MORPHINE SULFATE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Bryant Ranch Prepack

INN (International Name):

MORPHINE SULFATE

Sammensetning:

MORPHINE SULFATE 15 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Morphine Sulfate Tablets are indicated for the management of acute and chronic pain severe enough to require an 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 Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: Morphine Sulfate Tablets are contraindicated in patients with: Risk Summary: Prolonged use of opioid analgesics during pregnancy can cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.4)]. There are no available data with Morphine Sulfate Tablets 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]. In published animal rep

Produkt oppsummering:

NDC: 63629-4175-1: 60 Tablets in a BOTTLE NDC: 63629-4175-2: 90 Tablets in a BOTTLE NDC: 63629-4175-3: 30 Tablets in a BOTTLE NDC: 63629-4175-4: 120 Tablets in a BOTTLE NDC: 63629-4175-5: 45 Tablets in a BOTTLE NDC: 63629-4175-6: 15 Tablets in a BOTTLE NDC: 63629-4175-7: 20 Tablets in a BOTTLE

Autorisasjon status:

New Drug Application

Informasjon til brukeren

Bryant Ranch Prepack
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Medication Guide
MEDICATION GUIDE
Morphine Sulfate (mor’ feen sul’ fate) Tablets, CII
Rx only
Morphine Sulfate Tablets 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 Tablets:
•
Get emergency help or call 911 right away if you take too much
Morphine Sulfate Tablets (overdose).
When you first start taking Morphine Sulfate 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. Talk
to your healthcare provider about naloxone, a medicine for the
emergency treatment of an opioid
overdose.
•
Taking Morphine Sulfate Tablets 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 Tablets. They could die
from taking it. Selling or
giving away Morphine Sulfate Tablets is against the law.
•
Store Morphine Sulfate Tablets securely, out of sight and reach of
children, and in a location not
accessible by others, including visitors to the home.
Do not take Morphine Sulfate Tablets 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 Tablets, tell your healthcare provider
if you have a history of:
•
head injury, seizures.

Preparatomtale

MORPHINE SULFATE- MORPHINE SULFATE TABLET
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MORPHINE SULFATE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MORPHINE
SULFATE TABLETS.
MORPHINE SULFATE TABLETS, FOR ORAL USE CII
INITIAL U.S. APPROVAL: 1941
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION
STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL
INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND RISKS FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
•
•
•
RECENT MAJOR CHANGES
Indications and Usage (1)
06/2021
Dosage and Administration (2.2)
03/2021
Dosage and Administration (2.3)
06/2021
Warnings and Precautions (5.1, 5.3, 5.5)
03/2021
INDICATIONS AND USAGE
Morphine Sulfate Tablets are indicated for the management of:
•
•
Limitations of Use(1)
MORPHINE SULFATE TABLETS EXPOSE USERS TO RISKS OF ADDICTION, ABUSE,
AND MISUSE,
WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS PATIENT’S RISK BEFORE
PRESCRIBING
AND MONITOR REGULARLY FOR THESE BEHAVIORS AND CONDITIONS. (5.1)
TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF
ADDICTION,
ABUSE, AND MISUSE, THE FOOD AND DRUG ADMINISTRATION (FDA) HAS REQUIRED
A RISK
EVALUATION AND MITIGATION STRATEGY (REMS) FOR THESE PRODUCTS. (5.2)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR
CLOSELY, ESPECIALLY UPON INITIATION OR FOLLOWING A DOSE INCREASE.
(5.3)
ACCIDENTAL INGESTION OF MORPHINE SULFATE TABLETS, ESPECIALLY BY
CHILDREN, CAN RESULT
IN A FATAL OVERDOSE OF MORPHINE. (5.3)
PROLONGED USE OF MORPHINE SULFATE TABLETS DURING PREGNANCY CAN RESULT
IN NEONATAL
OPIOID WITHDRAWAL SYNDROME, WHICH MAY BE LIFE-THREATENING IF NOT
RECOGNIZED AND
TREATED. IF PROLONGED OPIOID USE IS REQUIRED IN A PREGNANT WOMAN,
ADVISE THE
PATIENT OF THE RISK OF NEONATAL OPIOID WITHDRAWAL SYNDROME AND ENSURE
TH