AZITHROMYCIN- azithromycin monohydrate injection, powder, lyophilized, for solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

AZITHROMYCIN MONOHYDRATE (UNII: JTE4MNN1MD) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)

Tilgjengelig fra:

Cardinal Health

INN (International Name):

AZITHROMYCIN MONOHYDRATE

Sammensetning:

AZITHROMYCIN ANHYDROUS 500 mg in 5 mL

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Azithromycin for Injection, USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below.  As recommended dosages, durations of therapy, and applicable patient populations vary among these infections, please see DOSAGE AND ADMINISTRATION for dosing recommendations. Community-acquired pneumonia due to Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus, or Streptococcus pneumoniae in patients who require initial intravenous therapy. Pelvic inflammatory disease due to Chlamydia trachomatis, Neisseria gonorrhoeae, or Mycoplasma hominis in patients who require initial intravenous therapy.  If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin for Injection, USP. Azithromycin for Injection, USP should be

Produkt oppsummering:

Azithromycin for Injection, USP is supplied in lyophilized form under a vacuum in a 10 mL vial equivalent to 500 mg of azithromycin for intravenous administration.  Each vial also contains sodium hydroxide and 413.6 mg citric acid. Product No. NDC No. NP309810    63323-398-12    Packaged in tens This container closure is not made with natural rubber latex.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

AZITHROMYCIN- AZITHROMYCIN MONOHYDRATE INJECTION, POWDER, LYOPHILIZED,
FOR SOLUTION
CARDINAL HEALTH
----------
AZITHROMYCIN FOR INJECTION USP
_FOR IV INFUSION ONLY_
Rx only
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Azithromycin
for Injection and other antibacterial drugs, Azithromycin for
Injection should be used only to treat or
prevent infections that are proven or strongly suspected to be caused
by bacteria.
DESCRIPTION
Azithromycin for Injection, USP contains the active ingredient
azithromycin, an azalide, a subclass of
macrolide antibiotics, for intravenous injection. Azithromycin has the
chemical name
_(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R_)-13-[(2,6-dideoxy-3-_C_-methyl-3-_O_-methyl-α-_L_-_ribo_-
hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-
(dimethylamino)-β-_D-xylo_-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.
Azithromycin is
derived from erythromycin; however, it differs chemically from
erythromycin in that a methyl-
substituted nitrogen atom is incorporated into the lactone ring.
Azithromycin has the following
structural formula:
Azithromycin, as the monohydrate, is a white crystalline powder with a
molecular formula of
C
H N O •H O and a molecular weight of 767.00.
Azithromycin for Injection, USP consists of azithromycin monohydrate
and the following inactive
ingredients: citric acid and sodium hydroxide. Azithromycin for
Injection, USP is supplied in
lyophilized form in a 10 mL vial equivalent to 500 mg of azithromycin
for intravenous administration.
Reconstitution, according to label directions, results in
approximately 5 mL of azithromycin for
intravenous injection with each mL containing azithromycin monohydrate
equivalent to 100 mg of
azithromycin. After reconstitution each mL contains: azithromycin
monohydrate equivalent to 100 mg of
azithromycin, 76.9 mg of citric acid, and sodium hydroxide for pH
adjustment.
CLINICAL PHARMACOLOGY
38
72
2
12
2
PHARMACOKINETICS
In patients hospitalized with