MORPHINE SULFATE tablet, extended release

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

SpecGx LLC

INN (আন্তর্জাতিক নাম):

MORPHINE SULFATE

রচনা:

MORPHINE SULFATE 15 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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 and Precautions (5.3)] - Acute or severe bronchial

পণ্য সারাংশ:

Each Morphine Sulfate Extended-Release Tablet 15 mg is available as a round, blue convex tablet, one side debossed  and the other side debossed “15”. Bottles of 100 ................................. NDC 0406-8315-01 Unit Dose (10 x 10)......................... NDC 0406-8315-62 Each Morphine Sulfate Extended-Release Tablet 30 mg is available as a round, purple convex tablet, one side debossed  and the other side debossed “30”. Bottles of 100 ................................. NDC 0406-8330-01 Unit Dose (10 x 10)......................... NDC 0406-8330-62 Each Morphine Sulfate Extended-Release Tablet 60 mg is available as a round, orange convex tablet, one side debossed  and the other side debossed “60”. Bottles of 100 ................................. NDC 0406-8380-01 Unit Dose (10 x 10)......................... NDC 0406-8380-62 Each Morphine Sulfate Extended-Release Tablet 100 mg is available as a round, gray convex tablet, one side debossed  and the other side debossed “100”. Bottles of 100 ................................. NDC 0406-8390-01 Unit Dose (10 x 10)......................... NDC 0406-8390-62 Each Morphine Sulfate Extended-Release Tablet 200 mg is available as a capsule-shaped, green convex tablet, one side debossed  and the other side debossed “200”. Bottles of 100 ................................. NDC 0406-8320-01 Storage: Store at 20° to 25°C (68° to 77°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.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

MORPHINE SULFATE- MORPHINE SULFATE TABLET, EXTENDED RELEASE
SpecGx LLC
----------
Medication Guide
Morphine Sulfate Extended-Release Tablets, CII
(MOR feen SUL fate)
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 morphine sulfate extended-r

পণ্য বৈশিষ্ট্য

MORPHINE SULFATE- MORPHINE SULFATE TABLET, EXTENDED RELEASE
SPECGX LLC
----------
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 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 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 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)
CONCOMITANT USE OF OPIOI