MORPHINE SULFATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

ATLANTIC BIOLOGICALS CORP.

INN (International Name):

MORPHINE SULFATE

Composition:

MORPHINE SULFATE 20 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 summary:

Morphine Sulfate Oral Solution 10 mg per 5 mL and 20 mg per 5 mL supplied as a clear/blue-green solution available in two strengths as follows: 10 mg per 5 mL Oral Solution NDC 0054-0237-41: Bottle of 15 mL NDC 0054-0237-49: Bottle of 100 mL NDC 0054-0237-63: Bottle of 500 mL 20 mg per 5 mL Oral Solution NDC 0054-0238-49: Bottle of 100 mL NDC 0054-0238-63: Bottle of 500 mL 100 mg per 5 mL supplied as a clear/colorless or clear/pink solution. The clear/colorless solution is available in one strength as follows: 100 mg per 5 mL (20 mg/mL) Oral Solution (colorless formulation) NDC 0054-0404-41: Bottle of 15 mL with an oral syringe NDC 0054-0404-44: Bottle of 30 mL with an oral syringe NDC 0054-0404-50: Bottle of 120 mL with an oral syringe The clear/pink solution available in one strength as follows: 100 mg per 5 mL (20 mg/mL) Oral Solution (color added) NDC 0054-0517-41: Bottle of 15 mL with an oral syringe NDC 0054-0517-44: Bottle of 30 mL with an oral syringe NDC 0054-0517-50: Bottle of 120 mL with an oral syringe Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] All opioids are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly.

Authorization status:

New Drug Application

Patient Information leaflet

MORPHINE SULFATE- MORPHINE SULFATE SOLUTION
ATLANTIC BIOLOGICALS CORP.
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MEDICATION GUIDE
Morphine Sulfate Oral Solution (CII)
(mor-pheen)
Rx only
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 narcotic
pain re

Summary of Product characteristics

MORPHINE SULFATE- MORPHINE SULFATE SOLUTION
ATLANTIC BIOLOGICALS CORP.
----------
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
CONCENTRATIONS 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
USP. For the 100 mg per 5 mL (20 mg/mL) strength, each mL contains 20
mg of morphine sulfate USP. (3)
CONTRAINDICATIONS
•
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
•
•
•
Morphine Sulfate Oral Solution: 10 mg 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 different conc