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:

Major Pharmaceuticals

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: Conditions for Distribution and Use of Methadone Products for the Treatment of Opioid Addiction Code of Federal Regulations, Title 42, Sec 8: Methadone products when used for the treatment of opioid addiction in detoxification or maintenance programs, shall be dispensed only by opioid treatment programs (and agencies, practitioners or institutions by formal agreement with the program sponsor) certified by the Substance Abuse and Mental Health Services Administration and approved by the designated state authority. Certified treatment programs shall dispense and use methadone in oral form only and according to the treatment requirements stipulated in the Federal Opioid Treatment Standards (42 CFR 8.12). See below for important regulatory exceptions to the general requirement for certification to provide opioid agonist treatment. Failure to abide by the requirements in these regulations may result in criminal prosecution, seizure of the drug supply,

Product summary:

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)]. Dispense in a tight, light-resistant container as defined in the USP/NF. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Methadone Hydrochloride Tablets, USP 10 mg tablets: white, round, biconvex tablet, scored on one side and debossed “ASC 116” on the other side. Bottles of 100 tablets, NDC 0904-6530-60 Cartons of 100 tablets (10 tablets each blister pack x 10), NDC 0904-6530-61 DEA order form required.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Major Pharmaceuticals
----------
MEDICATION GUIDE
Methadone Hydrochloride Tablets, CII
(METH a done hy.dro.chlo.ride)
Methadone hydrochloride tablets are:
1.
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.
2.
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.
3.
Not for use to treat pain that is not around-the-clock.
4.
Also used to manage drug addiction.
Important information about methadone hydrochloride tablets:
1.
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.
2.
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.
3.
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:
1.
Severe asthma, trouble breathing, or other lung problems.
2.
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:
1.
head injury, seizures
2.
liver, kidney, thyroi

Summary of Product characteristics

METHADONE HYDROCHLORIDE- METHADONE HYDROCHLORIDE TABLET
MAJOR PHARMACEUTICALS
----------
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._
10.
11.
12.
13.
14.
15.
16.
17.
18.
RECENT MAJOR CHANGES
Boxed Warning 11/2018
Warnings and Precautions (5) 11/2018
INDICATIONS AND USAGE
Methadone hydrochloride tablets, USP is an opioid agonist indicated
for the:
4.
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 occurred during trea