BUPRENORPHINE AND NALOXONE- buprenorphine hydrochloride and naloxone hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Golden State Medical Supply, Inc.

INN (International Name):

BUPRENORPHINE HYDROCHLORIDE

Composition:

BUPRENORPHINE 2 mg

Administration route:

SUBLINGUAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Buprenorphine and Naloxone Sublingual Tablets are available as follows: 2mg/0.5mg -White to off-white, round, biconvex uncoated tablet, debossed with a “↑” logo on one side and an "N2" on the other side. Tablets are supplied in bottles of 30 (NDC 60429-586-30). 8mg/2mg -White to off-white, round, biconvex uncoated tablet, debossed with a “↑” logo on one side and "N8" on the other side. Tablets are supplied in bottles of 30 (NDC 60429-587-30). Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Store buprenorphine and naloxone sublingual tablets securely and dispose of properly [see Patient Counseling Information ( 17)].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Golden State Medical Supply, Inc.
----------
Dispense the Medication Guide available at:
www.akorn.com/mg/bup-nal-tabto 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 depre

Summary of Product characteristics

BUPRENORPHINE AND NALOXONE- BUPRENORPHINE HYDROCHLORIDE AND NALOXONE
HYDROCHLORIDE TABLET
GOLDEN STATE MEDICAL SUPPLY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. 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 ( 2.1)
05/2023
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
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 mg/4 mg ( 2.3).
Administer buprenorphine and naloxone sublingual tablets as directed
in the Full Prescribing
Information. ( 2.3, 2.4)
When discontinuing treatment, gradually taper to avoid signs