HYDROCODONE BITARTRATE AND ACETAMINOPHEN- hydrocodone bitartrate, acetaminophen solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Par Pharmaceutical

INN (Nome Internazionale):

ACETAMINOPHEN

Composizione:

ACETAMINOPHEN 325 mg in 15 mL

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 ] - Hypersensitivity to hydrocodon

Dettagli prodotto:

Hydrocodone Bitartrate and Acetaminophen Oral Solution (7.5 mg/325 mg per 15 mL) is a red-colored, tropical fruit punch flavored liquid containing hydrocodone bitartrate (WARNING: may be habit-forming ) 7.5 mg and acetaminophen 325 mg per 15 mL, with 7% alcohol. It is supplied in a container of 16 oz (473 mL) NDC 64376-640-16 and 4 oz (118 mL) NDC 64376-640-40. 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.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

ACETAMINOPHEN SOLUTION
Par Pharmaceutical
----------
Medication Guide
Hydrocodone Bitartrate (hye’’ droe koe’ done bye tar’ trate)
and Acetaminophen (a seet’’ a min’ oh
fen) Oral Solution CII
(7.5 mg/325 mg per 15 mL)
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 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.
•
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. Store Hydrocodone Bitartrate and
Acetaminophen Oral Solution
away from children and in a safe place to prevent stealing or abuse.
Selling or giving away
Hydrocodone Bitartrate and Acetaminophen Oral Solution is against the
law.
Do not take Hydrocodone Bitartrate and Acetaminophen Oral Solution if
you have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel bloc

Scheda tecnica

HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE,
ACETAMINOPHEN SOLUTION
PAR PHARMACEUTICAL
----------
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ORAL SOLUTION
(7.5 MG/325 MG PER 15 ML)
CII
RX ONLY
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,
EMPHASIZE TO PATIENTS AND THEIR CAREGIVERS