TYLENOL WITH CODEINE- acetaminophen and codeine phosphate tablet

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

A-S Medication Solutions

INN (Међународно име):

ACETAMINOPHEN

Састав:

ACETAMINOPHEN 300 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

TYLENOL® with Codeine (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. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS ), reserve TYLENOL® with Codeine 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. TYLENOL® with Codeine is 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 ). TYLENOL® with Codeine is contraindicated in patients with: - Significant respiratory depression (see WARNINGS ). - Acute or severe bronchial asthma in an unmonitor

Резиме производа:

Product: 50090-0006 NDC: 50090-0006-2 20 TABLET in a BOTTLE

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

A-S Medication Solutions
----------
MEDICATION GUIDE
TYLENOL® (TAHY-LUH-NAWL) WITH CODEINE TABLETS, CIII
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
TYLENOL® with Codeine 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 TYLENOL® with Codeine tablets:
•
Get emergency help right away if you take too much TYLENOL® with
Codeine tablets
(overdose). When you first start taking TYLENOL® with 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 TYLENOL® with 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 TYLENOL® with Codeine tablets. They could
die from taking it.
Store TYLENOL® with Codeine tablets away from children and in a safe
place to prevent
stealing or abuse. Selling or giving away TYLENOL® with Codeine
tablets is against the law.
Important Information Guiding Use in Pediatric Patients:
•
Do not give TYLENOL® with Codeine tablets to a child younger than 12
years of age.
•
Do not give TYLENOL® with Codeine tablets to a child younger than 18
years of age after
surgery to remove the tonsils and/or adenoids.
•
Avoid giving TYLENOL® with Codeine tablets to children between 12 to
18 years of age who
have risk factors for breathing problems such as obstructive sleep
apnea, obesity, or underlying
lung

Карактеристике производа

TYLENOL WITH CODEINE- ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET
A-S MEDICATION SOLUTIONS
----------
TYLENOL
WITH CODEINE
CIII
(ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLETS
®
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
TYLENOL WITH CODEINE EXPOSES 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 TYLENOL WITH CODEINE 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
TYLENOL WITH CODEINE TABLETS. MONITOR FOR RESPIRATORY DEPRESSION,
E