AZITHROMYCIN tablet, film coated

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

AZITHROMYCIN ANHYDROUS (UNII: J2KLZ20U1M) (AZITHROMYCIN - UNII:F94OW58Y8V)

Prieinama:

Dispensing Solutions Inc.

INN (Tarptautinis Pavadinimas):

AZITHROMYCIN ANHYDROUS

Sudėtis:

AZITHROMYCIN 500 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Produkto santrauka:

Azithromycin tablets 250 mg are supplied as white film-coated oval shaped biconvex tablets debossed with W961 on one side and other side plain containing anhydrous azithromycin 250 mg. Azithromycin tablets 500 mg are supplied as white film-coated oval shaped biconvex tablets debossed with W964 on one side and other side plain containing anhydrous azithromycin 500 mg. They are supplied by Dispensing Solutions Inc. as follows: This product was Manufactured By: Wockhardt Limited Mumbai, India Distributed by: Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA And Relabeled By: Dispensing Solutions Inc. 3000 West Warner Ave Santa Ana, CA 92704 United States Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

AZITHROMYCIN - AZITHROMYCIN TABLET, FILM COATED
DISPENSING SOLUTIONS INC.
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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 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)-ß-_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:
Anhydrous azithromycin is a white amorphous powder with a molecular
formula of C
H N O and a
molecular weight of 749.
Azithromycin tablet is supplied for oral administration as white,
film-coated, oval shaped biconvex
tablets containing anhydrous azithromycin 250 mg or 500 mg and the
following inactive ingredients:
microcrystalline cellulose, corn starch, croscarmellose sodium,
magnesium trisilicate, magnesium
stearate, colloidal silicon dioxide, hydroxypropyl cellulose, sodium
lauryl sulfate, hypromellose,
titanium dioxide and polyethylene glycol.
CLINICAL PHARMACOLOGY
38
72
2
12
38
72
2
12
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) hours.
With a regimen of 500 mg (two 250 mg capsules*) on day 1, followed by
250 mg daily (one 250 mg