BUPRENORPHINE AND NALOXONE tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

REMEDYREPACK INC.

Administreringssätt:

SUBLINGUAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Buprenorphine and naloxone sublingual tablets are indicated for 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 tablet is 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

Produktsammanfattning:

Buprenorphine and Naloxone Sublingual Tablet, USP is an orange, round flat faced beveled edge tablet debossed with an alphanumeric word identifying the product strength (RP on one side for each strength, and "n2" and "n8" on 2 mg and 8 mg tablets, respectively), supplied in NDC: 70518-3389-00 PACKAGING: 30 in 1 BLISTER PACK Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store Buprenorphine and Naloxone Sublingual Tablets securely and dispose of properly [see PATIENT COUNSELING INFORMATION (17)]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

BUPRENORPHINE AND NALOXONE- BUPRENORPHINE AND NALOXONE TABLET
REMEDYREPACK INC.
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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 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
•
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") bu

Produktens egenskaper

BUPRENORPHINE AND NALOXONE- BUPRENORPHINE AND NALOXONE TABLET
REMEDYREPACK 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, USP SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION
FOR BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS, USP.
BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS, USP, 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 tablet contains 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 tablet sublingually
as a single daily dose. ( 2.2)
Strongly consider prescribing naloxone at the time buprenorphine and
naloxone sublingual tablet 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
tablet for maintenance is
16/4 mg. ( 2.4)
Administer buprenorphine and naloxone sublingual tablets as directed
in the Full Prescribing
Information. ( 2.4, 2.5)
When discontinuing treatment, gradual