MORPHINE SULFATE tablet, extended release

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Zydus Pharmaceuticals (USA) 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 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

Prehľad produktov:

Morphine Sulfate Extended-Release Tablets 15 mg are oval, film-coated, green tablets debossed "N" on one side and "15" on the other.  They are supplied as follows: NDC 68382-903-01…………Bottles of 100 tablets Morphine Sulfate Extended-Release Tablets 30 mg are oval, film-coated, pink tablets, debossed "N" on one side and "30" on the other.  They are supplied as follows: NDC 68382-904-01…………Bottles of 100 tablets Morphine Sulfate Extended-Release Tablets 60 mg are oval, film-coated, white tablets debossed "N" on one side and "60" on the other.  They are supplied as follows: NDC 68382-905-01…………Bottles of 100 tablets Morphine Sulfate Extended-Release Tablets 100 mg are oval, film-coated, gray tablets debossed "N" on one side and "100" on the other.  They are supplied as follows: NDC 68382-906-01…………Bottles of 100 tablets Morphine Sulfate Extended-Release Tablets 200 mg are oval, film-coated, brown tablets debossed "N" on one side and "200" on the other.  They are supplied as follows: NDC 68382-907-01…………Bottles of 100 tablets 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 and child-resistant container. CAUTION DEA FORM REQUIRED

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

MORPHINE SULFATE- morphine sulfate tablet, extended release
Zydus Pharmaceuticals (USA) Inc.
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Medication Guide
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 right away if you take too much 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.
•
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 Morphine Sulfate Extended-Release Tablets if you have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel

Súhrn charakteristických

MORPHINE SULFATE- MORPHINE SULFATE TABLET, EXTENDED RELEASE
ZYDUS PHARMACEUTICALS (USA) INC.
----------
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 TO
USE 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 AND 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 TABLETSWHOLE 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 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 AVAILABLE. (5.4