TRAMADOL HYDROCHLORIDE tablet, film coated

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

NuCare Pharmaceuticals,Inc.

INN (Rahvusvaheline Nimetus):

TRAMADOL HYDROCHLORIDE

Koostis:

TRAMADOL HYDROCHLORIDE 50 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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 othe

Toote kokkuvõte:

traMADOL HCL 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 68071-4070-6 Bottles of 6 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.

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

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 INTERACTIONS