METHADONE HYDROCHLORIDE- 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:

Sun Pharmaceutical Industries, Inc.

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Methadone hydrochloride tablets are indicated for the: Limitations of Use Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 CFR 8.12 [see Dosage and Administration (2.1)] . Methadone hydrochloride tablets are contraindicated in patients with: Risk Summary Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy [see Warnings and Precautions (5.4)]. Pregnant women in methadone maintenance programs may have reduced incidence of obstetric and fetal complications and neonatal morbidity and mortality when compared to women using illicit drugs. Untreated opioid addiction in pregnancy is associated with adverse obstetrical outcomes and risk of continued or relapsing illicit opioid use. These risks should be considered in women treated with methadone hydrochloride tablets for maintenance treatment of opioid addiction. For wom

Proizvod sažetak:

Methadone hydrochloride tablets, USP Methadone hydrochloride tablets 5 mg, are white to off-white colored, round, biconvex, uncoated, tablets debossed “S” above “602” on one side and scored on the other side. Methadone hydrochloride tablets 10 mg, are white to off-white colored, round, biconvex, uncoated, tablets debossed “S” above “603” on one side and scored on the other side. Store at 20º to 25ºC (68º to 77ºF), with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP/NF.

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

Sun Pharmaceutical Industries, Inc.
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MEDICATION GUIDE
Methadone Hydrochloride Tablets, USP (“meth’a done hye” droe
cklo’ ride”) CII
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 methadonehydrochloride 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 methadonehydrochloride tablets if you have:
•
Severe asthma, trouble breathing, or other lung problems.
•
A bowel blockage or have narrowing of the stomach or intestines.
Before taking methadonehydrochloride tablets, tell your healthcare
provider if you have a history of:
•
head

Svojstava lijeka

METHADONE HYDROCHLORIDE- METHADONE HYDROCHLORIDE TABLET
SUN PHARMACEUTICAL INDUSTRIES, INC.
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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 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._
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RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Methadone hydrochloride is an opioid agonist indicated for the:
•
METHADONE HYDROCHLORIDE TABLETS EXPOSE 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)
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. (5.2)
ACCIDENTAL INGESTION OF METHADONE HYDROCHLORIDE TABLETS, ESPECIALLY BY
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