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. 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 m L of suspension contains 100 mg or 200 mg of azithromycin, USP. Each 5 ml prepared suspension contains 204.8 mg azithromycin monohydrate equivalent to 200 mg azithromycin. Each 1 ml prepared suspension contains 40.96 mg azithromycin monohydrate equivalent to 40 mg azithromycin. Excipients with known effect: • Sucrose 3.70 g/ 5 ml • Aspartame (E951) 0.030 g/ 5 ml • Sodium 7.739 mg (0.336 mmol) /5 ml For the full list of excipients, see section 6.1. Azithromycin powder for oral suspension is indicated for the treatment of the following infections, when caused by micro-organisms sensitive to azithromycin (see section 4.4 and 5.1): - acute bacterial sinusitis (adequately diagnosed) - acute bacterial otitis media (adequately diagnosed) - pharyngitis, tonsillitis - acute exacerbation of chronic bronchitis (adequately diagnosed) - mild to moderately severe community acquired pneumonia - skin and soft tissue infections - uncomplicated Chlamydia trachomatis urethritis and cervicitis Considerations should be given to official guidance on the appropriate use of antibacterial agents. Adults In uncomplicated Chlamydia trachomatis urethritis and cervicitis, the dose is 1,000 mg in one single oral dose. For all other indications the dose is 1,500 mg, to be administered as 500 mg per day for three consecutive days. Alternatively the same total dose (1,500 mg) can also be given over a period of 5 days with 500 mg on the first day and then 250 mg on days 2 to 5.
STORAGE Store in the refrigerator or at room temperature. Do not store in the bathroom. Discard after 10 days. Keep all medications. Azithromycin for oral suspension USP contains the active ingredient. After mixing, store suspension at 5° to 25°C 41° to 77°F and use within 10 days.