MORPHINE SULFATE solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Akorn

INN (Internationale Bezeichnung):

MORPHINE SULFATE

Zusammensetzung:

MORPHINE SULFATE 100 mg in 5 mL

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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]: Morphine sulfate oral solution is contraindicated in patients with: Risk Summary Prolonged use of opioid analgesics during pregnancy can cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.5) ]. There are no available data with morphine sulfate oral solution 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 administe

Produktbesonderheiten:

Morphine Sulfate Oral Solution: 100 mg per 5 mL (20 mg/mL) Oral Solution (colorless) (only for opioid tolerant adults) is supplied as a clear, colorless solution. Each 1 mL of clear, colorless oral solution contains 20 mg of morphine sulfate, USP (equivalent to 15 mg morphine). Bottle of 30 mL with an oral syringe - NDC 50383-965-30 Bottle of 120 mL with an oral syringe - NDC 50383-965-04 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)]

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

Akorn
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MEDICATION GUIDE
Morphine Sulfate Oral Solution,
(mor’ feen sul’ fate)
Morphine sulfate oral solution is:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage short
term (acute) pain in adults and older and long term (chronic) pain in
adults 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 takeyour 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
provide

Fachinformation

MORPHINE SULFATE- MORPHINE SULFATE SOLUTION
AKORN
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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._
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RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Morphine sulfate oral solution is an opioid agonist.
Morphine sulfate oral solution 20 mg/mL is indicated for:
•
Limitations of Use (1):
Because of the risks of addiction, abuse, and misuse with opioids,
even at recommended doses, reserve
morphine sulfate oral solution for use in patients for whom
alternative treatment options [e.g., non-opioid
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 SULFAT