ACETAMINOPHEN AND CODEINE tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Northwind Pharmaceuticals

INN (International namn):

CODEINE PHOSPHATE

Sammansättning:

CODEINE PHOSPHATE 30 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 Please review the manufacturer's complete drug information available from the FDA at www.fda.gov Permanent Link: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=02386806-02d4-47e3-9c8b-7810146ee795 Acetaminophen and codeine phosphate tablets are contraindicated in patients with: Patients with significant respiratory depression [see WARNINGS].

Produktsammanfattning:

Acetaminophen and codeine phosphate tablets, USP are supplied as follows: 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 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 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 Revised: 12/2016 LM 2126 Bottles of 6 NDC: 51655-808-87 Bottles of 10 NDC: 51655-808-53 Bottles of 15 NDC: 51655-808-54 Bottles of 30 NDC: 51655-808-52 Repackaged for: Northwind Pharmaceuticals, LLC Indianapolis, IN 46203 Please review the manufacturer's complete drug information available from the FDA at www.fda.gov Permanent Link: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=02386806-02d4-47e3-9c8b-7810146ee795

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

ACETAMINOPHEN AND CODEINE- ACETAMINOPHEN AND CODEINE TABLET
NORTHWIND PHARMACEUTICALS
----------
MANUFACTURER'S 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 who
recei