ERYTHROMYCIN tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

STAT RX USA LLC

INN (Kansainvälinen yleisnimi):

ERYTHROMYCIN

Koostumus:

ERYTHROMYCIN 250 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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

Tuoteyhteenveto:

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 100…...…………………………………………………..(NDC 0074-6326-13); Bottles of 500……………………………………………………….(NDC 0074-6326-53); ABBO-PAC® unit dose strip packages of 100 tablets……………...(NDC 0074-6326-11). 500 mg tablets (debossed with Abbott “A” logo and EA): Bottles of 100……………………………………………………….(NDC 0074-6227-13). Store below 86°F (30°C). Keep tightly closed.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

ERYTHROMYCIN - ERYTHROMYCIN TABLET, FILM COATED
STAT RX USA LLC
----------
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 and
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
13
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