MORPHINE SULFATE tablet, film coated, extended release

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

DIRECT RX

INN (nemzetközi neve):

MORPHINE SULFATE

Összetétel:

MORPHINE SULFATE 30 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 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 equipment

Termék összefoglaló:

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

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

DIRECT RX
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SPL MEDGUIDE SECTION
Morphine Sulfate 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
sulfate ER tablets during pregnancy
can cause withdrawal symptoms in your newborn baby that could

Termékjellemzők

MORPHINE SULFATE- MORPHINE SULFATE TABLET, FILM COATED, EXTENDED
RELEASE
DIRECT RX
----------
MORPHINE SULFATE
BOXED WARNING SECTION
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 or 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)].
INDICATIONS & USAGE SECTION
Morphine