BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM- buprenorphine and naloxone film

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Almatica Pharma Inc.

给药途径:

SUBLINGUAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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) ] . 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 among buprenorphine-

產品總結:

Buprenorphine and naloxone sublingual film is supplied as an orange rectangular film with white printing in child-resistant polyester/foil laminated pouches: Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store buprenorphine and naloxone sublingual film securely and dispose of properly [see Patient Counseling Information (17)] . 

授权状态:

Abbreviated New Drug Application

资料单张

Almatica Pharma Inc.
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MEDICATION GUIDE
Buprenorphine and Naloxone
(bue'' pre nor' feen and 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
uses buprenorphine and naloxone sublingual film, get emergency help
right away.
Read this Medication Guide that comes with buprenorphine and naloxone
sublingual film before
you start taking it and each time you get a refill. There may be new
information. This Medication
Guide does not take the place of talking to your doctor. Talk to your
doctor or pharmacist if you
have questions about buprenorphine and naloxone sublingual film.
Share the important information in this Medication Guide with members
of your household.
What is the most important information I should know about
buprenorphine and naloxone
sublingual film?
•
Buprenorphine is a medicine in buprenorphine and naloxone sublingual
film that can cause
serious and life-threatening problems, especially if you take or use
certain other medicines
or drugs. Call your healthcare provider right away or get emergency
help if you:
•
feel faint or dizzy
•
have mental changes such as confusion
•
have slower breathing than you normally have
•
have severe sleepiness
•
have blurred vision
•
have problems with coordination
•
have slurred speech
•
cannot think well or clearly
•
have slowed reflexes
•
have a high body temperature
•
feel agitated
•
have stiff muscles
•
have trouble walking
•
Do not switch from buprenorphine and naloxone sublingual film to other
medicines that
contain buprenorphine without talking with your doctor. The amount of
buprenorphine in a
dose of buprenorphine and naloxone sublingual film is not the same as
the amount of
buprenorphine in other medicines that contain buprenorphine. Your
doctor will prescribe a
starting dose of buprenorphine and naloxone sub

产品特点

BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM- BUPRENORPHINE AND NALOXONE FILM
ALMATICA PHARMA INC.
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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
Warnings and Precautions (5.2) 10/2019
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 a part of
a complete treatment plan that includes counseling
and psychosocial support. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Sublingual film: (3)
buprenorphine 2 mg and naloxone 0.5 mg,
buprenorphine 4 mg and naloxone 1 mg,
buprenorphine 8 mg and naloxone 2 mg and
buprenorphine 12 mg and naloxone 3 mg.
CONTRAINDICATIONS
Hypersensitivity to buprenorphine or naloxone. (4)
WARNINGS AND PRECAUTIONS
•
•
•
Prescription use of this product is limited under the Drug Addiction
Treatment Act. (2.1)
Administer buprenorphine and naloxone sublingual film as a single
daily dose. (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