RIFAMPIN FOR INJECTION, USP

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

INN (International Name):

RIFAMPIN

Composition:

RIFAMPIN 600 mg in 10 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Tuberculosis Rifampin is indicated in the treatment of all forms of tuberculosis. A three-drug regimen consisting of rifampin, isoniazid, and pyrazinamide (e.g., RIFATER® ) is recommended in the initial phase of short-course therapy which is usually continued for 2 months. The Advisory Council for the Elimination of Tube

Product summary:

Rifampin for injection USP is reddish brown lyophilized cake or powder. Rifampin for injection USP is available in glass vials containing 600 mg rifampin (NDC 23155-340-31). Storage: Store at 20°to 25°C (68°to 77°F), excursions permitted to 15°to 30°C (59°to 86°F) [see USP Controlled Room Temperature]. Avoid excessive heat (temperatures above 40°C or 104°F). Protect from light.   Rifater® and Rifamate® are registered trademarks of Sanofi-Aventis U.S. LLC. Rx only Manufactured by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune-411057, India. Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUGS (3784) Revised: 11/2019

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RIFAMPIN- RIFAMPIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
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RIFAMPIN FOR INJECTION, USP
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
Sterile Rifampin for injection USP contains rifampin 600 mg, sodium
formaldehyde sulfoxylate 10 mg,
and sodium hydroxide to adjust pH. The reconstituted solution is clear
reddish brown solution.
Rifampin is a semisynthetic antibiotic derivative of rifamycin SV.
Rifampin USP 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
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