Country: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
AZITHROMYCIN MONOHYDRATE (UNII: JTE4MNN1MD) (AZITHROMYCIN - UNII:F94OW58Y8V)
MedVantx, Inc.
AZITHROMYCIN MONOHYDRATE
AZITHROMYCIN 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 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
Azithromycin tablets USP, 250 mg are supplied as mottled pink, unscored, film-coated, modified-oval-shaped tablets, debossed with “93” on one side and “7146” on the other, containing azithromycin monohydrate equivalent to 250 mg of azithromycin. They are available in bottles of 30, boxes of 1 card x 6 tablets, and in unit-dose boxes of 100 (10 x 10). Azithromycin tablets USP, 500 mg are supplied as mottled pink, unscored, film-coated, modified-oval-shaped tablets, debossed with “93” on one side and “7169” on the other, containing azithromycin monohydrate equivalent to 500 mg of azithromycin. They are available in bottles of 30, boxes of 1 card x 3 tablets, and in unit-dose boxes of 100 (10 x 10). Store at 20º to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Abbreviated New Drug Application
AZITHROMYCIN- AZITHROMYCIN TABLET, FILM COATED MEDVANTX, INC. ---------- AZITHROMYCIN TABLETS USP, 250 MG AND 500 MG 7146 7169 RX ONLY 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 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. Azithromycin has the following structural formula: C H N O M.W. 749.00 Azithromycin, as the monohydrate, is a white to off-white crystalline powder with a molecular formula of C H N O •H O and a molecular weight of 767.02. Azithromycin tablets USP, 250 mg and 500 mg are supplied for oral administration as mottled pink, unscored, film-coated, modified-oval-shaped tablets containing azithromycin monohydrate equivalent to 250 mg or 500 mg azithromycin and the following inactive ingredients: butylated hydroxytoluene, calcium phosphate dibasic anhydrous, carmine, colloidal silicon dioxide, FD&C red # 40 lake, FD&C yellow # 6 lake, hypromellose (2910, 15cP), lactose monohydrate, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, talc, titanium dioxide and triacetin. 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 ( Прочитајте комплетан документ