ERYTHROMYCIN BASE FILMTAB- erythromycin tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Rebel Distributors Corp

INN (International Name):

ERYTHROMYCIN

Sammensetning:

ERYTHROMYCIN 250 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Erythromycin Base Filmtab tablets and other antibacterial drugs, Erythromycin Base Filmtab tablets 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 Base Filmtab tablets 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 ery

Produkt oppsummering:

Erythromycin Base Filmtab tablets (erythromycin tablets, USP) are supplied as pink, unscored oval tablets in the following strengths and packages. 250 mg tablets (debossed with Abbott “A” logo and EB): Bottles of 28…...…………………………………………………..(NDC 21695-387-28); Bottles of 30……………………………………………………….(NDC 21695-387-30). 500 mg tablets (debossed with Abbott “A” logo and EA): Bottles of 30……………………………………………………….(NDC 21695-389-30). Store below 86°F (30°C). Keep tightly closed.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

ERYTHROMYCIN BASE FILMTAB- ERYTHROMYCIN TABLET, FILM COATED
REBEL DISTRIBUTORS CORP
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ERYTHROMYCIN
BASE FILMTAB®
(ERYTHROMYCIN TABLETS, USP)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Erythromycin
Base Filmtab tablets and other antibacterial drugs, Erythromycin Base
Filmtab tablets would be used
only to treat or prevent infections that are proven or strongly
suspected to be caused by bacteria.
DESCRIPTION
Erythromycin Base Filmtab (erythromycin tablets, USP) is an
antibacterial product containing
erythromycin, USP, in a unique, nonenteric film coating for oral
administration. Erythromycin Base
Filmtab 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.
37
67
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CLINICAL PHARMACOLOGY
Orally administered erythromycin base and its salts are readily
absorbed in the microbiologically active
form. Interindividual variat