HYDROCODONE BITARTRATE AND ACETAMINOPHEN solution

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Redpharm Drug, Inc

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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]

Sommarju tal-prodott:

Hydrocodone Bitartrate and Acetaminophen Oral Solution is a yellow-colored, fruit flavored liquid containing 7.5 mg hydrocodone bitartrate and 325 mg acetaminophen per 15 mL, with 6.7% alcohol.  It is supplied in the following oral dosage forms: NDC 0121-0772-04:  4 fl oz (118 mL) bottle NDC 0121-0772-16:  16 fl oz (473 mL) bottle NDC 0121-4772-05:   5 mL unit dose cup NDC 0121-4772-40:  Case contains 40 unit dose cups of 5 mL (0121-4772-05)  NDC 0121-1544-10:  10mL unit dose cup NDC 0121-1544-40:  Case contains 40 unit dose cups of 10 mL (0121-1544-10)  NDC 0121-2316-15:  15mL unit dose cup NDC 0121-2316-40:  Case contains 40 unit dose cups of 15 mL (0121-2316-15) packaged in 4 trays of 10 unit dose cups each. NDC 0121-2316-50: Case contains 50 unit dose cups of 15 mL (0121-2316-15) packaged in 4 trays of 10 unit dose cups each.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

ACETAMINOPHEN SOLUTION
Redpharm Drug, Inc
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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

Karatteristiċi tal-prodott

HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE
AND ACETAMINOPHEN SOLUTION
REDPHARM DRUG, INC
----------
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ORAL SOLUTION CII
I07720720
REVISED: JULY 2020
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 OTHERHYDROCODONE 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
RISKPRIOR 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,
EMPHASIZE TO PATIENTS AND THEIR CAREGIVERS THE