RIFAMPIN injection, powder, lyophilized, for solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Hikma Pharmaceuticals USA Inc.

INN (इंटरनेशनल नाम):

RIFAMPIN

रचना:

RIFAMPIN 600 mg

प्रशासन का मार्ग:

INTRAVENOUS

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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 for Injection, USP 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 for Injection, USP and the patient is not responding to therapy, the drug regimen should be modified. Rifampin for Injection, USP is indicated in the treatment of all forms of tuberculosis. A three-drug regimen consisting of rifampin, isoniazid, and pyrazinamide is recommended in the initial phase of short-course therapy which is usually continued for 2 months. The Advisory Council f

उत्पाद समीक्षा:

Rifampin for Injection, USP is available in sterile glass vials containing 600 mg rifampin (NDC 0143-9230-01). Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].  Avoid excessive heat (temperatures above 40°C or 104°F). Protect from light. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mó, 8, 8A e 8B  - Fervença  - 2705-906 Terrugem SNT, PORTUGAL Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised: December 2021 PIN432-WES/7

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

RIFAMPIN- RIFAMPIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
HIKMA PHARMACEUTICALS USA 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 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-2,4,12,16,18, 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
43
58
4
12
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).
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 4.0 ± 1.32.5 �