TRAMADOL HCL AND ACETAMINOPHEN tablet, film coated

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Graviti Pharmaceuticals Private Limited

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 ade

Rezumat produs:

Tramadol hydrochloride and acetaminophen tablets containing 37.5 mg tramadol hydrochloride and 325 mg acetaminophen are yellow, oval, coated tablets, debossed with "OE" on one side and "B55" on the other side. Bottles of 100 tablets with child-resistant closure, NDC 69844-049-01 Bottles of 500 tablets, NDC 69844-049-02 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

TRAMADOL HCL AND ACETAMINOPHEN- TRAMADOL HCL AND ACETAMINOPHEN TABLET,
FILM
COATED
Graviti Pharmaceuticals Private Limited
----------
MEDICATION GUIDE
Tramadol Hydrochloride and Acetaminophen(tram´ a dol hye ̋ droe
klor´ ide and a seet ̋ a min´ oh
fen) Tablets, CIV
Tramadol Hydrochloride and Acetaminophen Tablets 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 acetaminophen
tablets:
•
Get emergency help right away if you take toomuch 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 seriou

Caracteristicilor produsului

TRAMADOL HCL AND ACETAMINOPHEN- TRAMADOL HCL AND ACETAMINOPHEN TABLET,
FILM
COATED
GRAVITI PHARMACEUTICALS PRIVATE LIMITED
----------
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 TABLETS 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