BUPRENORPHINE HYDROCHLORIDE SUBLINGUAL- buprenorphine hydrochloride sublingual tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

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. 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) ]. 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] . Observational studies have reported on congenital malformations among buprenorphine-exposed pregnancies, but w

Product summary:

Buprenorphine Sublingual Tablets are available containing buprenorphine hydrochloride, USP equivalent to 2 mg or 8 mg of buprenorphine. The 2 mg sublingual tablets are white, round, unscored tablets debossed with M over 923 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0923-93 bottles of 30 tablets The 8 mg sublingual tablets are white, round, unscored tablets debossed with M over 924 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0924-93 bottles of 30 tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription. 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 (17)]. Store buprenorphine sublingual tablets securely and dispose of properly [see Patient Counseling Information (17)] .

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

BUPRENORPHINE HYDROCHLORIDE SUBLINGUAL- BUPRENORPHINE HYDROCHLORIDE
SUBLINGUAL TABLET
Mylan Pharmaceuticals Inc.
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MEDICATION GUIDE
Buprenorphine Sublingual Tablets
(bue″ pre nor′ feen hye″ droe klor′ ide)
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
them 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:
o
You feel faint, dizzy or confused
o
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.
o
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 h

Summary of Product characteristics

BUPRENORPHINE HYDROCHLORIDE SUBLINGUAL- BUPRENORPHINE HYDROCHLORIDE
SUBLINGUAL TABLET
MYLAN PHARMACEUTICALS INC.
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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
Warnings and Precautions (5.2) 04/2019
INDICATIONS AND USAGE
Buprenorphine sublingual tablets contain buprenorphine, a partial
opioid agonist, and 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 that includes counseling and
psychosocial support. (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Sublingual tablet: 2 mg buprenorphine and 8 mg buprenorphine. (3)
CONTRAINDICATIONS
Hypersensitivity to buprenorphine. (4)
WARNINGS AND PRECAUTIONS
•
•
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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 tablets are 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)
Addiction, Abuse, and Misuse: Buprenorphine can be abused in a similar
manner