MORPHINE SULFATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

SpecGx LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Morphine Sulfate Tablets are indicated for the management of: - adults with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. - adults with chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve morphine sulfate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: - Have not been tolerated, or are not expected to be tolerated, - Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Pediatric use information is approved for Hikma Pharmaceuticals USA Inc.’s Morphine Sulfate Tablets. However, due to Hikma Pharmaceuticals USA Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Morphine sulfate t

Product summary:

Morphine Sulfate Tablets are supplied as follows: Each 15 mg tablet for oral administration contains: 15 mg morphine sulfate USP and is a white, biconvex tablet, debossed “M” on one side, and “15” with a score on the other side.  15 mg bottles of 100: NDC 0406-5118-01 15 mg box of 100 unit dose: NDC 0406-5118-62 Each 30 mg tablet for oral administration contains: 30 mg morphine sulfate USP and is a white, biconvex tablet, debossed “M” on one side, and “30” with a score on the other side.  30 mg bottles of 100: NDC 0406-5119-01 30 mg box of 100 unit dose: NDC 0406-5119-62 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Store morphine sulfate tablets securely and dispose of properly [see Patient Counseling Information (17)] .

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

SpecGx LLC
----------
Medication Guide
Morphine Sulfate (mor’ feen sul’
fate) Tablets CII
Rx only
Morphine sulfate tablets are:
•
A strong prescription pain
medicine that contains an
opioid (narcotic) that is used
to manage short-term (acute)
pain in adults and long-term
(chronic) pain in adults
severe enough to require an
opioid pain medicine, when
other pain treatments such as
non-opioid pain medicines do
not treat your pain well
enough or you cannot tolerate
them.
•
An 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.
Important information about
morphine sulfate tablets:
•
Get emergency help or call
911 right away if you take
too many morphine sulfate
tablets (overdose). When you
first start taking morphine
sulfate 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
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 tablets.
They could die from taking
it. Selling or giving away
morphine sulfate tablets is
against the law.
•
Store morphine sulfate
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 tablets
if you have:
•
Severe asthma, trouble
breathing, or other lung
problems.
•
A bowel blockage or have
narrowing of the stomach or
intestines.
•
An allergy to morphine.
Before taking morphine sulfate
tablets, tell your healthcare provider
if you have a history of:
•
Head
injury,
seizures.
�

Summary of Product characteristics

MORPHINE SULFATE- MORPHINE SULFATE TABLET
SPECGX LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MORPHINE SULFATE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MORPHINE SULFATE
TABLETS.
MORPHINE SULFATE 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 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. (5.3)
ACCIDENTAL INGESTION OF MORPHINE SULFATE TABLETS, ESPECIALLY BY
CHILDREN, CAN RESULT IN
A FATAL OVERDOSE OF MORPHINE. (5.3)
PROLONGED USE OF MORPHINE SULFATE 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 OPIOIDS WITH BENZODIAZEPINES OR OTHER CENTRAL
NERVOUS SYSTEM
(CNS) DEPRESSANTS, INCLUDING ALCOHOL, MAY RESULT IN PROFOUND SEDATION,
RESPIRATORY
DEPRESSION, COMA, AND DEATH. RESERVE CONCOMITANT PRESCRIBING FOR USE
IN PATIENTS
FOR WHOM ALTERNATIVE TREATMENT OPTIONS