ACETAMINOPHEN AND CODEINE tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Contract Pharmacy Services-PA

INN (Tarptautinis Pavadinimas):

ACETAMINOPHEN

Sudėtis:

ACETAMINOPHEN 300 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 sig

Produkto santrauka:

Acetaminophen and Codeine Phosphate Tablets, USP 300 mg /30 mg are white, round, flat, beveled edged tablets debossed “IP 33” on obverse and “3” on reverse. They are available as follows: Bottles of 100:            NDC 65162-033-10 Bottles of 500:            NDC 65162-033-50 Bottles of 1000:          NDC 65162-033-11 Store Acetaminophen and Codeine Phosphate Tablets, USP 300 mg/30 mg 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. Manufactured by: Amneal Pharmaceuticals of NY LLC Brookhaven, NY 11719 Rev. 05-2017-05

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

ACETAMINOPHEN AND CODEINE- ACETAMINOPHEN AND CODEINE TABLET
CONTRACT PHARMACY SERVICES-PA
----------
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 TH