AZITHROMYCIN tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvPAK

INN (International Name):

Azithromycin Anhydrous

Composition:

Azithromycin Anhydrous 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Azithromycin 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

Product summary:

Azithromycin tablets 250 mg are supplied as white film-coated oval shaped biconvex tablets debossed with W961 on one side and other side plain containing anhydrous azithromycin 250 mg. Available as follows: (NDC 50268-098-15) 10 Tablets per card, 5 cards per carton. Azithromycin tablets 500 mg are supplied as white film-coated oval shaped biconvex tablets debossed with W964 on one side and other side plain containing anhydrous azithromycin 500 mg. Available as follows: (NDC 50268-098-13) 10 Tablets per card, 3 cards per carton. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispensed in Unit Dose Package. For Institutional Use Only.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AZITHROMYCIN- AZITHROMYCIN TABLET, FILM COATED
AVPAK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
AZITHROMYCIN TABLETS
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AZITHROMYCIN TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AZITHROMYCIN
TABLETS.
AZITHROMYCIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Warnings and Precautions, Hypersensitivity ( 5.1) 3/2017
Warnings and Precautions, Infantile Hypertrophic Pyloric Stenosis (
5.3) 2/2017
INDICATIONS AND USAGE
Azithromycin is a macrolide antibacterial drug indicated for mild to
moderate infections caused by designated, susceptible
bacte ria:
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 ( 1.2)
Community-acquired pneumonia in adults and pediatric patients ( 1.1,
1.2)
Pharyngitis/tonsillitis in adults and pediatric patients ( 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 and other
antibacterial drugs, azithromycin 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