompletely tolerant to methadone.

Incomplete cross-tolerance is of particular concern for patients tolerant to other mu-opioid agonists who are being converted to treatment with methadone, thus making determination of dosing during opioid treatment conversion complex.

Deaths have been reported during conversion from chronic, high-dose treatment with other opioid agonists.

Therefore, it is critical to understand the pharmacokinetics of methadone when converting patients from other opioids (see DOSAGE AND ADMINISTRATION, Table 1, for appropriate conversion schedules).

A high degree of “opioid tolerance” does not eliminate the possibility of methadone overdose, iatrogenic or otherwise.Respiratory depression is of particular concern in elderly or debilitated patients as well as in those suffering from conditions accompanied by hypoxia or hypercapnia when even moderate therapeutic doses may dangerously decrease pulmonary ventilation.Methadone should be administered with extreme caution to patients with conditions accompanied by hypoxia, hypercapnia, or decreased respiratory reserve such as: asthma, chronic obstructive pulmonary disease or cor pulmonale, severe obesity, sleep apnea syndrome, myxedema, kyphoscoliosis, and CNS depression or coma.

In these patients, even usual therapeutic doses of methadone may decrease respiratory drive while simultaneously increasing airway resistance to the point of apnea.

Alternative, non-opioid analgesics should be considered, and methadone should be used at the lowest effective dose and only under careful medical supervision.
Branded Drugs
The following US Branded drugs contain Methadone Hydrochloride


METHADONE HYDROCHLORIDE INTENSOL -- ROXANE LABORATORIES INC

METHADOSE -- MALLINCKRODT CHEMICAL INC

DOLOPHINE HYDROCHLORIDE -- XANODYNE PHARMACEUTICS INC

DOLOPHINE HYDROCHLORIDE -- ROXANE LABORATORIES INC

WESTADONE -- SANDOZ INC


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