Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ)
Contract Pharmacy Services-PA
BUPRENORPHINE HYDROCHLORIDE
BUPRENORPHINE 2 mg
SUBLINGUAL
PRESCRIPTION DRUG
Buprenorphine sublingual tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine sublingual tablets 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 healthcare providers 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 sublingual tablets should not be administered to patients who have been shown to be hypersensitive to buprenorphine, as serious adverse reactions, including anaphylactic shock, have been reported [see Warnings and Precautions ( 5.9)]. Risk Summary There a
Buprenorphine Sublingual Tablets, 2 mg are available as uncoated, white, oval, flat-faced, beveled-edge, unscored tablets, debossed with 798 on one side and stylized b on the other side, containing 2.16 mg of buprenorphine hydrochloride, USP equivalent to 2 mg of buprenorphine base, packaged in blisterpacks of 30 tablets (NDC 67046-994-30). Buprenorphine Sublingual Tablets, 8 mg are available as uncoated, white, oval, flat-faced, beveled-edge, unscored tablets, debossed with 799 on one side and stylized b on the other side, containing 8.64 mg of buprenorphine hydrochloride, USP equivalent to 8 mg of buprenorphine base, packaged in blisterpacks of 30 tablets (NDC 67046-995-30). 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 the USP, with a child-resistant closure as required. Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children. Destroy any unused medication appropriately [see Patient Counseling ( 17.2 )] . Rx only
Abbreviated New Drug Application
BUPRENORPHINE- BUPRENORPHINE TABLET Contract Pharmacy Services-PA ---------- MEDICATION GUIDE BUPRENORPHINE (byoo-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 uses buprenorphine sublingual tablets, get emergency help right away. Read this Medication Guide that comes with buprenorphine 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 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? 1. Buprenorphine sublingual tablets can cause serious and life-threatening breathing problems. Call your doctor right away or get emergency help if: 2. You feel faint, dizzy or confused 3. Your breathing gets much slower than is normal for you 4. These can be signs of an overdose or other serious problems. 5. 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 may not be 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. 6. Buprenorphine sublingual tablets contain an opioid that can cause physical dependence. 7. Do not stop taking buprenorphine 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 8. Physical dependence is not the same Læs hele dokumentet
BUPRENORPHINE- BUPRENORPHINE TABLET CONTRACT PHARMACY SERVICES-PA ---------- 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 994 995 INITIAL U.S. APPROVAL: 2002 RECENT MAJOR CHANGES Warnings and Precautions ( 5.5, 5.6) 12/2016 INDICATIONS AND USAGE Buprenorphine sublingual tablets contain buprenorphine, a partial opioid agonist, and are indicated for the treatment of opioid dependence and are preferred for induction. Prescription use of this product is limited under the Drug Addiction Treatment Act. ( 1) DOSAGE AND ADMINISTRATION Administer buprenorphine sublingual tablets sublingually as a single daily dose. ( 2) To avoid precipitating withdrawal, induction with buprenorphine sublingual tablets should be undertaken when objective and clear signs of withdrawal are evident. ( 2.2) Buprenorphine and naloxone sublingual film CIII or buprenorphine and naloxone sublingual tablets CIII are generally initiated after two days of buprenorphine sublingual tablets titration. DOSAGE FORMS AND STRENGTHS Sublingual tablet: 2 mg buprenorphine and 8 mg buprenorphine. ( 3) CONTRAINDICATIONS Hypersensitivity to buprenorphine. ( 4) WARNINGS AND PRECAUTIONS 1. 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) 2. 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) 3. Consider dose reduction of CNS depressants, buprenorphine sublingual tablets, or both in situations of concomitant prescripti Læs hele dokumentet