Country: United States
Language: English
Source: NLM (National Library of Medicine)
AZITHROMYCIN DIHYDRATE (UNII: 5FD1131I7S) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)
Cardinal Health
AZITHROMYCIN DIHYDRATE
AZITHROMYCIN ANHYDROUS 250 mg
ORAL
PRESCRIPTION DRUG
Azithromycin Tablets, USP 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 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
Azithromycin Tablets, USP 250 mg are supplied as white, oval, biconvex film coated tablets containing azithromycin dihydrate equivalent to 250 mg of azithromycin. Azithromycin Tablets, USP 250 mg are engraved “APO” on one side and “AZ250” on the other side. Packaged as follows: NDC 50268-100-15 10 Tablets per card, 5 cards per carton Azithromycin Tablets, USP 500 mg are supplied as white, oval, biconvex film coated tablets containing azithromycin dihydrate equivalent to 500 mg of azithromycin. Azithromycin Tablets, USP 500 mg are engraved “APO” on one side and “AZ500” on the other. Packaged as follows: NDC 50268-101-13 10 Tablets per card, 3 cards per carton Dispensed in blister punch material. For Institutional Use Only. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Preserve in tight container
Abbreviated New Drug Application
AZITHROMYCIN DIHYDRATE- AZITHROMYCIN TABLET, FILM COATED CARDINAL HEALTH ---------- AZITHROMYCIN TABLETS, USP 250 MG AND 500 MG RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Azithromycin Tablets, USP 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: Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C H N O •2H O and a molecular weight of 785. Azithromycin is supplied for oral administration as film-coated, white oval shaped biconvex tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, croscarmellose sodium, magnesium stearate and Opadry II white (Opadry II white contains the following components: hypromellose, lactose monohydrate, titanium dioxide and triacetin). 38 72 2 12 38 72 2 12 2 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) h Read the complete document