ERYTHROMYCIN tablet, film coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

Erythromycin (UNII: 63937KV33D) (Erythromycin - UNII:63937KV33D)

제공처:

Arbor Pharmaceuticals, Inc.

INN (국제 이름):

Erythromycin

구성:

Erythromycin 250 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 are not susceptible to the erythromycin concentrations

제품 요약:

Erythromycin Tablets are supplied as pink, unscored oval tablets in the following strengths and packages. Store below 86°F (30°C).

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

ERYTHROMYCIN- ERYTHROMYCIN TABLET, FILM COATED
ARBOR 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
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
37
67
13
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
pati