MORPHINE SULFATE- morphine sulfate tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

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 Morphine sulfate extended-release tablets are contraindicated in patients with: Prolonged use of opioid analgesics during pregnancy may cause neonatal withdrawal syndrome [see Warnings and Precautions (5.4)]. There are no available data with morphine sulfate extended-release tablets in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Published studies with morphine use during pregnancy have not reported a clear association with morphine and major birth defects [see Human Data]. In published animal reproduction studies, morphine administered subcutaneously during the early gestational period produced neural tube defects (i.e., exencephaly and cranioschisis) at 5 and 16 times the human daily dose of 60 mg based on body surface area (HD

Product summary:

Morphine Sulfate Extended-Release Tablets are available containing 15 mg, 30 mg, 60 mg, 100 mg or 200 mg of morphine sulfate, USP. The 15 mg tablets are light blue, film-coated, round, unscored tablets debossed with M on one side of the tablet and MS over 15 on the other side. They are available as follows: NDC 0378-2658-01 bottles of 100 tablets The 30 mg tablets are purple, film-coated, round, unscored tablets debossed with M on one side of the tablet and MS over 30 on the other side. They are available as follows: NDC 0378-2659-01 bottles of 100 tablets The 60 mg tablets are peach, film-coated, round, unscored tablets debossed with M on one side of the tablet and MS over 60 on the other side. They are available as follows: NDC 0378-2660-01 bottles of 100 tablets The 100 mg tablets are gray, film-coated, round, unscored tablets debossed with M on one side of the tablet and MS over 100 on the other side. They are available as follows: NDC 0378-2661-01 bottles of 100 tablets The 200 mg tablets are light green, film-coated, oval, unscored tablets debossed with M on one side of the tablet and MS 200 on the other side. They are available as follows: NDC 0378-2662-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Mylan Pharmaceuticals Inc.
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MEDICATION GUIDE
Morphine Sulfate Extended-Release (ER) Tablets CII
(mor' feen sul' fate)
Morphine Sulfate ER 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 ER Tablets:
•
Get emergency help right away if you take too many Morphine Sulfate ER
Tablets (overdose).
When you first start taking Morphine Sulfate ER Tablets, when your
dose is changed, or if you take
too many (overdose), serious or life-threatening breathing problems
that can lead to death may
occur.
•
Taking Morphine Sulfate ER 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 ER Tablets. They could
die from taking it. Store
Morphine Sulfate ER Tablets away from children and in a safe place to
prevent stealing or abuse.
Selling or giving away Morphine Sulfate ER Tablets is against the law.
Do not take Morphine Sulfate ER 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 ER Tablets, tell your healthcare
provider if you have a history of:
•
head injury, seizures
•
•
liver, kidney, thyroid problems
•
problems urinati

Summary of Product characteristics

MORPHINE SULFATE- MORPHINE SULFATE TABLET, FILM COATED, EXTENDED
RELEASE
MYLAN PHARMACEUTICALS 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._
•
•
•
•
•
•
RECENT MAJOR CHANGES
Boxed Warning 09/2018
Warnings and Precautions (5.2) 09/2018
INDICATIONS AND USAGE
Morphine sulfate extended-release tablets are an opioid agonist
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. (1)
Limitations of Use
•
•
DOSAGE AND ADMINISTRATION
•
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 CHILD