ERYTHROMYCIN LACTOBIONATE injection, powder, lyophilized, for solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Exela Pharma Sciences, LLC

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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); Streptococcus pneumoniae (Diplococcus

Tuoteyhteenveto:

Erythromycin lactobionate for injection, USP is supplied as a sterile, lyophilized powder powder in cartons of ten vials (NDC 51754-7000-3), each vial containing the equivalent of 500 mg erythromycin. Store at 20 to 25° C (68 to 77° F). [See USP Controlled Room Temperature.]

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

ERYTHROMYCIN LACTOBIONATE- ERYTHROMYCIN LACTOBIONATE INJECTION,
POWDER, LYOPHILIZED, FOR SOLUTION
EXELA PHARMA SCIENCES, LLC
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ERYTHROMYCIN LACTOBIONATE INJECTION, USP
For Intravenous Use Only
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.
Erythromycin lactobionate for injection, USP is a soluble salt of
erythromycin suitable for
intravenous administration. It is available as a sterile, lyophilized
powder in vials
containing the equivalent of 500 mg of erythromycin activity. It is
prepared as a solution
and lyophilized in its final container.
Erythromycin lactobionate is chemically known as erythromycin mono
(4-0-β-D-
glactopyranosyl-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 biliary
excretion of
erythromycin is not known. From 12 to 15 percent of intravenously
administered
erythromycin is excreted in active form in the urine.
Intravenous infusion of 500 mg of erythromycin lactobionate at a
constant rate over 1
hour in fasting adults produced a mean serum erythromycin level of
approximately 7
mcg/mL at 20 minutes, 10 mcg/mL at 1 hour, 2.6 mcg/mL at 2.5 ho