TRAMADOL HYDROCHLORIDE - tramadol hydrochloride tablet, extended release

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J)

थमां उपलब्ध:

Aurobindo Pharma Limited

INN (इंटरनेशनल नाम):

TRAMADOL HYDROCHLORIDE

रचना:

TRAMADOL HYDROCHLORIDE 100 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Tramadol hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use - Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. - Tramadol hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic. Tramadol hydrochloride extended-release tablets are contraindicated for:   - all children younger than 12 years of  age [see Warnings and Precautions (5.4)] -

उत्पाद समीक्षा:

Tramadol hydrochloride extended-release tablets USP are supplied in the following package and dose strength forms: Tramadol Hydrochloride Extended-Release Tablets USP, 100 mg are round, convex, white to off-white tablets imprinted with “Z” over “07” on one side in black ink. Bottles of 30                           NDC 65862-683-30 Bottles of 1,000                      NDC 65862-683-99 Tramadol Hydrochloride Extended-Release Tablets USP, 200 mg are round, convex, white to off-white tablets imprinted with “Z” over “08” on one side in black ink. Bottles of 30                           NDC 65862-733-30 Bottles of 1,000                      NDC 65862-733-99 Tramadol Hydrochloride Extended-Release Tablets USP, 300 mg are round, convex, white to off-white tablets imprinted with “Z” over “09” on one side in black ink. Bottles of 30                           NDC 65862-734-30 Bottles of 1,000                      NDC 65862-734-99 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store tramadol hydrochloride extended-release tablets securely and dispose of properly [see Patient Counseling Information (17)] .

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

TRAMADOL HYDROCHLORIDE - TRAMADOL HYDROCHLORIDE TABLET, EXTENDED
RELEASE
Aurobindo Pharma Limited
----------
MEDICATION GUIDE
Tramadol hydrochloride extended-release tablets, USP CIV
(tram' a dol hye'' droe klor' ide)
Tramadol Hydrochloride Extended-Release Tablets are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage pain
severe enough to require daily around-the-clock, long-term treatment
with an opioid, when other pain
treatments such as non-opioid pain medicines or immediate-release
opioid medicines do not treat your
pain well enough or you cannot tolerate them.
•
A long-acting (extended-release) 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.
•
Not for use to treat pain that is not around-the-clock.
Important information about Tramadol Hydrochloride Extended-Release
Tablets:
•
Get emergency help right away if you take too much tramadol
hydrochloride extended-release tablets
(overdose). When you first start taking tramadol hydrochloride
extended-release 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.
•
Taking tramadol hydrochloride extended-release tablets with other
opioid medicines,
benzodiazepines, alcohol, or other central nervous system depressants
(including street drugs) can
cause severe drowsiness, decreased awareness, breathing problems,
coma, and death.
•
Never give anyone else your tramadol hydrochloride extended-release
tablets. They could die from
taking it. Selling or giving away tramadol hydrochloride
extended-release tablets is against the law.
•
Store tramadol hydrochloride extended-release tablets securely, out of
sight and reach of children,
and in a location not accessible by others, including visitors to the
home.
Important Information Guiding Use in Pediatric Patients:
•
D

उत्पाद विशेषताएं

TRAMADOL HYDROCHLORIDE - TRAMADOL HYDROCHLORIDE TABLET, EXTENDED
RELEASE
AUROBINDO PHARMA LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRAMADOL HYDROCHLORIDE EXTENDED-
RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR TRAMADOL
HYDROCHLORIDE EXTENDED-RELEASE TABLETS.
TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS FOR ORAL USE, CIV
INITIAL U.S. APPROVAL: 1995
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS EXPOSE USERS TO RISKS
OF ADDICTION, ABUSE, AND
MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS PATIENT’S RISK
BEFORE PRESCRIBING AND MONITOR
REGULARLY FOR THESE BEHAVIORS AND 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 UPON
INITIATION OR FOLLOWING A DOSE INCREASE. INSTRUCT PATIENTS TO SWALLOW
TRAMADOL HYDROCHLORIDE EXTENDED-
RELEASE TABLETS INTACT, AND NOT TO CUT, BREAK, CHEW, CRUSH, OR
DISSOLVE THE TABLETS TO AVOID EXPOSURE TO A
POTENTIALLY FATAL DOSE OF TRAMADOL. (5.3)
ACCIDENTAL INGESTION OF TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE
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
CHILD HAD EVIDENCE OF BEING AN ULTRA-RAPID METABOLIZER OF TRAMADOL DUE
TO A CYP2D6 POLYMORPHISM
(5.4). TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS ARE
CONTRAINDICATED IN CHILDREN YOUNGER THAN
12 YEARS OF AGE AND IN CHILDREN YOUNGER THAN 18 YEARS OF AGE FOLLOWING
TONSILLECTOMY AND/OR
ADENOIDECTOMY (4)_. _AVOID THE USE OF TRAMADOL HYDROCHLO