HYDROCODONE BITARTRATE AND ACETAMINOPHEN solution

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:

Preferred Pharmaceuticals Inc.

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): 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 hydrocodone or acetaminophen (e.g., anaphylaxis) [see

Produkt oversigt:

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 687878-6352-1 fl oz (118 mL) bottle

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

ACETAMINOPHEN SOLUTION
Preferred Pharmaceuticals 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 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 blockage or have narrowing of the stom

Produktets egenskaber

HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE AND
ACETAMINOPHEN SOLUTION
PREFERRED PHARMACEUTICALS INC.
----------
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ORAL SOLUTION CII
I07720417
REVISED: APRIL 2017
WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE;
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].
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH USE OF
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ORAL SOLUTION. FOLLOW
PATIENTS FOR SIGNS OF
RESPIRATORY DEPRESSION, ESPECIALLY DURINGINITIATION OF HYDROCODONE
BITARTRATE AND
ACETAMINOPHEN ORAL SOLUTION OR FOLLOWING A DOSE INCREASE [SEE
WARNINGS].
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF HYDROCODONE BITARTRATE AND ACETAMINOPHEN ORAL
SOLUTION,
ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF HYDROCODONE
BITARTRATE AND
ACETAMINOPHEN ORAL SOLUTION [SEE WARNINGS].
NEONATAL OPIOID WITHDRAWAL SYNDROME
PROLONGED USE OF HYDROCODONE BITARTRATE AND ACETAMINOPHEN ORAL
SOLUTION DURING
PREGNANCY CAN RESULT IN NEONATAL OP