MORPHINE SULFATE- morphine sulfate solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

VistaPharm, Inc.

INN (International Name):

MORPHINE SULFATE

Sammensetning:

MORPHINE SULFATE 10 mg in 5 mL

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Morphine Sulfate Oral Solution is indicated for the management of acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of acute and chronic pain in opioid-tolerant 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 Sulfate Oral Solution is contraindicated in patients with: - Significant respiratory depression [see Warnings and Precautions (5.4) ]. - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resus

Produkt oppsummering:

Morphine Sulfate Oral Solution 10 mg per 5 mL (2 mg/mL) Oral Solution is supplied as a clear, red, cherry flavor solution. NDC 66689-032-50: Case contains 50 unit dose cups of 5 mL (NDC 66689-032-01), packaged in 5 trays of 10 unit dose cups each. NDC 66689-032-04: Bottles of 100 mL; supplied with calibrated measuring cup NDC 66689-032-16: Bottles of 500 mL; supplied with calibrated measuring cup 20 mg per 5 mL (4 mg/mL) Oral Solution is supplied as a clear, red, cherry flavor solution. NDC 66689-033-50: Case contains 50 unit dose cups of 5 mL (NDC 66689-033-01), packaged in 5 trays of 10 unit dose cups each. NDC 66689-033-04: Bottles of 100 mL; supplied with calibrated measuring cup NDC 66689-033-16: Bottles of 500 mL; supplied with calibrated measuring cup Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

VistaPharm, Inc.
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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 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.
•
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. Store
Morphine Sulfate Oral Solution away from children and in a safe place
to prevent stealing or
abuse. Selling or giving away Morphine Sulfate Oral Solution is
against the law.
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 a history of:
•
head injury, seizures
•
problems urinating
•
liver, kidney, thyroid problems
•
pancreas or gallbladder problems
•
abuse of street or prescription drugs, alc

Preparatomtale

MORPHINE SULFATE- MORPHINE SULFATE SOLUTION
VISTAPHARM, INC.
----------
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
WITHDRAWAL SYNDROME AND ENSURE THA