BUPRENORPHINE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

INN (International Name):

BUPRENORPHINE HYDROCHLORIDE

Composition:

BUPRENORPHINE 2 mg

Administration route:

SUBLINGUAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Buprenorphine sublingual tablets is 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 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 buprenorphine-exposed pregnanci

Product summary:

NDC: 63629-7125-8: 120 Tablets in a BOTTLE NDC: 63629-7125-1: 60 Tablets in a BOTTLE NDC: 63629-7125-2: 90 Tablets in a BOTTLE NDC: 63629-7125-3: 30 Tablets in a BOTTLE NDC: 63629-7125-4: 7 Tablets in a BOTTLE NDC: 63629-7125-5: 28 Tablets in a BOTTLE NDC: 63629-7125-6: 1 Tablets in a BOTTLE NDC: 63629-7125-7: 12 Tablets in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Bryant Ranch Prepack
----------
Dispense the Medication Guide available at: www.akorn.com/mg/bupre-tab
to each patient.
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Revised: 06/2022
MEDICATION GUIDE
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 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
•
have blurred vision
•
have slurred speech
•
are breathing slower than normal
•
cannot think well or clearly
•
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

Summary of Product characteristics

BUPRENORPHINE HYDROCHLORIDE- BUPRENORPHINE HYDROCHLORIDE TABLET
BRYANT RANCH PREPACK
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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
Dosage and Administration (2.6)
05/2022
Warnings and Precautions (5.13, 5.14)
05/2022
Adverse Reactions (6.2)
05/2022
Clinical Pharmacology (12.2)
05/2022
Information for Patients (17)
05/2022
INDICATIONS AND USAGE
Buprenorphine sublingual tablets contains buprenorphine, a partial
opioid agonist, and is 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 is 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, gradual