MORPHINE SULFATE solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

ATLANTIC BIOLOGICALS CORP.

INN (International Name):

MORPHINE SULFATE

Sammensætning:

MORPHINE SULFATE 20 mg in 5 mL

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Morphine sulfate solution 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 solution is an opioid analgesic indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients. oral (10 mg per 5 mL and 20 mg per 5 mL) oral 100 mg per 5 mL (20 mg/mL) 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 con

Produkt oversigt:

NDC:17856-0238-5 in a CUP, UNIT-DOSE of 5 SOLUTIONS

Autorisation status:

New Drug Application

Indlægsseddel

MORPHINE SULFATE- morphine sulfate solution
ATLANTIC BIOLOGICALS CORP.
----------
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 narcotic
pain relievers

Produktets egenskaber

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
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 analgesic 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 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 diff