BUPRENORPHINE HCL tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

PD-Rx Pharmaceuticals, Inc.

INN (Միջազգային անվանումը):

BUPRENORPHINE HYDROCHLORIDE

Կազմը:

BUPRENORPHINE 8 mg

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

BUPRENORPHINE HCL- BUPRENORPHINE HCL TABLET
PD-RX PHARMACEUTICALS, INC.
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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
INITIAL U.S. APPROVAL: 2002
RECENT MAJOR CHANGES
Warnings and Precautions
1. Neonatal Opioid Withdrawal Syndrome ( 5.5) 1/2017
2. Adrenal Insufficiency ( 5.6) 1/2017
INDICATIONS AND USAGE
Buprenorphine Sublingual Tablets are indicated for the treatment of
opioid dependence and is 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. ( 2.1) Buprenorphine and
naloxone sublingual film CIII or buprenorphine and
naloxone sublingual tablet CIII is 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
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 alcohol). ( 5.2)
Consider dose reduction of CNS depressants, Buprenorphine Sublingual
Tablets, or both in situations of concomitant
presc