MORPHINE SULFATE solution

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Rhodes Pharmaceuticals L.P.

SNN (starptautisko nepatentēto nosaukumu):

MORPHINE SULFATE

Kompozīcija:

MORPHINE SULFATE 10 mg in 5 mL

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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

Produktu pārskats:

Morphine Sulfate Oral Solution is supplied as: 10 mg per 5 mL, (2 mg/mL) Morphine SulfateOral Solution is a clear pink liquid available as follows: 500 mL Bottle supplied with a calibrated dosage cup ......………………………….          NDC 42858-810-17 20 mg per 5 mL, (4 mg/mL) Morphine Sulfate Oral Solution is a clear light pink to reddish pink liquid available as follows: 500 mL Bottle supplied with a calibrated dosage cup ......………………………….          NDC 42858-811-17 100 mg per 5 mL (20 mg/mL), Morphine Sulfate Oral Solution is a clear colorless to light yellow liquid available as follows: 30 mL Bottle supplied with a calibrated oral syringe ......………………………….           NDC 42858-812-15 120 mL Bottle supplied with a calibrated oral syringe......………………………….          NDC 42858-812-12 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) ].

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

MORPHINE SULFATE- MORPHINE SULFATE SOLUTION
Rhodes Pharmaceuticals L.P.
----------
MEDICATION GUIDE
Morphine Sulfate (mor-pheen) 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 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 healthcar

Produkta apraksts

MORPHINE SULFATE- MORPHINE SULFATE SOLUTION
RHODES PHARMACEUTICALS L.P.
----------
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, 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
THAT AP