BUPRENORPHINE tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Bryant Ranch Prepack

INN (Kansainvälinen yleisnimi):

BUPRENORPHINE HYDROCHLORIDE

Koostumus:

BUPRENORPHINE 2 mg

Antoreitti:

SUBLINGUAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Buprenorphine sublingual tablets are indicated for the treatment of opioid dependence and is 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 studies have reported on congenital malformations among buprenorphine-exposed pre

Tuoteyhteenveto:

NDC: 71335-0353-8: 120 Tablets in a BOTTLE NDC: 71335-0353-1: 60 Tablets in a BOTTLE NDC: 71335-0353-2: 90 Tablets in a BOTTLE NDC: 71335-0353-3: 30 Tablets in a BOTTLE NDC: 71335-0353-4: 7 Tablets in a BOTTLE NDC: 71335-0353-5: 28 Tablets in a BOTTLE NDC: 71335-0353-6: 1 Tablets in a BOTTLE NDC: 71335-0353-7: 12 Tablets in a BOTTLE

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

Bryant Ranch Prepack
----------
MEDICATION GUIDE
Dispense with Medication Guide available at: www.tevausa.com/medguides
BUPRENORPHINE (bue" 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 takes buprenorphine sublingual tablets, get
emergency help or call 911 right away. Tell your healthcare provider
if you are living in a
household where there are small children.
What is the most important information I should know about
buprenorphine sublingual tablets?
•
Buprenorphine sublingual tablets contain a medicine called
buprenorphine. Buprenorphine is an opioid that can cause serious and
life‐threatening
breathing problems, especially if you take or use certain other
medicines or drugs.
•
Talk to your healthcare provider about naloxone. Naloxone is a
medicine that is available to patients for the emergency treatment of
an opioid
overdose, including accidental use of buprenorphine sublingual tablets
by a child. If naloxone is given, you must call 911 or get emergency
medical help right away to treat an overdose or accidental use of an
opioid.
•
Buprenorphine sublingual tablets may cause serious and
life‐threatening breathing problems. Get emergency help right away
if you:
•
feel faint
•
•
feel dizzy
•
•
are confused
•
•
feel sleepy or uncoordinated
•
•
Do not take buprenorphine sublingual tablets with certain medicines.
Taking buprenorphine sublingual tablets with other opioid medicines,
benzodiazepines, alcohol, or other central nervous system depressants
(including street drugs) can cause severe drowsiness, decreased
awareness,
breathing problems, coma, and death.
•
Do not inject (“shoot‐up”) buprenorphine sublingual tablets.
Injecting buprenorphine sublingual tablets may cause
life‐threatening infections and
other serious health problems.
•
Do not switch from buprenorphine sublingual tablets to other med

Valmisteyhteenveto

BUPRENORPHINE- BUPRENORPHINE TABLET
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO
USEBUPRENORPHINE
SUBLINGUAL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
BUPRENORPHINESUBLINGUAL TABLETS.
BUPRENORPHINE SUBLINGUAL TABLETS, CIII
INITIAL U.S. APPROVAL: 1981
RECENT MAJOR CHANGES
Dosage and Administration (2.3)
03/2021
Warnings and Precautions (5.2, 5.3) 03/2021
INDICATIONS AND USAGE
Buprenorphine sublingual tablets contain buprenorphine, a partial
opioid agonist, and are indicated for the
treatment of opioid dependence and is 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)
Strongly consider prescribing naloxone at the time buprenorphine
sublingual tablets are initiated or
renewed because patients being treated for opioid use disorder have
the potential for relapse, putting
them at risk for opioid overdose. (2.3)
To avoid precipitating withdrawal, induction with buprenorphine
sublingual tablets should be undertaken
when objective and clear signs of withdrawal are evident. (2.4)
Buprenorphine and naloxone sublingual film or buprenorphine and
naloxone sublingual tablet is
generally initiated after two days of buprenorphine sublingual tablets
titration. (2.5)
Administer buprenorphine sublingual tablets as directed in the Full
Prescribing Information. (2.4, 2.5,
2.6)
Buprenorphine sublingual tablets must be administered whole. Do not
cut, chew, or swallow
buprenorphine sublingual tablets. (2.6)
When discontinuing treatment, gradually taper to avoid signs and
symptoms of withdrawal. (2.10)
DOSAGE FORMS AND STRENGTHS
Sublingual tablet: buprenorphine 2 mg and buprenorphine 8 mg. (3)
CONTRAINDICATION