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

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Cumpara asta acum

Descarcare Prospect (PIL)
08-02-2022

Ingredient activ:

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

Disponibil de la:

Bryant Ranch Prepack

INN (nume internaţional):

MORPHINE SULFATE

Compoziție:

MORPHINE SULFATE 100 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 (5.3)] - Acute or severe bronchial

Rezumat produs:

NDC: 63629-4514-1: 90 Tablets in a BOTTLE NDC: 63629-4514-2: 60 Tablets in a BOTTLE NDC: 63629-4514-3: 30 Tablets in a BOTTLE NDC: 63629-4514-4: 120 Tablets in a BOTTLE

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

                                Bryant Ranch Prepack
----------
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:
03/2021
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 or call 911 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. 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 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, 
                                
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Caracteristicilor produsului

                                MORPHINE SULFATE EXTENDED RELEASE- MORPHINE SULFATE TABLET, FILM
COATED, EXTENDED RELEASE
BRYANT RANCH PREPACK
----------
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._
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
CHILDREN, CAN RESULT IN 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
THAT APPROPRIATE TREATMENT WILL BE AVAI
                                
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