BUPRENORPHINE HYDROCHLORIDE tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

TYA Pharmaceuticals

INN (Rahvusvaheline Nimetus):

BUPRENORPHINE HYDROCHLORIDE

Koostis:

BUPRENORPHINE 2 mg

Manustamisviis:

SUBLINGUAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Buprenorphine HCl sublingual tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine HCl 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 HCl 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

Toote kokkuvõte:

NDC:64725-1924-3 in a BOTTLE of 30 TABLETS NDC:64725-1924-4 in a CARTON of 30 TABLETS Storage Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Destroy any unused medication appropriately. Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children. [see Disposal of Unused Buprenorphine HCl Sublingual Tablets ( )]. 17.2

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

TYA Pharmaceuticals
----------
MEDICATION GUIDE
Buprenorphine hydrochloride
Sublingual Tablet (CIII)
IMPORTANT:
Keep Buprenorphine HCl 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 HCl
sublingual tablets, get emergency help right away.
Read this Medication Guide before you start taking Buprenorphine HCl
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 HCl
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 HCl sublingual tablets?
•
Buprenorphine HCl 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 HCl sublingual tablets contains an opioid that can cause
physical dependence
•
Do not stop taking Buprenorphine HCl 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 addictio
•
Buprenorphine HCl 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 HCl 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 think well or clearly
•
Have slowe

Toote omadused

BUPRENORPHINE HYDROCHLORIDE- BUPRENORPHINE HYDROCHLORIDE TABLET
TYA PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUPRENORPHINE HCL SUBLINGUAL TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
BUPRENORPHINE HCL SUBLINGUAL TABLETS.
BUPRENORPHINE HYDROCHLORIDE SUBLINGUAL TABLETS FOR SUBLINGUAL
ADMINISTRATION
CIII
INITIAL U.S. APPROVAL: 2002
INDICATIONS AND USAGE
Buprenorphine HCl 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
DOSAGE AND ADMINISTRATION
Administer buprenorphine HCl sublingual tablets sublingually as a
single daily dose. ( ) 2
To avoid precipitating withdrawal, induction with buprenorphine HCl
sublingual tablets should be undertaken when
objective and clear signs of withdrawal are evident. ( ) Buprenorphine
and naloxone sublingual film CIII or buprenorphine
and naloxone sublingual tablets CIII are generally initiated after two
days of buprenorphine HCl sublingual tablet titration. (
) 2.12
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 HCl
sublingual tablets, or both in situations of concomitant
prescription. ( ) 5.3
Store buprenorphine HCl sublingual tablets safely out of