Methadone hydrochloride tablets USP

Země: Arménie

Jazyk: angličtina

Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivní složka:

methadone (methadone hydrochloride)

Dostupné s:

SpecGx LLC

INN (Mezinárodní Name):

methadone (methadone hydrochloride)

Dávkování:

5mg

Léková forma:

tablets

Druh předpisu:

Prescription

Informace pro uživatele

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_
• 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
TREATABLE
OUTCOME OF USE OF METHADONE HYDROCHLORIDE TABLETS DURING PREGNANCY.
NOWS
MAY BE LIFE-THREATENING IF NOT RECOGNIZED AND TREATED IN THE NEONATE.
THE BALANCE
BETWEEN THE RISKS OF NOWS AND THE BENEFITS OF MATERNAL METHADONE
HYDRO-
CHLORIDE TABLETS USE MAY DIFFER BASED ON

Charakteristika produktu

Methadone Hydrochloride Tablets USP, 5mg and 10mg
SpecGx LLC • 385 Marshall Avenue • Webster Groves, MO 63119 •
314.654.2000 T • www.mallinckrodt.com
Appendix 1.9 Summary of Product Characteristics
1.
NAME OF MEDICINAL PRODUCT:
Methadone Hydrochloride Tablets USP, 5mg and 10mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION (5MG):
Active Ingredient:

Methadone Hydrochloride, USP 5.00 mg
Excipients:

Microcrystalline Cellulose, NF
39.63 mg

Lactose Monohydrate, NF
79.25 mg

Silicon Dioxide, NF
0.50 mg

Magnesium Stearate, NF
0.62 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION (10MG):
Active Ingredient:

Methadone Hydrochloride, USP
10.00 mg
Excipients:

Microcrystalline Cellulose, NF
79.26 mg

Lactose Monohydrate, NF
158.50 mg

Silicon Dioxide, NF
1.00 mg

Magnesium Stearate, NF
1.24 mg
3.
PHARMACEUTICAL FORM:
tablet
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS:
Methadone hydrochloride tablets are an opioid agonist 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,
reserve methadone hydrochloride tablets for use in patients for whom
alternative
treatment options (e.g., non-opioid analgesics or immediate-release
opioids) 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).
Methadone Hydrochloride Tablets USP, 5mg and 10mg
SpecGx LLC • 385 Marshall Avenue • Webster Groves, MO 63119 •
314.654.2000 T • www.mallinckrodt.com
3. Maintenance treatment of opioid addiction (heroin or other
morphine-like drugs), in
conjunction with ap