BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Major Pharmaceuticals

Manustamisviis:

SUBLINGUAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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

Toote kokkuvõte:

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. Carton of 50 tablets (10 tablets per blister pack x 5), NDC 0904-7009-06 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. Carton of 50 tablets (10 tablets per blister pack x 5), NDC 0904-7010-06 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. Advise patients to store buprenorphine-containing medications safely and out of sight and reach of children and to destroy any unused medication appropriately [see Patient Counseling Information (17) ]. Store Buprenorphine and Naloxone Sublingual Tablets securely and dispose of properly [see Patient CounselingInformation (17)] .

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE-
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE
TABLET
Major Pharmaceuticals
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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.
Read this Medication Guide that comes with Buprenorphine and Naloxone
Sublingual Tablets before you
start taking it and each time you get a refill. There may be new
information. This Medication Guide does not
take the place of talking to your doctor. Talk to your doctor or
pharmacist if you have questions about
Buprenorphine and Naloxone Sublingual Tablets.
Share the important information in this Medication Guide with members
of your household.
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. Call your healthcare provider
right away or get emergency help
if you:
•
feel faint or dizzy
•
cannot think well or clearly
•
have mental changes such as confusion
•
have slowed reflexes
•
have slower breathing than you normally have
•
have a high body temperature
•
have severe sleepiness
•
feel agitated
•
have blurred vision
•
have stiff muscles
•
•
have problems with coordination
have trouble walking
•
have slurred speech
•
Talk to your healthcare provider about naloxone. Naloxone is a
medicine that is available to patients
for the emergency trea

Toote omadused

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
DIHYDRATE- BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
DIHYDRATE TABLET
MAJOR PHARMACEUTICALS
----------
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
RECENT MAJOR CHANGES
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
•
•
•
•
•
•
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DOSAGE FORMS AND STRENGTHS
Sublingual Tablet:
•
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CONTRAINDICATIONS
Hypersensitivity to buprenorphine or naloxone. (4)
WARNINGS AND PRECAUTIONS
•
•
•
Warnings and Precautions (5.2) 10/2019
Prescription use of this product is limited under the Drug Addiction
Treatment Act. (2.1)
Administer Buprenorphine and Naloxone Sublingual Tablets sublingually
as a single daily dose. (2.2)
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 (2.3)
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. (2.4)
The recommended target dosage of Bup