BUPRENORPHINE AND NALOXONE film

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Mylan Pharmaceuticals Inc.

Manustamisviis:

SUBLINGUAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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-e

Toote kokkuvõte:

Buprenorphine and Naloxone Sublingual Film are available in child resistant polyester/foil laminated pouches containing 8.62 mg or 12.9 mg of buprenorphine hydrochloride, USP equivalent to 8 mg or 12 mg of buprenorphine free base, respectively, and 2.44 mg or 3.66 mg of naloxone hydrochloride, USP dihydrate equivalent to 2 mg or 3 mg of naloxone free base, respectively, providing for the following combinations: 8 mg/2 mg or 12 mg/3 mg. The 8 mg/2 mg buprenorphine and naloxone sublingual film is an orange rectangular film printed in white with “B8/N”. Each film is contained in a square, flat pouch that is imprinted with lot number and expiration date. They are available as follows: NDC 0378-8767-93 carton containing 30 sublingual films The 12 mg/3 mg buprenorphine and naloxone sublingual film is an orange rectangular film printed in white with “B12/N”. Each film is contained in a square, flat pouch that is imprinted with lot number and expiration date. They are available as follows: NDC 0378-8768-93 carton containing 30 sublingual films Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store buprenorphine and naloxone sublingual film securely and dispose of properly [see Patient Counseling Information (17)] . PHARMACIST: Dispense a Medication Guide with each prescription.

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

Mylan Pharmaceuticals Inc.
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MEDICATION GUIDE
Buprenorphine and Naloxone Sublingual Film CIII
for sublingual or buccal administration
(bue″ pre nor′ feen nal ox′ one)
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:
o
feel faint or dizzy
o
have mental changes such as confusion
o
have slower breathing than you normally have
o
have severe sleepiness
o
have blurred vision
o
have problems with coordination
o
have slurred speech
o
cannot think well or clearly
o
have slowed reflexes
o
have a high body temperature
o
feel agitated
o
have stiff muscles
o
have trouble walking
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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 sublingual film that may

Toote omadused

BUPRENORPHINE AND NALOXONE- BUPRENORPHINE AND NALOXONE FILM
MYLAN PHARMACEUTICALS 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 part of a
complete treatment plan that includes counseling
and psychosocial support. (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Sublingual film:
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CONTRAINDICATIONS
Hypersensitivity to buprenorphine or naloxone. (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Adverse events commonly observed with the sublingual/buccal
administration of the buprenorphine and naloxone
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 methadone or l