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:

McKesson Corporation

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: Clinical Considerations Fetal/neonatal adverse reactions Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Observe newborns for symptoms of neonatal opioid withdrawal syndrome, such as poor feeding, diarrhea, irritability, tremor, rigidity, and seizures, and manage accordingly [see Warnings and Precautions (5.3)]. Teratogenic Effects (Pregnancy Category C) There are no adequate and well-controlled studies in pregnant women. Morphine sulfate extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential r

Product summary:

Morphine Sulfate Extended-Release Tablets 15 mg are oval, film-coated, green tablets debossed "N" on one side and "15" on the other.  They are supplied as follows: Boxes of 10x10 UD 100 NDC 63739-899-10 Morphine Sulfate Extended-Release Tablets 30 mg are oval, film-coated, pink tablets, debossed "N" on one side and "30" on the other.  They are supplied as follows: Boxes of 10x10 UD 100 NDC 63739-726-10 Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant and child-resistant container. CAUTION Manufactured by: Zydus Pharmaceuticals 73 Route 31 N. Pennington, NJ 08534 Distributed by: McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Rd., Concord, NC 28027 IS-4015286 November 2015 DEA FORM REQUIRED

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MORPHINE SULFATE- MORPHINE SULFATE TABLET, EXTENDED RELEASE
McKesson Corporation
----------
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 drug

Summary of Product characteristics

MORPHINE SULFATE- MORPHINE SULFATE TABLET, EXTENDED RELEASE
MCKESSON CORPORATION
----------
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 EXPOSES 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-the-clock, lon