TRAMADOL HYDROCHLORIDE tablet, extended release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Quality Care Products LLC

INN (International Name):

TRAMADOL HYDROCHLORIDE

Sammensetning:

TRAMADOL HYDROCHLORIDE 100 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 ( 5.3)] -

Produkt oppsummering:

Tramadol hydrochloride extended-release tablets are supplied in the following package and dose strength forms: 100 mg: White, round shape, biconvex, beveled edge, coated tablet with release portal on the center of the tablet on any one side, imprinted “531” with black ink on one side and plain on other side. Bottles of 30's with Child Resistant Cap ……………... NDC 47335-859-83 Bottles of 100's with Child Resistant Cap ……………. NDC 47335-859-88 Bottles of 100's with Non Child Resistant Cap ……… NDC 47335-859-08 Bottles of 1000's with Non Child Resistant Cap …….. NDC 47335-859-18 200 mg: White, round shape, biconvex, beveled edge, coated tablet with release portal on the center of the tablet on any one side, imprinted “533” with black ink on one side and plain on other side. Bottles of 30's with Child Resistant Cap ……………... NDC 47335-860-83 Bottles of 100's with Child Resistant Cap ……………. NDC 47335-860-88 Bottles of 100's with Non Child Resistant Cap ……… NDC 47335-860-08 Bottles of 1000's with Non Child Resistant Cap …….. NDC 47335-860-18 300 mg: White, round shape, biconvex, beveled edge, coated tablet with release portal on the center of the tablet on any one side, imprinted “537” with black ink on one side and plain on other side. Bottles of 30's with Child Resistant Cap ……………... NDC 47335-861-83 Bottles of 100's with Child Resistant Cap ……………. NDC 47335-861-88 Bottles of 100's with Non Child Resistant Cap ……… NDC 47335-861-08 Bottles of 1000's with Non Child Resistant Cap …….. NDC 47335-861-18 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light resistant container. Warning: keep out of reach of children.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, EXTENDED
RELEASE
Quality Care Products LLC
----------
MEDICATION GUIDE
Tramadol Hydrochloride (tram a dol hye droe klor ide) Extended-Release
Tablets, CIV
Tramadol hydrochloride extended-release tablet is:
· 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. Store tramadol hydrochloride extended-release tablets away from
children and in a safe place to prevent
stealing or abuse. Selling or giving away tramadol hydrochloride
extended-release tablets is against the law.
Important Information Guiding Use in Pediatric Patients:
•
Do not give tramadol hydrochloride extended-release tablets to a child
you

Preparatomtale

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, EXTENDED
RELEASE
QUALITY CARE PRODUCTS LLC
----------
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_.
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