BUPRENORPHINE AND NALOXONE film

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Apotex Corp.

Spôsob podávania:

SUBLINGUAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Buprenorphine and naloxone sublingual film is indicated for treatment of opioid dependence. Buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support. Buprenorphine and naloxone sublingual film 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 film, 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 congenital malformations a

Prehľad produktov:

Buprenorphine 8 mg and naloxone 2 mg sublingual film is supplied as an orange-white to dark orange rectangular film which contains lighter colored areas of whitish particulates dispersed throughout the film. The film is imprinted with “8” in blue ink (“8” may appear to be green in color), in child-resistant polyester/foil laminated pouches: Buprenorphine 12 mg and naloxone 3 mg sublingual film is supplied as an orange-white to dark orange rectangular film which contains lighter colored areas of whitish particulates dispersed throughout the film. The film is imprinted with “12” in blue ink (“12” may appear to be green in color), in child-resistant polyester/foil laminated pouches: Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].   Store buprenorphine and naloxone sublingual film securely and dispose of properly [see Patient Counseling Information ( 17)] .

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

BUPRENORPHINE AND NALOXONE- BUPRENORPHINE AND NALOXONE FILM
Apotex Corp.
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MEDICATION GUIDE
Buprenorphine ( bue” pre nor’ feen) and Naloxone ( nal ox’ one)
Sublingual Film for sublingual or buccal administration (CIII)
IMPORTANT:
Keep buprenorphine and naloxone sublingual film 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 film, 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
aboutbuprenorphine and naloxone sublingual film?
•
Buprenorphine and naloxone sublingual film 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 film 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 film 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 takebuprenorphine and naloxone sublingual film with certain
medicines.
Takingbuprenorphine and naloxone sublingual film 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 (“s

Súhrn charakteristických

BUPRENORPHINE AND NALOXONE- BUPRENORPHINE AND NALOXONE FILM
APOTEX CORP.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUPRENORPHINE AND
NALOXONE SUBLINGUAL FILM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM.
BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM, FOR SUBLINGUAL OR BUCCAL
USE 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 film contains buprenorphine, a
partial-opioid agonist, and
naloxone, an opioid antagonist, and is indicated for treatment of
opioid dependence. ( 1)
Buprenorphine and naloxone sublingual film 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 film as a single
daily dose. ( 2.1)
Strongly consider prescribing naloxone at the time buprenorphine and
naloxone sublingual film 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 and
naloxone sublingual film should be undertaken when objective and clear
signs of withdrawal are evident
and buprenorphine and naloxone sublingual film should be administered
in divided doses when used as
initial treatment. ( 2.3)
For patients dependent on short-acting opioid products who are in
opioid withdrawal; on Day 1,
administer up to 8 mg/2 mg buprenorphine and naloxone sublingual film
(in divided doses). On Day 2,
administer up to 16 mg/4 mg of buprenorphine and naloxone sublingual
film as a single dose. ( 2.3)
For patients dependent on methadone or long-acting opioid products,
induction onto sublingual buprenorphine monotherapy is recommended on
Days 1 and 2 of
treatment. ( 2.3)
For maint