MORPHINE SULFATE tablet, film coated, extended release

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Mayne Pharma Commercial LLC

INN (International namn):

Morphine Sulfate

Sammansättning:

Morphine Sulfate 15 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)] , 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 [see Warnings and Precautions

Produktsammanfattning:

Morphine sulfate extended-release 15 mg tablets are round, film-coated, blue tablets, debossed with "15" on one side and "ML" on the other side. They are available as follows: Morphine sulfate extended-release 30 mg tablets are round, film-coated, purple tablets, debossed with "30" on one side and "ML" on the other side. They are available as follows: Morphine sulfate extended-release 60 mg tablets are round, film-coated, orange tablets, debossed with "60" on one side and "ML" on the other side. They are available as follows: Morphine sulfate extended-release 100 mg tablets are round, film-coated, gray tablets, debossed with "100" on one side and "ML" on the other side. They are available as follows: Store at 20° to 25°C (68° to 77°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 as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription. CAUTION DEA FORM REQUIRED

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

Mayne Pharma Commercial LLC
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Medication Guide
Morphine sulfate extended-release tablets (MOR feen SUL fate), CII
Morphine sulfate 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 or call 911 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. Talk to your
healthcare provider about
naloxone, a medicine for the emergency treatment of an opioid
overdose.
•
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. Selling or giving away morphine sulfate extended-release
tablets is against the law.
•
Store morphine sulfate extended-release 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 extended-release tablets if you have:
•
severe ast

Produktens egenskaper

MORPHINE SULFATE- MORPHINE SULFATE TABLET, FILM COATED, EXTENDED
RELEASE
MAYNE PHARMA COMMERCIAL LLC
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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 (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_.
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)
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
CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF MORPHINE. ( 5.3)
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 RISK OF NEONATAL OPIOID WITHDRAWAL SYNDROME
AND ENSURE