MORPHINE SULFATE ORAL SOLUTION- morphine sulfate oral solution solution MORPHINE SULFATE- 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:

Nostrum Laboratories, Inc.

INN (International Name):

MORPHINE SULFATE

Composition:

MORPHINE SULFATE 10 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 is contraindicated in patients with known hypersensitivity to morphine, morphine salts, or any components of the product. Morphine sulfate is contraindicated in patients with respiratory depression in the absence of resuscitative equipment. Morphine sulfate is contraindicated in patients with acute or severe bronchial asthma or hypercarbia. Morphine sulfate is contraindicated in any patient who has or is suspected of having paralytic ileus. No formal studies to assess the teratogenic effects of morphine in animals have been conducted.  It is also not known whether morphine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.  Morphine should be given to a pregnant woman only if clearly needed. In humans, the frequency

Product summary:

Morphine Sulfate Oral Solution Morphine sulfate oral solution is a blue-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 Storage Store at 25°C (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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MORPHINE SULFATE ORAL SOLUTION- MORPHINE SULFATE ORAL SOLUTION
SOLUTION
MORPHINE SULFATE- MORPHINE SULFATE SOLUTION
Nostrum Laboratories, Inc.
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MEDICATION GUIDE
Morphine Sulfate (mor-phen) Oral Solution CII
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.
• The oral solution comes in several different doses (amount of
medicine per mL) and strengths (number
of mgs).
What is Morphine Sulfate Oral Solution?
Morphine Sulfate Oral Solution is in a group of drugs called narcotic
pain relievers. Morphine Sulfate
Oral Solution is only for adults who have moderate to severe pain.
• Morphine Sulfate Oral Solution is a prescription medicine that is
used to manage moderate to severe
pain that is expected to last a short period of time (acute), and pain
that continues around-the- clock and is
expected to last for a long period of time (chronic).
• Morphine Sulfate Oral Solution is a federally co

Summary of Product characteristics

MORPHINE SULFATE ORAL SOLUTION- MORPHINE SULFATE ORAL SOLUTION
SOLUTION
MORPHINE SULFATE- 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 AND 20
MG PER 5 ML CONCENTRATIONS.
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)
DOSAGE AND ADMINISTRATION
Morphine sulfate oral solution: 10 to 20 mg every 4 hours as needed.
(2.2)
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
s ulfate .(3)
CONTRAINDICATIONS
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)
WARNINGS AND PRECAUTIONS
Risk of Medication Errors: Use caution when prescribing, dispensing,
and administering 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)
Respiratory depression: Increased risk in elderly, debilitated
patients, those suffering from conditions accompanied by
hypoxia, hypercapnia, or upper airway obstruction. (5.2)
Controlled substance: Morphine sulfate is a Schedule II controlled
substance with an abuse liability sim