Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ)
REMEDYREPACK INC.
BUPRENORPHINE HYDROCHLORIDE
BUPRENORPHINE 2 mg
SUBLINGUAL
PRESCRIPTION DRUG
Buprenorphine sublingual tablet is indicated for the treatment of opioid dependence and is preferred for induction. Buprenorphine sublingual tablet should be used as part of a complete treatment plan to include counseling and psychosocial support. Buprenorphine sublingual tablet is contraindicated in patients with a history of hypersensitivity to buprenorphine, as serious adverse reactions, including anaphylactic shock, have been reported [see Warnings and Precautions (5.9)]. Risk Summary The data on use of buprenorphine, the active ingredient in buprenorphine 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 congenital malformations among bup
Buprenorphine sublingual tablets containing 2 mg buprenorphine (as the free base, equivalent to 2.16 mg buprenorphine hydrochloride USP) are uncoated, round, biconvex, white to off-white, sublingual tablets, debossed with ‘459’ on one side and plain on other side and are supplied as: Bottles of 30’s with Child Resistant Cap……………..NDC 62756-459-83 Unit-Dose blister pack of 30 (3×10) tablets ……..... NDC 62756-459-64 Buprenorphine sublingual tablets containing 8 mg buprenorphine (as the free base, equivalent to 8.64 mg buprenorphine hydrochloride USP) are uncoated, round, biconvex, white to off-white, sublingual tablets, debossed with ‘460’ on one side and plain on other side and are supplied as: Bottles of 30’s with Child Resistant Cap……………..NDC 62756-460-83 Unit-Dose blister pack of 30 (3×10) tablets ……..... NDC 62756-460-64 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]. Protect from light. Store buprenorphine sublingual tablets securely and dispose of properly [see Patient Counseling Information (17)] .
Abbreviated New Drug Application
REMEDYREPACK INC. ---------- MEDICATION GUIDE Buprenorphine Sublingual Tablets CIII (BUE-pre-NOR-feen) IMPORTANT: Keep buprenorphine 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 sublingual tablets, get emergency help right away. Read this Medication Guide that comes with buprenorphine sublingual tablets before you start taking them 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 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 sublingual tablets? • Buprenorphine is a medicine in buprenorphine sublingual tablets that can cause serious and life- threatening problems, especially if you take or use certain other medicines or drugs. Call your healthcare provider right away or get emergency help if you: feel faint or dizzy • cannot think well or clearly • have mental changes such as confusion • have slowed reflexes • have slower breathing than you normally have • have a high body temperature • have severe sleepiness • feel agitated o have blurred vision • have stiff muscles • have problems with coordination • have trouble walking o have slurred speech These can be signs of an overdose or other serious problems. • Do not switch from buprenorphine sublingual tablets to other medicines that contain buprenorphine without talking with your doctor. The amount of buprenorphine in a dose of buprenorphine sublingual tablets is not the same as the amount of buprenorphine in other medicines that contain buprenorphine. Your doctor will prescribe a starting dose of buprenorphine sublingual tablets that may be different than other buprenorphine containing medicines you may have been taking. Läs hela dokumentet
BUPRENORPHINE- BUPRENORPHINE TABLET REMEDYREPACK INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BUPRENORPHINE SUBLINGUAL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE SUBLINGUAL TABLETS FOR SUBLINGUAL ADMINISTRATION CIII INITIAL U.S. APPROVAL: 1981 RECENT MAJOR CHANGES Warnings and Precautions (5.2) 10/2019 INDICATIONS AND USAGE Buprenorphine sublingual tablet, contains buprenorphine, a partial opioid agonist, and is indicated for the treatment of opioid dependence and is preferred for induction. (1) Buprenorphine sublingual tablet 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 sublingual tablet sublingually as a single daily dose. (2.2) To avoid precipitating withdrawal, induction with buprenorphine sublingual tablet should be undertaken when objective and clear signs of withdrawal are evident. (2.3) Buprenorphine and naloxone sublingual film or buprenorphine and naloxone sublingual tablet is generally initiated after two days of buprenorphine sublingual tablet titration. (2.3) Administer buprenorphine sublingual tablets as directed in the Full Prescribing Information. (2.3, 2.4,2.5) Buprenorphine sublingual tablet must be administered whole. Do not cut, chew, or swallow buprenorphine sublingual tablets. (2.5) When discontinuing treatment, gradually taper to avoid signs and symptoms of withdrawal. (2.9) DOSAGE FORMS AND STRENGTHS Sublingual tablet: 2 mg buprenorphine and 8 mg buprenorphine. ( 3) CONTRAINDICATIONS Hypersensitivity to buprenorphine. ( 4) WARNINGS AND PRECAUTIONS Addiction, Abuse, and Misuse: Buprenorphine can be abused in a similar manner to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictiv Läs hela dokumentet