Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J)
Trigen Laboratories, LLC
TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE 100 mg
ORAL
PRESCRIPTION DRUG
Tramadol Hydrochloride Extended-Release Capsules 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. Limitation 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/long-acting opioid formulations [see Warnings and Precautions (5.1) ], reserve Tramadol Hydrochloride Extended-Release Capsules 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 Capsules are not indicated as an as-needed (prn) analgesic. Tramadol Hydrochloride Extended-Release Capsules are contraindicated for: - all children younger than 12 years of age [see Warnings and Precautions (5.
Tramadol Hydrochloride Extended-Release Capsules are supplied as opaque white hard gelatin capsules, imprinted as follows. Dispense in a tight container. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature ]. Keep out of reach of children. Store Tramadol Hydrochloride Extended-Release Capsules securely and dispose of properly [see Patient Counseling Information (17) ].
New Drug Application Authorized Generic
Trigen Laboratories, LLC ---------- This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 1/2022 Medication Guide Tramadol Hydrochloride Extended-Release Capsules , CIV Tramadol Hydrochloride Extended-Release Capsules are: • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them. • A long-acting (extended-release) 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. • Not for use to treat pain that is not around-the-clock. Important information about Tramadol Hydrochloride Extended-Release Capsules: • Get emergency help right away or call 911 right away if you take too much Tramadol Hydrochloride Extended-Release Capsules (overdose). When you first start taking Tramadol Hydrochloride Extended-Release Capsules, 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. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose. • Taking Tramadol Hydrochloride Extended-Release Capsules 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 Hydrochloride Extended-Release Capsules. They could die from taking it. Selling or giving away Tramadol Hydrochloride Extended-Release Capsules is against the law. • Store Tramadol Hydrochloride Extended-Release Capsules securely, out of sight and reach of children, and in a Lees het volledige document
TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE- TRAMADOL HYDROCHLORIDE CAPSULE TRIGEN LABORATORIES, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES FOR ORAL USE, CIV INITIAL U.S. APPROVAL: 1995 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 _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES EXPOSE USERS TO RISKS OF ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS PATIENT'S RISK BEFORE PRESCRIBING AND MONITOR REGULARLY FOR THESE BEHAVIORS AND CONDITIONS. (5.1) 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 RISK EVALUATION AND MITIGATION STRATEGY (REMS) FOR THESE PRODUCTS. (5.2) SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR. MONITOR CLOSELY, ESPECIALLY UPON INITIATION OR FOLLOWING A DOSE INCREASE. INSTRUCT PATIENTS TO SWALLOW TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES INTACT, AND NOT TO SPLIT, CHEW, CRUSH, OR DISSOLVE CONTENT OF THE CAPSULES TO AVOID EXPOSURE TO A POTENTIALLY FATAL DOSE OF TRAMADOL. (5.3) ACCIDENTAL INGESTION OF TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF TRAMADOL. (5.3) LIFE-THREATENING RESPIRATORY DEPRESSION AND DEATH HAVE OCCURRED IN CHILDREN WHO RECEIVED TRA Lees het volledige document