MORPHINE SULFATE EXTENDED RELEASE- morphine sulfate tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Major Pharmaceuticals

INN (International Name):

MORPHINE SULFATE

Composition:

MORPHINE SULFATE 15 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 (5.4)]. 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 su

Product summary:

Morphine Sulfate Extended-Release Tablets are supplied as follows: 15 mg – round, blue-colored, film-coated tablet bearing the symbol ABG on one side and 15 on the other. Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6557-61 30 mg – round, lavender-colored, film-coated tablet bearing the symbol ABG on one side and 30 on the other. Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6558-61 60 mg – round, orange-colored, film-coated tablet bearing the symbol ABG on one side and 60 on the other. Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6559-61 100 mg – round, gray-colored, film-coated tablet bearing the symbol ABG on one side and 100 on the other. Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6560-61 Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store morphine sulfate extended-release tablets securely and dispose of properly [see Patient Counseling Information (17)] . Dispense in a tight, light-resistant container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Major Pharmaceuticals
----------
Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI 02816 US,
http://rhodespharma.com, or call 1-
888-827-0616.
This Medication Guide has been approved by the U.S. Food and Drug
Administration. Revised:
10/2019
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.
•
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 ER tablets. They could
die from taking it. Selling or
giving away morphine sulfate ER tablets is against the law.
•
Store morphine sulfate ER 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 ER tablets if you have:
•
severe asthma, trouble breathing,

Summary of Product characteristics

MORPHINE SULFATE EXTENDED RELEASE- MORPHINE SULFATE TABLET, FILM
COATED, EXTENDED RELEASE
MAJOR PHARMACEUTICALS
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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; 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
Dosage and Administration (2.5)
10/2019
Warnings and Precautions (5.3, 5.13)
10/2019
INDICATIONS AND USAGE
Morphine sulfate extended-release tablets are 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
•
MORPHINE SULFATE EXTENDED-RELEASE 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_._
INSTRUCT PATIENTS TO
SWALLOW MORPHINE SULFATE EXTENDED-RELEASE TABLETS WHOLE TO AVOID
EXPOSURE TO A
POTENTIALLY FATAL DOSE OF MORPHINE. (5.3)
ACCIDENTAL INGESTION OF MORPHINE SULFATE EXTENDED-RELEASE TABLETS,
ESPECIALLY BY
CHILD