AZITHROMYCIN for suspension

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Lupin Pharmaceuticals,Inc.

INN (Medzinárodný Name):

AZITHROMYCIN MONOHYDRATE

Zloženie:

AZITHROMYCIN ANHYDROUS 200 mg in 5 mL

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 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 ski

Prehľad produktov:

Azithromycin for oral suspension, USP after constitution contains a cherry, banana and vanilla flavored suspension. The dry powder before constitution is white to off-white. The suspension after constitution is pink in color. Azithromycin for oral suspension, USP is supplied to provide 100 mg/5 mL or 200 mg/5 mL suspension in bottles as follows: [see Dosage and Administration (2)] for constitution instructions with each bottle type. Storage: Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].  Store constituted suspension between 5° to 30°C (41° to 86°F) and discard when full dosing is completed.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

AZITHROMYCIN- AZITHROMYCIN FOR SUSPENSION
LUPIN PHARMACEUTICALS,INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AZITHROMYCIN FOR ORAL SUSPENSION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
AZITHROMYCIN FOR ORAL SUSPENSION.
AZITHROMYCIN FOR ORAL SUSPENSION
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
se ve rity)
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