ERYTHROCIN LACTOBIONATE- erythromycin lactobionate injection, powder, lyophilized, for solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

ERYTHROMYCIN LACTOBIONATE (UNII: 33H58I7GLQ) (ERYTHROMYCIN - UNII:63937KV33D)

Tillgänglig från:

Hospira, Inc.

INN (International namn):

ERYTHROMYCIN LACTOBIONATE

Sammansättning:

ERYTHROMYCIN 500 mg in 10 mL

Administreringssätt:

INTRAVENOUS

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Erythrocin Lactobionate-IV (erythromycin lactobionate for injection, USP) is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below when oral administration is not possible or when the severity of the infection requires immediate high serum levels of erythromycin. Intravenous therapy should be replaced by oral administration at the appropriate time. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci); Streptococcus pneumoniae  (Diplococcus pneumoniae);  Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci);

Produktsammanfattning:

Erythrocin Lactobionate-IV (erythromycin lactobionate for injection, USP) is supplied as a sterile, white to off-white lyophilized powder as follows: Unit of Sale Concentration NDC 0409-6482-01 Tray of 10 single-dose vials 500 mg/vial Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature].

Bemyndigande status:

New Drug Application

Produktens egenskaper

ERYTHROCIN LACTOBIONATE- ERYTHROMYCIN LACTOBIONATE INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
HOSPIRA, INC.
----------
ERYTHROCIN™ LACTOBIONATE - IV
Erythromycin Lactobionate for Injection, USP
INTRAVENOUS USE ONLY
SINGLE-DOSE VIALS
Rx only
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF ERYTHROMYCIN AND OTHER ANTIBACTERIAL DRUGS,
ERYTHROMYCIN
SHOULD BE USED ONLY TO TREAT OR PREVENT INFECTIONS THAT ARE PROVEN OR
STRONGLY SUSPECTED TO BE CAUSED BY BACTERIA.
DESCRIPTION
Erythromycin is produced by a strain of _Streptomyces erythraeus_ and
belongs to the
macrolide group of antibiotics. It is basic and readily forms salts
with acids.
Erythrocin Lactobionate-IV (erythromycin lactobionate for injection,
USP), is a soluble
salt of erythromycin suitable for intravenous administration. It is
available as a sterile,
white to off-white lyophilized powder in single-dose vials. Each vial
contains the
equivalent of 500 mg of erythromycin activity. It is prepared as a
solution and lyophilized
in its final container. The lactobionic acid content is 244 mg per
vial. Lactobionic acid
and/or erythromycin are used to adjust the pH during the manufacture
of the product.
When reconstituted as directed, each mL contains 50 mg of erythromycin
activity. The
pH of the reconstituted solution is 6.5 - 7.5.
Erythromycin lactobionate is chemically known as erythromycin mono
(4-0-β-D-
galactopyranosyl-D-gluconate) (salt). The structural formula is:
CLINICAL PHARMACOLOGY
Erythromycin diffuses readily into most body fluids. In the absence of
meningeal
inflammation, low concentrations are normally achieved in the spinal
fluid but the
passage of the drug across the blood-brain barrier increases in
meningitis. Erythromycin
crosses the placental barrier and is excreted in breast milk.
Erythromycin is not
removed by peritoneal dialysis or hemodialysis.
In the presence of normal hepatic function, erythromycin is
concentrated in the liver and
is excreted in the bile; the effect of hepatic dysfunction on bilia