BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Bryant Ranch Prepack

Via di somministrazione:

SUBLINGUAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

Buprenorphine and Naloxone Sublingual Tablets, USP are uncoated white to off-white, round biconvex tablets, debossed with W22 for 8 mg/2 mg strength, respectively, on one side, and plain on the other. NDC: 71335-1858-7: 6 Tablets in a BOTTLE, PLASTIC NDC: 71335-1858-8: 10 Tablets in a BOTTLE, PLASTIC NDC: 71335-1858-6: 28 Tablets in a BOTTLE, PLASTIC NDC: 71335-1858-5: 14 Tablets in a BOTTLE, PLASTIC NDC: 71335-1858-9: 21 Tablets in a BOTTLE, PLASTIC NDC: 71335-1858-0: 42 Tablets in a BOTTLE, PLASTIC NDC: 71335-1858-1: 30 Tablets in a BOTTLE, PLASTIC NDC: 71335-1858-2: 60 Tablets in a BOTTLE, PLASTIC NDC: 71335-1858-3: 90 Tablets in a BOTTLE, PLASTIC NDC: 71335-1858-4: 120 Tablets in a BOTTLE, PLASTIC 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.] Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 9150

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE
TABLET
Bryant Ranch Prepack
----------
Dispense with Medication Guide available
atwww.accordhealthcare.us/medication-guides
MEDICATION GUIDE
BUPRENORPHINE (byoo-pre-NOR-feen) AND NALOXONE (nah-LOX-own)
SUBLINGUAL TABLETS (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 (includi

Scheda tecnica

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
DIHYDRATE- BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
DIHYDRATE TABLET
BRYANT RANCH PREPACK
----------
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 (2.3) 03/2021
Warnings and Precautions (5.2,5.3) 03/2021
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
Prescription use of this product is limited under the Drug Addiction
Treatment Act. (_2.1_)
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 is
initiated or renewed because patients being treated for opioid use
disorder have the potential for
relapse, putting them at risk for opioid overdose ( _2.3_)
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. _(2.3)_
The recommended target dosage of buprenorphine and naloxone sublingual
tablets for maintenance is
16/4 mg. (_2.4_)
Administer buprenorphine and naloxone sublingual tablets