TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN tablet, film coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J)

Disponible des:

Bryant Ranch Prepack

Designació comuna internacional (DCI):

ACETAMINOPHEN

Composición:

ACETAMINOPHEN 325 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: - Have not been tolerated, or are not expected to be tolerated, - Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Tramadol hydrochloride and acetaminophen tablets are contraindicated for: -   all children younger than 12 years of age [see Warnings and Precautions (5.4)] -   post-operative management in children younger than 18 years of age following tonsillectomy and/or aden

Resumen del producto:

NDC: 71335-0619-8: 15 Tablets in a BOTTLE NDC: 71335-0619-1: 30 Tablets in a BOTTLE NDC: 71335-0619-2: 60 Tablets in a BOTTLE NDC: 71335-0619-3: 90 Tablets in a BOTTLE NDC: 71335-0619-4: 120 Tablets in a BOTTLE NDC: 71335-0619-5: 20 Tablets in a BOTTLE NDC: 71335-0619-6: 40 Tablets in a BOTTLE NDC: 71335-0619-7: 100 Tablets in a BOTTLE

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN- tramadol hydrochloride and
acetaminophen tablet, film coated
Bryant Ranch Prepack
----------
Medication Guide
Tramadol Hydrochloride (TRAM-a-dol HYE-droe-KLOR-ide) and
Acetaminophen(a-SEET-a-MIN-oh-fen)
Tablets, USP CIV
Tramadol Hydrochloride and AcetaminophenTablets are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used for the short-term
(five days or less) management of acute 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 Tramadol Hydrochloride and
AcetaminophenTablets:
•
Get emergency help right away if you take too much tramadol
hydrochloride and acetaminophen
tablets (overdose). When you first start taking tramadol hydrochloride
and acetaminophen 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.
•
Tramadol hydrochloride and acetaminophen tablets can cause severe
drowsiness, breathing problems
(respiratory depression), coma and death when taken with
benzodiazepines or other medicines that
depress consciousness.
•
Never give anyone else your tramadol hydrochloride and acetaminophen
tablets. They could die from
taking it. Selling or giving away tramadol hydrochloride and
acetaminophen tablets is against the law.
•
Store tramadol hydrochloride and acetaminophen tablets securely, out
of sight and reach of children,
and in a location not accessible by others, including visitors to the
home.
•
Get emergency help right away if you take more than 4,000 mg of
acetaminophen in 1 day. Taking
tramadol hydrochloride and acetaminophen tablets with other products
that contain acetaminophen
can lead to serious liver prob

Fitxa tècnica

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN- TRAMADOL HYDROCHLORIDE
AND ACETAMINOPHEN TABLET, FILM COATED
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRAMADOL
HYDROCHLORIDE AND ACETAMINOPHEN TABLETS SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS, FOR ORAL USE, C-IV
INITIAL U.S. APPROVAL:2001
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION
STRATEGY (REMS); LIFETHREATENING RESPIRATORY DEPRESSION; ACCIDENTAL
INGESTION; ULTRA-RAPID METABOLISM OF TRAMADOL 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
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET EXPOSES USERS TO THE
RISKS OF
ADDICTION, ABUSE AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH.
ASSESS EACH
PATIENT'S RISK PRIOR TO PRESCRIBING TRAMADOL HYDROCHLORIDE AND
ACETAMINOPHEN
TABLETS, AND MONITOR REGULARLY FOR THESE BEHAVIORS OR CONDITIONS
(5.1).
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 RISK
EVALUATION AND MITIGATION STRATEGY (REMS) FOR THESE PRODUCTS. (5.2)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY,
ESPECIALLY DURING INITIATION OR FOLLOWING A DOSE INCREASE (5.3)
ACCIDENTAL INGESTION OF TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
TABLETS,
ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF TRAMADOL.
(5.3).
LIFE-THREATENING RESPIRATORY DEPRESSION AND DEATH HAVE OCCURRED IN
CHILDREN WHO
RECEIVED TRAMADOL. SOME OF THE REPORTED CASES FOLLOWED TONSILLECTOMY
AND/OR
ADENOIDECTOMY; IN AT LEAST ONE CASE, THE CHIL