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:

Eywa Pharma Inc

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 ). Acetaminophen and codeine phosphate tablets are contraindicated in patients with: · Significant respiratory dep

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, 300 mg/30 mg contain acetaminophen 300 mg and codeine phosphate 30 mg. The tablets are white colored, round flat-faced beveled edge, debossed one side with W242. Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/60 mg contain acetaminophen 300 mg and codeine phosphate 60 mg. The tablets are blue colored, round flat-faced beveled edge, debossed one side with W243. Acetaminophen and Codeine Phosphate Tablets, USP are supplied as follows: Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/15 mg bottles of 100 - NDC 71930-054-12 Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/15 mg bottles of 500 - NDC 71930-054-52 Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/30 mg bottles of 100 - NDC 71930-055-12 Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/30 mg bottles of 500 - NDC 71930-055-52 Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/60 mg bottles of 100 - NDC 71930-056-12 Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/60 mg bottles of 500 - NDC 71930-056-52 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. Store acetaminophen and codeine phosphate tablets securely and dispose of properly (see PRECAUTIONS, Information for Patients ). Manufactured by:  WES Pharma Inc Westminster, MD 21157 USA Manufactured for : Eywa Pharma Inc., 2 Research Way, Floor 3, Princeton, NJ 08540 Revised: 05/21

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

Eywa Pharma Inc
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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 18 yea

제품 특성 요약

ACETAMINOPHEN AND CODEINE PHOSPHATE - ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
EYWA PHARMA INC
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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 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 ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS. MONITOR FOR
RESPIR