RIFABUTIN capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

RIFABUTIN (UNII: 1W306TDA6S) (RIFABUTIN - UNII:1W306TDA6S)

Tilgjengelig fra:

American Health Packaging

INN (International Name):

RIFABUTIN

Sammensetning:

RIFABUTIN 150 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Rifabutin capsules USP are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection. Rifabutin capsules are contraindicated in patients who have had clinically significant hypersensitivity to rifabutin or to any other rifamycins.

Produkt oppsummering:

Rifabutin Capsules USP are supplied as size '0' capsules having opaque red-brown cap imprinted with 'LU' in white ink and opaque red-brown body imprinted with 'R01' in white ink, containing red-violet granular powder equivalent to 150 mg of rifabutin USP. Rifabutin Capsules USP are available as follows: Unit does packages of 30 (5 x 6) NDC 60687-198-25 Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Protect from light and from excessive heat. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

RIFABUTIN- RIFABUTIN CAPSULE
AMERICAN HEALTH PACKAGING
----------
RIFABUTIN CAPSULES USP
RX ONLY
8419825/0319F
DESCRIPTION
Rifabutin Capsules USP for oral administration contain 150 mg of the
rifamycin antimycobacterial agent
rifabutin, USP, per capsule, along with the inactive ingredients
crospovidone, gelatin, iron oxide red,
magnesium stearate, microcrystalline cellulose, potassium hydroxide,
shellac, silicon dioxide, sodium
lauryl sulphate, and titanium dioxide.
The chemical name for rifabutin is
1',4-didehydro-1-deoxy-1,4-dihydro-5'-(2-methylpropyl)-1-
oxorifamycin XIV (Chemical Abstracts Service, 9th Collective Index) or
(9 _S_, 12 _E_, 14 _S_, 15 _R_, 16 _S_, 17
_R_, 18 _R_, 19 _R_, 20 _S_, 21 _S_, 22 _E_, 24
_Z_)-6,16,18,20-tetrahydroxy-1'-isobutyl-14-methoxy-
7,9,15,17,19,21,25-heptamethyl-spiro [9,4-(epoxypentadeca
[1,11,13]trienimino)-2 _H-_furo[2',3':7,8]
naphth[1,2-d]imidazole-2,4'-piperidine]-5,10,26-(3 _H_,9
_H_)-trione-16-acetate. Rifabutin has a molecular
formula of C
H
N
O
, a molecular weight of 847.02 and the following structure:
Rifabutin is a red-violet powder soluble in chloroform and methanol,
sparingly soluble in ethanol, and
very slightly soluble in water (0.19 mg/mL). Its log P value (the base
10 logarithm of the partition
coefficient between n-octanol and water) is 3.2 (n-octanol/water).
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
_ABSORPTION_
Following a single oral dose of 300 mg to nine healthy adult
volunteers, rifabutin was readily absorbed
from the gastrointestinal tract with mean (±SD) peak plasma levels (C
) of 375 (±267) ng/mL (range:
141 to 1033 ng/mL) attained in 3.3 (±0.9) hours (T
range: 2 to 4 hours). Absolute bioavailability
assessed in five HIV-positive patients, who received both oral and
intravenous doses, averaged 20%.
Total recovery of radioactivity in the urine indicates that at least
53% of the orally administered
46
62
4
11
max
max
rifabutin dose is absorbed from the gastrointestinal tract. The
bioavailability of rifabutin from the
capsule dosage form, relative to