BUPRENORPHINE tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

REMEDYREPACK INC.

प्रशासन का मार्ग:

SUBLINGUAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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 are 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 st

उत्पाद समीक्षा:

Buprenorphine Sublingual Tablets are available in the following strengths: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Advise patients to store buprenorphine-containing medications safely and out of sight and reach of children and to destroy any unused medication appropriately [see Patient Counseling Information (17)] . Store Buprenorphine Sublingual Tablets securely and dispose of properly [see Patient Counseling Information (17)].

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

BUPRENORPHINE- BUPRENORPHINE TABLET
REMEDYREPACK INC.
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MEDICATION GUIDE
BUPRENORPHINE
(BYOO-PRE-NOR-FEEN)
SUBLINGUAL TABLETS, CIII
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 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

उत्पाद विशेषताएं

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: 2002
RECENT MAJOR CHANGES
Warnings and Precautions ( 5.18)
10/2019
INDICATIONS AND USAGE
Buprenorphine sublingual tablets, contain buprenorphine, a partial
opioid agonist, and are indicated for the treatment of
opioid dependence and are preferred for induction. ( 1)
Buprenorphine sublingual tablets 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 tablets sublingually as a single
daily dose. ( 2.2)
To avoid precipitating withdrawal, induction with buprenorphine
sublingual tablets should be undertaken when objective
and clear signs of withdrawal are evident. ( 2.3).
Buprenorphine and naloxone sublingual film or buprenorphine and
naloxone sublingual tablets are 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 tablets 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: buprenorphine 2 mg and buprenorphine 8 mg ( 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 depe