PROBUPHINE- buprenorphine hydrochloride implant

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

buprenorphine hydrochloride (UNII: 56W8MW3EN1) (buprenorphine - UNII:40D3SCR4GZ)

Sẵn có từ:

Braeburn Pharmaceuticals

INN (Tên quốc tế):

buprenorphine hydrochloride

Thành phần:

buprenorphine 80 mg

Tuyến hành chính:

SUBCUTANEOUS

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

PROBUPHINE is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of a transmucosal buprenorphine-containing product (i.e., doses of no more than 8 mg per day of Subutex or Suboxone sublingual tablet or generic equivalent). PROBUPHINE should be used as part of a complete treatment program to include counseling and psychosocial support. PROBUPHINE is not appropriate for new entrants to treatment and patients who have not achieved and sustained prolonged clinical stability, while being maintained on buprenorphine 8 mg per day or less of a Subutex or Suboxone sublingual tablet equivalent or generic equivalent. PROBUPHINE is contraindicated in patients with a history of hypersensitivity to buprenorphine or any other ingredients in PROBUPHINE (e.g., EVA). [see Warnings and Precautions (5.11)]. Risk Summary The data on use of buprenorphine, the active ingredient in PROBUPHINE implant, in pregnancy, are limited

Tóm tắt sản phẩm:

One PROBUPHINE implant kit consists of four individually packaged sterile implants and one individually packaged sterile disposable applicator. Each implant is 26 mm in length and 2.5 mm in diameter and contains 74.2 mg of buprenorphine (equivalent to 80 mg of buprenorphine hydrochloride). One applicator kit consists of one sterile, single patient use, disposable PROBUPHINE applicator. Store PROBUPHINE at 20 to 25°C (68 to 77°F); excursions permitted at 15 to 30°C (59-86°F) [see USP Controlled Room Temperature]. Store PROBUPHINE in accordance with Federal and State controlled substance laws and regulations. Contact state controlled substances authority for information on how to store and prevent diversion of this product. The PROBUPHINE implant is a Schedule III drug product. Handle with adequate security and accountability. Expired implants should be properly disposed, per facility procedure for a Schedule III drug product, and per applicable federal, state, and local regulations. NDC code for set of four implants is 58284-100-14.

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

PROBUPHINE- BUPRENORPHINE HYDROCHLORIDE IMPLANT
BRAEBURN PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PROBUPHINE SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR PROBUPHINE.
PROBUPHINE (BUPRENORPHINE) IMPLANT FOR SUBDERMAL ADMINISTRATION CIII
INITIAL U.S. APPROVAL: 2002
WARNING: IMPLANT MIGRATION, PROTRUSION, EXPULSION, AND NERVE DAMAGE
ASSOCIATED
WITH INSERTION AND REMOVAL
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INSERTION AND REMOVAL OF PROBUPHINE ARE ASSOCIATED WITH THE RISK OF
IMPLANT MIGRATION, PROTRUSION,
EXPULSION, AND NERVE DAMAGE RESULTING FROM THE PROCEDURE. (5.1)
PROBUPHINE IS AVAILABLE ONLY THROUGH A RESTRICTED PROGRAM CALLED THE
PROBUPHINE REMS PROGRAM.
(5.2)
RECENT MAJOR CHANGES
Warnings and Precautions (5.4, 5.5)
02/2018
INDICATIONS AND USAGE
PROBUPHINE contains buprenorphine, a partial opioid agonist.
PROBUPHINE is indicated for the maintenance treatment of
opioid dependence in patients who have achieved and sustained
prolonged clinical stability on low-to-moderate doses of a
transmucosal buprenorphine- containing product (i.e., doses of no more
than 8 mg per day of Subutex or Suboxone
sublingual tablet or generic equivalent). (1)
PROBUPHINE should be used as part of a complete treatment program to
include counseling and psychosocial support. (1)
PROBUPHINE is not appropriate for new entrants to treatment and
patients who have not achieved and sustained
prolonged clinical stability, while being maintained on buprenorphine
8 mg per day or less of a Subutex or Suboxone
sublingual tablet or generic equivalent. (1)
DOSAGE AND ADMINISTRATION
Prescription use of this product is limited under the Drug Addiction
Treatment Act. (2.1)
Four PROBUPHINE implants are inserted subdermally in the upper arm for
6 months of treatment and are removed by the
end of the sixth month. (2.2)
PROBUPHINE implants should not be used for additional treatment cycles
after one insertion in each upper arm. (2.