BUPRENORPHINE tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ)

から入手可能:

Sun Pharmaceutical Industries, Inc.

INN（国際名）:

BUPRENORPHINE HYDROCHLORIDE

構図:

BUPRENORPHINE 2 mg

投与経路:

SUBLINGUAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Buprenorphine sublingual tablet is indicated for the treatment of opioid dependence and is preferred for induction. Buprenorphine sublingual tablet should be used as part of a complete treatment plan to include counseling and psychosocial support. Buprenorphine sublingual tablet 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 pregnanci

製品概要:

Buprenorphine sublingual tablets containing 2 mg buprenorphine (as the free base, equivalent to 2.16 mg buprenorphine hydrochloride USP) are uncoated, round, biconvex, white to off-white, sublingual tablets, debossed with ‘459’ on one side and plain on other side and are supplied as: Bottles of 30 with child-resistant cap……………..NDC 62756-459-83 Unit-Dose blister pack of 30 (3×10) tablets ……..... NDC 62756-459-64 Buprenorphine sublingual tablets containing 8 mg buprenorphine (as the free base, equivalent to 8.64 mg buprenorphine hydrochloride USP) are uncoated, round, biconvex, white to off-white, sublingual tablets, debossed with ‘460’ on one side and plain on other side and are supplied as: Bottles of 30 with child-resistant cap……………..NDC 62756-460-83 Unit-Dose blister pack of 30 (3×10) tablets ……..... NDC 62756-460-64 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from light. Store buprenorphine sublingual tablets securely and dispose of properly [see Patient Counseling Information (17)] .

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

Sun Pharmaceutical Industries, Inc.
----------
MEDICATION GUIDE
Buprenorphine Sublingual Tablets, CIII
(BUE-pre-NOR-feen)
IMPORTANT: Keep buprenorphine sublingual tablet 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 takes buprenorphine
sublingual tablet, 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 sublingual tablet?
•
Buprenorphine sublingual tablet contains 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 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 sublingual tablets may cause serious and
life‐threatening breathing problems. Get
emergency help right away if you:
•
feel faint
•
feel dizzy
•
are confused
•
feel sleepy or uncoordinated
•
have blurred vision
•
have slurred speech
•
are breathing slower than normal
•
cannot think well or clearly
•
Do not take buprenorphine sublingual tablet with certain medicines.
Taking buprenorphine
sublingual tablet 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 sublingual tablet.
Injecting buprenorphine sublingual
tablet may cause life‐threatening infections and other serious
health problems
•
Do not switch from buprenorphin

製品の特徴

BUPRENORPHINE- BUPRENORPHINE TABLET
SUN PHARMACEUTICAL INDUSTRIES, 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, CIII
INITIAL U.S. APPROVAL: 1981
INDICATIONS AND USAGE
Buprenorphine sublingual tablet, contains buprenorphine, a partial
opioid agonist, and is indicated for the
treatment of opioid dependence and is preferred for induction. (1)
Buprenorphine sublingual tablet should be used as part of a complete
treatment plan that includes
counseling and psychosocial support. (1)
DOSAGE AND ADMINISTRATION
Administer buprenorphine sublingual tablet sublingually as a single
daily dose. (2.1)
Strongly consider prescribing naloxone at the time buprenorphine
sublingual tablet is initiated or
renewed because patients being treated for opioid use disorder have
the potential for relapse, putting
them at risk for opioid overdose. (2.2)
To avoid precipitating withdrawal, induction with buprenorphine
sublingual tablet 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 tablet
titration. (2.4)
Administer buprenorphine sublingual tablets as directed in the Full
Prescribing Information. (2.3, 2.4,
2.5)
Buprenorphine sublingual tablet 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)
DOSAGE FORMS AND STRENGTHS
Sublingual tablet: 2 mg buprenorphine and 8 mg buprenorphine. (3)
CONTRAINDICATIONS
Hypersensitivity to buprenorphine. (4)
WARNINGS AND PRECAUTIONS
Addiction, Abuse, and Misuse: Buprenorphine can be abused in a similar
manner to other opioids.
Monitor patients for con