BUPRENORPHINE AND NALOXONE- buprenorphine hydrochloride and naloxone hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ), NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N)

Available from:

Aidarex Pharmaceuticals LLC

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 and should be used as part of a complete treatment plan to include counseling and psychosocial support. Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to physicians who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription. Buprenorphine and Naloxone Sublingual Tablets should not be administered to patients who have been shown to be hypersensitive to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported [see Warnings and Precautions (5.8)] . Pregnancy Category C. Risk Summary There are no adequate and well-contr

Product summary:

Buprenorphine and Naloxone Sublingual Tablets are uncoated, white to off-white, round, biconvex tablet, debossed with a “↑” logo on one side and an "N8" indicating the 8 mg/2 mg strength on the other side, supplied in white HDPE bottles: BOTTLES of 30 tablets Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children. Destroy any unused medication appropriately [see Disposal of Unused Buprenorphine and Naloxone Sublingual Tablets (17)] . Repackaged by Aidarex Pharmaceuticals, LLC Corona, CA 92880

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

BUPRENORPHINE AND NALOXONE- BUPRENORPHINE HYDROCHLORIDE AND NALOXONE
HYDROCHLORIDE TABLET
Aidarex Pharmaceuticals LLC
----------
MEDICATION GUIDE
BUPRENORPHINE (byoo-pre-NOR-feen) AND NALOXONE (nah-LOX-own)
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 before you start taking Buprenorphine and
Naloxone Sublingual Tablets 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 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 contains 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 is not for occasional or
“as needed” use
•
An overdose, and even death, can happen if you take benzodiazepines,
sedatives, tranquilizers, or
alcohol while using Buprenorphine and Naloxone Sublingual Tablets. Ask
your doctor wh

Summary of Product characteristics

BUPRENORPHINE AND NALOXONE- BUPRENORPHINE HYDROCHLORIDE AND NALOXONE
HYDROCHLORIDE TABLET
AIDAREX PHARMACEUTICALS LLC
----------
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
Neonatal Opioid Withdrawal Syndrome (5.5)
11/2016
Adrenal Insufficiency (5.6)
11/2016
INDICATIONS AND USAGE
Buprenorphine and Naloxone Sublingual Tablets are indicated for the
maintenance treatment of opioid dependence.
Prescription use of this product is limited under the Drug Addiction
Treatment Act. (1)
DOSAGE AND ADMINISTRATION
Administer Buprenorphine and Naloxone Sublingual Tablets sublingually
as a single daily dose. (2)
The recommended daily dose for maintenance is 16 mg/4 mg.
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
Buprenorphine can be abused in a similar manner to other opioids.
Clinical monitoring appropriate to the patient’s level
of stability is essential. Multiple refills should not be prescribed
early in treatment or without appropriate patient follow-
up visits. (5.1)
Significant respiratory depression and death have occurred in
association with buprenorphine, particularly when taken
by the intravenous (IV) route in combination with benzodiazepines or
other CNS depressants (including alcohol). (5.2)
Consider dose reduction of CNS depressants, Buprenorphine and Naloxone
Sublingual Tablets, or both in situations of
concomitant prescription. (5.3)
Store Buprenorphine and Naloxone Sublingual Tablets safely out of the
sight and reach of children. Buprenorphine can
cause severe, possibl