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:

ANI Pharmaceuticals, 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 is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. 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 (5.4)] . Available data with Oxycodone Hydrochloride Oral Solution are insufficient to inform a drug-associated risk for major birth defects and miscarriage. Animal reproduction studies with oral administrations of oxycodone hydrochloride in rats and rabbits during the period of organogenesis at doses 2.6 and 8.

Product summary:

Oxycodone Hydrochloride Oral Solution USP 100 mg per 5 mL (20 mg per mL) is a clear, yellow solution available in as follows: NDC 62559-152-30: Bottle of 30 mL supplied with a calibrated oral syringe Store at Controlled Room Temperature, 25°C (77°F); excursions permitted at 15° to 30°C (59° to 86°F). PROTECT from MOISTURE and LIGHT.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ANI Pharmaceuticals, Inc.
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MEDICATION GUIDE
Oxycodone Hydrochloride (ox-ee-CO-dohn) Oral Solution, (CII)
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. Store Oxycodone Hydrochloride Oral Solution away from children and
in a safe place to prevent
stealing or abuse. Selling or giving away Oxycodone Hydrochloride Oral
Solution is against the
law.
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 provider if you have a
history of:
•
head injury, seizures
•
liver, kidney, thyroid problems
•
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Summary of Product characteristics

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE SOLUTION
ANI PHARMACEUTICALS, INC.
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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;
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._
•
•
•
•
•
•
•
RECENT MAJOR CHANGES
Boxed Warning 12/2016
Indications and Usage 12/2016
Dosage and Administration 12/2016
Warnings and Precautions 12/2016
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, reserve Oxycodone
Hydrochloride Oral Solution for use in patients for whom alternative
treatment options [e.g., non-opioid analgesics or opioid
combination products]:
•
•
DOSAGE AND ADMINISTRATION
•
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)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCC