AZITHROMYCIN tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

DirectRX

INN (mednarodno ime):

AZITHROMYCIN MONOHYDRATE

Sestava:

AZITHROMYCIN ANHYDROUS 500 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

- To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets USP and other antibacterial drugs, azithromycin tablets USP 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 tablets USP are 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)]. 1.1 Adult Patients•Acute bacterial exacerbations of chronic bronchitis due to Haemophi

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

AZITHROMYCIN- AZITHROMYCIN TABLET, FILM COATED
DIRECTRX
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AZITHROMYCIN
INDICATIONS & USAGE SECTION
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of azithromycin
tablets USP and other antibacterial drugs, azithromycin tablets USP
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 tablets USP are 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)].
1.1 Adult Patients•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 infections due
to Staphylococcus aureus,
Streptococcus pyogenes, or Streptococcus agalactiae.•Urethritis and
cervicitis due to Chlamydia
trachomatis or Neisseria gonorrhoeae.•Genital ulcer disease in men
due to Haemophilus ducreyi
(chancroid). Due to the small number of women included in clinical
trials, the efficacy of
azithromycin in the treatment of chancroid