HYDROCODONE BITARTRATE AND ACETAMINOPHEN syrup

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Mikart, LLC

INN (International Name):

HYDROCODONE BITARTRATE

Sammensætning:

HYDROCODONE BITARTRATE 7.5 mg in 15 mL

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

Hydrocodone bitartrate and acetaminophen oral solution, each 15 mL of which contains hydrocodone bitartrate 7.5 mg, acetaminophen 325 mg, and alcohol 7%, is supplied as a red-colored, tropical fruit punch-flavored liquid, in the following containers. Bottles of 4 fl. oz. (118 mL), NDC 46672-642-04 Bottles of 16 fl. oz. (473 mL), NDC 46672-642-16 Bottles of 128 fl. oz. (3785 mL), NDC 46672-642-28 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/Caregivers ]. Manufactured by Mikart, LLC Atlanta, GA 30318 Rev. 07/2020 Code 866Z00

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

ACETAMINOPHEN SYRUP
Mikart, LLC
----------
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 be others, including
visitors to the home.
Do not take Hydrocodone Bitartra

Produktets egenskaber

HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE AND
ACETAMINOPHEN SYRUP
MIKART, LLC
----------
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ORAL SOLUTION 7.5 MG/325 MG
PER 15 ML
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 THE IMPORTANCE OF RE