ACETAMINOPHEN AND CODEINE PHOSPHATE solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)

Dostupno od:

RPK Pharmaceuticals, Inc.

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Acetaminophen and codeine phosphate oral solution is indicated for the management of mild to moderate pain where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS ], reserve acetaminophen and codeine phosphate 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 Acetaminophen and codeine phosphate oral solution is contraindicated for: - all children younger than 12 years of age [see WARNINGS ]. - post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see WARNINGS ]. Acetaminophen and codeine phosphate oral solution is contraindicated in patients with: - Significant respiratory depression [see WARNINGS

Proizvod sažetak:

Product: 53002-3410 NDC: 53002-3410-1 118 mL in a BOTTLE

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

RPK Pharmaceuticals, Inc.
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MEDICATION GUIDE
Acetaminophen and Codeine Phosphate (a seet' a min' oh fen and koe'
deen fos'fate) Oral Solution, CV
Acetaminophen and Codeine Phosphate Oral Solution is:
•
A strong prescription pain medicine that contains an opioid
(narcotic) that is used to manage mild to moderate pain 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 Acetaminophen and Codeine Phosphate
Oral Solution:
•
Get emergency help right away if you take too much
acetaminophen and codeine phosphate oral solution
(overdose). When you first start taking acetaminophen and
codeine phosphate 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 acetaminophen and codeine phosphate 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 acetaminophen and codeine
phosphate oral solution. They could die from taking it. Selling
or giving away acetaminophen and codeine phosphate oral
solution is against the law.
•
Store acetaminophen and codeine phosphate oral solution
securely, out of sight and reach of children, and in a location
not accessible by others, including visitors to the home.
Important Information Guiding Use in Pediatric Patients:
•
Do not give acetaminophen and codeine phosphate oral
solution to a child younger than 12 years of age.
•
Do not give acetaminophen and codeine phosphate oral
solution to a child younger than 18 years of age after surgery to
remove the tonsils

Svojstava lijeka

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE SOLUTION
RPK PHARMACEUTICALS, INC.
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ACETAMINOPHEN AND CODEINE PHOSPHATE ORAL SOLUTION USP CV
WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND
MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-
THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION;
ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR
LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL
OPIOID WITHDRAWAL SYNDROME; DEATH RELATED TO ULTRA-RAPID
METABOLISM OF CODEINE TO MORPHINE; INTERACTIONS WITH DRUGS
AFFECTING CYTOCHROME P450 ISOENZYMES; HEPATOTOXICITY; AND
RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER
CNS DEPRESSANTS
RISK OF MEDICATION ERRORS
ENSURE ACCURACY WHEN PRESCRIBING, DISPENSING, AND ADMINISTERING
ACETAMINOPHEN AND CODEINE PHOSPHATE ORAL SOLUTION. DOSING ERRORS DUE
TO CONFUSION BETWEEN MG AND ML, AND OTHER CODEINE CONTAINING ORAL
PRODUCTS OF DIFFERENT CONCENTRATIONS CAN RESULT IN ACCIDENTAL OVERDOSE
AND DEATH [SEE WARNINGS, DOSAGE AND ADMINISTRATION].
ADDICTION, ABUSE, AND MISUSE
ACETAMINOPHEN AND CODEINE PHOSPHATE 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 ACETAMINOPHEN AND CODEINE PHOSPHATE 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