MORPHINE SULFATE solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

PAI Holdings, LLC

INN (Tên quốc tế):

MORPHINE SULFATE

Thành phần:

MORPHINE SULFATE 100 mg in 5 mL

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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]: - 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) or use of MAOIs

Tóm tắt sản phẩm:

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 to slightly yellow solution . Each 1 mL of clear, colorless to slightly yellow oral solution contains 20 mg of morphine sulfate, USP (equivalent to 15 mg morphine). NDC 0121-0825-15: 15 mL Bottle with an Oral Syringe NDC 0121-0825-01: 1 fl oz (30 mL) Bottle with an Oral Syringe NDC 0121-0825-04: 4 fl oz (118 mL) Bottle with an Oral Syringe NDC 0121-0825-08: 8 fl oz (240 mL) Bottle 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)].

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

PAI Holdings, LLC
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MEDICATION GUIDE
Morphine Sulfate (mor’ feen sul’fate) 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) pain in adults 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 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 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

Đặc tính sản phẩm

MORPHINE SULFATE- MORPHINE SULFATE SOLUTION
PAI HOLDINGS, LLC
----------
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
THAT