METHADONE HYDROCHLORIDE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

VistaPharm, Inc.

INN (Διεθνής Όνομα):

METHADONE HYDROCHLORIDE

Σύνθεση:

METHADONE HYDROCHLORIDE 10 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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: Hypersensitivity (e.g., anaphylaxis) to methadone [see Adverse Reactions (6)] . 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 meth

Περίληψη προϊόντος:

Methadone Hydrochloride Tablets, USP 10 mg, white, round, unscored tablet, debossed “E ” over “131” on one side and plain on the other side and available as: NDC 66689-810-10: Bottles of 100 DEA order form required. Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP/NF. 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].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

VistaPharm, Inc.
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MEDICATION GUIDE
Methadone Hydrochloride Tablets, USP (METH-ah-done), 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 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 right away if you take too many 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.
Before taking Methadone Hydrochloride Tablets, tell your healthcare
provider if
you have a history of:
•
head injury, seizures
•
liver, kidney, thyroid pro

Αρχείο Π.Χ.Π.

METHADONE HYDROCHLORIDE- METHADONE HYDROCHLORIDE TABLET
VISTAPHARM, 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._
•
•
•
•
•
•
•
•
RECENT MAJOR CHANGES
Boxed Warning 09/2017
Warnings and Precautions (5.2, 5.6) 02/2018
INDICATIONS AND USAGE
Methadone hydrochloride tablets are an opioid agonist indicated for
the:
1.
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
TREAT