MORPHINE SULFATE EXTENDED RELEASE- morphine sulfate tablet, film coated, extended release MORPHINE SULFATE EXTENDED RELEASE- mo

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

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 moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Limitations of Use Morphine sulfate extended-release tablets are not for use: - As an as-needed (prn) analgesic. - For pain that is mild or not expected to persist for an extended period of time - For acute pain - In the immediate postoperative period (the first 24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established. - For postoperative pain unless the patient is already receiving chronic opioid therapy prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Morphine sulfate extended-release 100 mg and 200 mg tablets are only for patients in whom tolerance to an opioid of comparable potency is established.  Patients considered opioid-tolerant are those taking at least 6

Product summary:

Morphine Sulfate Extended-Release Tablets 15 mg are round, blue-colored, film-coated tablets bearing the symbol ABG on one side and 15 on the other. They are supplied as follows: NDC 42858-801-01: opaque plastic bottles containing 100 tablets Morphine Sulfate Extended-Release Tablets 30 mg are round, lavender-colored, film-coated tablets bearing the symbol ABG on one side and 30 on the other. They are supplied as follows: NDC 42858-802-01: opaque plastic bottles containing 100 tablets Morphine Sulfate Extended-Release Tablets 60 mg are round, orange-colored, film-coated tablets bearing the symbol ABG on one side and 60 on the other. They are supplied as follows: NDC 42858-803-01: opaque plastic bottles containing 100 tablets Morphine Sulfate Extended-Release Tablets 100 mg are round, gray-colored, film-coated tablets bearing the symbol ABG on one side and 100 on the other. They are supplied as follows: NDC 42858-804-01: opaque plastic bottles containing 100 tablets Morphine Sulfate Extended-Release Tablets 200 mg are capsule-shaped, green-colored, film-coated tablets bearing the symbol ABG on one side and 200 on the other. They are supplied as follows: NDC 42858-805-01: opaque plastic bottles containing 100 tablets Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F). Dispense in a tight, light-resistant container. CAUTION DEA FORM REQUIRED

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MORPHINE SULFATE EXTENDED RELEASE- MORPHINE SULFATE TABLET, FILM
COATED, EXTENDED
RELEASE
MORPHINE SULFATE EXTENDED RELEASE- MORPHINE SULFATE TABLET, FILM
COATED, EXTENDED
RELEASE
Lake Erie Medical DBA Quality Care Products LLC
----------
MEDICATION GUIDE
Morphine Sulfate Extended-Release (ER) Tablets, CII
Morphine sulfate extended-release tablets are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to treat
moderate to severe around-the-clock pain.
Important information about morphine sulfate extended-release tablets:
•
Get emergency help right away if you take too much morphine sulfate ER
tablets (overdose).
Morphine sulfate ER overdose can cause life threatening breathing
problems that can lead to
death.
•
Never give anyone else your morphine sulfate extended-release 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
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 ER, tell your healthcare provider if
you have a history of:
•
head injury, seizures
•
liver, kidney, thyroid problems
•
problems urinating
•
pancreas or gallbladder problems
•
abuse of street or prescription drugs, alcohol addiction, or mental
health problems.
Tell your healthcare provider if you are:
•
pregnant or planning to become pregnant. Morphine sulfate may harm
your unborn baby.
•
breastfeeding. Morphine sulfate passes into breast milk and may harm
your baby.
•
taking prescription or over-the-counter medicines, vitamins, or herbal
supplements.
When taking morphine sulfate extended-release tablets:
•
Do not change your dose. Take morphine sulfate extended-release
tablets exactly as prescribed by
your healthcare provider.
•
Take e

Summary of Product characteristics

MORPHINE SULFATE EXTENDED RELEASE- MORPHINE SULFATE TABLET, FILM
COATED, EXTENDED
RELEASE
MORPHINE SULFATE EXTENDED RELEASE- MORPHINE SULFATE TABLET, FILM
COATED, EXTENDED
RELEASE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
MORPHINE SULFATE EXTENDED-RELEASE TABLETS, CII
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MORPHINE SULFATE SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR MORPHINE SULFATE.
MORPHINE SULFATE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED
RELEASE FOR ORAL USE.
INITIAL U.S. APPROVAL: 1941
WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, AND
ACCIDENTAL EXPOSURE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
Morphine sulfate extended-release tablets contain morphine sulfate, a
Schedule II controlled substance. Monitor
for signs of misuse, abuse, and addiction during morphine sulfate
extended-release tablet therapy (5.1, 9).
Fatal respiratory depression may occur, with highest risk at
initiation and with dose increases. Instruct patients on
proper administration of morphine sulfate extended-release tablets to
reduce the risk (5.2).
Accidental ingestion of morphine sulfate extended-release tablets can
result in fatal overdose of morphine,
especially in children (5.3).
RECENT MAJOR CHANGES
Boxed Warning 2/2012
Indications and Usage (1) 2/2012
Dosage and Administration (2) 2/2012
Contraindications (4) 2/2012
Warnings and Precautions (5) 2/2012
INDICATIONS AND USAGE
Morphine sulfate extended-release tablets are an opioid agonist
product indicated for the management of moderate to
severe pain when a continuous, around-the-clock opioid analgesic is
needed for an extended period of time. (1)
Limitations of Use
Morphine sulfate extended-release tablets are not for use:
As an as-needed (prn) analgesic (1)
For pain that is mild or not expected to persist for an extended
period of time (1)
For acute pain (1)
In the immediate postoperative period (1)
For postoperative pain, unless the pat