AZITHROMYCIN- azithromycin monohydrate powder, for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AZITHROMYCIN (UNII: F94OW58Y8V) (AZITHROMYCIN - UNII:F94OW58Y8V)

Available from:

Physicians Total Care, Inc.

INN (International Name):

AZITHROMYCIN

Composition:

AZITHROMYCIN 100 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Azithromycin is 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 ri

Product summary:

Azithromycin for oral suspension after constitution contains a flavored suspension. Azithromycin for oral suspension is supplied to provide 100 mg/5 mL or 200 mg/5 mL suspension in bottles as follows: See DOSAGE AND ADMINISTRATION for constitution instructions with each bottle type. Store dry powder below 30°C (86°F). Store constituted suspension between 5° to 30°C (41° to 86°F) and discard when full dosing is completed.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AZITHROMYCIN - AZITHROMYCIN MONOHYDRATE POWDER, FOR SUSPENSION
PHYSICIANS TOTAL CARE, INC.
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To reduce the development of drug-resistant bacteria and maintain the
effectiveness of azithromycin for
oral suspension and other antibacterial drugs, azithromycin for oral
suspension should be used only to
treat or prevent infections that are proven or strongly suspected to
be caused by bacteria.
DESCRIPTION
Azithromycin tablets and azithromycin for oral suspension 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 749.00. 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 785.0.
Azithromycin is supplied for oral administration as film-coated,
modified capsular shaped tablets
containing azithromycin dihydrate equivalent to either 250 mg or 500
mg azithromycin and the following
inactive ingredients: dibasic calcium phosphate anhydrous,
pregelatinized starch, sodium
croscarmellose, magnesium stearate, sodium lauryl sulfate,
hypromellose, lactose, titanium dioxide,
triacetin and D&C Red #30 aluminum lake.
Azithromycin for oral suspension is supplied in bottles containing
azithromycin dihydrate powder
equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per
bottle and the following inactive
ingredients: sucrose; sodium phosphate, tribasic, anhydrous;
hydroxypropyl cellulos