ERYTHROMYCIN tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ERYTHROMYCIN (UNII: 63937KV33D) (ERYTHROMYCIN - UNII:63937KV33D)

Available from:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

ERYTHROMYCIN

Composition:

ERYTHROMYCIN 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Erythromycin Tablets, USP and other antibacterial drugs, Erythromycin Tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin Tablets, USP are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below: Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes ; Streptococcus pneumoniae ; Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae ar

Product summary:

Erythromycin Tablets are supplied as pink, unscored oval tablets in the following strength and packages. 500 mg tablets (debossed with EA): NDC 55289-025-04 Bottles of 4 NDC 55289-025-20 Bottles of 20 NDC 55289-025-28 Bottles of 28 NDC 55289-025-30 Bottles of 30 NDC 55289-025-40 Bottles of 40 Store below 86°F (30°C).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ERYTHROMYCIN- ERYTHROMYCIN TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
----------
ERYTHROMYCIN
TABLETS, USP
Film-coated Tablets
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Erythromycin Tablets and other antibacterial drugs, Erythromycin
Tablets should be
used only to treat or prevent infections that are proven or strongly
suspected to be
caused by bacteria.
DESCRIPTION
Erythromycin Tablets, USP are an antibacterial product containing
erythromycin, USP, in
a unique, nonenteric film coating for oral administration.
Erythromycin Tablets are
available in two strengths containing either 250 mg or 500 mg of
erythromycin base.
Erythromycin is produced by a strain of _Saccharopolyspora erythraea_
(formerly
_Streptomyces erythraeus_) and belongs to the macrolide group of
antibiotics. It is basic
and readily forms salts with acids. Erythromycin is a white to
off-white powder, slightly
soluble in water, and soluble in alcohol, chloroform, and ether.
Erythromycin is known
chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*,
14R*)-4-[(2,6-dideoxy-3-
C-methyl-3-O-methyl-α-L-
_ribo_-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-
3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-
_xylo_ -
hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular
formula is C
H
NO
, and the molecular weight is 733.94. The structural formula is:
INACTIVE INGREDIENTS
37
67
13
Colloidal silicon dioxide, croscarmellose sodium, crospovidone, D&C
Red No. 30
Aluminum Lake, hydroxypropyl cellulose, hypromellose, hydroxypropyl
methylcellulose
phthalate, magnesium stearate, microcrystalline cellulose, povidone,
polyethylene glycol,
propylene glycol, sodium citrate, sodium hydroxide, sorbic acid,
sorbitan monooleate,
talc, and titanium dioxide.
CLINICAL PHARMACOLOGY
Orally administered erythromycin base and its salts are readily
absorbed in the
microbiologically active form. Interindividual variations in the
absorption of erythromycin
are, however, observed, and some p