MORPHINE SULFATE capsule, extended release

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

Morphine Sulfate (UNII: X3P646A2J0) (Morphine - UNII:76I7G6D29C)

Pieejams no:

Quality Care Products LLC

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Morphine Sulfate Extended-release Capsules, USP is an 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, reserve Morphine Sulfate Extended-release Capsules 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 Capsules are not indicated as an as-needed (prn) analgesic. Morphine Sulfate Extended-release Capsules are contraindicated in patients with - Significant respiratory depression - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitativ

Produktu pārskats:

NDC:55700-349-60 in a BOTTLE of 60 CAPSULE, EXTENDED RELEASES Store at 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a sealed tamper-evident, childproof, light-resistant container.

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

MORPHINE SULFATE- morphine sulfate capsule, extended release
Quality Care Products LLC
----------
Medication Guide
Morphine Sulfate (mor∙feen sul∙fate) Extended-release Capsules,
CII
Morphine Sulfate Extended-release Capsules 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
Capsules:
•
When you first start taking Morphine Sulfate Extended-release
Capsules, 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. Get emergency help right away if you take too much
Morphine Sulfate Extended-
release Capsules (overdose).
•
Never give anyone else your Morphine Sulfate Extended-release
Capsules. They could die from
taking it. Store Morphine Sulfate Extended-release Capsules away from
children and in a safe place to
prevent stealing or abuse. Selling or giving away Morphine Sulfate
Extended-release Capsules is
against the law.
Do not take Morphine Sulfate Extended-release Capsules 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 Capsules, tell your
healthcare provider if you have a
history of:
•
head injury, seizures
•
problems urinating
•
liver, kidney, thyroid problems
•
pancreas or gallbladder problems
•
abuse of street

Produkta apraksts

MORPHINE SULFATE- MORPHINE SULFATE CAPSULE, EXTENDED RELEASE
QUALITY CARE PRODUCTS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
MORPHINE SULFATE EXTENDED-RELEASE CAPSULES, FOR ORAL USE, CII THESE
HIGHLIGHTS DO NOT
INCLUDE ALL THE INFORMATION NEEDED TO USE MORPHINE SULFATE
EXTENDED-RELEASE CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MORPHINE
SULFATE EXTENDED-
RELEASE CAPSULES. MORPHINE SULFATE EXTENDED-RELEASE CAPSULES, 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
INTERACTION WITH ALCOHOL
. _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
MORPHINE SULFATE EXTENDED-RELEASE CAPSULES EXPOSES USERS TO RISKS OF
ADDICTION,
ABUSE, AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS EACH
PATIENT'S
RISK BEFORE PRESCRIBING, AND MONITOR REGULARLY FOR DEVELOPMENT OF
THESE BEHAVIORS
OR 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 CAPSULES WHOLE TO AVOID EXPOSURE TO
A
POTENTIALLY FATAL DOSE OF MORPHINE. ( ) 5.2
ACCIDENTAL INGESTION OF MORPHINE SULFATE EXTENDED-RELEASE CAPSULES,
ESPECIALLY IN
CHILDREN, CAN RESULT IN FATAL OVERDOSE OF MORPHINE. ( ) 5.3
PROLONGED USE OF MORPHINE SULFATE EXTENDED-RELEASE CAPSULES DURING
PREGNANCY
CAN RESULT IN NEONATAL OPIOID WITHDRAWAL SYNDROME, WHICH MAY BE
LIFE-THREATENING IF
NOT RECOGNIZED AND TREATED. IF OPIOID USE IS REQUIRED FOR A PROLONGED
PERIOD IN A
PREGNANT WOMAN, ADVISE THE PATIENT OF THE RISK OF NEONATAL OPIOID
WITHDRAWAL
SYNDROME AND ENSURE THAT APPROPRIATE TREATMENT WILL BE AVAILABLE ( ).
5.3
INSTRUCT PATIENTS NOT TO CONSUME ALCOHOL OR ANY PRODUCTS CONTAINING
ALCOHOL WHILE
TAKING MORPHINE SULFATE EXTENDED-RELEASE CAPSULES BECAUSE CO-INGESTION
CAN RESULT
IN FATAL PLASMA MORPHINE LEVELS. ( ) 5.4
INDICATIONS AND USA