AZITHROMYCIN injection, powder, lyophilized, for solution

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

AZITHROMYCIN DIHYDRATE (UNII: 5FD1131I7S) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)

Dostupné z:

Baxter Healthcare Corporation

INN (Medzinárodný Name):

AZITHROMYCIN DIHYDRATE

Zloženie:

AZITHROMYCIN ANHYDROUS 100 mg in 1 mL

Spôsob podávania:

INTRAVENOUS

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. 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 gonorrhoea

Prehľad produktov:

AZITHROMYCIN for injection 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:

Stav Autorizácia:

New Drug Application Authorized Generic

Súhrn charakteristických

AZITHROMYCIN- AZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
BAXTER HEALTHCARE CORPORATION
----------
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 IV INFUSION ONLY
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
AZITHROMYCIN 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.
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 is 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 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)
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 c