ACETAMINOPHEN AND CODEINE PHOSPHATE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Bryant Ranch Prepack

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 )

제품 요약:

Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/15 mg contain acetaminophen 300 mg and codeine phosphate 15 mg. The tablets are pink colored, round flat-faced beveled edge, debossed one side with W241. Acetaminophen and Codeine Phosphate Tablets, USP are supplied as follows: Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/15 mg bottles of 100 - NDC 63629-1185-1 Store Acetaminophen and Codeine Phosphate Tablets, USP at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in tight, light-resistant container as defined in the USP.

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

Bryant Ranch Prepack
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MEDICATION GUIDE
Acetaminophen and Codeine Phosphate Tablets USP, CIII
(a seet' a min' oh fen and koe' deen fos' fate)
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 phosphate 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. Talk to your healthcare provider about
naloxone, a medicine for the
emergency treatment of an opioid overdose.
· Taking acetaminophen and codeine phosphate 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
is 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 1

제품 특성 요약

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
BRYANT RANCH PREPACK
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BOXED WARNING
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 MISUSEACETAMINOPHEN 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 DEPRESSIONSERIOUS, LIFE-THREATENING, OR
FATAL RESPIRATORY DEPRESSION MAY OCCUR WITH USE OF ACETAMINOPHEN AND
CODEINE PHOSPHATE TABLETS. MONITOR FOR RESPI