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

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

AZITHROMYCIN MONOHYDRATE (UNII: JTE4MNN1MD) (Azithromycin Anhydrous - UNII:J2KLZ20U1M)

Disponível em:

APOTEX CORP.

DCI (Denominação Comum Internacional):

AZITHROMYCIN MONOHYDRATE

Composição:

AZITHROMYCIN 500 mg in 10 mL

Via de administração:

INTRAVENOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Azithromycin for injection 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 a

Resumo do produto:

Azithromycin for injection is supplied in lyophilized form under a vacuum in a 10 mL vial (NDC 60505-6076-4) equivalent to 500 mg of azithromycin for intravenous administration. Each vial also contains 384.5 mg of citric acid and sodium hydroxide. These are packaged as follows: 10 vials of 500 mg NDC 60505-6076-4 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. *Normosol®-M in 5% dextrose and Normosol®-R in 5% dextrose are the trademarks of Hospira.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

AZITHROMYCIN- AZITHROMYCIN FOR INJECTION INJECTION, POWDER,
LYOPHILIZED, FOR
SOLUTION INJECTION
APOTEX CORP.
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AZITHROMYCIN FOR INJECTION
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of azithromycin and
other bacterial 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 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-a-L- _ribo_-
hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-hepta-methyl-11-[[3,4,6-trideoxy-3-
(dimethylamino)-ß- _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. Its
molecular formula is C
H N O ,
and its molecular weight is 749. 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.
Azithromycin for injection consists of azithromycin monohydrate and
the following inactive ingredients:
citric acid and sodium hydroxide. Azithromycin for injection is
supplied in lyophilized form in a 10 mL
vial equivalent to 500 mg of azithromycin, 384.5 mg of citric acid,
and sodium hydroxide for pH
adjustment. Reconstitution, according to label directions, results in
approximately 5 mL of azithromycin
for intravenous injection with each mL containing 100 mg azithromycin
(from azithromycin
monohydrate).
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
In patients hospitalized with community-acquired pneumonia receiving
single daily one-hour
intravenous infusions for 2 to 5 days of 500 mg azithromycin at a
concentration of