TRAMADOL HYDROCHLORIDE- tramadol hydrochloride tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

NuCare Pharmaceuticals, Inc.

INN (שם בינלאומי):

TRAMADOL HYDROCHLORIDE

הרכב:

TRAMADOL HYDROCHLORIDE 50 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Tramadol Hydrochloride Tablets, USP are indicated for the management of pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses (see WARNINGS ), reserve tramadol for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: - Have not been tolerated, or are not expected to be tolerated. - Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Tramadol Hydrochloride Tablets contraindicated in patients with: - Significant respiratory depression (see WARNINGS ). - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment (see WARNINGS ). - Known or suspected gastrointestinal obstruction, including paralytic ileus (see WARNINGS ). - Hypersensitivity to tramadol, any other component of this product or opioids (see WARNINGS ). - Co

leaflet_short:

Tramadol Hydrochloride Tablets, USP 50 mg are white to off-white, round, film-coated tablets debossed with '319' on one side and plain on the other side and are supplied as follows: NDC 68071-3280-6 bottle of 6 NDC 68071-3280-1 bottle of 12 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. *Tylenol is a registered trademark of McNeil Cons. $Tylox is a registered trademark of Ortho McNeil Pharm. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, FILM COATED
NUCARE PHARMACEUTICALS, INC.
----------
TRAMADOL HYDROCHLORIDE TABLETS, USP C-IV
RX ONLY
BOXED WARNING
ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL INGESTION; 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 EXPOSES 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, AND MONITOR ALL PATIENTS REGULARLY FOR THE
DEVELOPMENT OF THESE
BEHAVIORS AND CONDITIONS (SEE WARNINGS).
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH USE OF TRAMADOL.
MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY DURING INITIATION OF
TRAMADOL OR FOLLOWING A
DOSE INCREASE (SEE WARNINGS).
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF TRAMADOL, ESPECIALLY BY CHILDREN, CAN BE
FATAL. (SEE WARNINGS).
NEONATAL OPIOID WITHDRAWAL SYNDROME
PROLONGED USE OF TRAMADOL DURING PREGNANCY CAN RESULT IN NEONATAL
OPIOID WITHDRAWAL
SYNDROME, WHICH MAY BE LIFE-THREATENING IF NOT RECOGNIZED AND TREATED,
AND REQUIRES
MANAGEMENT ACCORDING TO PROTOCOLS DEVELOPED BY NEONATOLOGY EXPERTS. IF
OPIOID USE IS
REQUIRED FOR A PROLONGED PERIOD IN A PREGNANT WOMAN, ADVISE THE
PATIENT OF THE RISK OF
NEONATAL OPIOID WITHDRAWAL SYNDROME AND ENSURE THAT APPROPRIATE
TREATMENT WILL BE
AVAILABLE (SEE WARNINGS).
INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES
THE EFFECTS OF CONCOMITANT USE OR DISCONTINUATION OF CYTOCHROME P450
3A4 INDUCERS, 3A4
INHIBITORS, OR 2D6 INHIBITORS WITH TRAMADOL ARE COMPLEX. USE OF
CYTOCHROME P450 3A4
INDUCERS, 3A4 INHIBITORS, OR 2D6 INHIBITORS WITH TRAMADOL REQUIRES
CAREFUL CONSIDERATION OF
THE EFFECTS ON THE PARENT DRUG, TRAMADOL, AND THE ACTIVE METABOLITE,
M1 (SEE WARNINGS,
PRECAUTIONS; DRUG INTERACTION