ACETAMINOPHEN AND CODEINE PHOSPHATE tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

DIRECT RX

DCI (Dénomination commune internationale):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 300 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 in patients with: Patients with significant respiratory depression [see WARNINGS]. Patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS]. Postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy [see WARNI

Descriptif du produit:

Acetaminophen and codeine phosphate tablets, USP are supplied as follows: 300 mg/15 mg White to off-white, round, flat-faced, beveled-edged tablets, debossed with “U35” on one side and plain on the other side. Bottles of 30 NDC 13107-058-30 Bottles of 100 NDC 13107-058-01 Bottles of 500 NDC 13107-058-05 Bottles of 1000 NDC 13107-058-99 300 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. Bottles of 30 NDC 13107-059-30 Bottles of 100 NDC 13107-059-01 Bottles of 500 NDC 13107-059-05 Bottles of 1000 NDC 13107-059-99 300 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. Bottles of 30 NDC 13107-060-30 Bottles of 100 NDC 13107-060-01 Bottles of 500 NDC 13107-060-05 Bottles of 1000 NDC 13107-060-99 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Keep this and all medication out of the reach of children. Protect from moisture. Dispense in a tight, light-resistant container as described in the USP. PROTECT FROM LIGHT Dispense with Medication Guide availableat www.aurobindousa.com/product-medication-guides

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
DIRECT RX
----------
APAP CODEINE C-III
BOXED WARNING
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL
SYNDROME; DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO
MORPHINE; HEPATOTOXICITY; CYTOCHROME P450 2D6 INTERACTION; 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 even one dose of acetaminophen and codeine
phosphate tablets,
especially by children, can result in a fatal overdose of
acetaminophen and codeine phosphate
tablets [see WARNINGS].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of acetaminophen and codeine phosphate tablets during
pregnancy can result in
neonatal opioid withdrawal syndrome, which may be life-threatening if
not recognized and treated,
and requires management according to protocols developed by
neonatology experts. If opioid use
is required for a prolonged period in a pregnant woman, advise the
patient of the risk of neonatal
opioid withdrawal syndrome and ensure that appropriate treatment will
be available [see
WARNINGS].
Death Related to Ultra-Rapid Metabolism of Codeine to Morphine
Respiratory depression and death have occurred in children w