BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ), NALOXONE HYDROCHLORIDE DIHYDRATE (UNII: 5Q187997EE) (NALOXONE - UNII:36B82AMQ7N)

Sẵn có từ:

Quality Care Products, LLC

Tuyến hành chính:

SUBLINGUAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Buprenorphine and naloxone sublingual tablets are indicated for the maintenance treatment of opioid dependence. Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. Buprenorphine and naloxone sublingual tablets are contraindicated in patients with a history of hypersensitivity to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported [see Warnings and Precautions (5.9)] . Risk Summary The data on use of buprenorphine, one of the active ingredients in buprenorphine and naloxone 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 co

Tóm tắt sản phẩm:

Buprenorphine and naloxone sublingual tablets, 2 mg/0.5 mg are supplied as orange, mottled, hexagonal tablets debossed “2N” on one side and “M” in a box on the other side; content expressed in terms of free base, equivalent to 2.16 mg buprenorphine hydrochloride USP and 0.61 mg naloxone hydrochloride dihydrate USP. Bottles of 30……………NDC 55700-901-30 Buprenorphine and naloxone sublingual tablets, 8 mg/2 mg are supplied as orange, mottled, hexagonal tablets debossed “8N” on one side and “M” in a box on the other side; content expressed in terms of free base, equivalent to 8.64 mg buprenorphine hydrochloride USP and 2.44 mg naloxone hydrochloride dihydrate USP. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in USP. 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) ] . Store buprenorphine and naloxone sublingual tablets securely and dispose of properly [see Patient Counseling Information (17)] .

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE
TABLET
Quality Care Products, LLC
----------
MEDICATION GUIDE
BUPRENORPHINE (byoo-pre-NOR-feen) AND NALOXONE (nah-LOX-own)
SUBLINGUAL TABLETS (CIII)
IMPORTANT:
Keep buprenorphine and naloxone 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 and naloxone sublingual
tablets, get emergency help right away.
Read this Medication Guide that comes with buprenorphine and naloxone
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 and naloxone
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 and naloxone sublingual tablets?
•
Buprenorphine is a medicine in buprenorphine and naloxone sublingual
tablets that can cause serious and
life-threatening problems, especially if you take or use certain other
medicines or drugs. Call your healthcare
provider right away or get emergency help if you:
•
feel faint or dizzy
•
have mental changes such as confusion
•
have slower breathing than you normally have
•
have severe sleepiness
•
have blurred vision
•
have problems with coordination
•
have slurred speech
•
cannot think well or clearly
•
have slowed reflexes
•
have a high body temperature
•
feel agitated
•
have stiff muscles
•
have trouble walking
•
Do not switch from buprenorphine and naloxone sublingual tablets to
other medicines that contain
buprenorphine without talking with your doctor. The amount of
buprenorphine in a dose of buprenorphine
and naloxone sublingual tablets is not the same as the amount of
buprenorphine in other medicines that
contain buprenorphine. Your doctor wil

Đặc tính sản phẩm

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
DIHYDRATE- BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
DIHYDRATE TABLET
QUALITY CARE PRODUCTS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUPRENORPHINE AND
NALOXONE SUBLINGUAL TABLETS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS.
BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS, FOR SUBLINGUAL
ADMINISTRATION, CIII
INITIAL U.S. APPROVAL: 2002
RECENT MAJOR CHANGES
Warnings and Precautions (5.2) 10/2019
INDICATIONS AND USAGE
Buprenorphine and naloxone sublingual tablets contain buprenorphine, a
partial opioid agonist, and
naloxone, an opioid antagonist, and are indicated for the maintenance
treatment of opioid
dependence. (1)
Buprenorphine and naloxone 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 and naloxone 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. After
induction, doses of burprenorphine and
naloxone sublingual tablets should be progressively adjusted to a
level that holds the patient in
treatment and suppresses opioid withdrawal signs and symptoms. (2.3)
The recommended target dosage of buprenorphine and naloxone sublingual
tablets for maintenance is
16 mg/4 mg. (2.3)
Administer buprenorphine and naloxone sublingual tablets as directed
in the Full Prescribing
Information. (2.3, 2.4)
When discontinuing treatment, gradually taper to avoid signs and
symptoms of withdrawal. (2.7)
DOSAGE FORMS AND STRENGTHS
Sublingual tablet:
buprenorphine 2 mg/naloxone 0.5 mg and
buprenorphine 8 mg/naloxone 2 mg. (3)
CONTRAINDICATIONS
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