ERYTHROMYCIN ETHYLSUCCINATE granule, for suspension

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

ERYTHROMYCIN ETHYLSUCCINATE (UNII: 1014KSJ86F) (ERYTHROMYCIN - UNII:63937KV33D)

Διαθέσιμο από:

ANI Pharmaceuticals, Inc.

INN (Διεθνής Όνομα):

ERYTHROMYCIN ETHYLSUCCINATE

Σύνθεση:

ERYTHROMYCIN 200 mg in 5 mL

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate and other antibacterial drugs, erythromycin ethylsuccinate 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 ethylsuccinate for oral suspension USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below: Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae, or 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 pneumonia or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes . 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. 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). 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 : 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. Syphilis caused by Treponema pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the 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 is 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 is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum . 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). Erythromycin is indicated for the treatment of penicillin-allergic patients.1 The therapeutic dose should be administered for 10 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, pimozide, or cisapride. (See PRECAUTIONS - Drug Interactions .) Do not use erythromycin concomitantly with HMG CoA reductase inhibitors (statins) that are extensively metabolized by CYP 3A4 (lovastatin or simvastatin), due to the increased risk of myopathy, including rhabdomyolysis.

Περίληψη προϊόντος:

Erythromycin Ethylsuccinate for Oral Suspension USP is available as: 200mg/5mL: Each 5 mL teaspoon of reconstituted cherry-flavored suspension contains activity equivalent to 200 mg of erythromycin. Available in bottles of: 100 mL NDC 62559-440-01 200 mL NDC 62559-440-02 Recommended storage Store granules, prior to mixing, at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. After mixing, refrigerate and use within ten days. Manufactured by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 9857 Rev 06/18

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

ERYTHROMYCIN ETHYLSUCCINATE- ERYTHROMYCIN ETHYLSUCCINATE GRANULE, FOR
SUSPENSION
ANI PHARMACEUTICALS, INC.
----------
ERYTHROMYCIN ETHYLSUCCINATE FOR ORAL SUSPENSION USP
RX ONLY
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF ERYTHROMYCIN ETHYLSUCCINATE AND OTHER ANTIBACTERIAL
DRUGS,
ERYTHROMYCIN ETHYLSUCCINATE SHOULD BE USED ONLY TO TREAT OR PREVENT
INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED TO BE CAUSED BY
BACTERIA.
DESCRIPTION
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. The base, the stearate salt, and
the esters are poorly
soluble in water. Erythromycin ethylsuccinate is an ester of
erythromycin suitable for
oral administration. Erythromycin ethylsuccinate is known chemically
as erythromycin 2'-
(ethylsuccinate). The molecular formula is C
H
NO
and the molecular weight is
862.06. The structural formula is:
The granules are intended for reconstitution with water. Each 5 mL
teaspoonful of
reconstituted palatable cherry-flavored suspension contains
erythromycin
ethylsuccinate equivalent to 200 mg of erythromycin.
Granules are intended primarily for pediatric use but can also be used
in adults.
Inactive Ingredients: artificial cherry flavor, lactose anhydrous,
methylparaben,
polysorbate 80, povidone, simethicone, sodium citrate anhydrous, and
sucrose.
43
75
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CLINICAL PHARMACOLOGY
Orally administered erythromycin ethylsuccinate suspension is readily
and reliably
absorbed. Comparable serum levels of erythromycin are achieved in the
fasting and
nonfasting states.
Erythromycin diffuses readily into most body fluids. Only low
concentrations are
normally achieved in the spinal fluid, but passage of the drug across
the blood-brain
barrier increases in meningitis. In the presence of normal hepatic
function, erythromycin
is concentrated in the liver and excreted in the bile; the effect of
hepatic dysfunction on
excre