AZITHROMYCIN injection, powder, lyophilized, for solution

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Hospira, Inc.

INN (Rahvusvaheline Nimetus):

AZITHROMYCIN MONOHYDRATE

Koostis:

AZITHROMYCIN ANHYDROUS 500 mg

Manustamisviis:

INTRAVENOUS

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Azithromycin for Injection, USP is a macrolide antibacterial drug indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below. due to Chlamydophila pneumoniae , Haemophilus influenzae , Legionella pneumophila , Moraxella catarrhalis , Mycoplasma pneumoniae , Staphylococcus aureus , or Streptococcus pneumoniae in patients who require initial intravenous therapy. 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. Azithromycin for Injection, USP should be followed by azithromycin the oral route as required [see Dosage and Administration (2) ]. To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial dr

Toote kokkuvõte:

Azithromycin for Injection, USP is supplied as white to off-white lyophilized powder in a single-dose ADD-Vantage® vial equivalent to 500 mg of azithromycin for intravenous administration. These are packaged as follows: Store the lyophilized cake at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

AZITHROMYCIN- AZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
HOSPIRA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AZITHROMYCIN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AZITHROMYCIN.
AZITHROMYCIN FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2009
RECENT MAJOR CHANGES
Warnings and Precautions, Cardiovascular Death (5.5)
11/2021
INDICATIONS AND USAGE
Azithromycin is a macrolide antibacterial drug indicated for mild to
moderate infections caused by
designated, susceptible bacteria:
•
•
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of azithromycin and
other antibacterial drugs, azithromycin should be used only to treat
or prevent infections that are proven
or strongly suspected to be caused by susceptible bacteria. (1.3)
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Azithromycin for Injection is supplied as white to off-white
lyophilized powder in a single-dose ADD-
Vantage vial equivalent to 500 mg of azithromycin for intravenous
administration. (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
Serious (including fatal) allergic and skin reactions. Discontinue
azithromycin and initiate appropriate
therapy if reaction occurs. (5.1)
Hepatotoxicity: Severe and sometimes fatal, hepatoxicity has been
reported. Discontinue Azithromycin
immediately if signs and symptoms of hepatitis occur. (5.2)
Infantile Hypertrophic Pyloric Stenosis (IHPS): Following the use of
azithromycin in neonates (treatment
up to 42 days of life), IHPS has been reported. Direct parents and
caregivers to contact their physician
if vomiting or irritability with feeding occurs. (5.3)
Prolongation of QT interval and cases of torsades de pointes have been
reported. This risk which can be
fatal should be considered in patients with certain cardiovascular
disorders including known QT
prolongation or history torsades de pointes, those with proarrhythmic
conditions and with other