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:

PD-Rx Pharmaceuticals, Inc.

INN (Nama Internasional):

AZITHROMYCIN MONOHYDRATE

Komposisi:

AZITHROMYCIN ANHYDROUS 500 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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)] - 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 appropria

Ringkasan produk:

Azithromycin tablets USP are supplied in the following strengths and package configurations: Azithromycin tablets USP, 500 mg are supplied as pink, oval shaped film-coated tablets, engraved with "LU" on one side and "L12" on the other side containing azithromycin monohydrate USP equivalent to 500 mg of azithromycin USP. These are packaged in bottles and blister cards as follows: NDC 43063-713-79 Bottles of 1 Tablet NDC 43063-713-02 Bottles of 2 Tablets NDC 43063-713-03 Bottles of 3 Tablets NDC 43063-713-05 Bottles of 5 Tablets NDC 43063-713-07 Bottles of 7 Tablets Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

AZITHROMYCIN MONOHYDRATE- AZITHROMYCIN MONOHYDRATE TABLET
PD-RX PHARMACEUTICALS, INC.
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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, 500 MG, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Warnings and Precautions, Cardiovascular Death ( 5.5) 11/2021
INDICATIONS AND USAGE
Azithromycin tablets are 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
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. (
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, followe