BUPRENORPHINE AND NALOXONE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

BUPRENORPHINE (UNII: 40D3SCR4GZ) (BUPRENORPHINE - UNII:40D3SCR4GZ), NALOXONE (UNII: 36B82AMQ7N) (NALOXONE - UNII:36B82AMQ7N)

Commercializzato da:

REMEDYREPACK INC.

Via di somministrazione:

SUBLINGUAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Buprenorphine and naloxone sublingual tablets are indicated for the 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 tablets are 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

Dettagli prodotto:

Buprenorphine and naloxone sublingual tablets are a hexagonal light pink tablet, debossed with a numeric imprint on one side identifying the strength, supplied in white HDPE bottles: Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature] Advise patients to store buprenorphine-containing medications safely and out of sight and reach of children and to destroy any unused medication appropriately [see Patient Counseling Information ( 17)]. Store Buprenorphine and naloxone sublingual tablets securely and dispose of properly [see Patient Counseling Information ( 17)].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

BUPRENORPHINE AND NALOXONE- BUPRENORPHINE AND NALOXONE TABLET
REMEDYREPACK INC.
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MEDICATION GUIDE
Buprenorphine (bue'' pre nor' feen)
and Naloxone (nal ox' one)
Sublingual Tablets
(CIII)
CIB71921D Rev. 09/2019
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 uses buprenorphine and naloxone sublingual
tablets, get
emergency help right away.
Read this Medication Guide that comes with buprenorphine and naloxone
sublingual tablets 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 tablets.
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 tablets?
•
Buprenorphine and naloxone sublingual tablets can cause serious and
life-threatening breathing
problems. Call your doctor right away or get emergency help if:
•
You feel faint, dizzy, or confused
•
Your breathing gets much slower than is normal for you
These can be signs of an overdose or other serious problems.
•
Do not switch from buprenorphine and naloxone sublingual tablets to
other medicines that contain
buprenorphine without talking with your doctor. The amount of
buprenorphine in a dose of
buprenorphine and naloxone sublingual tablets may not be 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 tablets that may be different
than other buprenorphine
containing medicines you may have been taking.
•
Buprenorphine and naloxone sublingual tablets contain an opioid that
can cause physical dependence.
•
Do not stop taking buprenorphine and nalox

Scheda tecnica

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 SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR BUPRENORPHINE AND
NALOXONE SUBLINGUAL TABLETS.
BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS FOR SUBLINGUAL
ADMINISTRATION
CIII
INITIAL U.S. APPROVAL: 2002
RECENT MAJOR CHANGES
Dosage and Administration ( 2.2, 2.3) 09/2017
Warnings and Precautions (5.2, 5.3) 01/2018
Warnings and Precautions ( 5.5, 5.6) 12/2016
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
Prescription use of this product is limited under the Drug Addiction
Treatment Act. ( 2.1)
Administer buprenorphine and naloxone sublingual tablets sublingually
as a single daily dose. ( 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
tablets for maintenance is 16 mg/4 mg. (
2.2)
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. (