TRAMADOL HYDROCHLORIDE tablet, film coated, extended release TRAMADOL HYDROCHLORIDE tablet, film coated, extended release

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Par Pharmaceutical, Inc.

INN (mednarodno ime):

TRAMADOL HYDROCHLORIDE

Sestava:

TRAMADOL HYDROCHLORIDE 100 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 ], 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 ] - post-operative management in children younger than

Povzetek izdelek:

Tramadol Hydrochloride Extended-Release Tablets, USP are available as follows: 100 mg, white to off-white, round film-coated tablets, engraved with “A221” on one side and plain on the other side. NDC # 10370-221-11, bottle of 30 tablets 200 mg, white to off-white, oval film-coated tablets, engraved with “A222” on one side and plain on the other side. NDC # 10370-222-11, bottle of 30 tablets 300 mg, white to off-white, oval film-coated tablets, engraved with “A223” on one side and plain on the other side. NDC # 10370-223-11, bottle of 30 tablets 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. Warning: Keep out of reach of children. Store Tramadol Hydrochloride Extended-Release Tablets securely and dispose of properly [ see PRECAUTIONS/Information for Patients] .

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED RELEASE
PAR PHARMACEUTICAL, INC.
----------
TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP CIV
RX ONLY
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
ADDICTION, ABUSE, AND MISUSE
TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS EXPOSE PATIENTS AND
OTHER USERS TO THE RISKS OF OPIOID ADDICTION, ABUSE, AND MISUSE, WHICH
CAN LEAD TO OVERDOSE AND DEATH. ASSESS EACH PATIENT’S RISK PRIOR TO
PRESCRIBING TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS, AND
MONITOR ALL PATIENTS REGULARLY FOR THE DEVELOPMENT OF THESE BEHAVIORS
AND CONDITIONS [SEE WARNINGS].
OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS):
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 REMS FOR THESE PRODUCTS [SEE WARNINGS]. UNDER THE
REQUIREMENTS OF THE REMS, DRUG COMPANIES WITH APPROVED OPIOID
ANALGESIC PRODUCTS MUST MAKE REMS-COMPLIANT EDUCATION PROGRAMS
AVAILABLE TO HEALTHCARE PROVIDERS. HEALTHCARE PROVIDERS ARE STRONGLY
ENCOURAGED TO
COMPLETE A REMS-COMPLIANT EDUCATION PROGRAM,
COUNSEL PATIENTS AND/OR THEIR CAREGIVERS, WITH EVERY PRESCRIPTION, ON
SAFE USE, SERIOUS RISKS, STORAGE, AND DISPOSAL OF THESE PRODUCTS,
EMPHASIZE TO PATIENTS AND THEIR CAREGIVERS THE IMPORTANCE OF READING
THE MEDICATION GUIDE EVERY TIME IT IS PROVIDED BY THEIR PHARMACIST,
AND
CONSIDER OTHER TOOLS TO IMPROVE PATIENT, HOUSEHOLD, AND COMMUNITY
SAFETY.
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH
USE OF TRAMADOL HYDROCHLORIDE