BUPRENORPHINE HYDROCHLORIDE tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

bryant ranch prepack

INN (Միջազգային անվանումը):

BUPRENORPHINE HYDROCHLORIDE

Կազմը:

BUPRENORPHINE HYDROCHLORIDE 8 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

SUBOXONE and SUBUTEX are indicated for the treatment of opioid dependence. SUBOXONE and SUBUTEX should not be administered to patients who have been shown to be hypersensitive to buprenorphine, and SUBOXONE should not be administered to patients who have been shown to be hypersensitive to naloxone. SUBOXONE and SUBUTEX are controlled as Schedule III narcotics under the Controlled Substances Act. Buprenorphine is a partial agonist at the mu-opioid receptor and chronic administration produces dependence of the opioid type, characterized by moderate withdrawal upon abrupt discontinuation or rapid taper. The withdrawal syndrome is milder than seen with full agonists, and may be delayed in onset (SEE WARNINGS)   Neonatal withdrawal has been reported in the infants of women treated with SUBUTEX during pregnancy (See PRECAUTIONS)  SUBOXONE contains naloxone and if misused parenterally, is highly likely to produce marked and intense withdrawal symptoms in subjects dependent on other opioid agonists.

Ապրանքի ամփոփագիր:

Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature] SUBUTEX is supplied as sublingual tablets. Oval white tablets containing 8mg buprenorphine Distributed By:  Bryant Ranch Prepack  12623 Sherman Way  North Hollywood, CA 91605  Voice [phone]   Fax [phone]

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

BUPRENORPHINE HYDROCHLORIDE - BUPRENORPHINE HYDROCHLORIDE TABLET
BRYANT RANCH PREPACK
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BUPRENORPHINE HYDROCHLORIDE 8MG
DESCRIPTION
RX ONLY
Under the Drug Addiction Treatment Act of 2000 (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 have notified the Secretary of Health and
Human Services (HHS) of their
intent to prescribe this product for the treatment of opioid
dependence.
DESCRIPTION
SUBUTEX sublingual tablets contain buprenorphine HCl.
Buprenorphine hydrochloride is a white powder, weakly acidic with
limited solubility in water
(17mg/mL). Chemically, buprenorphine is
17-(cyclopropylmethyl)-α-(1,1-dimethylethyl)-4,5-epoxy-
18,19-dihydro-3-hydroxy-6-methoxy-
α-methyl-6,14-ethenomorphinan-7-methanol, hydrochloride [5α,
7α(S)]-. Buprenorphine hydrochloride has the molecular formula C
H N0 HCl and the molecular
weight is 504.10.
SUBUTEX is an uncoated OVAL WHITE TABLET intended for sublingual
administration. It is available in two
dosage strengths, 2mg buprenorphine and 8mg buprenorphine free base.
Each tablet also contains
lactose, mannitol, cornstarch, povidone K30, citric acid, sodium
citrate and magnesium stearate.
CLINICAL PHARMACOLOGY
Subjective Effects:
Comparisons of buprenorphine with full agonists such as methadone and
hydromorphone suggest that
sublingual buprenorphine produces typical opioid agonist effects which
are limited by a ceiling effect.
In non-dependent subjects, acute sublingual doses of SUBOXONE tablets
produced opioid agonist
effects, which reached a maximum between doses of 8 mg and 16mg of
SUBUTEX. The effects of
16mg SUBOXONE were similar to those produced by 16mg SUBUTEX
(buprenorphine alone).
Opioid agonist ceiling effects were also observed in a double-blind,
parallel group, dose ranging
comparison of single doses of buprenorphine sublingual solution (1, 2,
4, 8, 16, or 32 mg), placebo, and
a full agonist control at various doses. The treatm