TRAMADOL HYDROCHLORIDE- tramadol hydrochloride tablet, extended release

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Unit Dose Services

INN (Algemene Internationale Benaming):

TRAMADOL HYDROCHLORIDE

Samenstelling:

TRAMADOL HYDROCHLORIDE 300 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Tramadol hydrochloride extended-release tablets is 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 is 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 (5.3)] - post-operat

Product samenvatting:

Product: 50436-0823 NDC: 50436-0823-1 30 TABLET, EXTENDED RELEASE in a BOTTLE

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

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, C IVInitial U.S. Approval: 1995

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TRAMADOL HYDROCHLORIDE-
tramadol hydrochloride tablet, extended
release  Unit Dose Services
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Medication Guide
Tramadol Hydrochloride
Extended-release Tablets, 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

Lees het volledige document

Productkenmerken

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, EXTENDED
RELEASE
UNIT DOSE SERVICES
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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, C IV
INITIAL U.S. APPROVAL: 1995
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION;
ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF TRAMADOL AND OTHER
RISK FACTORS
FOR LIFE-THREATENING RESPIRATOY DEPRESSION IN CHILDREN; NEONATAL
OPIOID
WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450
ISOENZYMES; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR
OTHER CNS
DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS EXPOSES 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)
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. (5.2)
ACCIDENTAL INGESTION OF TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE
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 ONCE CASE, THE
CHILD HAD EVIDENCE OF BEING AN ULTRA-RAPID METABOLIZER OF TRAMADOL DUE
TO A CYP2D6 POLYMORPHISM
(5.3). TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS ARE
CONTRAINDICATED IN CHILDREN