ULTRAM ER tramadol hydrochloride tablet extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Janssen Pharmaceuticals, Inc.

INN (International Name):

TRAMADOL HYDROCHLORIDE

Composition:

TRAMADOL HYDROCHLORIDE 300 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

ULTRAM ER- TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE
JANSSEN PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ULTRAM ER SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ULTRAM ER.
ULTRAM ER (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 CHIDLREN; 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
INDICATIONS AND USAGE
ULTRAM ER is an opioid agonist 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. (1)
®
ULTRAM ER 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
ULTRAM ER 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 ULTRAM ER, 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