OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Available from:

FH2 Pharma LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oxycodone hydrochloride and acetaminophen 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 ], reserve oxycodone hydrochloride and acetaminophen oral solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - Have not been tolerated, or are not expected to be tolerated, - Have not provided adequate analgesia, or are not expected to provide adequate analgesia Oxycodone hydrochloride and acetaminophen oral solution is contraindicated in patients with: - Significant respiratory depression [see WARNINGS ] - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS ] - Known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS ] Hypersensitivity

Product summary:

Oxycodone hydrochloride and acetaminophen oral solution, each 5 mL (teaspoonful) of which contains oxycodone hydrochloride 10 mg and acetaminophen 300 mg, is supplied as a red, tropical fruit punch flavored liquid in 120 mL bottles, NDC 72887-648-12. Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. Store oxycodone hydrochloride and acetaminophen oral solution securely and dispose of properly [see PRECAUTIONS; Information for Patients/Caregivers ]. Distributed by: FH2 Pharma LLC Las Vegas, NV 89148

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN- OXYCODONE HYDROCHLORIDE AND
ACETAMINOPHEN SOLUTION
FH2 Pharma LLC
----------
MEDICATION GUIDE
MEDICATION GUIDE
Oxycodone (ox" i koe' done hye" droe klor' ide) Hydrochloride and
Acetaminophen (a seet" a min' oh fen) Oral Solution, CII
Oxycodone Hydrochloride and Acetaminophen 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 analgesic and for which alternative
treatments are inadequate
and 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 and Acetaminophen
Oral Solution:
•
Get emergency help or call 911 right away if you take too much
Oxycodone Hydrochloride and
Acetaminophen Oral Solution (overdose). When you first start taking
Oxycodone Hydrochloride
and Acetaminophen 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 and Acetaminophen 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.
Talk to your healtcare provider about naloxone, a medicine for the
emrgency treatment of an
opioid overdose.
•
Never give anyone else your Oxycodone Hydrochloride and Acetaminophen
Oral Solution. They
could die from taking it. Selling or giving away Oxycodone
Hydrochloride and Acetaminophen
Oral Solution is against the law.
•
Store Oxycodone Hydrochloride and Acetaminophen Oral Solution
securely, out of sight and
reach of children, and in a l

Summary of Product characteristics

OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN- OXYCODONE
HYDROCHLORIDE AND ACETAMINOPHEN SOLUTION
FH2 PHARMA LLC
----------
OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN ORAL SOLUTION
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; HEPATOTOXICITY, AND RISKS FROM CONCOMITANT USE
WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
RISK OF MEDICATION ERRORS
ENSURE ACCURACY WHEN PRESCRIBING, DISPENSING, AND ADMINISTERING
OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN ORAL SOLUTION. DOSING ERRORS
DUE TO CONFUSION BETWEEN MG AND ML, AND OTHER OXYCODONE
HYDROCHLORIDE AND ACETAMINOPHEN SOLUTIONS OF DIFFERENT CONCENTRATIONS
CAN RESULT IN ACCIDENTAL OVERDOSE AND DEATH [SEE WARNINGS, DOSAGE
AND ADMINISTRATION].
ADDICTION, ABUSE, AND MISUSE
OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN ORAL SOLUTION EXPOSES
PATIENTS AND OTHER USERS TO THE RISKS OF OPIOID ADDICTION, ABUSE, AND
MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS EACH PATIENT’S
RISK PRIOR TO PRESCRIBING OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN
ORAL SOLUTION, AND MONITOR ALL PATIENTS REGULARLY FOR THE DEVELOPMENT
OF
THESE BEHAVIORS AND CONDITIONS [SEE WARNINGS].
OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS)
TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF
ADDICTION, ABUSE, AND MISUSE, THE FOOD AND DRUG ADMINISTRATION (FDA)
HAS REQUIRED A REMS FOR THESE PRODUCTS [SEE WARNINGS]. UNDER THE
REQUIREMENTS OF THE REMS, DRUG COMPANIES WITH APPROVED OPIOID
ANALGESIC PRODUCTS MUST MAKE REMS-COMPLIANT EDUCATION PROGRAMS
AVAILABLE TO HEALTHCARE PROVIDERS. HEALTHCARE PROVIDERS ARE STRONGLY
ENCOURAGED TO
COMPLETE A REMS-COMPLIANT EDUCATION PROGRAM,
COUNSEL PATIENTS AND/OR THEIR CAREGIVERS, WITH EVERY PRESCRIPTION, ON
SAFE USE, SERIOUS RISKS, STORAGE, AND DISPOSAL OF THESE PRODUCTS,
EMPHASIZE TO PATIENTS AND THEIR CAREGIVERS THE IMPORTANCE OF READING
THE MEDIC