METHADONE HYDROCHLORIDE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

American Health Packaging

INN (International ime):

METHADONE HYDROCHLORIDE

Sastav:

METHADONE HYDROCHLORIDE 10 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 opioi

Proizvod sažetak:

Methadone hydrochloride tablets, USP contains methadone which is a controlled substance. Like fentanyl, morphine, oxycodone, hydromorphone, and oxymorphone, methadone is controlled under Schedule II of the Federal Controlled Substances Act. Methadone hydrochloride tablets, USP may be targeted for theft and diversion by criminals [see Warnings and Precautions ( 5.1)]. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. Methadone Hydrochloride Tablets, USP 10 mg Tablets: white, round, biconvex tablet, scored on one side and debossed “ASC 116” on the other side. Unit dose packages of 100 (10 x 10) NDC 68084-738-01. DEA order form required.

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

American Health Packaging
----------
MEDICATION GUIDE
8273801/0420
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.
•
Store methadone hydrochloride tablets securely, out of sight and reach
of children, and in a location
not accessible by others, including visitors to the home.
Do not take methadone hydrochloride tablets if you have:
•
Severe asthma, trouble breathing, or other lung problems.
•
A bowel blockage or have na

Svojstava lijeka

METHADONE HYDROCHLORIDE- METHADONE HYDROCHLORIDE TABLET
AMERICAN HEALTH PACKAGING
----------
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; RISK EVALUATION AND MITIGATION
STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL
INGESTION; LIFE-THREATENING QT PROLONGATION; NEONATAL OPIOID
WITHDRAWAL
SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450
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 and conditions. ( 5.1)
To ensure that the benefits of opioid analgesics outweigh the risks of
addiction, abuse, and
misuse, the Food and Drug Administration (FDA) has required a Risk
Evaluation and Mitigation
Strategy (REMS) for these products. ( 5.2)
Serious, life-threatening, or fatal respiratory depression may occur.
The peak respiratory
depressant effect of methadone occurs later, and persists longer than
the peak analgesic effect.
Monitor closely, especially upon initiation or following a dose
increase. ( 5.3)
Accidental ingestion of methadone hydrochloride tablets, especially by
children, can result in fatal
overdose of methadone. ( 5.3)
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 conducti