Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ), NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N)
Aidarex Pharmaceuticals LLC
BUPRENORPHINE HYDROCHLORIDE
BUPRENORPHINE 8 mg
SUBLINGUAL
PRESCRIPTION DRUG
Buprenorphine and Naloxone Sublingual Tablets are indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to physicians who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription. Buprenorphine and Naloxone Sublingual Tablets should not be administered to patients who have been shown to be hypersensitive to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported [see Warnings and Precautions (5.8)] . Pregnancy Category C. Risk Summary There are no adequate and well-contr
Buprenorphine and Naloxone Sublingual Tablets are uncoated, white to off-white, round, biconvex tablet, debossed with a “↑” logo on one side and an "N8" indicating the 8 mg/2 mg strength on the other side, supplied in white HDPE bottles: BOTTLES of 30 tablets Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children. Destroy any unused medication appropriately [see Disposal of Unused Buprenorphine and Naloxone Sublingual Tablets (17)] . Repackaged by Aidarex Pharmaceuticals, LLC Corona, CA 92880
Abbreviated New Drug Application
BUPRENORPHINE AND NALOXONE- BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET Aidarex Pharmaceuticals LLC ---------- MEDICATION GUIDE BUPRENORPHINE (byoo-pre-NOR-feen) AND NALOXONE (nah-LOX-own) 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 before you start taking Buprenorphine and Naloxone Sublingual Tablets 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. • Buprenorphine and Naloxone Sublingual Tablets contains 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 is not for occasional or “as needed” use • An overdose, and even death, can happen if you take benzodiazepines, sedatives, tranquilizers, or alcohol while using Buprenorphine and Naloxone Sublingual Tablets. Ask your doctor wh Preberite celoten dokument
BUPRENORPHINE AND NALOXONE- BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET AIDAREX PHARMACEUTICALS 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 RECENT MAJOR CHANGES Warnings and Precautions Neonatal Opioid Withdrawal Syndrome (5.5) 11/2016 Adrenal Insufficiency (5.6) 11/2016 INDICATIONS AND USAGE Buprenorphine and Naloxone Sublingual Tablets are indicated for the maintenance treatment of opioid dependence. Prescription use of this product is limited under the Drug Addiction Treatment Act. (1) DOSAGE AND ADMINISTRATION Administer Buprenorphine and Naloxone Sublingual Tablets sublingually as a single daily dose. (2) The recommended daily dose for maintenance is 16 mg/4 mg. 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 Buprenorphine can be abused in a similar manner to other opioids. Clinical monitoring appropriate to the patient’s level of stability is essential. Multiple refills should not be prescribed early in treatment or without appropriate patient follow- up visits. (5.1) Significant respiratory depression and death have occurred in association with buprenorphine, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other CNS depressants (including alcohol). (5.2) Consider dose reduction of CNS depressants, Buprenorphine and Naloxone Sublingual Tablets, or both in situations of concomitant prescription. (5.3) Store Buprenorphine and Naloxone Sublingual Tablets safely out of the sight and reach of children. Buprenorphine can cause severe, possibl Preberite celoten dokument