ERYTHROMYCIN tablet, film coated

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Amneal Pharmaceuticals NY LLC

INN (الاسم الدولي):

ERYTHROMYCIN

تركيب:

ERYTHROMYCIN 250 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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 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 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 ordinarily achieved) (see appropriate sulfonamide labeling for prescribing information). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenes or Streptococcus pneumoniae . Listeriosis caused by Listeria monocytogenes . Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Pertussis (whooping cough) caused by Bordetella pertussis . Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum . Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae : Erythrocin® Lactobionate-I.V. (erythromycin lactobionate for injection, USP) followed by erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Erythromycins tablets are indicated for treatment of the following infections caused by Chlamydia trachomatis : conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin tablets are  indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis . When tetracyclines are contraindicated or not tolerated, erythromycin tablets are indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum .  Primary syphilis caused by Treponema pallidum . Erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the follow-up after therapy. Legionnaires’ Disease caused by Legionella pneumophila . Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires’ Disease. Prophylaxis Prevention of Initial Attacks of Rheumatic Fever Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract e.g., tonsillitis, or pharyngitis).1 Erythromycin tablets are indicated for the treatment of penicillin-allergic patients. The therapeutic dose should be administered for ten days. Prevention of Recurrent Attacks of Rheumatic Fever Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).1 Erythromycin is contraindicated in patients with known hypersensitivity to this antibiotic. Erythromycin is contraindicated in patients taking terfenadine, astemizole, cisapride, pimozide, ergotamine, or dihydroergotamine (see PRECAUTIONS -Drug Interactions ).

ملخص المنتج:

Erythromycin tablets, USP, 250 mg are supplied as pink color, oval shaped, film-coated tablet, debossed with “AC39” on one side and plain on other side. They are available as follows: Bottles of 30:                          NDC 69238-1484-3 Bottles of 100:                         NDC 69238-1484-1 Erythromycin tablets, USP, 500 mg are supplied as pink color, oval shaped, film-coated tablet, debossed with “AC40” on one side and plain on other side. They are available as follows: Bottles of 30:                          NDC 69238-1485-3 Bottles of 100:                         NDC 69238-1485-1 Recommended storage Store at 20° to 25ºC (68° to 77ºF); excursions permitted between 15º to 30ºC (59° to 86ºF) [see USP Controlled Room Temperature]. Keep tightly closed.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

ERYTHROMYCIN- ERYTHROMYCIN TABLET, FILM COATED
AMNEAL PHARMACEUTICALS NY LLC
----------
ERYTHROMYCIN TABLETS, USP
(250 MG AND 500 MG)
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, USP 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: croscarmellose sodium, crospovidone, D&C red
#30/helendon
pink aluminum lake, hydroxypropyl cellulose, hypromellose,
hypromellose phthalate,
magnesium stearate, microcrystalline cellulose, polyethylene glycol,
povidone, propylene
glycol, silicon dioxide, sodium citrate, sodium hydroxide, 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. Inter individual variations in the
absorption of erythromycin
are, however, observed, and some patients do not achiev