TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN tablet

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Par Pharmaceutical, Inc.

INN (আন্তর্জাতিক নাম):

TRAMADOL HYDROCHLORIDE

রচনা:

TRAMADOL HYDROCHLORIDE 37.5 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opiod analgesic and for which alternative treatments are inadequate. L imitations of Use Tramadol hydrochloride and acetaminophen tablets are indicated for short-tern 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 (5.3)] - Post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see

পণ্য সারাংশ:

Tramadol Hydrochloride and Acetaminophen Tablets 37.5 mg/325 mg, (orange, film-coated capsule-shaped tablets) debossed “083” on one side and “KALI” on the other side are available as follows: Dispense in a tight container. Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

ACETAMINOPHEN TABLET
Par Pharmaceutical, Inc.
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MEDICATION GUIDE
Medication Guide
Tramadol Hydrochloride and Acetaminophen Tablets, CIV
(TRAM-a-dol HYE-droe-KLOR-ide and a-SEET-a-MIN-oh-fen)
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.
•
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. Store Tramadol Hydrochloride and Acetaminophen
Tablets away from
children and in a safe place to prevent stealing or abuse. Selling or
giving away Tramadol
Hydrochloride and Acetaminophen Tablets is against the law.
•
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 problems and death.
Important Information Guiding Use in Pediatric Patients:
•
Do not give Tramadol Hydrochloride and

পণ্য বৈশিষ্ট্য

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN- TRAMADOL HYDROCHLORIDE AND
ACETAMINOPHEN TABLET
PAR PHARMACEUTICAL, INC.
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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; 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
P450ISOENZYMES; 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 AND CONDITIONS.
(5.1)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY DURING
INITIATION OR FOLLOWING A DOSE INCREASE. (5.2)
ACCIDENTAL INGESTION OF TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
TABLETS, ESPECIALLY BY CHILDREN,
CAN RESULT IN A FATAL OVERDOSE OF TRAMADOL. (5.2)
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 ULTRA-RAPID METABOLIZER OF
TRAMADOL DUE TO A CYP2D6
POLYMORPHISM (5.3). TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS
ARE CONTRAINDICATED IN
CHILDREN YOUNGER THAN 12 YEARS OF AGE AND IN CHILDREN YOUNGER THAN 18
YEARS OF AGE FOLLOWING
TONSILLECTOMY AN