দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J)
NuCare Pharmaceuticals, Inc.
TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE 50 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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 সম্পূর্ণ নথি পড়ুন