MORPHINE SULFATE tablet, film coated, extended release

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

MORPHINE SULFATE (UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)

Предлага се от:

RedPharm Drug, Inc.

INN (Международно Name):

MORPHINE SULFATE

Композиция:

MORPHINE SULFATE 15 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Morphine sulfate extended-release 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 extended-release opioid formulations, reserve morphine sulfate extended-release 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. Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic. Morphine sulfate extended-release tablets are contraindicated in patients with: Significant respiratory depression Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipm

Каталог на резюме:

Morphine Sulfate Extended-Release Tablets are available as follows: 15 mg - round, blue-colored, film-coated tablet bearing the symbol ABG on one side and 15 on the other. Bottles (opaque plastic) of 100..........................................................................NDC 42858-801-01 30 mg - round, lavender-colored, film-coated tablet bearing the symbol ABG on one side and 30 on the other. Bottles (opaque plastic) of 100..........................................................................NDC 42858-802-01 60 mg - round, orange-colored, film-coated tablet bearing the symbol ABG on one side and 60 on the other. Bottles (opaque plastic) of 100..........................................................................NDC 42858-803-01 100 mg - round, gray-colored, film-coated tablet bearing the symbol ABG on one side and 100 on the other. Bottles (opaque plastic) of 100..........................................................................NDC 42858-804-01 200 mg - capsule-shaped, green-colored, film-coated tablet bearing the symbol ABG on one side and 200 on the other. Bottles (opaque plastic) of 100..........................................................................NDC 42858-805-01 Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. CAUTION DEA FORM REQUIRED

Статус Оторизация:

Abbreviated New Drug Application

Листовка

MORPHINE SULFATE- morphine sulfate tablet, film coated, extended
release
RedPharm Drug, Inc.
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MEDICATION GUIDE
Morphine Sulfate (Mor-feen-SUL-fate) Extended-Release (ER) Tablets,
CII
Morphine sulfate ER 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 (extended-release) 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.
Important information about morphine sulfate ER tablets:
Get emergency help right away if you take too much morphine sulfate ER
tablets (overdose). When you first
start taking morphine sulfate ER 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.
Never give anyone else your morphine sulfate ER tablets. They could
die from taking it. Store morphine
sulfate ER tablets away from children and in a safe place to prevent
stealing or abuse. Selling or giving away
morphine sulfate ER tablets is against the law.
Do not take morphine sulfate ER 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 morphine sulfate ER tablets, tell your healthcare
provider if you have a history of:
head injury, seizures
liver, kidney, thyroid problems
problems urinating
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 morphine

Данни за продукта

MORPHINE SULFATE- MORPHINE SULFATE TABLET, FILM COATED, EXTENDED
RELEASE
REDPHARM DRUG, INC.
----------
MORPHINE SULF ER 15MG #20
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL INGESTION; AND NEONATAL OPIOID WITHDRAWAL
SYNDROME
Addiction, Abuse, and Misuse
Morphine sulfate extended-release tablets expose 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 morphine sulfate
extended-release
tablets, and monitor all patients regularly for the development of
these behaviors
and conditions [see Warnings and Precautions (5.1)].
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur
with use of
morphine sulfate extended-release tablets. Monitor for respiratory
depression,
especially during initiation of morphine sulfate extended-release
tablets or following
a dose increase. Instruct patients to swallow morphine sulfate
extended-release
tablets whole; crushing, chewing, or dissolving morphine sulfate
extended-release
tablets can cause rapid release and absorption of a potentially fatal
dose of
morphine [see Warnings and Precautions (5.2)].
Accidental Ingestion
Accidental ingestion of even one dose of morphine sulfate
extended-release
tablets, especially by children, can result in a fatal overdose of
morphine [see
Warnings and Precautions (5.2)].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of morphine sulfate extended-release 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. If opioid use is required for a
prolonged period
in a pregnant woman, advise the patient of the risk of neonatal opioid
withdrawal
syndrome and ensure that appropriate treatment will be available [see
Warnings
and Precautions (5.3)].
HIGHLIGHTS OF PRESCRIBING INFORMATION
T