Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570), NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N)
Purdue Pharma LP
ORAL
PRESCRIPTION DRUG
TARGINIQ ER is 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. Limitations 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 opioid formulations [see Warnings and Precautions (5.1)] , reserve TARGINIQ ER 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. - TARGINIQ ER is not indicated as an as-needed (prn) analgesic. - The maximum total daily dose of TARGINIQ ER should not exceed 80 mg/40 mg (40 mg/20 mg q12h) because higher doses may be associated with symptoms of opioid withdrawal or decreased analgesia [see Warnings and Precautions 5.12] . TARGINIQ ER is contraindicated in patients
TARGINIQ ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets) 10 mg/5 mg are capsule shaped, white film-coated tablets debossed with “ONX” on one side and “10” on the other and are supplied as child-resistant closure, opaque HDPE bottles of 100 (NDC 59011-520-01). TARGINIQ ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets) 20 mg/10 mg are capsule shaped, pink film-coated tablets debossed with “ONX” on one side and “20” on the other and are supplied as child-resistant closure, opaque HDPE bottles of 100 (NDC 59011-521-01) . TARGINIQ ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets) 40 mg/20 mg are capsule shaped, yellow film-coated tablets debossed with “ONX” on one side and “40” on the other and are supplied as child-resistant closure, opaque HDPE bottles of 100 (NDC 59011-522-01) . Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container, with a child-resistant closing. CAUTION DEA FORM REQUIRED
New Drug Application
Purdue Pharma LP ---------- Medication Guide TARGINIQ™ ER (tar-gih-NEEK E-R) (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), CII TARGINIQ ER is: • 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 TARGINIQ ER: • Get emergency help right away if you take too much TARGINIQ ER (overdose). When you first start taking TARGINIQ ER, 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 TARGINIQ ER 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 TARGINIQ ER. They could die from taking it. Store TARGINIQ ER away from children and in a safe place to prevent stealing or abuse. Selling or giving away TARGINIQ ER is against the law. Do not take TARGINIQ ER if you have: • severe asthma, trouble breathing, or other lung problems. • a bowel blockage or have narrowing of the stomach or intestines. Before taking TARGINIQ ER, tell your healthcare provider if you have a history of: • head injury, seizures • liver, kidney, thyroid or heart problems • abuse of street or prescription drugs, alcohol addiction, or mental health problems • problems urinating • pancreas or gallbladder pr Citiți documentul complet
TARGINIQ ER- OXYCODONE HYDROCHLORIDE/NALOXONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE PURDUE PHARMA LP ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TARGINIQ™ ER SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TARGINIQ ER. TARGINIQ ER (OXYCODONE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS), FOR ORAL USE, CII INITIAL U.S. APPROVAL: 2014 WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES AND OTHER CNS DEPRESSANTS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ RECENT MAJOR CHANGES Box Warning 12/2016 Indications and Usage (1) 12/2016 Dosage and Administration (2) 12/2016 Warning and Precautions (5) 12/2016 INDICATIONS AND USAGE TARGINIQ ER is a combination product consisting of oxycodone, an opioid agonist, and naloxone, an opioid antagonist, 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. (1) Limitations 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 opioid formulations, reserve TARGINIQ ER 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. (1) TARGINIQ ER is not indicated as an as-needed (prn) analgesic. (1) Total daily dose should not exceed 80 mg/40 mg (40 mg/20 mg q12h) because higher doses may be associated with symptoms of opioid withdrawal. (1) TARGINIQ ER EXPOSES USERS TO RISKS OF ADDICTION, ABUSE AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS PATIENT’S RISK BEFORE PRESCR Citiți documentul complet