METHADONE HYDROCHLORIDE tablet

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Hikma Pharmaceuticals USA Inc.

INN (Jina la Kimataifa):

METHADONE HYDROCHLORIDE

Tungo:

METHADONE HYDROCHLORIDE 5 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Methadone Hydrochloride Tablets are indicated for the: Methadone Hydrochloride Tablets are contraindicated in patients with: Risk Summary: Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy [see Warnings and Precautions (5.5)] . 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 Methadone Hydrochloride Tablets for maintenance treatment of opioid addiction. For women treated with Methadone Hydrochloride Tablets for pain severe enough to require daily, around-the-clock, long-term opioid treatment, Methadone Hydrochloride Tablets should be used during pregnancy only if the potential benefit justifies the

Bidhaa muhtasari:

Methadone Hydrochloride Tablets USP 5 mg tablets are white, biconvex tablets, scored on one side and product identification “54 210” debossed on the other side. NDC 0054-4570-25: Bottle of 100 Tablets NDC 0054-8553-24: 10x10 Unit-Dose The 10 mg tablets are white, biconvex tablets, scored on one side and product identification “54 142” debossed on the other side. NDC 0054-4571-25: Bottle of 100 Tablets NDC 0054-8554-24: 10x10 Unit-Dose Store at 20º to 25ºC (68º to 77ºF), with excursions permitted between 15º to 30ºC (59º to 86ºF). [See USP Controlled Room Temperature.] Store Methadone Hydrochloride Tablets securely and dispose of properly [see Patient Counseling Information (17)] .

Idhini hali ya:

New Drug Application

Taarifa za kipeperushi

Hikma Pharmaceuticals USA Inc.
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MEDICATION GUIDE
Methadone Hydrochloride Tablets USP, CII
(meth’ a done hye” droe klor’ ide)
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 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 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 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 lung problems.
•
A bowel blockage or have narrowing of the stomach or intestines.
Before taking Methadone Hydrochloride Tablets, tel

Tabia za bidhaa

METHADONE HYDROCHLORIDE- METHADONE HYDROCHLORIDE TABLET
HIKMA PHARMACEUTICALS USA 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; 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._
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RECENT MAJOR CHANGES
Dosage and Administration (2.5) 10/2019
Warnings and Precautions (5.3, 5.15) 10/2019
INDICATIONS AND USAGE
Methadone Hydrochloride Tablets are 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 POINTE