AZITHROMYCIN powder, 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:

STATE HEALTH SERVICES, TEXAS DEPARTMENT OF

INN (Medzinárodný Name):

AZITHROMYCIN MONOHYDRATE

Zloženie:

AZITHROMYCIN ANHYDROUS 100 mg in 5 mL

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin for oral suspension USP and other antibacterial drugs, azithromycin for oral suspension 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 for oral suspension USP 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 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. - [see Use in Specific Populations ( 8.4) and Clinical Studies ( 14.2)] - Acute otitis media (> 6 months of age) c aused by Haemophilus influenzae , Moraxella catarrhalis, or Streptococcus pneumoniae - Community-acquired pneumonia (> 6 months of age) due to Chlamydophila pneumoniae , Haemophilus influenzae , Mycoplasma pneumonia , or Streptococcus pneumoniae in patients appropriate for oral therapy. - Pharyngitis/tonsillitis (> 2 years of age ) caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. 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 such as any of the following: - patients with cystic fibrosis, - patients with nosocomial infections, - patients with known or suspected bacteremia, - patients requiring hospitalization, - elderly or debilitated patients, or - patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia). Azithromycin for oral suspension is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drug. Azithromycin for oral suspension is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin. Teratogenic Effects Pregnancy Category B Reproduction studies have been performed in rats and mice at doses up to moderately maternally toxic dose concentrations (i.e., 200 mg/kg/day). These daily doses in rats and mice, based on body surface area, are estimated to be 4 and 2 times, respectively, an adult daily dose of 500 mg. In the animal studies, no evidence of harm to the fetus due to azithromycin was found. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, azithromycin should be used during pregnancy only if clearly needed. Azithromycin has been reported to be excreted in human breast milk in small amounts. Caution should be exercised when azithromycin is administered to a nursing woman. [see Clinical Pharmacology ( 12.3), Indications and Usage ( 1.2), and Dosage and Administration ( 2.2)] Safety and effectiveness in the treatment of pediatric patients with acute otitis media, acute bacterial sinusitis and community-acquired pneumonia under 6 months of age have not been established. Use of azithromycin for the treatment of acute bacterial sinusitis and community-acquired pneumonia in pediatric patients (6 months of age or greater) is supported by adequate and well-controlled trials in adults Pharyngitis/Tonsillitis: Safety and effectiveness in the treatment of pediatric patients with pharyngitis/tonsillitis under 2 years of age have not been established. In multiple-dose clinical trials of oral azithromycin, 9% of patients were at least 65 years of age (458/4949) and 3% of patients (144/4949) were at least 75 years of age. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients may be more susceptible to development of torsades de pointes arrhythmias than younger patients. [see WARNINGS AND PRECAUTIONS ( 5.3)] .

Prehľad produktov:

Azithromycin for oral suspension USP after constitution contains a flavored pink suspension. Azithromycin for oral suspension USP is supplied to provide 100 mg/5 mL or 200 mg/5 mL suspension in bottles as follows: Azithromycin contents per bottle 300 mg 600 mg 900 mg 1200 mg See DOSAGE AND ADMINISTRATION 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]. PROTECT FROM FREEZING. Store constituted suspension between 5° to 25°C (41° to 77°F) and discard when full dosing is completed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

AZITHROMYCIN- AZITHROMYCIN POWDER, FOR SUSPENSION
STATE HEALTH SERVICES, TEXAS DEPARTMENT OF
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AZITHROMYCIN FOR ORAL
SUSPENSION USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR AZITHROMYCIN FOR
ORAL SUSPENSION USP. AZITHROMYCIN FOR ORAL SUSPENSION USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
Azithromycin for oral suspension USP 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 ( 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 FOR ORAL SUSPENSION USP AND OTHER ANTIBACTERIAL DRUGS,
AZITHROMYCIN FOR ORAL
SUSPENSION USP SHOULD BE USED ONLY TO TREAT INFECTIONS THAT ARE PROVEN
OR STRONGLY
SUSPECTED TO BE CAUSED BY SUSCEPTIBLE BACTERIA
DOSAGE AND ADMINISTRATION
ADULT PATIENTS
INFECTION (2)
RECOMMENDED DOSE/DURATION OF THERAPY (2)
Community-acquired pneumonia (mild severity) (2)
Pharyngitis/tonsillitis (second-line therapy) (2)
Skin/skin structure (uncomplicated) (2)
500 mg as a single dose on Day 1, followed by 250
mg once daily on Days 2 through 5. (2)
Acute bacterial exacerbations of chronic bronchitis
(mild to moderate) (2)
500 mg as a single dose on Day 1, followed by 250
mg once daily on Days 2 through 5 or 500 mg once
da