MORPHINE SULFATE- morphine sulfate tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Par Pharmaceutical

INN (International Name):

MORPHINE SULFATE

Composition:

MORPHINE SULFATE 15 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 (5.2)] - Acute or severe bronchial

Product summary:

Morphine sulfate extended-release tablets 15 mg are blue, round tablets, debossed “E652” on one side, and “15” on the other side. They are supplied as follows: NDC 60951-652-70: bottles containing 100 tablets Morphine sulfate extended-release tablets 30 mg are green, round tablets, debossed “E653” on one side, and “30” on the other side.  They are supplied as follows: NDC 60951-653-70: bottles containing 100 tablets Morphine sulfate extended-release tablets 60 mg are orange, capsule-shaped tablets, debossed “E655” on one side, and “60” on the other side. They are supplied as follows: NDC 60951-655-70: bottles containing 100 tablets Morphine sulfate extended-release tablets 100 mg are blue, capsule-shaped tablets, debossed “E658” on one side, and “100” on the other side.  They are supplied as follows: NDC 60951-658-70: bottles containing 100 tablets Morphine sulfate extended-release tablets 200 mg are green, oval tablets, debossed “E659” on one side and “200” on the other side. They are supplied as follows: NDC 60951-659-70: bottles containing 100 tablets Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). Dispense in a tight, light-resistant container. CAUTION DEA FORM REQUIRED

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Par Pharmaceutical
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MEDICATION GUIDE
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. Store morphine sulfate extended-release tablets away from
children and in a safe place
to prevent stealing or abuse. Selling or giving away morphine sulfate
extended-release tablets is
against the law.
Do not take morphine sulfate extended-release tablets if you have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel blockage or have narrowing of the stomach or intestines.
Before taking morphine sulfate extended-release t

Summary of Product characteristics

MORPHINE SULFATE- MORPHINE SULFATE TABLET, EXTENDED RELEASE
PAR PHARMACEUTICAL
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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; 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)
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. (5.2)
ACCIDENTAL INGESTION OF MORPHINE SULFATE EXTENDED-RELEASE TABLETS,
ESPECIALLY BY CHILDREN, CAN RESULT IN
A FATAL OVERDOSE OF MORPHINE. (5.2)
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. (5.3)
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 ARE IN