METHADONE HYDROCHLORIDE tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Epic Pharma, LLC

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Methadone hydrochloride tablets, USP are indicated for the:        Limitations of Use Methadone hydrochloride tablets are contraindicated in patients with: Risk Summary The majority of available data from clinical trials, observational studies, case series, and case reports on methadone use in pregnancy do not indicate an increased risk of major malformations specifically due to methadone. Pregnant women involved in methadone maintenance programs have been reported to have improved prenatal care leading to reduced incidence of obstetric and fetal complications and neonatal morbidity and mortality when compared to women using illicit drugs. Several factors, including maternal use of illicit drugs, nutrition, infection and psychosocial circumstances, complicate the interpretation of investigations of the children of women who take methadone during pregnancy. Information is limited regarding dose and duration of methadone use during pregnancy, and most maternal exposure in these studies appears to occur after th

Ringkasan produk:

Methadone Hydrochloride Tablets, USP 5 mg are white to off-white, round flat-faced beveled-edge tablets, debossed “Є” above "317" on one side and bisect on the other side. They are supplied as follows: Bottles of 100 (NDC 42806-317-01) Methadone Hydrochloride Tablets, USP 10 mg are white to off-white, round biconvex tablets, debossed “Є” above "318" on one side and bisect on the other side. They are supplied as follows: Bottles of 100 (NDC 42806-318-01) Store at 20° to 25°C (68° to 77°F), 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. Store methadone hydrochloride tablets securely and dispose of properly [see Patient Counseling Information (17) ].

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

Epic Pharma, LLC
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Medication Guide
Dispense with Medication Guide available at:
www.epic-pharma.com/medguide/Methadone-Hydrochloride-
Tablet.pdf
MEDICATION GUIDE
Methadone Hydrochloride Tablets USP, CII
(meth' a done hye” droe klor’ ide)
Rx only
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 that 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 or call 911 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. Talk to your healthcare provider about naloxone, a
medicine for emergency
treatment of opioid overdose.
•
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 else your methadone hydrochloride tablets. They
could die from taking it. 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

Karakteristik produk

METHADONE HYDROCHLORIDE- METHADONE HYDROCHLORIDE TABLET
EPIC PHARMA, LLC
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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; 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._
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RECENT MAJOR CHANGES
Dosage and Administration (2.3) 06/2021
Warnings and Precautions (5.1, 5.3, 5.7) 06/2021
INDICATIONS AND USAGE
Methadone hydrochloride tablets, USP are 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)
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 oc