METHADONE HYDROCHLORIDE tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

VistaPharm, LLC

INN (Mezinárodní Name):

METHADONE HYDROCHLORIDE

Složení:

METHADONE HYDROCHLORIDE 10 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Methadone hydrochloride tablets 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 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 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 morphine-like drugs), in conjunction with appropriate so

Přehled produktů:

Methadone Hydrochloride Tablets, USP 10 mg, white, round, biconvex, tablet, de-bossed  “E” over “131” on one side and bisected on the other side and available as: NDC 66689-820-10: Bottles of 100 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.] Store methadone hydrochloride tablets securely and dispose of properly [see Patient Counseling Information (17) ].

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

METHADONE HYDROCHLORIDE- METHADONE HYDROCHLORIDE TABLET
VistaPharm, LLC
----------
MEDICATION GUIDE
Methadone Hydrochloride Tablets, USP (METH-ah-done), CII
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 Methadone Hydrochloride Tablets if you have:
•
Severe asthma, trouble breathing, or other lu

Charakteristika produktu

METHADONE HYDROCHLORIDE- METHADONE HYDROCHLORIDE TABLET
VISTAPHARM, LLC
----------
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 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 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)
NEONATAL O