RIFAMPIN injection, powder, lyophilized, for solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

RIFAMPIN (UNII: VJT6J7R4TR) (RIFAMPIN - UNII:VJT6J7R4TR)

제공처:

Akorn

INN (국제 이름):

RIFAMPIN

구성:

RIFAMPIN 600 mg in 10 mL

관리 경로:

INTRAVENOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified. Rifampin is indicated in the treatment of all forms of tuberculosis. A three-drug regimen consisting of rifampin, isoniazid, and pyrazinamide [e.g., RIFATER® ]1 is recommended in the initial phase of short-course therapy which is usually continued for 2 months. The Advisory Council for the Elimination of Tuberculosis, th

제품 요약:

Rifampin for Injection USP, containing 600 mg of rifampin, is supplied in sterile glass vials, individually boxed (NDC # 17478-151-42) .  Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Avoid excessive heat (temperatures above 40°C or 104°F). Protect from light.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

RIFAMPIN- RIFAMPIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
AKORN
----------
RIFAMPIN FOR INJECTION USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
rifampin for injection USP and other antibacterial drugs, rifampin
should be used only to
treat or prevent infections that are proven or strongly suspected to
be caused by
bacteria.
DESCRIPTION
Rifampin for injection USP contains rifampin 600 mg, sodium
formaldehyde sulfoxylate
dihydrate 10 mg, and sodium hydroxide to adjust pH. Rifampin for
injection is a sterile,
lyophilized powder for intravenous infusion only.
Rifampin is a semisynthetic antibiotic derivative of rifamycin SV.
Rifampin is a red-brown
crystalline powder very slightly soluble in water at neutral pH,
freely soluble in
chloroform, soluble in ethyl acetate and in methanol. Its molecular
weight is 822.95 and
its chemical formula is C
H
N O
. The chemical name for rifampin is either:
3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycin
or
5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,20,22–heptamethyl-8-[N-(4-methyl-
1-piperazinyl)formimidoyl]-2,7-
(epoxypentadeca[1,11,13]trienimino)naphtho[2,1-
b]furan-1,11(2H)-dione 21-acetate.
Its structural formula is:
CLINICAL PHARMACOLOGY
INTRAVENOUS ADMINISTRATION
After intravenous administration of a 300 or 600 mg dose of rifampin
infused over 30
minutes to healthy male volunteers (n=12), mean peak plasma
concentrations were 9.0
± 3.0 and 17.5 ± 5.0 mcg/mL, respectively. Total body clearances
after the 300 and 600
mg IV doses were 0.19 ± 0.06 and 0.14 ± 0.03 L/hr/kg, respectively.
Volumes of
43
58
4
12
distribution at steady state were 0.66 ± 0.14 and 0.64 ± 0.11 L/kg
for the 300 and 600
mg IV doses, respectively. After intravenous administration of 300 or
600 mg doses,
rifampin plasma concentrations in these volunteers remained detectable
for 8 and 12
hours, respectively (see Table).
Plasma Concentrations (mean ± standard deviation, mcg/mL)
Rifampin
Dosage IV
30 min
1 hr
2 hr
4 hr
8 hr
12 hr
300 mg
8