AZITHROMYCIN- azithromycin monohydrate injection, powder, lyophilized, for solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Fresenius Kabi USA, LLC

DCI (Denominação Comum Internacional):

AZITHROMYCIN MONOHYDRATE

Composição:

AZITHROMYCIN ANHYDROUS 500 mg in 5 mL

Via de administração:

INTRAVENOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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.

Resumo do produto:

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. This container closure is not made with natural rubber latex. Storage Store the white to off-white lyophilized cake at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. When diluted according to the instructions (1 mg/mL to 2 mg/mL), azithromycin for injection, USP is stable for 24 hours at or below room temperature 30ºC (86ºF), or for 7 days if stored under refrigeration 5ºC (41ºF).

Status de autorização:

Abbreviated New Drug Application

Características técnicas

AZITHROMYCIN- AZITHROMYCIN MONOHYDRATE INJECTION, POWDER, LYOPHILIZED,
FOR SOLUTION
FRESENIUS KABI USA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AZITHROMYCIN FOR INJECTION, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AZITHROMYCIN FOR
INJECTION, USP.
AZITHROMYCIN FOR INJECTION, USP, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
Azithromycin for injection, USP 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 FOR
INJECTION, USP AND OTHER ANTIBACTERIAL DRUGS, AZITHROMYCIN FOR
INJECTION, USP 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)
Infantile Hypertroph