BUPRENORPHINE HYDROCHLORIDE tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

PD-Rx Pharmaceuticals, Inc.

Designació comuna internacional (DCI):

BUPRENORPHINE HYDROCHLORIDE

Composición:

BUPRENORPHINE 8 mg

tipo de receta:

PRESCRIPTION DRUG

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

BUPRENORPHINE HYDROCHLORIDE- BUPRENORPHINE HYDROCHLORIDE 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 HCL SUBLINGUAL TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
BUPRENORPHINE HCL SUBLINGUAL TABLETS.
BUPRENORPHINE HYDROCHLORIDE SUBLINGUAL TABLETS FOR SUBLINGUAL
ADMINISTRATION
CIII
INITIAL U.S. APPROVAL: 2002
RECENT MAJOR CHANGES
Dosage and Administration, Patients With
Hepatic Impairment ( 2.5) 12/2014
Warnings and Precautions, Use in Patients
With Impairment Hepatic Function ( 5.11) 12/2014
INDICATIONS AND USAGE
Buprenorphine HCl sublingual tablets 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 HCl sublingual tablets sublingually as a
single daily dose. ( 2)
To avoid precipitating withdrawal, induction with buprenorphine HCl
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 tablets CIII are generally
initiated after two days of buprenorphine HCl sublingual
tablet titration. ( 2)
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 d