AZITHROMYCIN MONOHYDRATE tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

DIRECT RX

INN (Nama Internasional):

AZITHROMYCIN MONOHYDRATE

Komposisi:

AZITHROMYCIN ANHYDROUS 500 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets and other antibacterial drugs, azithromycin tablets 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 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 ,

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

AZITHROMYCIN MONOHYDRATE- AZITHROMYCIN MONOHYDRATE TABLET
DIRECT RX
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AZITHROMYCIN
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of azithromycin
tablets and other antibacterial drugs, azithromycin tablets 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 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 in women
has not been established