MORPHINE SULFATE solution, concentrate

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Lannett Company, Inc.

INN (שם בינלאומי):

MORPHINE SULFATE

הרכב:

MORPHINE SULFATE 100 mg in 5 mL

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Morphine Sulfate Oral Solution is indicated for the management of acute and chronic pain in opioid-tolerant patients severe enough to require an opioid analgesic and for which alternative treatments are inadequate. 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 resuscitative equipment [see Warnings and Precautions (5.7)] - Concurrent use of monoamine oxidase inhibitors (MAOIs) o

leaflet_short:

Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg per mL) is a clear/colorless solution, supplied as: NDC 0527-1425-35: Bottles of 15 mL with an oral syringe and syringe adapter (bottle plug) NDC 0527-1425-36: Bottles of 30 mL with an oral syringe and syringe adapter (bottle plug) NDC 0527-1425-62: Bottles of 120 mL with an oral syringe and syringe adapter (bottle plug) NDC 0527-1425-63: Bottles of 240 mL with an oral syringe and syringe adapter (bottle plug) Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg per mL) is a clear/blue solution, supplied as: NDC 0527-1906-35: Bottles of 15 mL with an oral syringe and syringe adapter (bottle plug) NDC 0527-1906-36: Bottles of 30 mL with an oral syringe and syringe adapter (bottle plug) NDC 0527-1906-62: Bottles of 120 mL with an oral syringe and syringe adapter (bottle plug) NDC 0527-1906-63: Bottles of 240 mL with an oral syringe and syringe adapter (bottle plug) Store at Controlled Room Temperature, 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature.]. Protect from moisture.

מצב אישור:

New Drug Application

עלון מידע

Lannett Company, Inc.
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MEDICATION GUIDE
Morphine Sulfate Oral Solution (mȯr-ˌfēn)
Morphine Sulfate Oral Solution, 100 mg per 5 mL (20 mg per mL), (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, in people who are
already regularly
using 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.
•
are allergic to morphine, morphine salts or any of the ingredients in
Morphine Sulfate
Oral Solution.
Before taking Morphine Sulfate Oral Solution, tell your healthcare

מאפייני מוצר

MORPHINE SULFATE- MORPHINE SULFATE SOLUTION, CONCENTRATE
LANNETT COMPANY, INC.
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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, 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; 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
SULFATE ORAL SOLUTION 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 A