MORPHINE SULFATE ORAL SOLUTION CII- morphine sulfate solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Nostrum Laboratories, Inc.

INN (Algemene Internationale Benaming):

MORPHINE SULFATE

Samenstelling:

MORPHINE SULFATE 100 mg in 5 mL

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Morphine sulfate oral solution (10 mg per 5 mL and 20 mg per 5 mL) are formulations of morphine, an opioid agonist, indicated for the relief of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate. Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) is an opioid analgesic indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients. Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) may cause fatal respiratory depression when administered to patients not previously exposed to opioids. Patients considered to be opioid tolerant are those who are taking at least 60 mg oral morphine per day, or at least 30 mg of oral oxycodone per day, or at least 12 mg hydromorphone per day, or an equianalgesic dose of another opioid, for a week or longer. Morphine sulfate is contraindicated in patients with known hypersensitivity to morphine, morphine salts, or any components of the product. Morphine sulfate is contraindicated in patients

Product samenvatting:

Morphine Sulfate Oral Solution Morphine Sulfate Oral Solution 10 and 20 mg per 5 mL is a green solution available in two strengths as follows: 10 mg per 5 mL Oral Solution NDC 70408-358-31 Bottles of 100 mL with a dosing cup NDC 70408-358-35 Bottles of 500 mL with a dosing cup 20 mg per 5 mL Oral Solution NDC 70408-359-31 Bottles of 100 mL with a dosing cup NDC 70408-359-35 Bottles of 500 mL with a dosing cup Morphine Sulfate Oral Solution 100 mg per 5 mL is a clear/colorless solution available in one strengths as follows: 100 mg per 5 mL (20 mg/mL) Oral Solution NDC 70408-746-29 Bottle of 30 mL with an oral syringe NDC 70408-746-31 Bottle of 120 mL with an oral syringe Storage Store at 20º to 25°C (68º to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] PROTECT FROM MOISTURE. All opioids are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly.

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

MORPHINE SULFATE ORAL SOLUTION CII- MORPHINE SULFATE SOLUTION
Nostrum Laboratories, Inc.
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MEDICATION GUIDE
MORPHINE SULFATE (mor-pheen) (CII)
Oral Solution
IMPORTANT: Keep Morphine Sulfate Oral Solution in a safe place away
from children. Accidental
use by a child is a medical emergency and can cause death. If a child
accidentally takes Morphine
Sulfate Oral Solution, get emergency help right away.
Read the Medication Guide that comes with Morphine Sulfate Oral
Solution before you start taking it and
each time you get a new prescription. There may be new information.
This Medication Guide does not
take the place of talking with your healthcare provider about your
medical condition or your treatment.
What is the most important information I should know about Morphine
Sulfate Oral Solution?
Morphine Sulfate Oral Solution can cause serious side effects,
including death.
•
Take Morphine Sulfate Oral Solution exactly as prescribed by your
healthcare provider. If you
take the wrong dose or strength of Morphine Sulfate Oral Solution, you
could overdose and die.
•
It is especially important when you take Morphine Sulfate Oral
Solution that you know exactly
what dose and strength to take, and the right way to measure your
medicine. Your healthcare
provider or pharmacist should show you the right way to measure your
medicine.
•
Always use the oral syringe provided with Morphine Sulfate Oral
Solution, 100 mg per 5 mL (20
mg/mL) to help make sure you measure the right amount.
•
The oral solution comes in several different doses (amount of medicine
per mL) and strengths
(number of mgs).
•
Do not take the strongest dose of Morphine Sulfate Oral Solution, 100
mg per 5 mL (20 mg /mL),
unless you are “opioid tolerant.” Opioid tolerant means that you
have been regularly using
Morphine Sulfate Oral Solution or another opioid medicine for your
constant (around the clock)
pain and your body is used to it.
What is Morphine Sulfate Oral Solution?
Morphine Sulfate Oral Solution is in a group of drugs called narco

Productkenmerken

MORPHINE SULFATE ORAL SOLUTION CII- MORPHINE SULFATE SOLUTION
NOSTRUM LABORATORIES, 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
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
MORPHINE SULFATE ORAL SOLUTION IS AVAILABLE IN 10 MG PER 5 ML, 20 MG
PER 5 ML AND 100 MG PER 5 ML (20
MG/ML) CONCENTRATIONS. THE 100 MG PER 5 ML (20 MG/ML) CONCENTRATION IS
INDICATED FOR USE IN OPIOID-
TOLERANT PATIENTS ONLY.
TAKE CARE TO AVOID DOSING ERRORS DUE TO CONFUSION BETWEEN DIFFERENT
CONCENTRATION AND BETWEEN MG AND
ML, WHICH COULD RESULT IN ACCIDENTAL OVERDOSE AND DEATH. (5.1)
KEEP MORPHINE SULFATE ORAL SOLUTION OUT OF THE REACH OF CHILDREN.
INDICATIONS AND USAGE
Morphine sulfate is an opioid agonist indicated for the relief of
moderate to severe acute and chronic pain where an opioid
analgesic is appropriate. (1)
Morphine sulfate 100 mg per 5 mL (20 mg/mL) solution is indicated for
the relief of moderate to severe acute and chronic
pain in opioid-tolerant patients. (1)
DOSAGE AND ADMINISTRATION
•
DOSAGE FORMS AND STRENGTHS
Oral Solution: For the 10 mg per 5 mL or 20 mg per 5 mL strengths,
each mL contains 2 mg or 4 mg of morphine sulfate.
For the 100 mg per 5 mL (20 mg/mL) strength, each mL contains 20 mg of
morphine sulfate. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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•
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Morphine Sulfate Oral Solution: 10 to 20 mg every 4 hours as needed.
(2.2)
Known hypersensitivity to morphine. (4)
Respiratory depression in the absence of resuscitative equipment. (4)
Acute or severe bronchial asthma or hypercarbia. (4)
Paralytic ileus. (4)
Risk of Medication Errors: Use caution when prescribing, dispensing,
and administering to avoid dosing errors due to
confusion between differe