TRAMADOL HYDROCHLORIDE- 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:

Preferred Pharmaceuticals Inc.

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: Tramadol hydrochloride extended-release tablets are contraindicated for: Tramadol hydrochloride extended-release tablets are also contraindicated in patients with: Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.5)] . Available data with tramadol hydrochloride extended-release tablets in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, tramadol administration during organogenesis decreased fetal weights and reduced ossification in mice, rats, and rabbits at 1.4, 0.6, and 3.6 times the maximum recommended human daily dosage (MRHD). Tramadol decreased pup body weight and increased pup mortality at 1.2

Produkt oppsummering:

Tramadol Hydrochloride Extended-Release Tablets, USP are available containing 100 mg, 200 mg or 300 mg of tramadol hydrochloride, USP. The 200 mg tablets are white to off-white, coated, oval, unscored tablets imprinted with MT2 in black ink on one side of the tablet and plain on the other side. They are available as follows: Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, EXTENDED
RELEASE
Preferred Pharmaceuticals Inc.
----------
MEDICATION GUIDE
Tramadol Hydrochloride Extended-Release Tablets, USP CIV
(tramʹ a dol hyeʹʹ droe klorʹ 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 many 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 many (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 them. 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-r

Preparatomtale

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, EXTENDED
RELEASE
PREFERRED 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 CIV
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 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 06/2018
Contraindications (4) 08/2017
Warnings and Precautions (5) 06/2018
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)
TO ENSURE THAT THE BENEFITS OF OPIOID 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