AZITHROMYCIN- azithromycin tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Azithromycin Anhydrous (UNII: J2KLZ20U1M) (Azithromycin Anhydrous - UNII:J2KLZ20U1M)

Available from:

Cardinal Health

INN (International Name):

Azithromycin Anhydrous

Composition:

Azithromycin Anhydrous 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Azithromycin tablets are 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 Chlamydia 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 r

Product summary:

Azithromycin tablets 250 mg are supplied as white film-coated oval shaped biconvex tablets debossed with W961 on one side and other side plain containing anhydrous azithromycin 250 mg. These are packaged as follows: NDC 50268-098-15 10 Tablets per card, 5 cards per carton. Azithromycin tablets 500 mg are supplied as white film-coated oval shaped biconvex tablets debossed with W964 on one side and other side plain containing anhydrous azithromycin 500 mg. NDC 50268-099-13 10 Tablets per card, 3 cards per carton. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in blister punch material for Institutional use only.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AZITHROMYCIN- AZITHROMYCIN TABLET, FILM COATED
CARDINAL HEALTH
----------
AZITHROMYCIN TABLETS, 250 MG AND 500 MG
RX ONLY
IN098
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 or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
Azithromycin tablets contain the active ingredient azithromycin, an
azalide, a subclass of macrolide
antibiotics, for oral administration. Azithromycin 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 is
derived from erythromycin; however, it differs chemically from
erythromycin in that a methyl-
substituted nitrogen atom is incorporated into the lactone ring. Its
molecular formula is C
H N O ,
and its molecular weight is 749. Azithromycin has the following
structural formula:
Anhydrous azithromycin is a white amorphous powder with a molecular
formula of C
H N O and a
molecular weight of 749.
Azithromycin tablet is supplied for oral administration as white,
film-coated, oval shaped biconvex
tablets containing anhydrous azithromycin 250 mg or 500 mg and the
following inactive ingredients:
microcrystalline cellulose, corn starch, croscarmellose sodium,
magnesium trisilicate, magnesium
stearate, colloidal silicon dioxide, hydroxy propyl cellulose, sodium
lauryl sulfate, hypromellose,
titanium dioxide and polyethylene glycol.
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•h/mL; C
= 0.5
(0.2) mcg/mL; T
= 2.2 (0.9) hours.
With a regimen of 500 mg (two 250 mg capsules ) on day 1, followe