MORPHINE SULFATE EXTENDED-RELEASE- morphine sulfate extended-release tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Sun Pharmaceutical Industries, Inc.

Designación común internacional (DCI):

MORPHINE SULFATE

Composición:

MORPHINE SULFATE 15 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 Morphine Sulfate Extended-release tablets are contraindicated in patients with: Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal withdrawal syndrome [see Warnings and Precautions (5.3)] . There are no available data with Morphine Sulfate Extended-release 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 reproduction studies, morphine administered subcutaneously during the early gestational period produced neural tube defects (i.e., exencephaly and cranioschisis) at 5 and 16 times the human daily dose of 60 mg based on body surf

Resumen del producto:

Morphine sulfate extended-release tablets 15 mg are blue colored, round, biconvex, bevel edged coated tablets debossed with “S” and “15” on one side and “196” on the other side. They are supplied as follows: NDC 57664-196-88: 100 count CRC Morphine sulfate extended-release tablets 30 mg are lavender colored, round, biconvex, bevel edged coated tablets debossed with “S” and “30” on one side and “190” on the other side. They are supplied as follows: NDC 57664-190-88: 100 count CRC Morphine sulfate extended-release tablets 60 mg are orange colored, round, biconvex, bevel edged coated tablets debossed with “S” and “60” on one side and “191” on the other side. They are supplied as follows: NDC 57664-191-88: 100 count CRC Morphine sulfate extended-release tablets 100 mg are grey colored, round, biconvex, bevel edged coated tablets debossed with “S” and “100” on one side and “192” on the other side. They are supplied as follows: NDC 57664-192-88: 100 count CRC Morphine sulfate extended-release tablets 200 mg are green colored, capsule-shaped, biconvex coated tablets debossed with “S” and “200” on one side and “197” on the other side. They are supplied as follows: NDC 57664-197-88: 100 count CRC Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. CAUTION DEA FORM REQUIRED

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

Sun Pharmaceutical Industries, Inc.
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MEDICATION GUIDE
Morphine Sulfate Extended-Release Tablets, CII
(MOR-feen SUL-fate)
Morphine Extended-Release 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 Extended-release tablets:
•
Get emergency help right away if you take too much Morphine Sulfate
Extended-release tablets
(overdose). When you first start taking Morphine Sulfate
Extended-release 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.
•
Taking Morphine Sulfate Extended-release 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 Extended-release tablets.
They could die from
taking it. Store Morphine Sulfate Extended-release tablets away from
children and in a safe place
to prevent stealing or abuse. Selling or giving away Morphine Sulfate
Extended-release tablets is
against the law.
Do not take Morphine Sulfate Extended-release 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 Extended-release tablets, tell y

Ficha técnica

MORPHINE SULFATE EXTENDED-RELEASE- MORPHINE SULFATE EXTENDED-RELEASE
TABLET
SUN PHARMACEUTICAL INDUSTRIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MORPHINE SULFATE EXTENDED-RELEASE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MORPHINE SULFATE EXTENDED-
RELEASE TABLETS.
MORPHINE SULFATE EXTENDED-RELEASE TABLETS, FOR ORAL USE CII
INITIAL U.S. APPROVAL: 1941
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE- THREATENING RESPIRATORY
DEPRESSION,
ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND RISKS
FROM
CONCOMITANT USE WITH BENZODIAZEPINES AND OTHER CNS DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
•
•
•
•
•
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Morphine Sulfate Extended-release tablet is an opioid agonist
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. (1)
Limitations of Use
•
•
DOSAGE AND ADMINISTRATION
•
MORPHINE SULFATE EXTENDED-RELEASE TABLETS EXPOSES 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)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR FOLLOWING A DOSE INCREASE. INSTRUCT PATIENTS TO SWALLOW
MORPHINE SULFATE EXTENDED-
RELEASE TABLETS WHOLE TO AVOID EXPOSURE TO A POTENTIALLY FATAL DOSE OF
MORPHINE. (5.2)
ACCIDENTAL INGESTION OF MORPHINE SULFATE EXTENDED-RELEASE TABLETS,
ESPECIALLY BY CHILDREN, CAN RESULT
IN A FATAL OVERDOSE OF MORPHINE. (5.2)
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.
IF PROLONGED OPIOID USE IS REQUIRED IN A PREGNANT WOMAN, ADVISE THE
PATIENT OF THE RI