BUPRENORPHINE HCL tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Hikma Pharmaceuticals USA Inc.

INN (International namn):

BUPRENORPHINE HYDROCHLORIDE

Sammansättning:

BUPRENORPHINE 2 mg

Administreringssätt:

SUBLINGUAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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

Produktsammanfattning:

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. NDC 0054-0176-13: Bottle of 30 Sublingual Tablets 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. NDC 0054-0177-13: Bottle of 30 Sublingual Tablets 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) ].

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

Hikma Pharmaceuticals USA Inc.
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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 n

Produktens egenskaper

BUPRENORPHINE HCL- BUPRENORPHINE HCL TABLET
HIKMA PHARMACEUTICALS USA INC.
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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
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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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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Administer Buprenorphine Sublingual Tablets sublingually as a single
daily dose. (2.1)
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 (2.2)
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. (2.4)
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)
Addiction, Abuse, and