BUPRENORPHINE HYDROCHLORIDE injection

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:

Par Pharmaceutical, Inc.

INN (Tên quốc tế):

BUPRENORPHINE HYDROCHLORIDE

Thành phần:

BUPRENORPHINE 0.324 mg in 1 mL

Tuyến hành chính:

INTRAMUSCULAR

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Buprenorphine hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see WARNINGS: Addiction, Abuse, and Misuse] reserve buprenorphine for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: - Have not been tolerated, or are not expected to be tolerated, Have not been tolerated, or are not expected to be tolerated, - Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Buprenorphine hydrochloride is contraindicated in patients with: - Significant respiratory depression [See WARNINGS]. Significant respiratory depression [See WARNINGS]. - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [See WARNINGS]. Acute or severe bronchial asthma i

Tóm tắt sản phẩm:

Buprenorphine Hydrochloride Injection NDC 42023-179-05:  0.3 mg buprenorphine in a 1 mL single dose clear glass vial, supplied in packages of five vials. Store at 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) Protect from prolonged exposure to light. The vial stopper is not made with natural rubber latex.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

BUPRENORPHINE HYDROCHLORIDE- BUPRENORPHINE HYDROCHLORIDE INJECTION
PAR PHARMACEUTICAL, INC.
----------
BUPRENORPHINE HYDROCHLORIDE INJECTION
CIII
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING
RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL
SYNDROME AND RISKS FROM CONCOMITANT USE WITH
BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
ADDICTION, ABUSE, AND MISUSE
BUPRENORPHINE EXPOSES PATIENTS AND OTHER USERS TO THE RISKS OF OPIOID
ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH.
ASSESS EACH PATIENT'S RISK PRIOR TO PRESCRIBING BUPRENORPHINE, AND
MONITOR ALL PATIENTS REGULARLY FOR THE DEVELOPMENT OF THESE BEHAVIORS
AND CONDITIONS (SEE WARNINGS).
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH
USE OF BUPRENORPHINE. MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY
DURING INITIATION OF BUPRENORPHINE OR FOLLOWING A DOSE INCREASE (SEE
WARNINGS).
NEONATAL OPIOID WITHDRAWAL SYNDROME
PROLONGED USE OF BUPRENORPHINE DURING PREGNANCY CAN RESULT IN NEONATAL
OPIOID WITHDRAWAL SYNDROME, WHICH MAY BE LIFE-THREATENING IF NOT
RECOGNIZED AND TREATED, AND REQUIRES MANAGEMENT ACCORDING TO
PROTOCOLS DEVELOPED BY NEONATOLOGY EXPERTS. IF OPIOID USE IS REQUIRED
FOR A PROLONGED PERIOD IN A PREGNANT WOMAN, ADVISE THE PATIENT OF THE
RISK OF NEONATAL OPIOID WITHDRAWAL SYNDROME AND ENSURE THAT
APPROPRIATE
TREATMENT WILL BE AVAILABLE (SEE WARNINGS).
RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
CONCOMITANT USE OF OPIOIDS WITH BENZODIAZEPINES OR OTHER CENTRAL
NERVOUS SYSTEM (CNS) DEPRESSANTS, INCLUDING ALCOHOL, MAY RESULT IN
PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH (SEE
WARNINGS, PRECAUTIONS).
RESERVE CONCOMITANT PRESCRIBING OF BUPRENORPHINE AND
BENZODIAZEPINES OR OTHER CNS DEPRESSANTS FOR USE IN PATIENTS FOR
WHOM ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
LIMIT DOSAGES AND DURATIONS TO THE MINIMUM REQUIRED. FOLLOW PATIENTS
FOR SIGNS AND SYMPTOMS OF RESPIRATORY DEPRESSION AND SEDATION.
DESCRIPTION
Buprenorphine hy