ACETAMINOPHEN AND CODEINE tablet

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Unit Dose Services

INN (আন্তর্জাতিক নাম):

ACETAMINOPHEN

রচনা:

ACETAMINOPHEN 300 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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.   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 in: - Children less than 12 years of age [see WARNINGS  and PRECAUTIONS ]. - Postoperative pain management in children of any age who have undergone tonsillectomy and/or adenoidectomy [see WARNINGS  and PRECAUTIONS ]. - Patients with significant respiratory depression [see WARNINGS ]. - Patients with acute or severe bronchial asthma in an unmonit

পণ্য সারাংশ:

Product: 50436-3227 NDC: 50436-3227-2 20 TABLET in a BOTTLE NDC: 50436-3227-9 12 TABLET in a BOTTLE NDC: 50436-3227-1 10 TABLET in a BOTTLE NDC: 50436-3227-7 60 TABLET in a BOTTLE

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

ACETAMINOPHEN AND CODEINE- ACETAMINOPHEN AND CODEINE TABLET
UNIT DOSE SERVICES
----------
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP CIII
300 MG/30 MG
RX ONLY BOXED WARNING
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING
RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID
METABOLISM OF CODEINE AND LIFE-THREATENING RESPIRATORY
DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME;
HEPATOTOXICITY; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME
P450 ISOENZYMES; 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].
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH USE OF
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS. MONITOR FOR RESPIRATORY
DEPRESSION,
ESPECIALLY DURING INITIATION OF ACETAMINOPHEN AND CODEINE PHOSPHATE
TABLETS OR FOLLOWING A
DOSE INCREASE [SEE WARNINGS].
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS,
ESPECIALLY BY
CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLETS [SEE
WARNINGS].
ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR
LIFE-THREATENING
RESPIRATORY DEPRESSION IN CHILDREN
LIFE-THREATENING RESPIRATORY DEPRESSION AND DEATH HAVE OCCURRED IN
CHILDREN WHO RECEIVED
CODEINE; MOST CASES FOLLOWING TONSILLECTOMY AND/OR ADENOIDECTOMY, AND
MANY OF THE
CHILDREN HAD EVIDENCE OF BEING AN ULTRA-RAPID METABOLIZERS OF CODEINE
DUE TO A CYP2D6
POLYMORPHISM. CODEINE IS CONTRAINDICATED IN CHILDREN YOUNGER THAN
TWELVE YEARS OF AGE AND
IN CHILDREN OF ANY AGE WHO ARE UNDERGOING TONSILLECTOMY AND/OR
ADENOIDECTOMY. AVOID THE
USE OF AC