BUPRENORPHINE HCL AND NALOXONE HCL- buprenorphine and naloxone 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 studies have reported on con

Dettagli prodotto:

NDC: 71335-1514-1: 30 Tablets in a BOTTLE NDC: 71335-1514-2: 10 Tablets in a BOTTLE

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

Bryant Ranch Prepack
----------
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 takes
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 and naloxone. Injecting
buprenorphi

Scheda tecnica

BUPRENORPHINE HCL AND NALOXONE HCL- BUPRENORPHINE AND
NALOXONE 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, 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
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 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 t