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:

RxChange Co.

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 risk factors such

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: Bottles of 30: NDC 64679-961-01 Bottles of 500: NDC 64679-961-07 Unit dose package of 100: NDC 64679-961-02 Cartons of 3 blister cards (6 tablets per blister card): NDC 64679-961-05 Unit dose package of 50: NDC 64679-961-06 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. These are packaged as follows: Bottles of 30: NDC 64679-964-01 Bottles of 500: NDC 64679-964-07 Unit dose package of 100: NDC 64679-964-02 Cartons of 3 blister cards (3 tablets per blister card): NDC 64679-964-05 Unit dose package of 50: NDC 64679-964-06 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AZITHROMYCIN- AZITHROMYCIN TABLET, FILM COATED
RXCHANGE CO.
----------
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)-ß-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
C38H72N2O12 , 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, hydroxypropyl cellulose, sodium
lauryl sulfate, hypromellose,
titanium dioxide and polyethylene glycol.
CLINICAL PHARMACOLOGY
38
72
2
12
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