HYDROCODONE BITARTRATE AND ACETAMINOPHEN solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Available from:

Eywa Pharma Inc

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hydrocodone bitartrate 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 hydrocodone bitartrate 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 Hydrocodone bitartrate 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] • Hype

Product summary:

Hydrocodone Bitartrate and Acetaminophen Oral Solution, each 15 mL of which contains hydrocodone bitartrate 7.5 mg (WARNING: May be habit-forming ), acetaminophen 325 mg, and alcohol 7%. is supplied as a red-colored, tropical fruit punch-flavored liquid, in the following containers. Bottles of 16 fl. oz. (473 mL), NDC 71930-027-43. 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 Hydrocodone Bitartrate and Acetaminophen Oral Solution securely and dispose of properly [see PRECAUTIONS/Information for Patients ]. Manufactured by: Wes Pharma Inc. Westminster, MD 21157 USA Distributed by: Eywa Pharma Inc. 2 Research Way, Floor 3 Princeton, NJ 08540 Revised: 10/2022

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ACETAMINOPHEN SOLUTION
Eywa Pharma Inc
----------
MEDICATION GUIDE
Hydrocodone Bitartrate (hye" droe koe' done bye tar trate) and
Acetaminophen (a seet"a min' oh fen) Oral
Solution, CII
Hydrocodone Bitartrate 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 pain medicine 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 Hydrocodone Bitartrate and Acetaminophen
Oral Solution:
• Get emergency help or call 911 right away if you take too much
Hydrocodone Bitartrate and
Acetaminophen Oral Solution (overdose).When you first start taking
Hydrocodone Bitartrate 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.
Talk to your healthcare provider about
naloxone, a medicine for the emergency treatment of an opioid
overdose.
• Taking Hydrocodone Bitartrate 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.
• Never give anyone else your Hydrocodone Bitartrate and
Acetaminophen Oral Solution. They could die
from taking it. Selling or giving away Hydrocodone Bitartrate and
Acetaminophen Oral Solution is against
the law.
• Store Hydrocodone Bitartrate and Acetaminophen 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 Hydrocodone B

Summary of Product characteristics

HYDROCODONE BITARTRATE AND ACETAMINOPHEN - HYDROCODONE BITARTRATE
AND ACETAMINOPHEN SOLUTION
EYWA PHARMA INC
----------
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ORAL SOLUTION, 7.5 MG/325 MG
PER
15 ML
EYWA PHARMA INC.
BOXED WARNING
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
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ORAL SOLUTION. DOSING ERRORS
DUE TO CONFUSION BETWEEN MG AND ML, AND OTHER HYDROCODONE BITARTRATE
AND ACETAMINOPHEN ORAL SOLUTIONS OF DIFFERENT CONCENTRATIONS CAN
RESULT
IN ACCIDENTAL OVERDOSE AND DEATH [SEE WARNINGS, DOSAGE AND
ADMINISTRATION].
ADDICTION, ABUSE, AND MISUSE
HYDROCODONE BITARTRATE 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 HYDROCODONE BITARTRATE 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,
• EMPHASIZ