BUPRENORPHINE tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Clinical Solutions Wholesale, LLC

מסלול נתינה (של תרופות):

SUBLINGUAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and is preferred for induction. Buprenorphine Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. Buprenorphine Sublingual Tablets are contraindicated in patients with a history of hypersensitivity to buprenorphine, as serious adverse reactions, including anaphylactic shock, have been reported [see Warnings and Precautions ( 5.9)]. Risk Summary The data on use of buprenorphine, the active ingredient in Buprenorphine 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] . Observationa

leaflet_short:

Buprenorphine Sublingual Tablets are available as follows: 2 mg – Oval, orange tablets debossed with on one side and 156 on the other side. Tablets are supplied in bottles of 30 (NDC 0228-3156-03). 8 mg – Oval, orange tablets debossed with on one side and 153 on the other side. Tablets are supplied in bottles of 30 (NDC 0228-3153-03). Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in USP. CAUTION: DEA Order  Form Required. 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)].

מצב אישור:

Abbreviated New Drug Application

עלון מידע

BUPRENORPHINE- BUPRENORPHINE TABLET
Clinical Solutions Wholesale, 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 that comes with Buprenorphine 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 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.
•
Do not switch from Buprenorphine Sublingual Tablets to other medicines
that contain
buprenorphine without talking with your doctor. The amount of
buprenorphine in a dose of
Buprenorphine Sublingual Tablets may not be the same as the amount of
buprenorphine in other
medicines that contain buprenorphine. Your doctor will prescribe a
starting dose of Buprenorphine
Sublingual Tablets that may be different than other buprenorphine
containing medicines you may
have been taking.
•
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

מאפייני מוצר

BUPRENORPHINE- BUPRENORPHINE TABLET
CLINICAL SOLUTIONS WHOLESALE, LLC
----------
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 ( 2.2, 2.3, 2.8) 09/2017
Warnings and Precautions ( 5.2, 5.3) 02/2018
INDICATIONS AND USAGE
Buprenorphine Sublingual Tablets, contain buprenorphine, a partial
opioid agonist, and are indicated for the treatment of
opioid dependence and is preferred for induction ( 1).
Buprenorphine 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 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. (2.3)
Buprenorphine and naloxone sublingual film or buprenorphine and
naloxone sublingual tablet is generally initiated after
two days of Buprenorphine Sublingual Tablets titration. (2.3)
Administer Buprenorphine Sublingual Tablets as directed in the Full
Prescribing Information. (2.3, 2.4, 2.5)
Buprenorphine Sublingual Tablets must be administered whole. Do not
cut, chew, or swallow Buprenorphine Sublingual
Tablets. (2.5)
When discontinuing treatment, gradually taper to avoid signs and
symptoms of withdrawal. (2.9)
DOSAGE FORMS AND STRENGTHS
Sublingual tablet: buprenorphine 2 mg and buprenorphine 8 mg. ( 3)
CONTRAINDICATIONS
Hypersensitivity to buprenorphine. ( 4)
WARNINGS AND PRECAUTIONS
Addiction, Abuse, and Misuse: Buprenorphine can be abused in a similar
manner to other opioids. Monitor patients for