BUPRENORPHINE HCL SL- buprenorphine hcl tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

H.J. Harkins Company, Inc.

Vía de administración:

SUBLINGUAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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. Buprenorphine Sublingual Tablets is contraindicated in patients with a history of hypersensitivity to buprenorphine, as serious adverse reactions, including anaphylactic shock, have been reported [see Warnings and Precautions (5.9)]. 8.1 Pregnancy Risk Summary The data on use of buprenorphine, the active ingredient in Buprenorphine Sublingual Tablets, in pregnancy, are limited; however, these data do not indicate an increased risk of major malformations specifically due to buprenorphine exposure. There are limited data from randomized clinical trials in women maintained on buprenorphine that were not designed appropriately to assess the risk of major malformations [see Data].Observational studies have reported on congenital malformations among buprenorphine-expo

Resumen del producto:

Buprenorphine Sublingual Tablets:

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

BUPRENORPHINE HCL SL- BUPRENORPHINE HCL TABLET
H.J. Harkins Company, Inc.
----------
Buprenorphine (bue” pre nor’ feen) Sublingual Tablets CIII
Rx Only
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 before you start taking Buprenorphine
Sublingual Tablets 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?
•
Buprenorphine Sublingual Tablets can cause serious and
life-threatening breathing problems. Call
your doctor right away or get emergency help if:
•
You feel faint, dizzy or confused
•
Your breathing gets much slower than is normal for you
These can be signs of an overdose or other serious problems.
•
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.
•
Buprenorphine Sublingual Tablets contain an opioid that can cause
physical dependence.
•
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
•
Physical dependence is not the same as drug ad

Ficha técnica

BUPRENORPHINE HCL SL- BUPRENORPHINE HCL TABLET
H.J. HARKINS COMPANY, INC.
----------
1170 BUPRENORPHINE SL 8MG
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.
2.1 Drug Addiction Treatment Act
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.
2.2 Important Dosage and Administration Instructions
Buprenorphine Sublingual Tablets are administered sublingually as a
single daily dose.
Buprenorphine Sublingual Tablets do not contain naloxone and is
preferred for use only during
induction. Following induction, buprenorphine sublingual film or
buprenorphine sublingual tablet is
preferred due to the presence of naloxone when clinical use includes
unsupervised administration. The
use of Buprenorphine Sublingual Tablets for unsupervised
administration should be limited to those
patients who cannot tolerate buprenorphine sublingual film or
buprenorphine sublingual tablet; for
example, those patients who have been shown to be hypersensitive to
naloxone.
Medication should be prescribed in consideration of the frequency of
visits. Provision of multiple
refills is not advised early in treatment or without appropriate
patient follow-up visits.
2.3 Induction
Prior to induction, consideration should be given to the type of
opioid dependence (i.e., long- or short-
acting opioid products), the time since last opioid use, and the
degree or level of opioid dependence.
Patients Dependent on Heroin or Other Short-acting O