Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ), NALOXONE HYDROCHLORIDE DIHYDRATE (UNII: 5Q187997EE) (NALOXONE - UNII:36B82AMQ7N)
REMEDYREPACK INC.
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
Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg are supplied as orange, round, biconvex tablet, debossed “A” on one side and “14” on the other side. They are available as follows: Bottles of 30 NDC 65162-416-03 Bottles of 90 NDC 65162-416-09 Buprenorphine and Naloxone Sublingual Tablets, 8 mg/2 mg are supplied as orange, round, biconvex tablet debossed “AN 415” on one side and plain on the other side. They are available as follows: Bottles of 30 NDC 65162-415-03 Bottles of 90 NDC 65162-415-09 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 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
BUPRENORPHINE HCL AND NALOXONE HCL- BUPRENORPHINE AND NALOXONE TABLET REMEDYREPACK INC. ---------- 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 uses buprenorphine and naloxone sublingual tablets, get emergency help right away. Read this Medication Guide that comes with buprenorphine and naloxone sublingual tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor. Talk to your doctor or pharmacist if you have questions about buprenorphine and naloxone sublingual tablets. Share the important information in this Medication Guide with members of your household. What is the most important information I should know about buprenorphine and naloxone sublingual tablets? • Buprenorphine and naloxone sublingual tablets can cause serious and life-threatening breathing problems. Call your doctor right away or get emergency help if: • You feel faint, dizzy, or confused • Your breathing gets much slower than is normal for you These can be signs of an overdose or other serious problems. • Do not switch from buprenorphine and naloxone sublingual tablets to other medicines that contain buprenorphine without talking with your doctor. The amount of buprenorphine in a dose of buprenorphine and naloxone sublingual tablets may not be the same as the amount of buprenorphine in other medicines that contain buprenorphine. Your doctor will prescribe a starting dose of buprenorphine and naloxone sublingual tablets that may be different than other buprenorphine containing medicines you may have been taking. • Buprenorphine and naloxone sublingual tablets contain an opioid that can cause physical dependence. • Do not stop taking buprenorphine and naloxon Lue koko asiakirja
BUPRENORPHINE HCL AND NALOXONE HCL- BUPRENORPHINE AND NALOXONE TABLET REMEDYREPACK INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION 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 Warnings and Precautions (5.2) 10/2019 INDICATIONS AND USAGE Buprenorphine and Naloxone Sublingual Tablets contain buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist, and is 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 Prescription use of this product is limited under the Drug Addiction Treatment Act. ( 2.1) Administer Buprenorphine and Naloxone Sublingual Tablets sublingually as a single daily dose. ( 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 and symptoms of withdrawal. ( 2.7) DOSAGE FORMS AND STRENGTHS Sublingual tablet: 2 mg buprenorphine with 0.5 mg naloxone and 8 mg buprenorphine with 2 mg naloxone. ( 3) CONTRAINDICATIONS Hypersensitivity to buprenorphine or naloxone. ( 4) WARNINGS AND Lue koko asiakirja