Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ)
Mylan Pharmaceuticals Inc.
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. 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) ]. 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 pregnancies, but w
Buprenorphine Sublingual Tablets are available containing buprenorphine hydrochloride, USP equivalent to 2 mg or 8 mg of buprenorphine. The 2 mg sublingual tablets are white, round, unscored tablets debossed with M over 923 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0923-93 bottles of 30 tablets The 8 mg sublingual tablets are white, round, unscored tablets debossed with M over 924 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0924-93 bottles of 30 tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription. Advise patients to store buprenorphine-containing medications safely and out of sight and reach of children and to destroy any unused medication appropriately [see Patient Counseling (17)]. Store buprenorphine sublingual tablets securely and dispose of properly [see Patient Counseling Information (17)] .
Abbreviated New Drug Application
BUPRENORPHINE HYDROCHLORIDE SUBLINGUAL- BUPRENORPHINE HYDROCHLORIDE SUBLINGUAL TABLET Mylan Pharmaceuticals Inc. ---------- MEDICATION GUIDE Buprenorphine Sublingual Tablets (bue″ pre nor′ feen hye″ droe klor′ ide) 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 them 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: o You feel faint, dizzy or confused o Your breathing gets much slower than is normal for you These can be signs of an overdose or other serious problems. • 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. • Buprenorphine sublingual tablets contain an opioid that can cause physical dependence. o 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 h Lestu allt skjalið
BUPRENORPHINE HYDROCHLORIDE SUBLINGUAL- BUPRENORPHINE HYDROCHLORIDE SUBLINGUAL TABLET MYLAN PHARMACEUTICALS 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 Warnings and Precautions (5.2) 04/2019 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. Buprenorphine 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: 2 mg buprenorphine and 8 mg buprenorphine. (3) CONTRAINDICATIONS Hypersensitivity to buprenorphine. (4) WARNINGS AND PRECAUTIONS • • • • • • • • • 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 tablets are 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, 2.5) 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. (2.9) Addiction, Abuse, and Misuse: Buprenorphine can be abused in a similar manner Lestu allt skjalið