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:

American Health Packaging

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, 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 - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipmen

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: Unit dose packages of 100 (10 x 10) NDC 68084-403-01 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: Unit dose packages of 100 (10 x 10) NDC 68084-404-01 Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). FOR YOUR PROTECTION: Do not use if blister is torn or broken. CAUTION DEA FORM REQUIRED

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

American Health Packaging
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MEDICATION GUIDE
8240301/0318
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.
•
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 Tablets, 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, o

Summary of Product characteristics

MORPHINE SULFATE- MORPHINE SULFATE TABLET, EXTENDED RELEASE
AMERICAN HEALTH PACKAGING
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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; AND NEONATAL OPIOID WITHDRAWAL SYNDROME
_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 EACH PATIENT’S RISK BEFORE
PRESCRIBING, AND MONITOR REGULARLY
FOR DEVELOPMENT OF 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 IN CHILDREN, CAN RESULT IN
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 OPIOID
USE IS REQUIRED FOR A PROLONGED PERIOD 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)
RECENT MAJOR CHANGES
Boxed Warning
04/2014
Indications and Usage ( 1)
04/2014
Dosage and Administration ( 2)
04/2014
Warnings and Precautions ( 5)
04/2014
INDICATIONS AND USAGE
Morphine sulfate extended-release tablets are an opioid agonist
product indicated for the management of pain severe
enough to require daily, around-t