TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN tablet, film coated

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

American Health Packaging

INN（国際名）:

TRAMADOL HYDROCHLORIDE

構図:

TRAMADOL HYDROCHLORIDE 37.5 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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 a

製品概要:

Tramadol Hydrochloride and Acetaminophen Tablets USP, 37.5 mg/325 mg are available in the following form: light yellow colored, film coated, capsule shaped, biconvex tablets, debossed with “537” on one side and plain on the other side. Available as follows: Unit dose packages of 100 (10 x 10) NDC 68084-825-01 Store at 20 to 25°C (68 to 77°F). [see USP Controlled Room Temperature] Store tramadol hydrochloride and acetaminophen tablets securely and dispose of properly [see Patient Counseling Information (17)]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN- TRAMADOL HYDROCHLORIDE AND
ACETAMINOPHEN TABLET, FILM COATED
American Health Packaging
----------
MEDICATION GUIDE
8282501/0822
Tramadol Hydrochloride (tram a dol hye” droe cklo’ ride) and
Acetaminophen (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 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. Talk to your
healthcare provider about
naloxone, a medicine for the emergency treatment of an opioid
overdose.
•
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

製品の特徴

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN- TRAMADOL HYDROCHLORIDE
AND ACETAMINOPHEN TABLET, FILM COATED
AMERICAN HEALTH PACKAGING
----------
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); LIFE‑ THREATENING 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 EXPOSE 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 C