MORPHINE SULFATE capsule, extended release

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Actavis Pharma, Inc.

INN (Alþjóðlegt nafn):

MORPHINE SULFATE

Samsetning:

MORPHINE SULFATE 10 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Morphine sulfate extended-release capsules 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 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 [see Warnings and Pre cautions ( 5.3 )] - Acute or sever

Vörulýsing:

Morphine sulfate extended-release capsules contain white to off-white or tan colored polymer coated extended-release pellets of morphine sulfate and are available in eight dose strengths. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from light and moisture.  Dispense in a sealed tamper-evident, childproof, light-resistant container. Store morphine sulfate extended-release capsules securely and dispose of properly [see Patient Counseling Information ( 17 ) ] .

Leyfisstaða:

New Drug Application Authorized Generic

Upplýsingar fylgiseðill

Actavis Pharma, Inc.
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Medication Guide
Morphine Sulfate 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:
•
Get emergency help or call 911 right away if you take too much
morphine sulfate extended-
release capsules (overdose). 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. Talk
to your healthcare
provider about naloxone, a medicine for the emergency treatment of an
opioid overdose.
•
Taking morphine sulfate extended-release capsules 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
capsules. They could die from
taking it. Selling or giving away morphine sulfate extended-release
capsules is against the law.
•
Store morphine sulfate extended-release capsules 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 Capsules if you have:
•
severe asthma, trouble brea

Vara einkenni

MORPHINE SULFATE- MORPHINE SULFATE CAPSULE, EXTENDED RELEASE
ACTAVIS PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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; RISK EVALUATION AND MITIGATION
STRATEGY (REMS); LIFE- THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL
INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTION WITH
ALCOHOL;
AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
MORPHINE SULFATE EXTENDED-RELEASE CAPSULES EXPOSE 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 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 CAPSULES WHOLE TO AVOID EXPOSURE TO
A
POTENTIALLY FATAL DOSE OF MORPHINE. (5.3)
ACCIDENTAL INGESTION OF MORPHINE SULFATE EXTENDED-RELEASE CAPSULES,
ESPECIALLY BY
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 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 W