OXYCODONE HYDROCHLORIDE- 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:

Roxane Laboratories, Inc.

INN (International Name):

OXYCODONE HYDROCHLORIDE

Composition:

OXYCODONE HYDROCHLORIDE 100 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oxycodone Hydrochloride Oral Solution USP, 100 mg per 5 mL (20 mg/mL ) is an opioid analgesic indicated for the management of moderate to severe acute and chronic pain in opioid-tolerant patients. 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 bronchial asthma or hypercarbi

Product summary:

Oxycodone Hydrochloride Oral Solution USP Oxycodone Hydrochloride Oral Solution USP, 20 mg/mL is a clear, light yellow to yellow solution available in one strength as follows: 100 mg per 5 mL (20 mg/mL) oral solution NDC# 0054-0522-44: Bottle of 30 mL supplied with a calibrated oral syringe Storage Store at Controlled Room Temperature, 25°C (77°F); excursions are permitted to 15° to 30°C (59° to 86°F). PROTECT from MOISTURE and LIGHT. Handling All opioids, including oxycodone hydrochloride, are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly. DEA Order Form Required

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE SOLUTION
Roxane Laboratories, Inc.
----------
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.
Take oxycodone hydrochloride oral solution exactly as prescribed by
your healthcare provider. If
you take the wrong dose or strength of oxycodone hydrochloride oral
solution, you could overdose
and die.
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.
Oral Syringe. 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.
4.
Do not drink alcohol. Using alcohol with oxycodone hydrochloride oral
solution may increase your
risk of dangerous side effects, including death.
5.
Opioid Tolerance. Do not take oxycodone hydrochloride oral solution,
100 mg per 5 mL (20 mg per
mL), unless you are “opioid tolerant.” Opioid tolerant means that
you take another opioid medicine
for your constant (around the clock) pain and your body is used to it.
What is Oxycodone Hydrochloride Oral

Summary of Product characteristics

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE SOLUTION
ROXANE LABORATORIES, INC.
----------
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.
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
•
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
•
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions are nausea, constipation, vomiting,
headache, pruritus, insomnia, dizziness, asthenia, and
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