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:

Ascend Laboratories, LLC

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: 1. 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, USP 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, USP are not indicated as an as-needed (prn) analgesic. 2. Detoxification treatment of opioid addiction (heroin or other morphine-like drugs). 3. Maintenance treatment of opioid addiction (heroin or other morph

Product summary:

16.1 Storage and Handling 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]. 16.2 How Supplied Methadone Hydrochloride Tablets, USP 10 mg tablets: white, round, biconvex tablet, scored on one side and debossed “ASC 116” on the other side. NDC 67877-116-01: Bottles of 100 Tablets DEA order form required.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Ascend Laboratories, LLC
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MEDICATION GUIDE
Medication Guide
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. 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 narrowing of the stomach or intestines.
Before taking methadone hydrochloride tablets, tell your healthcare

Summary of Product characteristics

METHADONE HYDROCHLORIDE - METHADONE HYDROCHLORIDE TABLET
ASCEND LABORATORIES, 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._
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
CONDUCTION (5.4