ACETAMINOPHEN AND CODEINE PHOSPHATE tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

NuCare Pharmaceuticals,Inc.

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 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

Podsumowanie produktu:

Each Acetaminophen and Codeine Phosphate Tablet USP 300 mg/30 mg tablet contains acetaminophen 300 mg and codeine phosphate 30 mg. It is available as a round, white to off-white tablet debossed with 3 on one side and an M on the other side. NDC 68071-4533-5 BOTTLES OF 15 NDC 68071-4533-2 BOTTLES OF 20 NDC 68071-4533-4 BOTTLES OF 24 NDC 68071-4533-3 BOTTLES OF 30 NDC 68071-4533-6 BOTTLES OF 60 NDC 68071-4533-8 BOTTLES OF 84 Store acetaminophen and codeine phosphate tablets 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. Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and M are trademarks of a Mallinckrodt company. © 2018 Mallinckrodt. SpecGx LLC Webster Groves, MO 63119 USA Rev 02/2018 Mallinckrodt TM Pharmaceuticals An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/MG20A08.pdf or by calling 1-800-778-7898 for alternate delivery options.

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

NuCare Pharmaceuticals,Inc.
----------
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 right away if you take too many 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.
•
Taking acetaminophen and codeine 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. Store acetaminophen and codeine phosphate tablets away from
children and in a safe place
to prevent stealing or abuse. Selling or giving away acetaminophen and
codeine phosphate tablets is
against the law.
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 years of age
after surgery to remove the tonsils and/or adenoids.
•
Avoid giving acetaminophen and codeine phosphate tablets to children
between 12 to 18 years of age
wh

Charakterystyka produktu

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
NUCARE PHARMACEUTICALS,INC.
----------
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII
WARNING: ADDICTION, ABUSE, AND MISUSE; 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).
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 OF THE REPORTED CASES OCCURRED
FOLLOWING TONSILLECTOMY AND/OR ADENOIDECTOMY, AND MANY OF THE CHILDREN
HAD EVIDENCE OF BEING ULTRA-RAPID METABOLIZERS OF CODEINE DUE TO A
CYP2D6 POLYMORPHISM ( _SEE _WARNINGS, PRECAUTIONS; INFORMATION FOR
PATIENTS/CAREGIVERS, NURSING MOTHERS). ACETAMINOPHEN AND CODEINE
PHOSPHATE TAB