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:

West-Ward Pharmaceuticals Corp.

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 is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of pain in opioid-tolerant patients. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, [see Warnings and Precautions (5.2)] , reserve Oxycodone Hydrochloride Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: Oxycodone Hydrochloride Oral Solution is contraindicated in patients with: Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.5)] . Available data with Oxycodone Hydrochloride Oral Solution are insufficient to inform a drug-associated risk for major birth defects and miscarriage. Animal reproduction studi

Product summary:

Oxycodone Hydrochloride Oral Solution, USP The 100 mg per 5 mL (20 mg/mL) is supplied as a clear, light yellow to yellow solution. NDC 0054-0393-44: Bottle of 30 mL supplied with a calibrated oral syringe Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] PROTECT from MOISTURE and LIGHT. Store Oxycodone Hydrochloride Oral Solution securely and dispose of properly [see Patient Counseling Information (17)].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

West-Ward Pharmaceuticals Corp.
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MEDICATION GUIDE
Medication Guide
Oxycodone Hydrochloride (ox” i koe’ done) Oral Solution, USP CII
Rx Only
Oxycodone Hydrochloride Oral Solution is:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage pain
severe enough to require an opioid pain medicine, when other pain
treatments such as non-opioid pain
medicines do not treat your pain well enough or you cannot tolerate
them.
•
An opioid pain medicine that can put you at risk for overdose and
death. Even if you take your dose
correctly as prescribed you are at risk for opioid addiction, abuse,
and misuse that can lead to death.
Important information about Oxycodone Hydrochloride Oral Solution:
•
Get emergency help right away if you take too much Oxycodone
Hydrochloride Oral Solution
(overdose). When you first start taking Oxycodone Hydrochloride Oral
Solution, when your dose is
changed, or if you take too much (overdose), serious or
life-threatening breathing problems that can
lead to death may occur.
•
Taking Oxycodone Hydrochloride Oral Solution with other opioid
medicines, benzodiazepines,
alcohol, or other central nervous system depressants (including street
drugs) can cause severe
drowsiness, decreased awareness, breathing problems, coma, and death.
•
Never give anyone else your Oxycodone Hydrochloride Oral Solution.
They could die from taking it.
Selling or giving away Oxycodone Hydrochloride Oral Solution is
against the law.
•
Store Oxycodone Hydrochloride Oral Solution securely, out of sight and
reach of children, and in a
location not accessible by others, including visitors to the home.
Do not take Oxycodone Hydrochloride Oral Solution if you have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel blockage or have narrowing of the stomach or intestines.
•
an allergy to oxycodone or any of the ingredients in Oxycodone
Hydrochloride Oral Solution.
Before taking Oxycodone Hydrochloride Oral Solution, tell your
healthcare provid

Summary of Product characteristics

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE SOLUTION
WEST-WARD PHARMACEUTICALS CORP.
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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 CII
INITIAL U.S. APPROVAL: 1950
WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; RISK
EVALUATION
AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY
DEPRESSION;
ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME
P450 3A4
INTERACTION; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR
OTHER CNS
DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
•
•
•
•
•
•
•
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RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Oxycodone Hydrochloride Oral Solution is an opioid agonist indicated
for the management of pain severe enough to
require an opioid analgesic and for which alternative treatments are
inadequate. (1)
_Limitations of Use (1)_
Because of the risks of addiction, abuse, and misuse with opioids,
even at recommended doses,_ [see Warnings and_
_Precautions (5.2_)], reserve Oxycodone Hydrochloride Oral Solution
for use in patients for whom alternative treatment
options [e.g., non-opioid analgesics or opioid combination products]:
•
•
ENSURE ACCURACY WHEN PRESCRIBING, DISPENSING, AND ADMINISTERING
OXYCODONE HYDROCHLORIDE ORAL
SOLUTION. DOSING ERRORS DUE TO CONFUSION BETWEEN MG AND ML, AND OTHER
OXYCODONE HYDROCHLORIDE
ORAL SOLUTIONS OF DIFFERENT CONCENTRATIONS CAN RESULT IN ACCIDENTAL
OVERDOSE AND DEATH. (2.1, 5.1).
OXYCODONE HYDROCHLORIDE ORAL SOLUTION EXPOSES USERS TO RISKS OF
ADDICTION, ABUSE, AND MISUSE,
WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS PATIENT’S RISK BEFORE
PRESCRIBING AND MONITOR REGULARLY
FOR THESE BEHAVIORS AND CONDITIONS. (5.2)
TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF
ADDICTION, ABUSE, AND MISUSE,
THE FOOD AND