OXYCODONE HYDROCHLORIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570)

Available from:

Atlantic Biologicals Corps

INN (International Name):

OXYCODONE HYDROCHLORIDE

Composition:

OXYCODONE HYDROCHLORIDE 100 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oxycodone Hydrochloride Solution USP, 100 mg per 5 mL ( ) is an opioid analgesic indicated for the management of moderate to severe acute and chronic pain in opioid-tolerant patients. Oral 20 mg/mL Oxycodone Hydrochloride Oral Solution USP, 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 30 mg of oral oxycodone per day, or at least 60 mg oral morphine per day, or at least 12 mg hydromorphone per day, or an equianalgesic dose of another opioid, for a week or longer. Oxycodone Hydrochloride Oral Solution USP is contraindicated in patients with respiratory depression in the absence of resuscitative equipment. Oxycodone Hydrochloride Oral Solution USP is contraindicated in any patient who has or is suspected of having paralytic ileus. Oxycodone Hydrochloride Oral Solution USP is contraindicated in patients with acute or severe br

Product summary:

NDC:17856-0393-1 1 mL in a SYRINGE, PLASTIC

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE SOLUTION
Atlantic Biologicals Corps
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MEDICATION GUIDE
Oxycodone Hydrochloride USP (ox-ee-CO-dohn) CII
Oral Solution
IMPORTANT: Keep oxycodone hydrochloride 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
oxycodone hydrochloride oral solution, get emergency help right away.
Read the Medication Guide that comes with oxycodone hydrochloride 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 to your healthcare provider
about your medical condition or your
treatment.
What is the Most Important Information I Should Know About Oxycodone
Hydrochloride Oral Solution?
Oxycodone hydrochloride oral solution can cause serious side effects,
including, death.
1.
If you take the wrong dose or strength of oxycodone hydrochloride oral
solution, you could
overdose and die. Take oxycodone hydrochloride oral solution exactly
as prescribed by your
healthcare provider.
2.
It is especially important when you take oxycodone hydrochloride 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.
3.
Always use the oral syringe provided with oxycodone hydrochloride oral
solution, 100 mg per 5 mL
(20 mg per mL) to help make sure you measure the right amount. Oral
Syringe.
4.
Using alcohol with oxycodone hydrochloride oral solution may increase
your risk of dangerous side
effects, including death. Do not drink alcohol.
5.
Opioid tolerant means that you take another opioid medicine for your
constant (around the clock)
pain and your body is used to it. Opioid Tolerance. Do not take
oxycodone hydrochloride oral
solution, 100 mg per 5 mL (20 mg per mL), unless you are “opioid
tolerant.”
What is Oxycodone Hydrochloride Ora

Summary of Product characteristics

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE SOLUTION
ATLANTIC BIOLOGICALS CORPS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXYCODONE HYDROCHLORIDE ORAL
SOLUTION USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR OXYCODONE HYDROCHLORIDE
ORAL SOLUTION USP. OXYCODONE HYDROCHLORIDE ORAL SOLUTION USP, FOR ORAL
USE, CII INITIAL U.S. APPROVAL:
1950
WARNING: RISK OF MEDICATION ERRORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
OXYCODONE HYDROCHLORIDE ORAL SOLUTION USP, 100 MG PER 5 ML (20 MG/ML)
IS AVAILABLE IN ONE
CONCENTRATION, AS 20 MG OXYCODONE HYDROCHLORIDE PER ML OF SOLUTION.
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 MG AND ML,
AND OTHER OXYCODONE SOLUTIONS
WITH DIFFERENT CONCENTRATIONS, WHICH COULD RESULT IN ACCIDENTAL
OVERDOSE AND DEATH. (5.1)
KEEP OXYCODONE HYDROCHLORIDE ORAL SOLUTION USP OUT OF THE REACH OF
CHILDREN.
INDICATIONS AND USAGE
Oxycodone Hydrochloride Oral Solution USP, 20 mg per mL solution is an
opioid agonist indicated for the management of
moderate to severe acute and chronic pain in opioid-tolerant patients.
(1) (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Oral Solution 100 mg per 5 mL (20 mg/mL): Each mL contains 20 mg of
oxycodone hydrochloride. (3) (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Oxycodone hydrochloride oral solution: 5 to 15 mg every 4 to 6 hours
as needed. (2.2).
Respiratory depression in the absence of resuscitative equipment. (4)
Paralytic ileus. (4)
Acute or severe bronchial asthma or hypercarbia. (4)
Known hypersensitivity to oxycodone. (4)
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