BUPRENORPHINE HYDROCHLORIDE SUBLINGUAL tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ)

Commercializzato da:

Contract Pharmacy Services-PA

INN (Nome Internazionale):

BUPRENORPHINE HYDROCHLORIDE

Composizione:

BUPRENORPHINE 2 mg

Via di somministrazione:

SUBLINGUAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Buprenorphine hydrochloride sublingual tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine hydrochloride sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription. Buprenorphine hydrochloride sublingual tablets should not be administered to patients who have been shown to be hypersensitive to buprenorphine, as serious adverse reactions, including anaphylactic shock, have been reported [see Warnings and Precautions (

Dettagli prodotto:

Buprenorphine Hydrochloride Sublingual Tablets are available containing buprenorphine hydrochloride, USP equivalent to 2 mg or 8 mg of buprenorphine. The 2 mg sublingual tablets are white, round, unscored tablets debossed with M over 923 on one side of the tablet and blank on the other side. They are available as follows: NDC 67046-996-30 blisterpacks of 30 tablets The 8 mg sublingual tablets are white, round, unscored tablets debossed with M over 924 on one side of the tablet and blank on the other side. They are available as follows: NDC 67046-997-30 blisterpacks of 30 tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription. Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children. Destroy any unused medication appropriately [see Patient Counseling (17.2) ]. Rx only

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

BUPRENORPHINE HYDROCHLORIDE SUBLINGUAL- BUPRENORPHINE HYDROCHLORIDE
SUBLINGUAL TABLET
Contract Pharmacy Services-PA
----------
MEDICATION GUIDE
Buprenorphine Hydrochloride Sublingual Tablets
(bue″ pre nor′ feen hye″ droe klor′ ide)
IMPORTANT:
Keep buprenorphine hydrochloride 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 hydrochloride sublingual tablets, get emergency
help right away.
Read this Medication Guide that comes with buprenorphine hydrochloride
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 hydrochloride 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 hydrochloride sublingual
tablets?
•
Buprenorphine hydrochloride 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 hydrochloride sublingual tablets to
other medicines that
contain buprenorphine without talking with your doctor. The amount of
buprenorphine in a dose
of buprenorphine hydrochloride 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 hydrochloride sublingual tablets that may be
different than other
buprenorphine containing medicines you may have been taking.
•
Buprenorphine hydrochloride sublingual tablets contain an opioid that
can cause physical
dependence.
•
Do not

Scheda tecnica

BUPRENORPHINE HYDROCHLORIDE SUBLINGUAL- BUPRENORPHINE HYDROCHLORIDE
SUBLINGUAL TABLET
CONTRACT PHARMACY SERVICES-PA
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUPRENORPHINE HYDROCHLORIDE
SUBLINGUAL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR BUPRENORPHINE
HYDROCHLORIDE SUBLINGUAL TABLETS.
BUPRENORPHINE HYDROCHLORIDE SUBLINGUAL TABLETS, FOR SUBLINGUAL
ADMINISTRATION CIII 996 997
INITIAL U.S. APPROVAL: 2002
RECENT MAJOR CHANGES
Warnings and Precautions ( 5.5, 5.6) 12/2016
INDICATIONS AND USAGE
Buprenorphine hydrochloride sublingual tablets, contain buprenorphine,
a partial opioid agonist, and are indicated for the
treatment of opioid dependence and are preferred for induction.
Prescription use of this product is limited under the Drug
Addiction Treatment Act. ( 1)
DOSAGE AND ADMINISTRATION
Administer buprenorphine hydrochloride sublingual tablets sublingually
as a single daily dose. ( 2)
To avoid precipitating withdrawal, induction with buprenorphine
hydrochloride sublingual tablets should be undertaken
when objective and clear signs of withdrawal are evident. ( 2.2)
Buprenorphine and naloxone sublingual film CIII or
buprenorphine and naloxone sublingual tablets CIII are generally
initiated after two days of buprenorphine hydrochloride
sublingual tablets titration.
DOSAGE FORMS AND STRENGTHS
Sublingual tablet: 2 mg buprenorphine and 8 mg buprenorphine. ( 3)
CONTRAINDICATIONS
Hypersensitivity to buprenorphine. ( 4)
WARNINGS AND PRECAUTIONS
Buprenorphine can be abused in a similar manner to other opioids.
Clinical monitoring appropriate to the patient’s level
of stability is essential. Multiple refills should not be prescribed
early in treatment or without appropriate patient follow-
up visits. ( 5.1)
Significant respiratory depression and death have occurred in
association with buprenorphine, particularly when taken
by the intravenous (IV) route in combination with benzodiazepines or
other CNS depressants (including al