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)
Hikma Pharmaceuticals USA 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 to include 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 congenita
Buprenorphine and Naloxone Sublingual Tablets, USP 2 mg/0.5 mg are supplied as speckled-peach to peach, flat faced beveled edge tablets with product identification “54” [above] “122” on one side and plain on the other. NDC 0054-0188-13: Bottle of 30 Tablets 8 mg/2 mg are supplied as speckled-peach to peach, flat faced beveled edge tablets with product identification “54” [above] “375” on one side and plain on the other. NDC 0054-0189-13: Bottle of 30 Tablets Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in USP. Store Buprenorphine and Naloxone Sublingual Tablets securely and dispose of properly [see Patient Counseling Information (17)] .
Abbreviated New Drug Application
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE- BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE TABLET Hikma Pharmaceuticals USA 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 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 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: o feel faint o have blurred vision o feel dizzy o have slurred speech o are confused o are breathing slower than normal o feel sleepy or uncoordinated o 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 depressants (including street drugs) can cause severe drowsiness, decreased awareness, br Đọc toàn bộ tài liệu
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE- BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE TABLET HIKMA PHARMACEUTICALS USA 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 INDICATIONS AND USAGE Buprenorphine and Naloxone Sublingual Tablets contain 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 • • • • • • DOSAGE FORMS AND STRENGTHS Sublingual Tablet: • • CONTRAINDICATIONS Hypersensitivity to buprenorphine or naloxone. (4) WARNINGS AND PRECAUTIONS • • • • • 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 are initiated or renewed because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose (2.2) 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 Đọc toàn bộ tài liệu