AZITHROMYCIN powder, for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AZITHROMYCIN DIHYDRATE (UNII: 5FD1131I7S) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)

Available from:

Physicians Total Care, Inc.

INN (International Name):

AZITHROMYCIN DIHYDRATE

Composition:

AZITHROMYCIN ANHYDROUS 1 g

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Azithromycin is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis . Azithromycin at the recommended dose, should not be relied upon to treat gonorrhea or syphilis. Antimicrobial agents used in high doses for short periods of time to treat non-gonococcal urethritis may mask or delay the symptoms of incubating gonorrhea or syphilis. All patients with sexually-transmitted urethritis or cervicitis should have a serologic test for syphilis and appropriate cultures for gonorrhea performed at the time of diagnosis. Appropriate antimicrobial therapy and follow-up tests for these diseases should be initiated if infection is confirmed. Appropriate culture and susceptibility tests should be performed before treatment to determine the causative organism and its susceptibility to azithromycin. Therapy with azithromycin may be in

Product summary:

Azithromycin for oral suspension is supplied in single dose packets containing azithromycin dihydrate equivalent to 1 gram of azithromycin as follows:       Boxes of 3 Single Dose Packets (1 g)                      NDC 54868-5938-0 Store single dose packets between 5° and 30°C (41° and 86°F).

Authorization status:

New Drug Application

Summary of Product characteristics

AZITHROMYCIN - AZITHROMYCIN POWDER, FOR SUSPENSION
PHYSICIANS TOTAL CARE, INC.
----------
AZITHROMYCIN
AZITHROMYCIN TABLETS
AND
AZITHROMYCIN FOR ORAL SUSPENSION
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 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 749.0. 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 tablets contain azithromycin dihydrate equivalent to 600
mg azithromycin. The tablets are
supplied as white, modified oval-shaped, film-coated tablets. They
also contain the following inactive
ingredients: dibasic calcium phosphate anhydrous, pregelatinized
starch, sodium croscarmellose,
magnesium stearate, sodium lauryl sulfate and an aqueous film coat
consisting of hypromellose, titanium
dioxide, lactose and triacetin.
Azithromycin for oral suspension is supplied in a single dose packet
containing azithromycin dihydrate
equivalent to 1 g azithromycin. It also contains the following
inactive ingredients: colloidal silicon
dioxide, sodium phosphate tribasic, anhydrous; s