BUPRENORPHINE AND NALOXONE- buprenorphine hydrochloride and naloxone hydrochloride tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ), NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N)

Saadav alates:

Bryant Ranch Prepack

INN (Rahvusvaheline Nimetus):

BUPRENORPHINE HYDROCHLORIDE

Koostis:

BUPRENORPHINE 2 mg

Manustamisviis:

SUBLINGUAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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 [se

Toote kokkuvõte:

NDC: 63629-7270-1: 30 Tablets in a BOTTLE, PLASTIC NDC: 63629-7270-2: 10 Tablets in a BOTTLE, PLASTIC

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

Bryant Ranch Prepack
----------
Dispense the Medication Guide available at:
www.akorn.com/mg/bup-nal-tab to each patient.
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Revised: 06/2022
MEDICATION GUIDE
BUPRENORPHINE (bue’’ pre nor’ feen) AND NALOXONE (nal ox’ one)
SUBLINGUAL TABLETS
(CIII)
Rx Only
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 tablets 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
•
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 tablets with certain
medicines. Taking
buprenorphine and naloxone sublingual tablets with other opioid
medicines, benzodiazepines,
alcohol, or other central nervous system depressants (i

Toote omadused

BUPRENORPHINE AND NALOXONE- BUPRENORPHINE HYDROCHLORIDE AND NALOXONE
HYDROCHLORIDE 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 (2.5)
05/2022
Warnings and Precautions (5.13, 5.14)
05/2022
Adverse reactions (6.2)
05/2022
Clinical Pharmacology (12.2)
05/2022
Information for Patients (17)
05/2022
INDICATIONS AND USAGE
Buprenorphine and naloxone sublingual tablets contains 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 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 (2.4).
The recommended target dosage of buprenorphine and naloxone sublingual
tablets for maintenance is
16 mg/4 mg (2.4).
Ad