MORPHINE SULFATE tablet, film coated, extended release

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Actavis Pharma, Inc.

INN (Medzinárodný Name):

MORPHINE SULFATE

Zloženie:

MORPHINE SULFATE 15 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 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. 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 for use in p

Prehľad produktov:

Morphine sulfate extended-release tablets are available as follows: 15 mg Each round, white to off white, film-coated, unscored tablet debossed with  on one side and 270 on the other side contains 15 mg of morphine sulfate, USP. Tablets are supplied in bottles of 100 (NDC 0228-4270-11). 30 mg Each round, yellow, film-coated, unscored tablet debossed with  on one side and 271 on the other side contains 30 mg of morphine sulfate, USP. Tablets are supplied in bottles of 100 (NDC 0228-4271-11). 60 mg Each round, pink, film-coated, unscored tablet debossed with  on one side and 311 on the other side contains 60 mg of morphine sulfate, USP. Tablets are supplied in bottles of 100 (NDC 0228-4311-11). 100 mg Each round, red, film-coated, unscored tablet debossed with  on one side and 323 on the other side contains 100 mg of morphine sulfate, USP. Tablets are supplied in bottles of 100 (NDC 0228-4323-11). 200 mg Each capsule-shaped, red, film-coated, unscored tablet debossed with  on one side and 347 on the other side contains 200 mg of morphine sulfate, USP. Tablets are supplied in bottles of 100 (NDC 0228-4347-11). Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°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.

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

Actavis Pharma, Inc.
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Medication Guide
Dispense with Medication Guide available at: www.tevausa.com/medguides
Morphine Sulfate (mor' feen sul' fate) Extended-Release Tablets, 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 many
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 morp

Súhrn charakteristických

MORPHINE SULFATE- MORPHINE SULFATE TABLET, FILM COATED, 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 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 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 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 O