Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J)
McKesson Corporation dba SKY Packaging
TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE 50 mg
ORAL
PRESCRIPTION DRUG
Tramadol HCl tablets 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 HCl tablets 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 HCl tablets are contraindicated for: - all children younger than 12 years of age (see WARNINGS ) all children younger than 12 years of age (see WARNINGS ) - post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (see WARNINGS ). post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (see WARNINGS ). Tramadol HCl t
Product: 63739-671 NDC: 63739-671-10 10 TABLET, COATED in a BLISTER PACK / 10 in a BOX, UNIT-DOSE
Abbreviated New Drug Application
McKesson Corporation dba SKY Packaging ---------- MEDICATION GUIDE Tramadol (TRAM-a-dol) Hydrochloride Tablets USP, CIV Tramadol HCl tablets are: • A strong prescription pain medicine that contains an opioid (narcotic) that is used for the management pain in adults, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them. • An 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. Important information about tramadol HCl tablets: • Get emergency help right away if you take too many tramadol HCl tablets (overdose). When you first start taking tramadol HCl tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. • Taking tramadol HCl 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 HCl tablets. They could die from taking it. Store tramadol HCl tablets away from children and in a safe place to prevent stealing or abuse. Selling or giving away tramadol HCl tablets is against the law. Important Information Guiding Use in Pediatric Patients: • Do not give tramadol HCl tablets to a child younger than 12 years of age. • Do not give tramadol HCl tablets to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids. • Avoid giving tramadol HCl tablets to children between 12 to 18 years of age who have risk factors for breathing problems such as obstructive sleep apnea, obesity, or underlying lung problems. Do not take tramadol HCl tablets if you have: • Severe asthma, trouble breathing, or other lung problems. • A bowel blockage or have narrowing of the stomach or Lue koko asiakirja
TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, COATED MCKESSON CORPORATION DBA SKY PACKAGING ---------- TRAMADOL HYDROCHLORIDE TABLETS, USP CIV (50 MG) 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 HCL 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 HCL, 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. 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 HCL. MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY DURING INITIATION OF TRAMADOL HCL OR FOLLOWING A DOSE I Lue koko asiakirja