BUPRENORPHINE HYDROCHLORIDE- buprenorphine hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

BUPRENORPHINE HYDROCHLORIDE

Composition:

BUPRENORPHINE 8 mg

Administration route:

SUBLINGUAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Buprenorphine sublingual tablets is 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 is 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] . Observational studies have reported on congenital malformations among buprenorphine-exposed preg

Product summary:

Buprenorphine sublingual tablets are supplied in white HDPE bottles. 2 mg - White, round, biconvex uncoated tablets with "2" debossed on one side and a dart "→" debossed on the other side 8 mg - White, round, biconvex uncoated tablets with "8" debossed on one side and a dart "→" debossed on the other side Storage 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. 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

REMEDYREPACK INC.
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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 contains 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 think well or clearly
•
Have slowed reflexes and breathing

Summary of Product characteristics

BUPRENORPHINE HYDROCHLORIDE- BUPRENORPHINE HYDROCHLORIDE TABLET
REMEDYREPACK 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
Dosage and Administration ( 2.1, 2.2, 2.3, 2.4, 2.5)
01/2018
Warnings and Precautions ( 5.1, 5.2, 5.3)
01/2018
Adverse Events ( 6.1, 6.2)
01/2018
Drug Interaction
01/2018
Use in Specific Populations ( 8.1, 8.2, 8.3)
01/2018
Clinical Pharmacology ( 12.2)
01/2018
Patient Counseling Information
01/2018
INDICATIONS AND USAGE
Buprenorphine sublingual tablets, contains buprenorphine, a partial
opioid agonist, and is 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 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) 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. ( 2.6)
DOSAGE FORMS AND STRENGTHS
Sublingual tablet: 2 mg buprenorphine and 8 mg buprenor