TRAMADOL HYDROCHLORIDE tablet extended release

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Preferred Pharmaceuticals, Inc.

INN (International Nazwa):

TRAMADOL HYDROCHLORIDE

Skład:

TRAMADOL HYDROCHLORIDE 200 mg

Typ recepty:

PRESCRIPTION DRUG

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, EXTENDED
RELEASE
PREFERRED PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CHILDREN WHO DEVELOPED LIFE-THREATENING
RESPIRATORY DEPRESSION OR DIED AFTER TAKING TRAMADOL FOR PAIN RELIEF
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 RESPIRATORY 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_.
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RECENT MAJOR CHANGES
Boxed Warning 08/2017
Indication and Usage (1) 12/2016
Dosage and Administration (2) 12/2016
Contraindications (4) 08/2017
Warnings and Precautions (5) 08/2017
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)
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 HAV