BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

Buprenorphine Hydrochloride (UNII: 56W8MW3EN1) (Buprenorphine - UNII:40D3SCR4GZ), Naloxone Hydrochloride Dihydrate (UNII: 5Q187997EE) (Naloxone - UNII:36B82AMQ7N)

Commercializzato da:

Mayne Pharma 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 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 congen

Dettagli prodotto:

Buprenorphine and naloxone sublingual tablets, USP 2 mg/0.5 mg are supplied as white, hexagonal tablets debossed with "ML" on one side and "2" on the other side. They are available as follows: Buprenorphine and naloxone sublingual tablets, USP 8 mg/2 mg are supplied as white, hexagonal tablets debossed with "ML" on one side and "8" on the other side. They are available as follows: Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. 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 HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE-
buprenorphine hydrochloride and naloxone hydrochloride dihydrate
tablet
Mayne Pharma Inc.
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MEDICATION GUIDE
Buprenorphine (Bu-pre-NOR-feen) and Naloxone (Na-LOX-own)
Sublingual Tablets, USP (CIII)
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 or call 911 right
away. Tell your healthcare provider if you
are living in a household where there are small children.
Read this Medication Guide that comes with buprenorphine and naloxone
sublingual tablets before you start
taking them 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 tablet contains a medicine
called buprenorphine.
Buprenorphine is an opioid 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
•
Talk to your healthcare provider about naloxone. Naloxone is a
medicine that is available to patients
for the emergency treatment of an

Scheda tecnica

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
DIHYDRATE- BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
DIHYDRATE TABLET
MAYNE 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 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
07/2020
Warnings and Precautions (5.2, 5.3)
07/2020
INDICATIONS AND USAGE
Buprenorphine and naloxone sublingual tablets contain 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 tablet sublingually
as a single daily dose. (2.2)
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 (2.3_)_
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 (2.4)
The recommended target dosage of buprenorphine and naloxone sublingual
tablet for maintenance is
16 mg/4 mg. (2.4)
Administer buprenorphine and naloxone sublingual tablets as directed
in the Ful