AZITHROMYCIN- azithromycin tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Wockhardt USA LLC.

INN (Kansainvälinen yleisnimi):

AZITHROMYCIN ANHYDROUS

Koostumus:

AZITHROMYCIN ANHYDROUS 250 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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

Tuoteyhteenveto:

Azithromycin tablets, USP are supplied in the following strengths and package configurations: 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. These are packaged as follows: Bottles of 30                                       NDC 64679-961-01 Unit dose package of 100                   NDC 64679-961-02 Cartons of 3 blister cards (6 tablets per blister card) NDC 64679-961-05 Bottles of 500                                                 NDC 64679-961-07 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. These are packaged as follows: Bottles of 30                                       NDC 64679-964-01 Unit dose package of 100                   NDC 64679-964-02 Cartons of 3 blister cards (3 tablets per blister card) NDC 64679-964-05 Bottles of 500                                                 NDC 64679-964-07 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

AZITHROMYCIN - AZITHROMYCIN TABLET, FILM COATED
WOCKHARDT USA LLC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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
INDICATIONS AND USAGE
Azithromycin 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 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 once daily
for 3 days.
Acute bacterial sinusitis
500 mg once daily for 3 days.
Gen