RIFABUTIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Marlex Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Rifabutin Capsules 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.

Product summary:

Rifabutin Capsules, USP are supplied as hard gelatin capsule shell with maroon colored cap and body, imprinted with black ink as 041 on cap and Novitium 150 mg (150 mg under Novitium) on body, filled with red-violet powder, each containing 150 mg of Rifabutin, USP. Rifabutin is available as follows: NDC 10135-0738-01 Bottles of 100 capsules Keep tightly closed and dispense in a tight container as defined in the USP. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Manufactured for/ Distributed by: Marlex Pharmaceuticals, Inc. Rev. 05/22 NP

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RIFABUTIN- RIFABUTIN CAPSULE
MARLEX PHARMACEUTICALS, INC.
----------
RIFABUTIN CAPSULES, USP
RX ONLY
DESCRIPTION
Rifabutin Capsules for oral administration contain 150 mg of the
rifamycin
antimycobacterial agent rifabutin, USP, per capsule along with the
inactive ingredients,
microcrystalline cellulose, sodium lauryl sulfate, colloidal silicon
dioxide, magnesium
stearate. The hard gelatin capsule contains titanium dioxide, red iron
oxide, gelatin,
sodium lauryl sulfate and purified water. The imprinting ink contains
shellac, dehydrated
alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong
ammonia solution, black
iron oxide, potassium hydroxide and purified water.
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 methanol, slightly soluble
in ethanol, and
slightly soluble in water (0.21 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).
46
62
4
11
FDA APPROVED DISSOLUTION METHOD DIFFERS FROM THE CURRENT USP MONOGRAPH
DISSOLUTION METHOD.
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 an