AZITHROMYCIN powder, for suspension

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

DIRECT RX

INN (Kansainvälinen yleisnimi):

AZITHROMYCIN MONOHYDRATE

Koostumus:

AZITHROMYCIN ANHYDROUS 200 mg in 5 mL

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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. Adults 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 illne

Tuoteyhteenveto:

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 SeeDOSAGE AND ADMINISTRATIONfor 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.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

AZITHROMYCIN- AZITHROMYCIN POWDER, FOR SUSPENSION
DIRECT RX
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AZITHROMYCIN
DESCRIPTION SECTION
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:
C38H72N2O12 M.W. 749.0
Azithromycin, USP, as the monohydrate, is a white crystalline powder
with a molecular formula of
C38H72N2O12•H2O and a molecular weight of 767.0.
Azithromycin for oral suspension USP is supplied in bottles containing
azithromycin 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 SECTION
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 AUC0-72 =
4.3 (1.2) mcg·h/mL; Cmax = 0.5
(0.2) mcg/mL; Tmax = 2.2 (0.9) hours.
With a regimen of 500 mg (two 250 mg capsules*) on day 1, followed by
250 mg daily (one 250 mg
capsule) on days 2 through 5, the pharmacokinetic parameters of
azithromycin in plasma in healthy
young adults (18 to 40 years of age) are portrayed in the chart below