Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ), NALOXONE HYDROCHLORIDE DIHYDRATE (UNII: 5Q187997EE) (NALOXONE - UNII:36B82AMQ7N)
SpecGx LLC
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 studies have reported on cong
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 0406-1923-03 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 0406-1924-03 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]. Advise patients to store buprenorphine-containing medications safely and out of sight and reach of children and to destroy any unused medication appropriately [see Patient Counseling Information (17)] . 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 SpecGx LLC ---------- 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 b uprenorphine 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. • Buprenorphine and naloxone sublingual tablets contain an opioid that can cause physical dependence. • Do not stop taking buprenorphine and naloxone sublingual tablets without talking to your doctor. You could become sick with uncomfortable withdrawal signs and symptoms because your body has become used to this medicine • Physical dependence is not the same as drug addiction • Buprenorphine and naloxone sublingual tablets are not for occasional or “as needed” use • 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 bupreno Đọc toàn bộ tài liệu
BUPRENORPHINE HCL AND NALOXONE HCL- BUPRENORPHINE AND NALOXONE TABLET SPECGX LLC ---------- 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 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 and Naloxone Sublingual Film should be undertaken when objective and clear signs of withdrawal are evident and Buprenorphine and Naloxone Sublingual Tablets should be administered in divided doses when used as initial treatment. (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 PRECAUTIONS Addiction, Abuse, and Misuse: Buprenorphine can be abused in a similar manner to other opioids. Clinical monitoring appropriate to the patie Đọc toàn bộ tài liệu