MORPHINE SULFATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PAI Holdings, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Morphine Sulfate Oral Solution 2 mg/mL is indicated for the management of • adults with acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. • pediatric patients 2 years of age and older with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Morphine Sulfate Oral Solution 20 mg/mL is indicated for the relief of acute and chronic pain in opioid-tolerant adult patients . Limitations of Use : Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see  Warnings and Precautions (5.2 )], reserve Morphine Sulfate Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: • Have not been tolerated, or are not expected to be tolerated, • Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Morphine Sulfat

Product summary:

Morphine Sulfate Oral Solution: 10 mg per 5 mL (2 mg/mL) Oral Solution is supplied as a clear, blue-green solution . Each 1 mL of clear, blue-green oral solution contains 2 mg of morphine sulfate, USP (equivalent to 1.5 mg morphine). NDC 0121-0904-05: 5 mL unit dose cup, in a tray of ten cups. Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Store Morphine Sulfate Oral Solution securely and dispose of properly [ see Patient Counseling Information ( 17) ].

Authorization status:

New Drug Application

Patient Information leaflet

PAI Holdings, LLC
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MEDICATION GUIDE
Medication Guide
Morphine (mor-pheen) Sulfate Oral Solution, CII
Morphine Sulfate Oral Solution is:
•
A strong prescription pain medicine that contains an opioid
(narcotic) that is used to manage short term (acute) and long
term (chronic) pain severe enough to require an opioid pain
medicine, when other pain treatments such as non-opioid pain
medicines do not treat your pain well enough or you cannot
tolerate them.
•
An 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.
Important information about Morphine Sulfate Oral Solution:
• Get emergency help or call 911 right away if you take too much
Morphine Sulfate Oral Solution (overdose). When you first start
taking Morphine Sulfate Oral Solution, 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. Talk to your healthcare
provider about naloxone, a medicine for the emergency treatment of
an opioid overdose.
• Taking Morphine Sulfate Oral Solution 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 Oral Solution. They
could die from taking it. Selling or giving away Morphine Sulfate Oral
Solution is against the law.
• Store Morphine Sulfate Oral Solution securely, out of sight and
reach of children, and in a location not accessible by others,
including
visitors to the home.
Do not take Morphine Sulfate Oral Solution if you have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel blockage or have narrowing of the stomach or
intestines.
•
an allergy to morphine.
Before taking Morphine Sulfate Oral Solution, tell your healthcare
provider if you have

Summary of Product characteristics

MORPHINE SULFATE- MORPHINE SULFATE SOLUTION
PAI HOLDINGS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MORPHINE SULFATE ORAL
SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MORPHINE SULFATE
ORAL SOLUTION.
MORPHINE SULFATE ORAL SOLUTION, FOR ORAL USE CII
INITIAL U.S. APPROVAL: 1941
WARNING: RISK OF MEDICATION ERRORS; 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._
• Ensure accuracy when prescribing, dispensing, and administering
Morphine Sulfate Oral Solution.
Dosing errors due to confusion between mg and mL, and other morphine
solutions of different
concentrations can result in accidental overdose and death. (2.1, 5.1)
• Morphine Sulfate Oral Solution exposes 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. (5.2)
• 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. (5.3)
• Serious, life-threatening, or fatal respiratory depression may
occur. Monitor closely, especially upon
initiation or following a dose increase. (5.4)
• Accidental ingestion of Morphine Sulfate Oral Solution, especially
by children, can result in a fatal
overdose of morphine. (5.4)
• Prolonged use of Morphine Sulfate Oral Solution 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 withdrawa