MORPHINE SULFATE solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Paddock Laboratories, LLC

INN (Nome Internazionale):

MORPHINE SULFATE

Composizione:

MORPHINE SULFATE 100 mg in 5 mL

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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]: 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 s

Dettagli prodotto:

Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) Oral Solution is supplied as a clear/colorless to light yellow solution. NDC 0574-0153-30: Bottle of 30 mL with an Oral Syringe NDC 0574-0153-12: Bottle of 120 mL with an Oral Syringe 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)].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

MORPHINE SULFATE- MORPHINE SULFATE SOLUTION
Paddock Laboratories, 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:
•
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. 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 a history of:
•
head injury, seizures • liver, kidney, thyroid problems
•
probl

Scheda tecnica

MORPHINE SULFATE- MORPHINE SULFATE SOLUTION
PADDOCK LABORATORIES, 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._
•
•
•
•
•
•
•
RECENT MAJOR CHANGES
Dosage and Administration (2.4)
10/2019
Warnings and Precautions (5.4, 5.14)
10/2019
INDICATIONS AND USAGE
Morphine Sulfate Oral Solution is an opioid agonist indicated for the
management of acute and chronic pain severe enough
to require an opioid analgesic and for which alternative treatments
are inadequate. (1)
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 analgesics or opioid combination
products]: (1)
•
•
DOSAGE AND ADMINISTRATION
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 (FD