BUPRENORPHINE tablet

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Contract Pharmacy Services-PA

INN (Isem Internazzjonali):

BUPRENORPHINE HYDROCHLORIDE

Kompożizzjoni:

BUPRENORPHINE 2 mg

Rotta amministrattiva:

SUBLINGUAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Buprenorphine sublingual tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine 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 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 ( 5.9)]. Risk Summary There a

Sommarju tal-prodott:

Buprenorphine Sublingual Tablets, 2 mg are available as uncoated, white, oval, flat-faced, beveled-edge, unscored tablets, debossed with 798 on one side and stylized b on the other side, containing 2.16 mg of buprenorphine hydrochloride, USP equivalent to 2 mg of buprenorphine base, packaged in blisterpacks of 30 tablets (NDC 67046-994-30). Buprenorphine Sublingual Tablets, 8 mg are available as uncoated, white, oval, flat-faced, beveled-edge, unscored tablets, debossed with 799 on one side and stylized b on the other side, containing 8.64 mg of buprenorphine hydrochloride, USP equivalent to 8 mg of buprenorphine base, packaged in blisterpacks of 30 tablets (NDC 67046-995-30). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure as required. 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

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

BUPRENORPHINE- BUPRENORPHINE TABLET
Contract Pharmacy Services-PA
----------
MEDICATION GUIDE
BUPRENORPHINE (byoo-pre-NOR-feen)
SUBLINGUAL TABLETS CIII
IMPORTANT:
Keep buprenorphine 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 sublingual tablets,
get emergency help right away.
Read this Medication Guide that comes with buprenorphine 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 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 sublingual tablets?
1.
Buprenorphine sublingual tablets can cause serious and
life-threatening breathing problems. Call
your doctor right away or get emergency help if:
2.
You feel faint, dizzy or confused
3.
Your breathing gets much slower than is normal for you
4.
These can be signs of an overdose or other serious problems.
5.
Do not switch from buprenorphine sublingual tablets to other medicines
that contain
buprenorphine without talking with your doctor. The amount of
buprenorphine in a dose of
buprenorphine 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
sublingual tablets that may be different than other buprenorphine
containing medicines you may
have been taking.
6.
Buprenorphine sublingual tablets contain an opioid that can cause
physical dependence.
7.
Do not stop taking buprenorphine sublingual tablets without talking to
your doctor. You could
become sick with uncomfortable withdrawal signs and symptoms because
your body has become
used to this medicine
8.
Physical dependence is not the same

Karatteristiċi tal-prodott

BUPRENORPHINE- BUPRENORPHINE TABLET
CONTRACT PHARMACY SERVICES-PA
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUPRENORPHINE SUBLINGUAL TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
BUPRENORPHINE SUBLINGUAL TABLETS.
BUPRENORPHINE SUBLINGUAL TABLETS, FOR SUBLINGUAL ADMINISTRATION CIII
994 995
INITIAL U.S. APPROVAL: 2002
RECENT MAJOR CHANGES
Warnings and Precautions ( 5.5, 5.6) 12/2016
INDICATIONS AND USAGE
Buprenorphine 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 sublingual tablets sublingually as a single
daily dose. ( 2)
To avoid precipitating withdrawal, induction with buprenorphine
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 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
1. 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)
2. 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 alcohol). ( 5.2)
3. Consider dose reduction of CNS depressants, buprenorphine
sublingual tablets, or both in situations of concomitant
prescripti