BUPRENORPHINE AND NALOXONE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Sun Pharmaceutical Industries, Inc.

INN (International Name):

BUPRENORPHINE HYDROCHLORIDE

Sammensetning:

BUPRENORPHINE 2 mg

Administreringsrute:

SUBLINGUAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Buprenorphine and naloxone sublingual tablet is indicated for the maintenance treatment of opioid dependence. Buprenorphine and naloxone sublingual tablet 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 Data]. Observational studies have reported on congenit

Produkt oppsummering:

Buprenorphine and naloxone sublingual tablets containing 2 mg buprenorphine with 0.5 mg naloxone (in terms of free base, equivalent to 2.16 mg buprenorphine hydrochloride USP and 0.61 mg naloxone hydrochloride dihydrate USP) are uncoated, round, biconvex, orange, sublingual tablets, debossed with ‘969’ on one side and plain on other side and are supplied as: Bottles of 30 with child-resistant cap……....………..NDC 62756-969-83 Unit-Dose blister pack of 30 (3×10) tablets ……..... NDC 62756-969-64 Buprenorphine and naloxone sublingual tablets containing 8 mg buprenorphine with 2 mg naloxone (in terms of free base, equivalent to 8.64 mg buprenorphine hydrochloride USP and 2.44 mg naloxone hydrochloride dihydrate USP) are uncoated, round, biconvex, orange, sublingual tablets, debossed with ‘970’ on one side and plain on other side and are supplied as: Bottles of 30 with child-resistant cap…....…………..NDC 62756-970-83 Unit-Dose blister pack of 30 (3×10) tablets ……..... NDC 62756-970-64 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Store buprenorphine and naloxone sublingual tablets securely and dispose of properly [see Patient Counseling Information (17)].

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Sun Pharmaceutical Industries, Inc.
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MEDICATION GUIDE
Buprenorphine (BUE-pre-NOR-feen) and Naloxone (NAH-lox-own)
Sublingual Tablets, CIII
IMPORTANT: Keep buprenorphine and naloxone sublingual tablet 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 tablet, 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
tablet?
•
Buprenorphine and naloxone sublingual tablet contains 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 tablet 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 tablet with certain
medicines. Taking
buprenorphine and naloxone sublingual tablet 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 sublingual
tablet. Injectin

Preparatomtale

BUPRENORPHINE AND NALOXONE - BUPRENORPHINE AND NALOXONE TABLET
SUN PHARMACEUTICAL INDUSTRIES, 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 SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS.
BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS, CIII
INITIAL U.S. APPROVAL: 2002
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 tablet 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 tablet sublingually
as a single daily dose. (2.1)
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. (2.2)
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
tablet 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 and
symptoms of withdrawal. (2.7)
DOSAGE FORMS AND STRENGTHS
Sublingual tablet: 2 mg buprenorphine with 0.5 mg naloxone and 8 mg
buprenorphine with 2 mg naloxone.
(3) (3)
CONTRA