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:

Safecor Health, LLC

INN (International Name):

MORPHINE SULFATE

Composition:

MORPHINE SULFATE 20 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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

Product summary:

Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) is available as a clear, light blue liquid with raspberry odor. Supplied as an individual overwrapped and flagged calibrated oral syringe:    Syringes of 0.5 mL containing 0.25 mL    NDC 48433-200-47    Syringes of 1 mL containing 0.5 mL         NDC 48433-200-55    Syringes of 3 mL containing 1 mL            NDC 48433-200-01 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT. 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- morphine sulfate solution
Safecor Health, LLC
----------
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 make sure the dose is measured and administered accurately.
•
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 relievers. Morphine sulfate oral
solution is only for adults who have moderate to severe pain.
•
M

Summary of Product characteristics

MORPHINE SULFATE- MORPHINE SULFATE SOLUTION
SAFECOR HEALTH, 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, 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 THE 100 MG PER 5 ML
(20 MG/ML) CONCENTRATION AND IS INDICATED
FOR USE IN OPIOID-TOLERANT PATIENTS ONLY.
TAKE CARE TO AVOID DOSING ERRORS DUE TO CONFUSION BETWEEN
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 oral solution 100 mg per 5 mL (20 mg/mL) is indicated
for the relief of moderate to
severe acute and chronic pain in opioid-tolerant patients. (1)
DOSAGE AND ADMINISTRATION
Morphine sulfate oral solution: 10 to 20 mg every 4 hours as needed.
(2.2)
DOSAGE FORMS AND STRENGTHS
Morphine sulfate oral solution: For the 100 mg per 5 mL (20 mg/mL)
strength, each mL contains 20 mg
of morphine sulfate. (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, hyp