AZITHROMYCIN- azithromycin injection, powder, lyophilized, for solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

azithromycin monohydrate (UNII: JTE4MNN1MD) (Azithromycin Anhydrous - UNII:J2KLZ20U1M)

Dostopno od:

Sagent Pharmaceuticals

INN (mednarodno ime):

azithromycin monohydrate

Sestava:

Azithromycin Anhydrous 500 mg in 5 mL

Pot uporabe:

INTRAVENOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Azithromycin for Injection and other antibacterial drugs, Azithromycin for Injection 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 trachom

Povzetek izdelek:

Azithromycin for Injection, USP is supplied as follows: Azithromycin for Injection, USP is available 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 anhydrous citric acid. Storage Conditions In dry powder form, Azithromycin for Injection, USP should be stored at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] When diluted according to the instructions (1 mg per mL to 2 mg per mL), Azithromycin for Injection, USP is stable for 24 hours at or below room temperature 30°C (86°F), or for 7 days if stored under refrigeration 5°C (41°F). Lyophilized. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

AZITHROMYCIN- AZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
SAGENT PHARMACEUTICALS
----------
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 IV INFUSION ONLY
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Warnings and Precautions, Hypersensitivity (5.1)
2/2016
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 FOR
INJECTION AND OTHER ANTIBACTERIAL DRUGS, AZITHROMYCIN FOR INJECTION
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, USP 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 occ