AZITHROMYCIN powder, for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

A-S Medication Solutions

INN (International Name):

AZITHROMYCIN MONOHYDRATE

Composition:

AZITHROMYCIN ANHYDROUS 200 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Azithromycin for oral suspension is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications [see Dosage and Administration ( 2)]. - Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae , Moraxella catarrhalis, or Streptococcus pneumoniae . - Acute bacterial sinusitis due to Haemophilus influenzae , Moraxella catarrhalis, or Streptococcus pneumoniae . - Community-acquired pneumonia due to Chlamydophila pneumoniae , Haemophilus influenzae , Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy. - Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. - Uncomplicated skin and skin structure

Product summary:

Product: 50090-0983 NDC: 50090-0983-0 22.5 mL in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AZITHROMYCIN- AZITHROMYCIN POWDER, FOR SUSPENSION
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AZITHROMYCIN FOR ORAL
SUSPENSION SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR AZITHROMYCIN FOR ORAL SUSPENSION.
AZITHROMYCIN FOR ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
Azithromycin for oral suspension is a macrolide antibacterial drug
indicated for mild to moderate infections
caused by designated, susceptible bacteria:
Acute bacterial exacerbations of chronic bronchitis in adults (1.1)
Acute bacterial sinusitis in adults (1.1)
Uncomplicated skin and skin structure infections in adults (1.1)
Urethritis and cervicitis in adults (1.1)
Genital ulcer disease in men (1.1)
Acute otitis media in pediatric patients (6 months of age and older)
(1.2)
Community-acquired pneumonia in adults and pediatric patients (6
months of age and older) (1.1, 1.2)
Pharyngitis/tonsillitis in adults and pediatric patients (2 years of
age and older) (1.1, 1.2)
Limitation of Use:
Azithromycin should not be used in patients with pneumonia who are
judged to be inappropriate for oral
therapy because of moderate to severe illness or risk factors. (1.3)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of azithromycin for
oral suspension and other antibacterial drugs, azithromycin for oral
suspension should be used only to
treat infections that are proven or strongly suspected to be caused by
susceptible bacteria. (1.4)
DOSAGE AND ADMINISTRATION
ADULT PATIENTS (2.1)
INFECTION
RECOMMENDED DOSE/DURATION OF THERAPY
Community-acquired pneumonia (mild
severity)
Pharyngitis/tonsillitis (second-line therapy)
Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once
daily on Days 2 through 5.
Acute bacterial exacerbations of chronic
bronchitis (mild to moderate)
500 mg as a single dose on Day 1, followed by 250 mg once
daily on Days 2 through 5 or 500 mg onc