BUPRENORPHINE tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

REMEDYREPACK INC.

Designación común internacional (DCI):

BUPRENORPHINE HYDROCHLORIDE

Composición:

BUPRENORPHINE 2 mg

Vía de administración:

SUBLINGUAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Buprenorphine sublingual tablet is indicated for the treatment of opioid dependence and is preferred for induction. Buprenorphine sublingual tablet should be used as part of a complete treatment plan to include counseling and psychosocial support. Buprenorphine sublingual tablet 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)]. 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 bup

Resumen del producto:

Buprenorphine sublingual tablets containing 2 mg buprenorphine (as the free base, equivalent to 2.16 mg buprenorphine hydrochloride USP) are uncoated, round, biconvex, white to off-white, sublingual tablets, debossed with ‘459’ on one side and plain on other side and are supplied as: Bottles of 30’s with Child Resistant Cap……………..NDC 62756-459-83 Unit-Dose blister pack of 30 (3×10) tablets ……..... NDC 62756-459-64 Buprenorphine sublingual tablets containing 8 mg buprenorphine (as the free base, equivalent to 8.64 mg buprenorphine hydrochloride USP) are uncoated, round, biconvex, white to off-white, sublingual tablets, debossed with ‘460’ on one side and plain on other side and are supplied as: Bottles of 30’s with Child Resistant Cap……………..NDC 62756-460-83 Unit-Dose blister pack of 30 (3×10) tablets ……..... NDC 62756-460-64 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from light. Store buprenorphine sublingual tablets securely and dispose of properly [see Patient Counseling Information (17)] .

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

REMEDYREPACK INC.
----------
MEDICATION GUIDE
Buprenorphine Sublingual Tablets CIII
(BUE-pre-NOR-feen)
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 that comes with buprenorphine sublingual
tablets before you start taking them
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 is a medicine in buprenorphine sublingual tablets that
can cause serious and life-
threatening problems, especially if you take or use certain other
medicines or drugs. Call your
healthcare provider right away or get emergency help if you: feel
faint or dizzy
•
cannot think well or clearly
•
have mental changes such as confusion
•
have slowed reflexes
•
have slower breathing than you normally have
•
have a high body temperature
•
have severe sleepiness
•
feel agitated o have blurred vision
•
have stiff muscles
•
have problems with coordination
•
have trouble walking o have slurred speech
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 is not 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.
�

Ficha técnica

BUPRENORPHINE- BUPRENORPHINE TABLET
REMEDYREPACK INC.
----------
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: 1981
RECENT MAJOR CHANGES
Warnings and Precautions (5.2) 10/2019
INDICATIONS AND USAGE
Buprenorphine sublingual tablet, contains buprenorphine, a partial
opioid agonist, and is indicated for the treatment of
opioid dependence and is preferred for induction. (1)
Buprenorphine sublingual tablet should be used as part of a complete
treatment plan that includes counseling and
psychosocial support. (1)
DOSAGE AND ADMINISTRATION
Prescription use of this product is limited under the Drug Addiction
Treatment Act. (2.1)
Administer buprenorphine sublingual tablet sublingually as a single
daily dose. (2.2)
To avoid precipitating withdrawal, induction with buprenorphine
sublingual tablet should be undertaken when objective
and clear signs of withdrawal are evident. (2.3)
Buprenorphine and naloxone sublingual film or buprenorphine and
naloxone sublingual tablet is generally initiated after
two days of buprenorphine sublingual tablet titration. (2.3)
Administer buprenorphine sublingual tablets as directed in the Full
Prescribing Information. (2.3, 2.4,2.5)
Buprenorphine sublingual tablet must be administered whole. Do not
cut, chew, or swallow buprenorphine sublingual
tablets. (2.5)
When discontinuing treatment, gradually taper to avoid signs and
symptoms of withdrawal. (2.9)
DOSAGE FORMS AND STRENGTHS
Sublingual tablet: 2 mg buprenorphine and 8 mg buprenorphine. ( 3)
CONTRAINDICATIONS
Hypersensitivity to buprenorphine. ( 4)
WARNINGS AND PRECAUTIONS
Addiction, Abuse, and Misuse: Buprenorphine can be abused in a similar
manner to other opioids. Monitor patients for
conditions indicative of diversion or progression of opioid dependence
and addictiv