TRAMADOL HYDROCHLORIDE tablet, extended release

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

NuCare Pharmaceuticals,Inc.

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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

Ringkasan produk:

Tramadol hydrochloride extended-release tablets USP are supplied in the following package and dose strength forms: 100 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with L010 on one side and plain on the other side. NDC 68071-1671-3 BOTTLES OF 30 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store tramadol hydrochloride extended-release tablets securely and dispose of properly [see Precautions/Information for Patients].

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, EXTENDED
RELEASE
NuCare Pharmaceuticals,Inc.
----------
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
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. Selling or giving away tramadol hydrochloride
extended-release tablets is against
the law.
•
Store tramadol hydrochloride extended-release tablets securely, out of
sight and reach of children,
and in a location not accessible by others, including visitors to the
home.
Important Information Guiding Use in Pediatric Patients:
•
D

Karakteristik produk

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, EXTENDED
RELEASE
NUCARE PHARMACEUTICALS,INC.
----------
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; RISK EVALUATION AND MITIGATION
STRATEGY
(REMS); 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._
TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLET 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)
TO ENSURE THAT THE BENEFITS OF OPIOD ANALGESICS OUTWEIGH THE RISKS OF
ADDICTION, ABUSE, AND MISUSE,
THE FOOD AND DRUG ADMINISTRATION (FDA) HAS REQUIRED A RISK EVALUATION
AND MITIGATION STRATEGY
(REMS) FOR THESE PRODUCTS. ( 5.2)
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. ( 5.3)
ACCIDENTAL INGESTION OF TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE
TABLETS, ESPECIALLY BY CHILDREN, CAN
RESULT IN A FATAL OVERDOSE OF TRAMADOL. ( 5.3)
LIFE-THREATENING RESPIRATORY DEPRESSION AND DEATH HAVE OCCURRED IN
CHILDREN WHO RECEIVED TRAMADO