BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ), NALOXONE HYDROCHLORIDE DIHYDRATE (UNII: 5Q187997EE) (NALOXONE - UNII:36B82AMQ7N)

Disponível em:

Hikma Pharmaceuticals USA Inc.

DCI (Denominação Comum Internacional):

BUPRENORPHINE HYDROCHLORIDE

Composição:

BUPRENORPHINE 2 mg

Via de administração:

SUBLINGUAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Buprenorphine and Naloxone Sublingual Tablets are indicated for the maintenance treatment of opioid dependence. Buprenorphine and Naloxone Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. Buprenorphine and Naloxone Sublingual Tablets are contraindicated in patients with a history of hypersensitivity to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported [see Warnings and Precautions (5.9)]. Risk Summary The data on use of buprenorphine, one of the active ingredients in Buprenorphine and Naloxone 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 congenita

Resumo do produto:

Buprenorphine and Naloxone Sublingual Tablets, USP 2 mg/0.5 mg are supplied as speckled-peach to peach, flat faced beveled edge tablets with product identification “54” [above] “122” on one side and plain on the other. NDC 0054-0188-13: Bottle of 30 Tablets 8 mg/2 mg are supplied as speckled-peach to peach, flat faced beveled edge tablets with product identification “54” [above] “375” on one side and plain on the other. NDC 0054-0189-13: Bottle of 30 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 and Naloxone Sublingual Tablets securely and dispose of properly [see Patient Counseling Information (17)] .

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
DIHYDRATE- BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
DIHYDRATE TABLET
Hikma Pharmaceuticals USA Inc.
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MEDICATION GUIDE
Buprenorphine (bue” pre nor’ feen) and Naloxone (nal ox’ one)
Sublingual Tablets CIII
Rx only
IMPORTANT: Keep Buprenorphine and Naloxone 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 and Naloxone 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 and Naloxone Sublingual
Tablets?
•
Buprenorphine and Naloxone Sublingual Tablets contain a medicine
called buprenorphine.
Buprenorphine is an opioid that can cause serious and life-threatening
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 and
Naloxone 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 and Naloxone Sublingual Tablets may cause serious and
life-threatening breathing
problems. Get emergency help right away if you:
o
feel faint
o
have blurred vision
o
feel dizzy
o
have slurred speech
o
are confused
o
are breathing slower than normal
o
feel sleepy or uncoordinated
o
cannot think well or clearly
•
Do not take Buprenorphine and Naloxone Sublingual Tablets with certain
medicines. Taking
Buprenorphine and Naloxone Sublingual Tablets with other opioid
medicines, benzodiazepines,
alcohol, or other central nervous system depressants (including street
drugs) can cause severe
drowsiness, decreased awareness, br

Características técnicas

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
DIHYDRATE- BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
DIHYDRATE 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 AND
NALOXONE SUBLINGUAL TABLETS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS.
BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS, FOR SUBLINGUAL
ADMINISTRATION CIII
INITIAL U.S. APPROVAL: 2002
INDICATIONS AND USAGE
Buprenorphine and Naloxone Sublingual Tablets contain buprenorphine, a
partial opioid agonist, and
naloxone, an opioid antagonist, and are indicated for the maintenance
treatment of opioid dependence.
(1)
Buprenorphine and Naloxone Sublingual Tablets should be used as part
of a complete treatment plan that
includes counseling and psychosocial support. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Sublingual Tablet:
•
•
CONTRAINDICATIONS
Hypersensitivity to buprenorphine or naloxone. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
Administer Buprenorphine and Naloxone Sublingual Tablets sublingually
as a single daily dose. (2.1)
Strongly consider prescribing naloxone at the time Buprenorphine and
Naloxone 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.
After induction, doses of
Buprenorphine and Naloxone Sublingual Tablets should be progressively
adjusted to a level that holds
the patient in treatment and suppresses opioid withdrawal signs and
symptoms. (2.3)
The recommended target dosage of Buprenorphine and Naloxone Sublingual
Tablets for maintenance
is 16 mg/4 mg. (2.3)
Administer Buprenorphine and Naloxone Sublingual Tablets