TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN tablet

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Bryant Ranch Prepack

ИНН (Международная Имя):

TRAMADOL HYDROCHLORIDE

состав:

TRAMADOL HYDROCHLORIDE 37.5 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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 adenoidectomy [see

Обзор продуктов:

Tramadol hydrochloride and acetaminophen tablets USP, 37.5 mg/325 mg, are supplied as beige colored, film-coated, biconvex capsule shaped tablets with “AN 617” debossed on one side and plain on the other side. NDC: 71335-0111-1: 30 Tablets in a BOTTLE NDC: 71335-0111-2: 60 Tablets in a BOTTLE NDC: 71335-0111-3: 90 Tablets in a BOTTLE NDC: 71335-0111-4: 120 Tablets in a BOTTLE NDC: 71335-0111-5: 20 Tablets in a BOTTLE NDC: 71335-0111-6: 40 Tablets in a BOTTLE NDC: 71335-0111-7: 100 Tablets in a BOTTLE NDC: 71335-0111-8: 15 Tablets in a BOTTLE Dispense in a tight container. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP. Store tramadol hydrochloride and acetaminophen tablets securely and dispose of properly [see PATIENT COUNSELING INFORMATION (17)].

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

ACETAMINOPHEN TABLET
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 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 or call 911 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 are
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
produ

Характеристики продукта

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN- TRAMADOL HYDROCHLORIDE
AND ACETAMINOPHEN TABLET
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); 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 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,
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,
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 CHILD HAD EVIDENCE OF BEING
AN ULTR