TRAMADOL HYDROCHLORIDE 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:

H.J. Harkins Company, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tramadol hydrochloride 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) 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, 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. (1) Tramadol hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic. (1) Children younger than 12 years of age (4) Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. (4) Significant respiratory de

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRAMADOL HYDROCHLORIDE ER- TRAMADOL HYDROCHLORIDE TABLET, EXTENDED
RELEASE
H.J. HARKINS COMPANY, INC.
----------
1142-03,06
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.
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 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 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
hydrochloride extended-
release tablets in adolescents 12 to 18 years of age who have other
risk factors that may increase
their sensitivity to the respiratory depressant effects of tramadol.