BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Accord Healthcare, Inc

Адміністрація маршрут:

SUBLINGUAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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 studies have reported on conge

Огляд продуктів:

Buprenorphine and Naloxone Sublingual Tablets, USP are uncoated white to off-white, round biconvex tablets, debossed with W21 and W22 for 2 mg/0.5 mg and 8 mg/2 mg strength, respectively, on one side, and plain on the other, supplied in white HDPE bottles: Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature.]  Store Buprenorphine and Naloxone Sublingual Tablets, USP securely and dispose of properly [see Patient Counseling Information (17)].

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE
TABLET
Accord Healthcare, Inc
----------
Dispense with Medication Guide available at
www.accordhealthcare.us/medication-guides
MEDICATION GUIDE
BUPRENORPHINE (byoo-pre-NOR-feen) AND NALOXONE (nah-LOX-own)
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 tablet contains a medicine
called buprenorphine.
Buprenorphine is an opioid that can cause serious and life-threatening
problems, especially if
you take or use certain other medicines or drugs. Call your healthcare
provider right away or
get emergency help if you:
•
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 tablet may cause serious and
life‐threatening breathing
problems. Get emergency help 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 and naloxone sublingual tablet with certain
medicines. Taking
Buprenorphine and naloxone sublingual tablet with other opioid
medicines, benzodiazepines,
alcohol, or other central nervous system depressants

Характеристики продукта

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
DIHYDRATE- BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
DIHYDRATE TABLET
ACCORD HEALTHCARE, INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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) 01/2022
Warnings and Precautions (5.13) 01/2022
Adverse Reactions (6.2) 01/2022
Information for Patients (17) 01/2022
INDICATIONS AND USAGE
Buprenorphine and naloxone sublingual tablets contain buprenorphine, a
partial opioid agonist, and
naloxone, an opioid antagonist, and are indicated for the maintenance
treatment of opioid dependence.
(1)
Buprenorphine and naloxone sublingual tablets should be used as a 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. (2.1)
Strongly consider prescribing naloxone at the time Buprenorphine and
naloxone sublingual tablets 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 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. (2.3)
The recommended target dosage of buprenorphine and naloxone sublingual
tablets for maintenance is
16/4 mg. (2.3)
Administer buprenorphine and naloxone sublingual tablets as directed
in the Full Prescri