Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ)
REMEDYREPACK INC.
BUPRENORPHINE HYDROCHLORIDE
BUPRENORPHINE 8 mg
SUBLINGUAL
PRESCRIPTION DRUG
Buprenorphine sublingual tablets is 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 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 buprenorphine-exposed preg
Buprenorphine sublingual tablets are supplied in white HDPE bottles. 2 mg - White, round, biconvex uncoated tablets with "2" debossed on one side and a dart "→" debossed on the other side 8 mg - White, round, biconvex uncoated tablets with "8" debossed on one side and a dart "→" debossed on the other side Storage 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. 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)].
Abbreviated New Drug Application
REMEDYREPACK INC. ---------- MEDICATION GUIDE BUPRENORPHINE (byoo-pre-NOR-feen) SUBLINGUAL TABLETS CIII Rx Only 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 before you start taking Buprenorphine 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 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 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 Sublingual Tablets contains an opioid that can cause physical dependence. • 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. • Physical dependence is not the same as drug addiction • Buprenorphine Sublingual Tablets are 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 Sublingual Tablets. Ask your doctor what you should do if you are taking one of these. • Call a doctor or get emergency help right away if you: • Feel sleepy and uncoordinated • Have blurred vision • Have slurred speech • Cannot think well or clearly • Have slowed reflexes and breathing Прочетете целия документ
BUPRENORPHINE HYDROCHLORIDE- BUPRENORPHINE HYDROCHLORIDE 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: 2002 RECENT MAJOR CHANGES Dosage and Administration ( 2.1, 2.2, 2.3, 2.4, 2.5) 01/2018 Warnings and Precautions ( 5.1, 5.2, 5.3) 01/2018 Adverse Events ( 6.1, 6.2) 01/2018 Drug Interaction 01/2018 Use in Specific Populations ( 8.1, 8.2, 8.3) 01/2018 Clinical Pharmacology ( 12.2) 01/2018 Patient Counseling Information 01/2018 INDICATIONS AND USAGE Buprenorphine sublingual tablets, contains buprenorphine, a partial opioid agonist, and is 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 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) To avoid precipitating withdrawal, induction with buprenorphine sublingual tablets 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 tablets titration. ( 2.3) Administer buprenorphine sublingual tablets as directed in the Full Prescribing Information. ( 2.3, 2.4) Buprenorphine sublingual tablets 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. ( 2.6) DOSAGE FORMS AND STRENGTHS Sublingual tablet: 2 mg buprenorphine and 8 mg buprenor Прочетете целия документ