BUPRENORPHINE HCL AND NALOXONE HCL- buprenorphine and naloxone tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

INN (International Name):

BUPRENORPHINE HYDROCHLORIDE

Composition:

BUPRENORPHINE 8 mg

Administration route:

SUBLINGUAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 that includes 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 con

Product summary:

Product: 63629-5074 Product: 63629-7269 NDC: 63629-7269-1 30 TABLET in a BOTTLE NDC: 63629-5074-1 30 TABLET in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

BUPRENORPHINE HCL AND NALOXONE HCL- BUPRENORPHINE AND NALOXONE TABLET
Bryant Ranch Prepack
----------
MEDICATION GUIDE
BUPRENORPHINE (bue” pre nor’ feen) AND NALOXONE (nal ox’ one)
SUBLINGUAL TABLETS
(CIII)
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 right away.
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 is a medicine in buprenorphine and naloxone sublingual
tablets 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
•
have mental changes such as confusion
•
have slower breathing than you normally have
•
have severe sleepiness
•
have blurred vision
•
have problems with coordination
•
have slurred speech
•
cannot think well or clearly
•
have slowed reflexes
•
have a high body temperature
•
feel agitated
•
have stiff muscles
•
have trouble walking
•
Do not switch from buprenorphine and naloxone sublingual tablets to
other medicines that contain
buprenorphine without talking with your doctor. The amount of
buprenorphine in a dose of
buprenorphine and naloxone sublingual tablets is not the same as the
amount of buprenorphine in
other medicines that contain buprenorphine. Your doctor will

Summary of Product characteristics

BUPRENORPHINE HCL AND NALOXONE HCL- BUPRENORPHINE AND
NALOXONE TABLET
BRYANT RANCH PREPACK
----------
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
Warnings and Precautions (5.2) 10/2019
INDICATIONS AND USAGE
Buprenorphine and Naloxone Sublingual Tablets contain buprenorphine, a
partial opioid agonist, and
naloxone, an opioid antagonist, and is 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
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)
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 as directed
in the Full Prescribing
Information. (2.3, 2.4)
When discontinuing treatment, gradually taper to avoid signs and
symptoms of withdrawal. (2.7)
DOSAGE FORMS AND STRENGTHS
Sublingual tablet:
2 mg buprenorphine with 0.5 mg naloxone and
8 mg buprenorphine with 2 mg naloxone. (3)
CONTRAINDICATIONS
Hypersensitivity to buprenorphine or naloxone. (4)
WARNINGS AND PRECAUT