METHADONE HYDROCHLORIDE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

DIRECT RX

INN (International Adı):

METHADONE HYDROCHLORIDE

Kompozisyon:

METHADONE HYDROCHLORIDE 10 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

- Methadone Hydrochloride Tablets USP 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 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.•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 social and medical services. Conditions

Ürün özeti:

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 25ºC (77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. 16.2 How Supplied Methadone Hydrochloride Tablets USP 5 mg Tablets: round, white tablets debossed with tablet identifier 54 210 on one side and scored on the other side. NDC 0054-4570-25: Bottles of 100 tablets. NDC 0054-8553-24: Unit dose, 25 tablets per card (reverse numbered), 4 cards per shipper. 10 mg Tablets: round, white tablet debossed with tablet identifier 54 142 on one side and scored on the other side. NDC 0054-4571-25: Bottles of 100 tablets. NDC 0054-8554-24: Unit dose, 25 tablets per card (reverse numbered), 4 cards per shipper. DEA order form required.

Yetkilendirme durumu:

New Drug Application

Bilgilendirme broşürü

DIRECT RX
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SPL MEDGUIDE SECTION
MEDICATION GUIDE
Methadone Hydrochloride Tablets USP, CII
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:
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 heart rhythm problems (Long QT
syndrome) pancreas or gallbladder problems abuse of street or
prescription drugs, alcohol addiction, or
mental health problems.
Tell your healthcare provider if you are:
pregnant or planning to become pregnant. Prolonged use of methadone
hydrochloride during pregnancy
can cause withdrawal symptoms in yo

Ürün özellikleri

METHADONE HYDROCHLORIDE- METHADONE HYDROCHLORIDE TABLET
DIRECT RX
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METHADONE HYDROCHLORIDE
BOXED WARNING SECTION
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 USP 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 USP, 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 USP. Monitor for respiratory depression,
especially during initiation of
Methadone Hydrochloride Tablets USP or following a dose increase [see
Warningsand
Precautions (5.2)].
Accidental Ingestion
Accidental ingestion of even one dose of Methadone Hydrochloride
Tablets USP, 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 USP[see Warnings and Precautions
(5.3)].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of Methadone Hydrochloride Tablets USP during pregnancy
can result in neonatal
opioid withdrawal syndrome, which may be life-threatening if not
recognized and treated, and
requires management accordi