Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ), NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N)
Golden State Medical Supply, Inc.
BUPRENORPHINE HYDROCHLORIDE
BUPRENORPHINE 2 mg
SUBLINGUAL
PRESCRIPTION DRUG
Buprenorphine and naloxone sublingual tablets are indicated for the maintenance treatment of opioid dependence. Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. Buprenorphine and naloxone sublingual tablets are contraindicated in patients with a history of hypersensitivity to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported [see Warnings and Precautions ( 5.9)] . Risk Summary The data on use of buprenorphine, one of the active ingredients in buprenorphine and naloxone sublingual tablets, in pregnancy, are limited; however, these data do not indicate an increased risk of major malformations specifically due to buprenorphine exposure. There are limited data from randomized clinical trials in women maintained on buprenorphine that were not designed appropriately to assess the risk of major malformations [see Data]. Observational
Buprenorphine and Naloxone Sublingual Tablets are available as follows: 2mg/0.5mg -White to off-white, round, biconvex uncoated tablet, debossed with a “↑” logo on one side and an "N2" on the other side. Tablets are supplied in bottles of 30 (NDC 60429-586-30). 8mg/2mg -White to off-white, round, biconvex uncoated tablet, debossed with a “↑” logo on one side and "N8" on the other side. Tablets are supplied in bottles of 30 (NDC 60429-587-30). Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Store buprenorphine and naloxone sublingual tablets securely and dispose of properly [see Patient Counseling Information ( 17)].
Abbreviated New Drug Application
Golden State Medical Supply, Inc. ---------- Dispense the Medication Guide available at: www.akorn.com/mg/bup-nal-tabto each patient. This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 06/2022 MEDICATION GUIDE BUPRENORPHINE(bue’’ pre nor’ feen) AND NALOXONE(nal ox’ one) SUBLINGUAL TABLETS (CIII) Rx Only IMPORTANT:Keep buprenorphine and naloxone sublingual tablets in a secure place away from children. Accidental use by a child is a medical emergency and can result in death. If a child accidentally takes buprenorphine and naloxone sublingual tablets, get emergency help or call 911 right away. Tell your healthcare provider if you are living in a household where there are small children. What is the most important information I should know about buprenorphine and naloxone sublingual tablets? • Buprenorphine and naloxone sublingual tablets contain a medicine called buprenorphine. Buprenorphine is an opioid that can cause serious and life-threatening breathing problems, especially if you take or use certain other medicines or drugs. • Talk to your healthcare provider about naloxone. Naloxone is a medicine that is available to patients for the emergency treatment of an opioid overdose, including accidental use of buprenorphine and naloxone sublingual tablets by a child. If naloxone is given, you must call 911 or get emergency medical help right away to treat an overdose or accidental use of an opioid. • Buprenorphine and naloxone sublingual tablets may cause serious and life‐threatening breathing problems. Get emergency help right away if you: • feel faint • feel dizzy • are confused • feel sleepy or uncoordinated • have blurred vision • have slurred speech • are breathing slower than normal • cannot think well or clearly • Do not take buprenorphine and naloxone sublingual tablets with certain medicines. Taking buprenorphine and naloxone sublingual tablets with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depre Perskaitykite visą dokumentą
BUPRENORPHINE AND NALOXONE- BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET GOLDEN STATE MEDICAL SUPPLY, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS FOR SUBLINGUAL ADMINISTRATION CIII INITIAL U.S. APPROVAL: 2002 RECENT MAJOR CHANGES Dosage and Administration ( 2.1) 05/2023 INDICATIONS AND USAGE Buprenorphine and naloxone sublingual tablets contains buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist, and are indicated for the maintenance treatment of opioid dependence. ( 1). Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. ( 1) DOSAGE AND ADMINISTRATION Administer buprenorphine and naloxone sublingual tablets sublingually as a single daily dose. ( 2.1) Strongly consider prescribing naloxone at the time buprenorphine and naloxone sublingual tablets is initiated or renewed because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose ( 2.2). To avoid precipitating withdrawal, induction with buprenorphine sublingual tablets should be undertaken when objective and clear signs of withdrawal are evident. After induction, doses of buprenorphine and naloxone sublingual tablets should be progressively adjusted to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms ( 2.3). The recommended target dosage of buprenorphine and naloxone sublingual tablets for maintenance is 16 mg/4 mg ( 2.3). Administer buprenorphine and naloxone sublingual tablets as directed in the Full Prescribing Information. ( 2.3, 2.4) When discontinuing treatment, gradually taper to avoid signs Perskaitykite visą dokumentą