Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ)
REMEDYREPACK INC.
SUBLINGUAL
PRESCRIPTION DRUG
Buprenorphine sublingual tablets are indicated for the treatment of opioid dependence and is preferred for induction. Buprenorphine sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. Buprenorphine sublingual tablets are 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 amo
Buprenorphine sublingual tablets are available as follows: 8 mg – Oval, orange tablets debossed with tablets debossed on one side and 153 on the other side. Tablets are supplied in NDC: 70518-1625-00 PACKAGING: 30 in 1 BLISTER PACK Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in USP. CAUTION: DEA Order Form Required. Store buprenorphine sublingual tablets securely and dispose of properly [see Patient Counseling Information (17)]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
Abbreviated New Drug Application
REMEDYREPACK INC. ---------- MEDICATION GUIDE BUPRENORPHINE (bue" pre nor' feen) SUBLINGUAL TABLETS, CIII 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 takes buprenorphine 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 sublingual tablets? • Buprenorphine 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 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 sublingual tablets may cause serious and life‐threatening breathing problems. Get emergency help right away if you: • feel faint • have blurred vision • feel dizzy • have slurred speech • are confused • are breathing slower than normal • feel sleepy or uncoordinated • cannot think well or clearly • Do not take buprenorphine sublingual tablets with certain medicines. Taking buprenorphine sublingual tablets 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. • Do not inject (“shoot‐up”) buprenorphine sublingual tablets. Injecting buprenorphine sublingual tablets may cause life‐threatening infections and other serious health problems. • Do not switch from buprenorphine sub Прочитать полный документ
BUPRENORPHINE- BUPRENORPHINE TABLET REMEDYREPACK INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USEBUPRENORPHINE SUBLINGUAL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BUPRENORPHINESUBLINGUAL TABLETS. BUPRENORPHINE SUBLINGUAL TABLETS, CIII INITIAL U.S. APPROVAL: 1981 RECENT MAJOR CHANGES Dosage and Administration ( 2.3) 03/2021 Warnings and Precautions ( 5.2, 5.3) 03/2021 INDICATIONS AND USAGE Buprenorphine sublingual tablets contain buprenorphine, a partial opioid agonist, and are indicated for the treatment of opioid dependence and is preferred for induction. ( 1) Buprenorphine 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 sublingual tablets sublingually as a single daily dose. ( 2.2) Strongly consider prescribing naloxone at the time buprenorphine sublingual tablets are initiated or renewed because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose. ( 2.3) To avoid precipitating withdrawal, induction with buprenorphine sublingual tablets should be undertaken when objective and clear signs of withdrawal are evident. ( 2.4) Buprenorphine and naloxone sublingual film or buprenorphine and naloxone sublingual tablet is generally initiated after two days of buprenorphine sublingual tablets titration. ( 2.5) Administer buprenorphine sublingual tablets as directed in the Full Prescribing Information. ( 2.4, 2.5, 2.6) Buprenorphine sublingual tablets must be administered whole. Do not cut, chew, or swallow buprenorphine sublingual tablets. ( 2.6) When discontinuing treatment, gradually taper to avoid signs and symptoms of withdrawal. ( 2.10) DOSAGE FORMS AND STRENGTHS Sublingual tablet: buprenorphine 2 mg and buprenorphine 8 mg. ( 3) CONTRA Прочитать полный документ