Country: United States
Language: English
Source: NLM (National Library of Medicine)
TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J)
Advanced Rx Pharmacy of Tennessee, LLC
ORAL
PRESCRIPTION DRUG
Tramadol hydrochloride extended-release tablets are contraindicated for: all children younger than 12 years of age [see WARNINGS]. postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see WARNINGS]. Tramadol hydrochloride extended-release tablets are also 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 (e.g., anaphylaxis) [see ADVERSE REACTIONS] Concurrent use of monoamine oxidase inhibitors (MAOIs) or use within the last 14 days [see PRECAUTIONS; Drug Interactions] INDICATIONS AND USAGE Tramadol hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for
Tramadol hydrochloride extended-release tablets are available as follows: 200 mg: White, round shape, biconvex, beveled edge, coated tablet with release portal on the center of the tablet on any one side, imprinted “533” with black ink on one side and plain on other side. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light resistant container. Warning: keep out of reach of children. Store tramadol hydrochloride extended-release tablets securely and dispose of properly [see PRECAUTIONS/ Information for Patients].
Abbreviated New Drug Application
TRAMADOL HCL ER- TRAMADOL HCL TABLET, EXTENDED RELEASE Advanced Rx Pharmacy of Tennessee, LLC ---------- MEDICATION GUIDE MEDICATION GUIDE Tramadol Hydrochloride (tram a dol hye droe klor ide) Extended-Release Tablets, C-IV Tramadol hydrochloride extended-release tablets 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 tablets: Get emergency help or call 911 right away if you take too many tramadol hydrochloride extended-release tablets (overdose). When you first start taking tramadol hydrochloride extended-release tablets, when your dose is changed, or if you take too many (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 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 hydrochloride extended-release tablets. They could die from taking them. Selling or giving away tramadol hydrochloride extended-release tablets is against the law. Store tramadol hydrochloride extended-release tablets securely, out of sight and reach of children, and in a location not accessible by Read the complete document
TRAMADOL HCL ER- TRAMADOL HCL TABLET, EXTENDED RELEASE ADVANCED RX PHARMACY OF TENNESSEE, LLC ---------- TRAMADOL HCL ER 200MG TABLETS BOXED WARNING 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 hydrochloride extended-release tablets expose 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 hydrochloride extended-release tablets, 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, and • 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 hydrochloride extended-release tab Read the complete document