ACETAMINOPHEN AND CODEINE PHOSPHATE tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

American Health Packaging

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Acetaminophen and codeine phosphate tablets are 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 tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - Have not provided adequate analgesia, or are not expected to provide adequate analgesia, - Have not been tolerated, or are not expected to be tolerated. Acetaminophen and codeine phosphate tablets are 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 tablets are contraindicated in patients with: - Significant respiratory depression [

Produkt oversigt:

Acetaminophen and codeine phosphate tablets, USP are supplied as follows: 300 mg/30 mg White to off-white, round, flat-faced, beveled-edged tablets, debossed with “U36” on one side and plain on the other side. Unit dose packages of 100 (10 x 10) NDC 60687-604-01 300 mg/60 mg White to off-white, round, flat-faced, beveled-edged tablets, debossed with “U37” on one side and plain on the other side. Unit dose packages of 100 (10 x 10) NDC 60687-615-01 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] FOR YOUR PROTECTION: Do not use if blister is torn or broken. Keep this and all medication out of the reach of children. Store acetaminophen and codeine phosphate tablets securely and dispose of properly [see PRECAUTIONS; Information for Patients ]. Protect from moisture. PROTECT FROM LIGHT Dispense with Medication Guide To order additional Medication Guides call American Health Packaging at 1-800-707-4621.

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
American Health Packaging
----------
MEDICATION GUIDE
8460401/1121
Acetaminophen and Codeine Phosphate Tablets (ass-cet-ah-MEE-noe-fen
with KOE-deen FOSS-fate),
USP CIII
Acetaminophen and Codeine Phosphate Tablets are:
•
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
tablets:
•
Get emergency help or call 911 right away if you take too much
acetaminophen and codeine
phosphate tablets (overdose). When you first start taking
acetaminophen and codeine tablets, 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 tablets 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
tablets. They could die from
taking it. Selling or giving away acetaminophen and codeine phosphate
tablets are against the law.
•
Store acetaminophen and codeine phosphate tablets 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 tablets to a child
younger than 12 years of age.
•
Do not give acetaminophen and codeine phosphate tablets to a child
younger than 18 years of age
after sur

Produktets egenskaber

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
AMERICAN HEALTH PACKAGING
----------
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP CIII
8460401/1121
RX ONLY
WARNING: 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; INTERACTIONS WITH DRUGS AFFECTING
CYTOCHROME P450 ISOENZYMES; HEPATOTOXICITY; AND RISKS FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
ADDICTION, ABUSE AND MISUSE
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS EXPOSE 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 TABLETS, 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 READING
THE MEDICATION GUIDE EVERY TIME IT IS PROVIDED BY THEIR PHARMACIST,
AND
CONSIDER OTHER TOOLS TO IMPROVE PATIENT, HOUSEHOLD, AND COMMUNITY
SAFETY.
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH
USE OF ACETAMINOP