BUPRENORPHINE HCL tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Lake Erie Medical DBA Quality Care Products LLC

INN (International namn):

BUPRENORPHINE HYDROCHLORIDE

Sammansättning:

BUPRENORPHINE 2 mg

Administreringssätt:

SUBLINGUAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 (5.7)] Teratogenic Effects Pregnancy Category C Risk Summary : The

Produktsammanfattning:

Buprenorphine Sublingual Tablets are supplied as white, sublingual tablets available in 2 mg and 8 mg strengths. The 2 mg buprenorphine tablet is debossed with product identification "54 775" on one side and plain on the other side. The 8 mg buprenorphine tablet is debossed with product identification "54 411" on one side and plain on the other side. 55700-302-30 2 mg tablet, Bottle of 30 55700-303-30 8 mg tablet, Bottle of 30 Storage Store at 20° to 25°C (68° to 77°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 Patient Counseling (17)]

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

BUPRENORPHINE HCL- BUPRENORPHINE HCL TABLET
Lake Erie Medical DBA Quality Care Products LLC
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MEDICATION GUIDE
BUPRENORPHINE (BUE-pre-NOR-feen)
Sublingual Tablets, CIII
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
•

Produktens egenskaper

BUPRENORPHINE HCL- BUPRENORPHINE HCL TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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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
INITIAL U.S. APPROVAL: 2002
RECENT MAJOR CHANGES
Dosage and Administration, Patients With Hepatic Impairment (2.5)
12/2014
Warnings and Precautions, Use in Patients With Hepatic Function (5.11)
12/2014
INDICATIONS AND USAGE
Buprenorphine Sublingual Tablets are indicated for the treatment of
opioid dependence and are preferred for induction.
Prescription use of this product is limited under the Drug Addiction
Treatment Act. (1) (1)
DOSAGE AND ADMINISTRATION
Administer Buprenorphine 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. (2.1) Buprenorphine and
naloxone sublingual film CIII or buprenorphine and
naloxone sublingual tablets CIII are generally initiated after two
days of buprenorphine sublingual tablet titration. (2)
DOSAGE FORMS AND STRENGTHS
Sublingual tablet: 2 mg buprenorphine and 8 mg buprenorphine. (3) (3)
CONTRAINDICATIONS
Hypersensitivity to buprenorphine. (4) (4)
WARNINGS AND PRECAUTIONS
•
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•
•
•
•
•
•
•
•
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ADVERSE REACTIONS
Adverse events most commonly observed during clinical trials and
post-marketing experience for buprenorphine
sublingual tablets are headache, nausea, vomiting, hyperhidrosis,
constipation, signs and symptoms of withdrawal,
insomnia, and pain. (6.1 and 6.2)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ROXANE LABORATORIES,
INC. AT 1-800-962-8364 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
Buprenorphine can be abused in a similar manner to other opioids.
Clinic