AZITHROMYCIN injection, powder, lyophilized, for solution

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Sun Pharmaceutical Industries, Inc.

INN (الاسم الدولي):

AZITHROMYCIN MONOHYDRATE

تركيب:

AZITHROMYCIN ANHYDROUS 500 mg in 5 mL

طريقة التعاطي:

INTRAVENOUS

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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 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 antibacterial

ملخص المنتج:

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. These are packaged as follows: 10 x 500 mg vials        NDC 62756-512-44 In dry powder form, store azithromycin for injection at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

AZITHROMYCIN - AZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
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 is a macrolide antibacterial drug indicated for mild to
moderate infections caused by designated, susceptible
bacte ria:
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 injectionis supplied in lyophilized form in a 10 mL
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 reactions and skin reactions.
Discontinue azithromycin for injection and initiate
appropriate therapy if reaction occurs. (5.1)
Hepatotoxicity: Severe and sometimes fatal, hepatoxicity has been
reported. Discontinue azithromycin for injection
immediately if signs and symptoms of hepatitis occur. (5.2)
Infantile Hypertrophic Pyloric Stenosis (IHPS): Following the use