Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J)
Sun Pharmaceutical Industries, Inc.
ORAL
PRESCRIPTION DRUG
Tramadol hydrochloride extended-release tablets are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use - Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosages or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings] , reserve tramadol hydrochloride extended-release tablets 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 tablets are not indicated as an as-needed (prn) analgesic. 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 ]
Tramadol hydrochloride extended-release tablets, USP are available as follows: 100 mg: White, round shape, biconvex, beveled edge, coated tablet with release portal on the center of the tablet on any one side, imprinted “531” with black ink on one side and plain on other side. Bottles of 30’s with Child Resistant Cap…………..….NDC 47335-531-83 Bottles of 100’s with Child Resistant Cap………….....NDC 47335-531-88 Bottles of 100’s with Non Child Resistant Cap…….....NDC 47335-531-08 Bottles of 1000’s with Non Child Resistant Cap……...NDC 47335-531-18 200 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. Bottles of 30’s with Child Resistant Cap………………NDC 47335-533-83 Bottles of 100’s with Child Resistant Cap……………..NDC 47335-533-88 Bottles of 100’s with Non Child Resistant Cap………..NDC 47335-533-08 Bottles of 1000’s with Non Child Resistant Cap……....NDC 47335-533-18 300 mg: White, round shape, biconvex, beveled edge, coated tablet with release portal on the center of the tablet on any one side, imprinted “537” with black ink on one side and plain on other side. Bottles of 30’s with Child Resistant Cap…...................NDC 47335-537-83 Bottles of 100’s with Child Resistant Cap….................NDC 47335-537-88 Bottles of 100’s with Non Child Resistant Cap….........NDC 47335-537-08 Bottles of 1000’s with Non Child Resistant Cap….......NDC 47335-537-18 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 ]. Dispense with Medication Guide available at: https://www.sunpharma.com/usa/products
Abbreviated New Drug Application
TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE Sun Pharmaceutical Industries, Inc. ---------- MEDICATION GUIDE Tramadol Hydrochloride (tram a dol hye droe klor ide) Extended-Release Tablets, USP, C-IV Tramadol hydrochloride extended-release tablets are: • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage severe and persistent pain that requires an extended treatment period with a daily opioid pain medicine when other pain 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 to be taken on an “as needed” basis. 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 others, including visitors to the home Preberite celoten dokument
TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE SUN PHARMACEUTICAL INDUSTRIES, INC. ---------- TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP C-IV RX ONLY WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS ADDICTION, ABUSE, AND MISUSE BECAUSE THE USE OF TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS 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 AND REASSESS 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 HYDROCHLORIDE EXTENDED-RELEASE TABLETS, ESPECIALLY DURING INITIATION OR FOLLOWING A DOSE INCREASE. TO REDUCE THE RISK OF RESPIRATORY DEPRESSION, PROPER DOSING AND TITRATION OF TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS ARE ESSENTIAL_ [SEE_ _WARNINGS]_. INSTRUCT PATIENTS TO SWALLOW TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS WHOLE TO AVOID EXPOSURE TO A POTENTIALLY FATAL DOSE OF TRAMADOL. ACCIDENTAL INGESTION ACCIDENTAL INGESTION OF EVEN ONE DOSE OF TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF TRAMADOL _[SEE WARNINGS]_. RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS CONCOMITANT USE OF OPIOIDS WITH BENZODIAZEPINES OR OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS, INCLUDING ALCOHOL, MAY RESULT IN PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH. RESERVE CONCOMITANT PRESCRIBING OF TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS AND BENZODIAZEPINES OR OTHER CNS DEPRESSANTS FOR USE IN PATIENTS FOR WHOM ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE_ [_SEE WARNINGS, PRECAUTIONS; DRUG INTERACTIONS_]_. NEONATAL OPIOID WITHDRAWAL SYNDROME (NOWS) IF OPIOID USE IS REQUIRED FOR AN EXTENDED PERIOD OF TIME IN A PREGNANT WOMAN, ADVISE THE PATI Preberite celoten dokument