BUPRENORPHINE HCL tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Major Pharmaceuticals

Pot uporabe:

SUBLINGUAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 studies have reported on congenital malformations among buprenorphine-exposed pregn

Povzetek izdelek:

Buprenorphine Sublingual Tablets 2 mg, supplied as white, flat faced, beveled-edge tablets with product identification "54” over “775" on one side and plain on the other side. Carton of 30 tablets (10 tablets per blister pack x 3), NDC 0904-7154-04 8 mg, supplied as white, flat faced, beveled-edge tablets with product identification "54” over “411" on one side and plain on the other side. Carton of 30 tablets (10 tablets per blister pack x 3), NDC 0904-7155-04 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in USP. Store Buprenorphine Sublingual Tablets securely and dispose of properly [see Patient Counseling Information (17) ].

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

Major Pharmaceuticals
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MEDICATION GUIDE
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 uses 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-up”) Buprenorphine Sublingual Tablets.
Injecting Buprenorphine Sublingual
Tablets may cause life-threatening infections and other serious health
problems.
•
Do not switch

Lastnosti izdelka

BUPRENORPHINE HCL- BUPRENORPHINE HCL TABLET
MAJOR PHARMACEUTICALS
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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: 1981
RECENT MAJOR CHANGES
Dosage and Administration (2.3)
03/2021
Dosage and Administration (2.6)
01/2022
Warnings and Precautions (5.2, 5.3)
03/2021
Warnings and Precautions (5.13)
01/2022
INDICATIONS AND USAGE
Buprenorphine Sublingual Tablets contain 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
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•
•
•
•
•
•
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DOSAGE FORMS AND STRENGTHS
Sublingual tablet: 2 mg buprenorphine and 8 mg buprenorphine. (3)
CONTRAINDICATIONS
Hypersensitivity to buprenorphine. (4)
WARNINGS AND PRECAUTIONS
•
•
•
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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 tablets are
generally initiated after two days of Buprenorphine Sublingual Tablet
titration. (2.5)
Administer Buprenorphine Sublingual Tablets as directed in the Full
Prescribing Information. (2.4, 2.