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:

Lannett Company, 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 (5 mg per mL) , an opioid agonist, is indicated for the relief of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate. Oxycodone hydrochloride oral solution 100 mg per 5 mL (20 mg per mL) , an opioid agonist, is indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients. Oxycodone hydrochloride oral solution USP, 100 mg per 5 mL (20 mg per 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 is contraindicated in patients with respiratory depression in the absence of resuscitative equipment. Oxycodone hydrochloride is contraindicated in any patient who has or is sus

Product summary:

Oxycodone Hydrochloride Oral Solution Oxycodone hydrochloride oral solution USP, 100 mg/5 mL (20 mg/mL) is a yellow solution available in one strength as follows: 100 mg per 5 mL (20 mg per mL) oral solution NDC 0527-1426-35: Bottle of 15 mL supplied with a calibrated oral syringe and syringe adapter (bottle plug) NDC 0527-1426-36: Bottle of 30 mL supplied with a calibrated oral syringe and syringe adapter (bottle plug) Storage Store at 20° to 25°C (68° to 77° F) [See USP Controlled Room Temperature]. 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
Lannett Company, Inc.
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MEDICATION GUIDE
Oxycodone Hydrochloride (ox-ee-CO-dohn) (CII)
Oral Solution, USP
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 calibrated oral syringe provided with
oxycodone hydrochloride oral
solution USP, 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
USP, 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 hydr

Summary of Product characteristics

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE SOLUTION
LANNETT COMPANY, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXYCODONE HYDROCHLORIDE ORAL
SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
OXYCODONE HYDROCHLORIDE ORAL SOLUTION.
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 IS AVAILABLE IN 5 MG PER 5
ML AND 100 MG PER 5 ML (20 MG
PER ML) CONCENTRATIONS.
THE 100 MG PER 5 ML (20 MG PER 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 OUT OF THE REACH OF
CHILDREN.
INDICATIONS AND USAGE
Oxycodone hydrochloride is an opioid agonist indicated for the relief
of moderate to severe acute and chronic pain where
the use of an opioid analgesic is appropriate. (1)
Oxycodone Hydrochloride Oral Solution USP, 100 mg per 5 mL (20 mg per
mL) is indicated for the relief of moderate to
severe acute and chronic pain in opioid-tolerant patients. (1)
DOSAGE AND ADMINISTRATION
Individualize dosage based on the severity of pain, the patient
response, and prior analgesic treatment. (2.1) Patients
who have not been receiving opioid analgesics should be started in a
dosing range of 5 to 15mg every 4 to 6 hours as
needed. (2.2).
DOSAGE FORMS AND STRENGTHS
Oral Solution 100 mg per 5 mL (20 mg per mL): Each mL contains 20 mg
of oxycodone hydrochloride. (3)
CONTRAINDICATIONS
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)
WARNINGS AND PRECAUTIONS
Risk of Medication Errors: Use