MORPHINE SULFATE suppository

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Padagis US LLC

INN (इंटरनेशनल नाम):

MORPHINE SULFATE

रचना:

MORPHINE SULFATE 5 mg

प्रशासन का मार्ग:

RECTAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Morphine sulfate suppositories are indicated for the management of acute and chronic pain severe enough to require and opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve morphine sulfate suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: Morphine sulfate suppositories are contraindicated in patients with: Risk Summary Prolonged use of opioid analgesics during pregnancy can cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.3)] . There are no available data with morphine sulfate suppositories in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Published studies with morphine use during pregnancy have not reported a clear association with morphine and major birth defects [see Human Data] . I

उत्पाद समीक्षा:

Morphine Sulfate Suppositories are white to cream torpedo shaped suppositories Strength Carton Count NDC Number 5 mg 12 suppositories 0574-7110-12 10 mg 12 suppositories 0574-7112-12 20 mg 12 suppositories 0574-7114-12 30 mg 12 suppositories 0574-7116-12 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

प्राधिकरण का दर्जा:

unapproved drug other

सूचना पत्रक

MORPHINE SULFATE- morphine sulfate suppository
Padagis US LLC
Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been
approved by FDA. For further information about unapproved drugs, click
here.
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Medication Guide
Morphine Sulfate (mor’ feen sul’ fate) Suppositories, CII
Morphine Sulfate Suppositories are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage short term
(acute) and long term (chronic) pain severe enough to require an
opioid pain medicine, when other pain
treatments such as non-opioid pain medicines do not treat your pain
well enough or you cannot tolerate
them.
•
An 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.
Important information about morphine sulfate:
•
Get emergency help right away if you take too many morphine sulfate
suppositories (overdose). When
you first start taking morphine sulfate suppositories, 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 morphine sulfate suppositories 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 morphine sulfate suppositories. They could
die from taking it. Store
morphine sulfate suppositories away from children and in a safe place
to prevent stealing or abuse.
Selling or giving away morphine sulfate suppositories is against the
law.
Do not take morphine sulfate suppositories if you have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel blockage or have narrowing of the stomach or intestines.
•
an allergy to morphine
Before taking morphine sulfate suppositories, tell your hea

उत्पाद विशेषताएं

MORPHINE SULFATE- MORPHINE SULFATE SUPPOSITORY
PADAGIS US LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MORPHINE SULFATE
SUPPOSITORIES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR MORPHINE
SULFATE SUPPOSITORIES.
MORPHINE SULFATE SUPPOSITORIES, FOR RECTAL USE, CII
INITIAL U.S. APPROVAL: 1941
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME;
AND RISKS FROM CONCOMITANT USE WITH ALCOHOL, BENZODIAZEPINES OR OTHER
CNS
DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
•
•
RECENT MAJOR CHANGES
Boxed Warning 11/2018
Indications and Usage (1) 11/2018
Dosage and Administration (2) 11/2018
Contraindications (4) 11/2018
Warnings and Precautions (5) 11/2018
INDICATIONS AND USAGE
Morphine sulfate suppositories is an opioid agonist indicated for the
management of acute and chronic
pain severe enough to require an opioid analgesic and for which
alternative treatments are inadequate. (1)
Limitations of Use (1)
Because of the risks of addiction, abuse, and misuse with opioids,
even at recommended doses, reserve
morphine sulfate suppositories for use in patients for whom
alternative treatment options [e.g., non-opioid
analgesics or opioid combination products]: (1)
•
•
MORPHINE SULFATE SUPPOSITORIES EXPOSE USERS TO RISKS OF OPIOID
ADDICTION, ABUSE,
AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS PATIENT’S
RISK BEFORE
PRESCRIBING AND MONITOR REGULARLY FOR THESE BEHAVIORS OR CONDITIONS.
(5.1)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR
CLOSELY, ESPECIALLY UPON INITIATION OR FOLLOWING A DOSE INCREASE.
(5.2)
ACCIDENTAL EXPOSURE OF MORPHINE SULFATE SUPPOSITORIES, ESPECIALLY BY
CHILDREN, CAN