Country: United States
Language: English
Source: NLM (National Library of Medicine)
ERYTHROMYCIN STEARATE (UNII: LXW024X05M) (ERYTHROMYCIN - UNII:63937KV33D)
Blenheim Pharmacal, Inc.
ERYTHROMYCIN STEARATE
ERYTHROMYCIN 250 mg
ORAL
PRESCRIPTION DRUG
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ERYTHROCIN STEARATE Filmtab tablets and other antibacterial drugs, ERYTHROCIN STEARATE 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. ERYTHROCIN STEARATE 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 e
ERYTHROCIN STEARATE Filmtab Tablets (erythromycin stearate tablets, USP) are supplied in the following strengths and packages. ERYTHROCIN STEARATE Filmtab, 250 mg pink tablets imprinted with the corporate Abbott “A” logo and the Abbo-Code designation ES: Bottles of 100…...…………………………………………………..(NDC 0074-6346-20) Bottles of 500…...…………………………………………………..(NDC 0074-6346-53) ERYTHROCIN STEARATE Filmtab, 500 mg pink tablets imprinted with the corporate Abbott “A” logo and the Abbo-Code designation ET: Bottles of 100……………………………………………………….(NDC 0074-6316-13) Store below 86°F (30°C).
Abbreviated New Drug Application
ERYTHROCIN STEARATE- ERYTHROMYCIN STEARATE TABLET, FILM COATED BLENHEIM PHARMACAL, INC. ---------- ERYTHROCIN® STEARATE (ERYTHROMYCIN STEARATE TABLETS, USP) FILMTAB® TABLETS To reduce the development of drug-resistant bacteria and maintain the effectiveness of ERYTHROCIN STEARATE Filmtab tablets and other antibacterial drugs, ERYTHROCIN STEARATE Filmtab tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION ERYTHROCIN STEARATE Filmtab tablets (erythromycin stearate tablets, USP) are an antibacterial product containing the stearate salt of erythromycin in a unique film coating. 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 stearate is known chemically as erythromycin octadecanoate. The molecular formula of erythromycin stearate is C H NO •C H O , and the molecular weight is 1018.43. The structural formula is: INACTIVE INGREDIENTS 250 mg tablet Cellulosic polymers, corn starch, D&C Red No. 7, polacrilin potassium, polyethylene glycol, povidone, propylene glycol, sodium carboxymethylcellulose, sodium citrate, sorbic acid, sorbitan monooleate and titanium dioxide. 500 mg tablet Cellulosic polymers, cornstarch, FD&C Red No. 3, magnesium hydroxide, polacrilin potassium, povidone, propylene glycol, sorbitan monooleate, titanium dioxide and vanillin. 37 67 13 18 36 2 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 patients do not achieve optimal serum levels. Erythromycin is largely bound to plasma proteins. After absorption, erythromycin diffuses readily into most body fluids Read the complete document