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:

SpecGx LLC

INN (International Name):

BUPRENORPHINE HYDROCHLORIDE

Composition:

BUPRENORPHINE 2 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 cong

Product summary:

Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg are supplied as orange, round, biconvex tablet, debossed “A” on one side and “14” on the other side. They are available as follows: Bottles of 30               NDC 0406-1923-03 Buprenorphine and Naloxone Sublingual Tablets, 8 mg/2 mg are supplied as orange, round, biconvex tablet debossed “AN 415” on one side and plain on the other side. They are available as follows: Bottles of 30               NDC 0406-1924-03 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. 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 Counseling Information (17)] .

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

BUPRENORPHINE HCL AND NALOXONE HCL- BUPRENORPHINE AND NALOXONE TABLET
SpecGx LLC
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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 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 b
uprenorphine and naloxone sublingual
tablets?
•
Buprenorphine and naloxone sublingual tablets can cause serious and
life-threatening breathing
problems. Call your doctor right away or get emergency help if:
•
You feel faint, dizzy, or confused
•
Your breathing gets much slower than is normal for you
These can be signs of an overdose or other serious problems.
•
Buprenorphine and naloxone sublingual tablets contain an opioid that
can cause physical dependence.
•
Do not stop taking buprenorphine and naloxone sublingual tablets
without talking to your
doctor. You could become sick with uncomfortable withdrawal signs and
symptoms because
your body has become used to this medicine
•
Physical dependence is not the same as drug addiction
•
Buprenorphine and naloxone sublingual tablets are not for occasional
or “as needed” use
•
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
bupreno

Summary of Product characteristics

BUPRENORPHINE HCL AND NALOXONE HCL- BUPRENORPHINE AND NALOXONE TABLET
SPECGX LLC
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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 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 and
Naloxone Sublingual Film should be undertaken
when objective and clear signs of withdrawal are evident and
Buprenorphine and Naloxone Sublingual Tablets should
be administered in divided doses when used as initial treatment. (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 PRECAUTIONS
Addiction, Abuse, and Misuse: Buprenorphine can be abused in a similar
manner to other opioids. Clinical monitoring
appropriate to the patie