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:

Eugia US LLC

INN (Rahvusvaheline Nimetus):

AZITHROMYCIN MONOHYDRATE

Koostis:

AZITHROMYCIN ANHYDROUS 500 mg

Manustamisviis:

INTRAVENOUS

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Azithromycin for injection 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. Community-Acquired Pneumonia due to Chlamydophila 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. Azithromycin for injection should be followed by azithromycin by the oral route as required. [see Dosage and Administration (2)] To reduce the development of drug-resistant bacteria and maintain the

Toote kokkuvõte:

Azithromycin for injection, USP is supplied as white lyophilized cake under a vacuum in a single-dose vial equivalent to 500 mg of azithromycin for intravenous administration. These are packaged as follows: 10 Single-Dose Vials in a Carton                                          NDC 55150-174-10 Before reconstitution, store vials at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] [see Dosage and Administration (2.3)] . Vial stoppers are not made with natural rubber latex. Sterile, Nonpyrogenic

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

AZITHROMYCIN - AZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
EUGIA US LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AZITHROMYCIN FOR
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
AZITHROMYCIN FOR
INJECTION.
AZITHROMYCIN FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
Azithromycin for injection is a macrolide antibacterial drug indicated
for mild to moderate infections
caused by designated, susceptible bacteria:
Community-acquired pneumonia in adults (1.1)
Pelvic inflammatory disease (1.2)
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
Community-acquired pneumonia: 500 mg as a single daily dose by the
intravenous route for at least
two days. (2.1)
Pelvic inflammatory disease in adults: 500 mg as a single daily dose
by the intravenous route for one or
two days. (2.2)
DOSAGE FORMS AND STRENGTHS
Azithromycin for injection, USP is supplied as white lyophilized cake
in a single-dose vial equivalent to 500
mg of azithromycin for intravenous administration. (3)
CONTRAINDICATIONS
Patients with known hypersensitivity to azithromycin, erythromycin,
any macrolide, or ketolide
antibacterial drug. (4.1)
Patients with a history of cholestatic jaundice/hepatic dysfunction
associated with prior use of
azithromycin. (4.2)
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 (t