AZITHROMYCIN MONOHYDRATE injection, powder, lyophilized, for solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Gland Pharma Limited

INN (Algemene Internationale Benaming):

AZITHROMYCIN MONOHYDRATE

Samenstelling:

AZITHROMYCIN ANHYDROUS 500 mg in 10 mL

Toedieningsweg:

INTRAVENOUS

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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. 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 for injection. 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 effectiveness of azithromycin and other antibacter

Product samenvatting:

Azithromycin for Injection, USP is supplied as white to off-white lyophilized powder under a vacuum in a single-dose vial equivalent to 500 mg of azithromycin for intravenous administration.  These are packaged as follows: NDC                           Azithromycin for Injection, USP, 500 mg/vial         Package Factor 68083-199-10             500 mg Single-Dose Vial                                             10 vials per carton Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]  Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.   All brands listed are the trademarks of their respective owners and are not trademarks of Gland Pharma Limited.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

AZITHROMYCIN MONOHYDRATE - AZITHROMYCIN MONOHYDRATE INJECTION,
POWDER, LYOPHILIZED, FOR SOLUTION
GLAND PHARMA LIMITED
----------
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
RECENT MAJOR CHANGES
Warnings and Precautions, Cardiovascular Death (5.5) 11/2021
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 to off-white
lyophilized powder 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 azithrom