ACETAMINOPHEN AND CODEINE PHOSPHATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Akorn

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 120 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Limitations of Use 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]: Acetaminophen and codeine phosphate oral solution is contraindicated in: Acetaminophen and codeine phosphate oral solution is contraindicated in patients with: Acetaminophen and codeine phosphate oral solution contains codeine. Codeine in combination with acetaminophen, is a Schedule V controlled substance. Acetaminophen and codeine phosphate oral solution contains codeine, a substance with a high potential for abuse similar to other opioids including, including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxy

Product summary:

Acetaminophen and Codeine Phosphate Oral Solution, USP is supplied in in 16 fl oz bottles, and 5 mL unit dose, 10 mL unit dose, 12.5 mL unit dose and 15 mL unit dose in tray of ten cups. STORAGE Store at 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistance closure. Store Acetaminophen and Codeine Phosphate Oral Solution securely and dispose of properly [see PRECAUTIONS; Information for Patients ]. Distributed by: Akorn Operating Company LLC Gurnee, IL 60031 Rev.079:19 08/22

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Akorn
----------
MEDICATION GUIDE
MEDICATION GUIDE
Acetaminophen and Codeine Phosphate (a seet’ a min’ oh fen and
koe’ deen fos’fate)
Oral Solution,
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 tonsil

Summary of Product characteristics

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE SOLUTION
AKORN
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ACETAMINOPHEN AND CODEINE PHOSPHATE ORAL SOLUTION, USP
RX ONLY
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
•
•
•
•
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATO