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:

Hikma Pharmaceuticals USA Inc.

INN (Tên quốc tế):

MORPHINE SULFATE

Thành phần:

MORPHINE SULFATE 20 mg in 5 mL

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Morphine Sulfate Oral Solution 2 mg/mL and 4 mg/mL is indicated for the management of 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]: 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 studies with morphine use during pregnancy have not reported a clear association with morphine and major birth

Tóm tắt sản phẩm:

Morphine Sulfate Oral Solution: 20 mg per 5 mL (4 mg/ mL) Oral Solution is supplied as a clear, blue-green solution. Each 1 mL of clear, blue-green oral solution contains 4 mg of morphine sulfate, USP (equivalent to 3 mg morphine). 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:

New Drug Application

Tờ rơi thông tin

Hikma Pharmaceuticals USA 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 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
provider

Đặc tính sản phẩm

MORPHINE SULFATE- MORPHINE SULFATE SOLUTION
HIKMA PHARMACEUTICALS USA 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, 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
Indications and Usage (1)
06/2021
Dosage and Administration (2.1, 2.2, 2.4)
06/2021
Dosage and Administration (2.3)
03/2021
Warnings and Precautions (5.2, 5.4, 5.6)
03/2021
INDICATIONS AND USAGE
Morphine Sulfate Oral Solution is an opioid agonist.
Morphine Sulfate 2 mg/mL and 4 mg/mL is indicated for the management
of
•
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, ESPEC