BUPRENORPHINE HCL AND NALOXONE HCL- buprenorphine and naloxone tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ), NALOXONE HYDROCHLORIDE DIHYDRATE (UNII: 5Q187997EE) (NALOXONE - UNII:36B82AMQ7N)

可用日期:

AvPAK

INN（国际名称）:

BUPRENORPHINE HYDROCHLORIDE

组成:

BUPRENORPHINE 2 mg

给药途径:

SUBLINGUAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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 that includes 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 st

產品總結:

Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg are supplied as orange, round, biconvex tablet, debossed “A” on one side and “14” on the other side. They are available as follows: NDC 50268-144-15 (10 tablets per card, 5 cards per carton). Buprenorphine and Naloxone Sublingual Tablets, 8 mg/2 mg are supplied as orange, round, biconvex tablet debossed “AN 415” on one side and plain on the other side. They are available as follows: NDC 50268-145-15 (10 tablets per card, 5 cards per carton). Dispensed in Unit Dose Package. For Institutional Use Only. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. 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 Information (17)] .

授权状态:

Abbreviated New Drug Application

资料单张

BUPRENORPHINE HCL AND NALOXONE HCL- BUPRENORPHINE AND NALOXONE TABLET
AvPAK
----------
MEDICATION GUIDE
BUPRENORPHINE (bue" pre nor' feen) AND NALOXONE (nal ox' one)
SUBLINGUAL TABLETS,
USP (CIII)
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 breathing
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 tablet 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:
•
feel faint
•
have blurred vision
•
feel dizzy
•
have slurred speech
•
are confused
•
are breathing slower than normal
•
feel sleepy or uncoordinated
•
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,
breathing problems, coma, and death.
Do not inject (“shoot‐up”) buprenorphine

产品特点

BUPRENORPHINE HCL AND NALOXONE HCL- BUPRENORPHINE AND
NALOXONE TABLET
AVPAK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS CIII
RX ONLY
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
Dosage and Administration (2.5) 06/2022
Warnings and Precautions (5.13, 5.14) 06/2022
INDICATIONS AND USAGE
Buprenorphine and Naloxone Sublingual Tablets contain buprenorphine, a
partial opioid agonist, and
naloxone, an opioid antagonist, and is 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
Administer Buprenorphine and Naloxone Sublingual Tablets sublingually
as a single daily dose. (2.2)
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. (2.3)
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. (2.4)
The recommended target dosage of Buprenorphine and Naloxone Sublingual
Tablets for maintenance
is 16 mg/4 mg. (2.4)
Administer Buprenorphine and Naloxone Sublingual Tablets as directed
in the Full Prescribing
Information. (2.4, 2.5)
When discontinuing treatment, gradually taper to avoid si