METHADONE HYDROCHLORIDE- methadone hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METHADONE HYDROCHLORIDE (UNII: 229809935B) (METHADONE - UNII:UC6VBE7V1Z)

Available from:

McKesson Corporation

INN (International Name):

METHADONE HYDROCHLORIDE

Composition:

METHADONE HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Methadone hydrochloride tablets, USP are 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. 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 long-acting opioids [see Warnings and Precautions (5.1)], reserve methadone hydrochloride tablets for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or immediate-release opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Methadone hydrochloride tablets are not indicated as an as-needed (prn) analgesic. - 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 long-acting opioids [see Wa

Product summary:

Product: 63739-006 NDC: 63739-006-10 10 TABLET in a BLISTER PACK / 10 in a BOX, UNIT-DOSE

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

McKesson Corporation
----------
MEDICATION GUIDE
Methadone Hydrochloride Tablets, CII
(METH a done hy.dro.chlo.ride)
Methadone hydrochloride tablets are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage pain severe
enough to require daily around-the-clock, long-term treatment with an
opioid, when other pain treatments
such as non-opioid pain medicines or immediate-release opioid
medicines do not treat your pain well
enough or you cannot tolerate them.
•
A long-acting opioid pain medicine that can put you at risk for
overdose and death. Even if you take your
dose correctly as prescribed you are at risk for opioid addiction,
abuse, and misuse than can lead to death.
•
Not for use to treat pain that is not around-the-clock.
•
Also used to manage drug addiction.
Important information about methadone hydrochloride tablets:
•
Get emergency help right away if you take too much methadone
hydrochloride tablets (overdose). When
you first start taking methadone hydrochloride tablets, when your dose
is changed, or if you take too much
(overdose), serious or life-threatening breathing problems that can
lead to death may occur.
•
Taking methadone hydrochloride tablets with other opioid medicines,
benzodiazepines, alcohol, or other
central nervous system depressants (including street drugs) can cause
severe drowsiness, decreased
awareness, breathing problems, coma, and death.
•
Never give anyone your methadone hydrochloride tablets. They could die
from taking it. Store methadone
hydrochloride tablets away from children and in a safe place to
prevent stealing or abuse. Selling or giving
away methadone hydrochloride tablets is against the law.
Do not take methadone hydrochloride tablets if you have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel blockage or have narrowing of the stomach or intestines.
•
head injury, seizures
•
liver, kidney, thyroid problems
•
problems urinating
•
heart rhythm problems (Long QT syndrome)
•
pancreas o

Summary of Product characteristics

METHADONE HYDROCHLORIDE- METHADONE HYDROCHLORIDE TABLET
MCKESSON CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METHADONE HYDROCHLORIDE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METHADONE
HYDROCHLORIDE TABLETS.
METHADONE HYDROCHLORIDE TABLETS, FOR ORAL USE, CII.
INITIAL U.S. APPROVAL: 1947
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION;
ACCIDENTAL INGESTION; LIFE-THREATENING QT PROLONGATION; NEONATAL
OPIOID
WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME
P-450
ISOENZYMES; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER
CNS
DEPRESSANTS ;AND TREATMENT FOR OPIOID ADDICTION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
Methadone hydrochloride tablets exposes users to risks of addiction,
abuse, and misuse, which can lead to
overdose and death. Assess each patient’s risk before prescribing,
and monitor regularly for development of
these behaviors or conditions. (5.1)
Serious, life-threatening, or fatal respiratory depression may occur.
Monitor closely, especially upon initiation or
following a dose increase. (5.2)
Accidental ingestion of methadone hydrochloride tablets, especially in
children, can result in fatal overdose of
methadone. (5.2)
QT interval prolongation and serious arrhythmia (_torsades de
pointes_) have occurred during treatment with
methadone. Closely monitor patients with risk factors for development
of prolonged QT interval, a history of
cardiac conduction abnormalities, and those taking medications
affecting cardiac conduction (5.3)
Neonatal opioid withdrawal syndrome (NOWS) is an expected and
treatable outcome of use of methadone
hydrochloride tablets during pregnancy. NOWS may be life-threatening
if not recognized and treated in the
neonate. The balance between the risks of NOWS and the benefits of
maternal methadone hydrochloride tablets
use may differ based on the risks associated with the mother's
underlying conditi