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Methadone Hydrocloride Tablets USP 40 mg (Dispersible)
Methadone Hydrochloride Tablets USP 40 mg
(Dispersible)
As of January 1, 2008, manufacturers of methadone
hydrochloride tablets 40 mg (dispersible) have voluntarily
agreed to restrict distribution of this formulation to only
those facilities authorized for detoxification and maintenance
treatment of opioid addiction, and hospitals. Manufacturers will
instruct their wholesale distributors to discontinue supplying
this formulation to any facility not meeting the above criteria.
Methadone is a long-lasting opioid medication used in the
treatment of pain and narcotic addiction. The 5mg and 10 mg
formulations indicated for the treatment of pain will continue
to be available to all authorized registrants, including retail
pharmacies. The 40 mg methadone formulation is indicated for the
detoxification and maintenance treatment of opioid addiction.
The 40 mg strength is not FDA approved for use in the management
of pain. Thus, the distribution and availability of the 40 mg
formulation will be limited to
registrants in only those settings using the 40 mg formulation
for the appropriate indication.
The DEA and pharmaceutical industry agree that the reported
increase in methadone-related adverse events merits action and
further agree to a united effort to assure that methadone is
properly distributed, consistent with its approved uses.
Industry and the federal entities involved commit to monitor the
progress of this initiative.
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