MORPHABOND ER- morphine sulfate tablet, extended release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Daiichi Sankyo Inc.

INN (International Name):

MORPHINE SULFATE

Sammensetning:

MORPHINE SULFATE 15 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

MORPHABOND ER is 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 MORPHABOND ER 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. - MORPHABOND ER is not indicated as an as-needed (prn) analgesic. MORPHABOND ER is contraindicated in patients with: - Significant respiratory depression [see Warnings and Precautions ( 5.3 )] - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (

Produkt oppsummering:

MORPHABOND™  ER (morphine sulfate) extended-release tablets 15 mg are round, blue-colored, coated tablets ink-printed with IDT/M15 on one side; and plain on the other. They are supplied as opaque plastic bottles containing 100 tablets (NDC 65597-301-10). MORPHABOND™ ER (morphine sulfate) extended-release tablets 30 mg are round, purple-colored, coated tablets ink-printed with IDT/M30 on one side; and plain on the other. They are supplied as opaque plastic bottles containing 100 tablets (NDC 65597-302-10). MORPHABOND™ ER (morphine sulfate) extended-release tablets 60 mg are round, orange-colored, coated tablets ink-printed with IDT/M60 on one side; and plain on the other. They are supplied as opaque plastic bottles containing 100 tablets (NDC 65597-303-10). MORPHABOND™ ER (morphine sulfate) extended-release tablets 100 mg are round, gray-colored, coated tablets ink-printed with IDT/M100 on one side; and plain on the other. They are supplied as opaque plastic bottles containing 100 tablets (NDC 65597-304-10). Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)   [see USP Controlled Room Temperature] . Dispense in a tight, light-resistant container. Store MORPHABOND ER securely and dispose of properly [see Patient Counseling Information (17)] .

Autorisasjon status:

New Drug Application

Informasjon til brukeren

Daiichi Sankyo Inc.
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Medication Guide
MORPHABOND™ ER ('môr-'fa-'bänd ē-r)
(morphine sulfate) extended-release tablets, CII
MORPHABOND ER is:
•
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 MORPHABOND ER:
•
Get emergency help right away if you take too much MORPHABOND
ER (overdose). When you first start taking MORPHABOND ER, 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 MORPHABOND ER 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 MORPHABOND ER. They could die from
taking it. Selling or giving away MORPHABOND ER is against the law.
•
Store MORPHABOND ER securely, out of sight and reach of children,
and in a location not accessible by others, including visitors to the
home.
Do not take MORPHABOND ER if you have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel blockage or have narrowing of the stomach or intestines.
Before taking MORPHABOND ER, tell your healthcare provider if you have
a
history of:
• head injury, seizures
• liver, kidney, thyroid problems
• problems urinating
• pancreas or gallbladder problems
• abuse of street or prescription d

Preparatomtale

MORPHABOND ER- MORPHINE SULFATE TABLET, EXTENDED RELEASE
DAIICHI SANKYO INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MORPHABOND ER SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR MORPHABOND ER.
MORPHABOND ER (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._
MORPHABOND ER 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
MORPHABOND ER TABLETS WHOLE TO
AVOID EXPOSURE TO A POTENTIALLY FATAL DOSE OF MORPHINE. (5.3)
ACCIDENTAL INGESTION OF MORPHABOND ER, ESPECIALLY BY CHILDREN, CAN
RESULT IN A FATAL OVERDOSE OF
MORPHINE. (5.3)
PROLONGED USE OF MORPHABOND ER 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 AVAILABLE. (5.4)
CONCOMITANT USE OF OPIOIDS WITH BENZODIAZEPINES OR OTHER CENTRAL
NERVOUS SYSTEM (CNS) DEPRESSANTS,
INCLUDING ALCOHOL, MAY RESULT IN PROFOUND SEDATION, RESPIRATORY
D