ACETAMINOPHEN AND CODEINE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Direct_Rx

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 for: All children younger than 12 years of age (see WARNINGS). Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (see WARNINGS). Acetaminophen and codeine phosphate tablets are contraindicated in patients with: significant respiratory depression (see WARNINGS). acut

Resumo do produto:

Each Acetaminophen and Codeine Phosphate Tablet USP 300 mg/15 mg tablet contains acetaminophen 300 mg and codeine phosphate 15 mg. It is available as a round, white to off-white tablet debossed with “2” on one side and an M on the other side. Bottles of 100......................................... 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. Bottles of 20............................................ Bottles of 30............................................ Bottles of 50............................................ Bottles of 100......................................... Bottles of 1000....................................... Unit Dose (10 x 10)............................... Each Acetaminophen and Codeine Phosphate Tablet USP 300 mg/60 mg tablet contains acetaminophen 300 mg and codeine phosphate 60 mg. It is available as a round, white to off-white tablet debossed with “4” on one side and an M on the other side. Bottles of 100......................................... Bottles of 500......................................... 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 07/2018 MallinckrodtTM 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 de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

ACETAMINOPHEN AND CODEINE- ACETAMINOPHEN AND CODEINE TABLET
Direct_Rx
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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

Características técnicas

ACETAMINOPHEN AND CODEINE- ACETAMINOPHEN AND CODEINE TABLET
DIRECT_RX
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ACETAMINOPHEN AND CODEINE
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION
STRATEGY (REMS); 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).
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS):
To ensure that the benefits of opioid analgesics outweigh the risks of
addiction, abuse, and
misuse, the Food and Drug Administration (FDA) has required a REMS for
these products (see
WARNINGS). Under the requirements of the REMS, drug companies with
approved opioid
analgesic products must make REMS-compliant education programs
available to healthcare
providers. Healthcare providers are strongly encouraged to:
complete a REMS-compliant education program,
counsel patients and/or their caregivers, with every prescription, on
safe use, serious risks,
storage, and disposal of these products,
emphasize to patients and their caregivers the importance of reading
the Medication Guide every
time it is provided by their pharmacist, and
consider other tools to improve patient, household, and community
safety.
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 d