RIFAMPIN injection powder lyophilized for solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Pfizer Laboratories Div Pfizer Inc

INN（国際名）:

RIFAMPIN

構図:

RIFAMPIN 600 mg in 10 mL

処方タイプ:

PRESCRIPTION DRUG

認証ステータス:

Abbreviated New Drug Application

製品の特徴

RIFAMPIN- RIFAMPIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
PFIZER LABORATORIES DIV PFIZER INC
----------
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 is a lyophilized powder that contains
rifampin 600 mg, sodium
formaldehyde sulfoxylate 10 mg, and sodium hydroxide to adjust pH.
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 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).
43
58
4
12
PLASMA CONCENTRATIONS (MEAN ± STANDARD DEVIATION, MCG/ML)
RIFAMPIN DOSAGE IV
30 MIN
1 HR
2 HR
4 HR
8 HR
12 HR
300 mg
8.9±2.9
4.9±1.3
4±1.3
2.5±1
1.1±