BUPRENORPHINE HCL- buprenorphine hcl tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ)

Available from:

Contract Pharmacy Services-PA

INN (International Name):

BUPRENORPHINE HYDROCHLORIDE

Composition:

BUPRENORPHINE 2 mg

Administration route:

SUBLINGUAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine Sublingual Tablets 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 Sublingual Tablets should not be administered to patients who have been shown to be hypersensitive to buprenorphine, as serious adverse reactions, including anaphylactic shock, have been reported [see Warnings and Precautions ( 5.9)]. Pregnancy Category C Risk Summary There are no adequate an

Product summary:

Buprenorphine Sublingual Tablets 2 mg, supplied as white, flat faced, beveled edge tablets with product identification "54” over “775" on one side and plain on the other side. NDC 67046-998-30: Blisterpacks of 30 Sublingual Tablets 8 mg, supplied as white, flat faced, beveled edge tablets with product identification "54” over “411" on one side and plain on the other side. NDC 67046-999-30: Blisterpacks of 30 Sublingual 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. CAUTION: DEA Order Form Required. Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children. Destroy any unused medication appropriately [see Patient Counseling ( 17)].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

BUPRENORPHINE HCL- BUPRENORPHINE HCL TABLET
Contract Pharmacy Services-PA
----------
MEDICATION GUIDE
Buprenorphine (byoo-pre-NOR-feen) Sublingual Tablets CIII
Rx Only
IMPORTANT:
Keep Buprenorphine 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 Sublingual
Tablets, get emergency help right away.
Read this Medication Guide before you start taking Buprenorphine
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 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 Sublingual Tablets?
•
Buprenorphine 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 Sublingual Tablets contain an opioid that can cause
physical dependence.
•
Do not stop taking Buprenorphine 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 Sublingual Tablets are 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 Sublingual Tablets. Ask your doctor
what you should do if
you are taking one of these.
•
Call a doctor or get emergency help right away if you:
•
Feel sleepy and uncoordinated
•
Have blurred vision
•
Have slurred speech
•
Cannot thi

Summary of Product characteristics

BUPRENORPHINE HCL- BUPRENORPHINE HCL TABLET
CONTRACT PHARMACY SERVICES-PA
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUPRENORPHINE SUBLINGUAL TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
BUPRENORPHINE SUBLINGUAL TABLETS.
BUPRENORPHINE SUBLINGUAL TABLETS, FOR SUBLINGUAL ADMINISTRATION CIII
998 999
INITIAL U.S. APPROVAL: 2002
RECENT MAJOR CHANGES
Warnings and Precautions
1. Neonatal Opioid Withdrawal Syndrome ( 5.5) 1/2017
2. Adrenal Insufficiency ( 5.6) 1/2017
INDICATIONS AND USAGE
Buprenorphine Sublingual Tablets are indicated for the treatment of
opioid dependence and is preferred for induction.
Prescription use of this product is limited under the Drug Addiction
Treatment Act. ( 1)
DOSAGE AND ADMINISTRATION
Administer Buprenorphine Sublingual Tablets sublingually as a single
daily dose. ( 2)
To avoid precipitating withdrawal, induction with Buprenorphine
Sublingual Tablets should be undertaken when objective
and clear signs of withdrawal are evident. ( 2.1) Buprenorphine and
naloxone sublingual film CIII or buprenorphine and
naloxone sublingual tablet CIII is generally initiated after two days
of Buprenorphine Sublingual Tablets titration.
DOSAGE FORMS AND STRENGTHS
Sublingual Tablet: 2 mg buprenorphine and 8 mg buprenorphine. ( 3)
CONTRAINDICATIONS
Hypersensitivity to buprenorphine. ( 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 Sublingual
Tablets, or both in situations of concomi