METHADONE HYDROCHLORIDE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Direct_Rx

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Methadone hydrochloride tablets are indicated for the: • 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 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. • Detoxification treatment of opioid addiction (heroin or other morphine-like drugs). • Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate

제품 요약:

16.1 Storage and Handling Methadone hydrochloride tablets contain 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 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 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] 16.2 How Supplied Methadone Hydrochloride Tablets USP 5 mg tablets supplied as round, white, biconvex tablets debossed with product identification “54” above “210” on one side and scored on the other side. : Bottle of 100 Tablets : 4x25 Unit-Dose Tablets (reverse numbered) 10 mg tablets supplied as round, white, biconvex tablets debossed with product identification “54” above “142” on one side and scored on the other side. : Bottle of 100 Tablets : 4x25 Unit-Dose Tablets (reverse numbered) DEA order form required.

승인 상태:

New Drug Application

환자 정보 전단

METHADONE HYDROCHLORIDE- METHADONE HYDROCHLORIDE TABLET
Direct_Rx
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MEDICATION GUIDE
Methadone Hydrochloride Tablets USP CII
(METH a done)
Rx Only
Methadone hydrochloride is:
•
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:
•
Get emergency help right away if you take too much methadone
hydrochloride (overdose). When you
first start taking methadone hydrochloride, 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.
•
Never give anyone your methadone hydrochloride. They could die from
taking it. Store methadone
hydrochloride away from children and in a safe place to prevent
stealing or abuse. Selling or giving away
methadone hydrochloride is against the law.
Do not take methadone hydrochloride 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, tell your healthcare provider
if you have a history of:
•
head injury, seizures
•
liver, kidney, thyroid problems
•
problems urinating
•
pancreas or gallbladder problems
•
heart rhythm problems (Long QT syndrome)
•
abuse of street or prescription drugs, alcohol addiction, or mental
health problems.
Tell your healthcare provider if you are:
•
pregnant or planning to bec

제품 특성 요약

METHADONE HYDROCHLORIDE- METHADONE HYDROCHLORIDE TABLET
DIRECT_RX
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METHADONE HYDROCHLORIDE
WARNING: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL INGESTION; LIFE-THREATENING QT PROLONGATION;
NEONATAL OPIOID WITHDRAWAL SYNDROME; and TREATMENT FOR OPIOID
ADDICTION
Addiction, Abuse, and Misuse
Methadone hydrochloride tablets exposes patients and other users to
the risks of opioid addiction,
abuse, and misuse, which can lead to overdose and death. Assess each
patient’s risk prior to
prescribing methadone hydrochloride tablets, and monitor all patients
regularly for the
development of these behaviors or conditions [see Warnings and
Precautions (5.1)].
Life-threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur
with use of methadone
hydrochloride tablets. Monitor for respiratory depression, especially
during initiation of
methadone hydrochloride tablets or following a dose increase [see
Warnings and Precautions
(5.2)].
Accidental Ingestion
Accidental ingestion of even one dose of methadone hydrochloride
tablets, especially by
children, can result in a fatal overdose of methadone [see Warnings
and Precautions (5.2)].
Life-threatening QT Prolongation
QT interval prolongation and serious arrhythmia (torsades de pointes)
have occurred during
treatment with methadone. Most cases involve patients being treated
for pain with large, multiple
daily doses of methadone, although cases have been reported in
patients receiving doses
commonly used for maintenance treatment of opioid addiction. Closely
monitor patients for
changes in cardiac rhythm during initiation and titration of methadone
hydrochloride tablets [see
Warnings and Precautions (5.3)].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of methadone hydrochloride tablets during pregnancy can
result in neonatal opioid
withdrawal syndrome, which may be life-threatening if not recognized
and treated, and requires
management according to protocols developed by neonatology experts