AZITHROMYCIN powder, for suspension

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Proficient Rx LP

DCI (Dénomination commune internationale):

AZITHROMYCIN MONOHYDRATE

Composition:

AZITHROMYCIN ANHYDROUS 200 mg in 5 mL

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Azithromycin for oral suspension USP is indicated for the treatment of patients with mild to moderate infections (pneumonia: see WARNINGS ) caused by susceptible strains of the designated microorganisms in the specific conditions listed below. As recommended dosages, durations of therapy and applicable patient populations vary among these infections, please see DOSAGE AND ADMINISTRATION for specific dosing recommendations. Acute bacterial exacerbations of chronic obstructive pulmonary disease 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. NOTE: 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 nosocomially acquired 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). Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. NOTE: Penicillin by the intramuscular route is the usual drug of choice in the treatment of Streptococcus pyogenes infection and the prophylaxis of rheumatic fever. Azithromycin for oral suspension USP is often effective in the  eradication of susceptible strains of Streptococcus pyogenes from the nasopharynx. Because some  strains are resistant to azithromycin for oral suspension USP, susceptibility tests should be performed when patients are treated with azithromycin for oral suspension USP. Data establishing efficacy of azithromycin in subsequent prevention of rheumatic fever are not available. Uncomplicated skin and skin structure infections due to Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae. Abscesses usually require surgical drainage. 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. Azithromycin for oral suspension USP, at the recommended dose, should not be relied upon to treat syphilis. Antimicrobial agents used in high doses for short periods of time to treat non-gonococcal urethritis may mask or delay the symptoms of incubating syphilis. All patients with sexually-transmitted urethritis or cervicitis should have a serologic test for syphilis and appropriate cultures for gonorrhea performed at the time of diagnosis. Appropriate antimicrobial therapy and follow-up tests for these diseases should be initiated if infection is confirmed. Appropriate culture and susceptibility tests should be performed before treatment to determine the causative organism and its susceptibility to azithromycin, USP. Therapy with azithromycin for oral suspension USP may be initiated before results of these tests are known; once the results become available, antimicrobial therapy should be adjusted accordingly. 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 or prevent 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. See PRECAUTIONS, Pediatric Use and CLINICAL STUDIES, Pediatric Patients. Acute otitis media   caused by Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae. (For specific dosage recommendation, see DOSAGE AND ADMINISTRATION .) Community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy. (For specific dosage  recommendation, see DOSAGE AND ADMINISTRATION .) NOTE: Azithromycin should not be used in pediatric 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 nosocomially acquired infections, patients with known or suspected bacteremia, patients requiring hospitalization, or patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia). Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. (For specific dosage recommendation, see DOSAGE AND ADMINISTRATION .) NOTE: Penicillin by the intramuscular route is the usual drug of choice in the treatment of Streptococcus pyogenes infection and the prophylaxis of rheumatic fever. Azithromycin for oral suspension USP is often effective in the eradication of susceptible strains of Streptococcus pyogenes from the nasopharynx. Because some  strains are resistant to azithromycin for oral suspension USP, susceptibility tests should be performed when patients are treated with azithromycin for oral suspension USP. Data establishing efficacy of azithromycin in subsequent prevention of rheumatic fever are not available. Appropriate culture and susceptibility tests should be performed before treatment to determine the causative organism and its susceptibility to azithromycin. Therapy with azithromycin for oral suspension USP may be initiated before results of these tests are known; once the results become available, antimicrobial therapy should be adjusted accordingly. Azithromycin is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin any macrolide or ketolide antibiotic. Azithromycin is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.

Descriptif du produit:

Azithromycin for oral suspension USP after constitution contains a flavored pink suspension. Azithromycin for oral suspension USP is supplied to provide 200 mg/5 mL suspension in bottles as follows: 200mg/5ml Suspension 15ml NDC (63187-093-15) 200mg/5ml Suspension 22.5ml NDC (63187-093-22) 200mg/5ml Suspension 30ml NDC (63187-093-30) Azithromycin contents per bottle 600 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]. 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.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

AZITHROMYCIN- AZITHROMYCIN POWDER, FOR SUSPENSION
PROFICIENT RX LP
----------
AZITHROMYCIN FOR ORAL SUSPENSION USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
azithromycin and other antibacterial drugs, azithromycin for oral
suspension should be
used only to treat or prevent infections that are proven or strongly
suspected to be
caused by bacteria.
DESCRIPTION
Azithromycin for oral suspension USP contains the active ingredient
azithromycin, USP,
an azalide, a subclass of macrolide antibiotics, for oral
administration. Azithromycin, USP
has the chemical name _(2R,3S,4R,5R,8R,
10R,11R,12S,13S,14R)_-13-[(2,6-dideoxy-3-_C_-
methyl-3-_O_-methyl-α-_L-ribo-_hexopyranosyl)
oxy]-2-ethyl-3,4,10-trihydroxy-
3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-
(dimethylamino)-β-_D-xylo_-
hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin,
USP is derived
from erythromycin; however, it differs chemically from erythromycin in
that a methyl-
substituted nitrogen atom is incorporated into the lactone ring.
Azithromycin, USP has the following structural formula:
C
H
N O
M.W. 749.0
Azithromycin, USP, as the monohydrate, is a white crystalline powder
with a molecular
formula of C
H
N O
•H O and a molecular weight of 767.0.
Azithromycin for oral suspension USP is supplied in bottles containing
azithromycin
38
72
2
12
38
72
2
12
2
monohydrate powder equivalent to 300 mg, 600 mg, 900 mg or 1200 mg
azithromycin,
USP per bottle and the following inactive ingredients: ammonio
methacrylate copolymer,
banana flavor, cherry flavor, colloidal silicon dioxide, FD&C Red No.
40, hydroxypropyl
cellulose, sucrose, tribasic sodium phosphate anhydrous, vanilla
flavor, and xanthan
gum. After constitution, each 5 mL of suspension contains 100 mg or
200 mg of
azithromycin, USP.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
Following oral administration of a single 500 mg dose (two 250 mg
tablets) to 36 fasted
healthy male volunteers, the mean (SD) pharmacokinetic parameters were
AUC
=
4.3 (1.2) mcg