ACETAMINOPHEN AND CODEINE tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Direct_Rx

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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). Post-operative 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 [seeWARNINGS].

Каталог на резюме:

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 Bottles of 100 Bottles of 500 Bottles of 1000 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 Bottles of 100 Bottles of 500 Bottles of 1000 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 Bottles of 100 Bottles of 500 Bottles of 1000 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store acetaminophen and codeine phosphate tablets securely and dispose of properly [see PRECAUTIONS/ Information for Patients]. 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 available at www.aurobindousa.com/product-medication-guides Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Revised:04/2019

Статус Оторизация:

Abbreviated New Drug Application

Листовка

ACETAMINOPHEN AND CODEINE- ACETAMINOPHEN AND CODEINE TABLET
Direct_Rx
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Acetaminophen and Codeine Phosphate Tablets, USP CIII
ass-cet-ah-MEE-noe-fen with KOE-deen FOSS-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
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 strret 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.
Selling or giving away acetaminophen and codeine phosphate tablets are
against the law.
Store acetaminophen and codeine phosphate tablets securely, out of
sight and reach of children, and in a
location not accessible by others, including visitors to the home.
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 childr

Данни за продукта

ACETAMINOPHEN AND CODEINE- ACETAMINOPHEN AND CODEINE TABLET
DIRECT_RX
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ACETAMINOPHEN AND CODEINE
BOXED WARNING
WARNING: ADDICTION, ABUSE, AND MISUSE:RISK EVALUATION AND MITIGATION
STRATEGY (REMS), 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].
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 during initiation of acetaminophen and codeine phosphate