ERYTHROMYCIN ETHYLSUCCINATE- erythromycin suspension

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Amneal Pharmaceuticals NY LLC

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate for oral suspension and other antibacterial drugs, erythromycin ethylsuccinate for oral suspension 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 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 pneumoniae 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 penicillin-allergic patients. In 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.4 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).4 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.

Ringkasan produk:

Erythromycin ethylsuccinate for oral suspension, USP, 200 mg/5 mL , dry powder is supplied as white to off-white granules. Reconstituted suspension is off-white to light pink colored suspension. It is available as follows: 100 mL Bottles (when mixed):                      NDC 69238-1503-1 Erythromycin ethylsuccinate for oral suspension, USP, 400 mg/5 mL , dry powder is supplied as white to off-white granules. Reconstituted suspension is off-white to light pink colored suspension. It is available as follows:   100 mL Bottles:                      NDC 69238-1504-2   Recommended Storage: Store erythromycin ethylsuccinate for oral suspension, USP, 200 mg/5 mL and 400 mg/5 mL, prior to mixing, below 86°F (30°C). After reconstitution, erythromycin ethylsuccinate for oral suspension, USP, 200 mg/5 mL and 400 mg/5 mL must be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] and used within 35 days; refrigeration is not required.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

ERYTHROMYCIN ETHYLSUCCINATE- ERYTHROMYCIN SUSPENSION
AMNEAL PHARMACEUTICALS NY LLC
----------
ERYTHROMYCIN ETHYLSUCCINATE FOR ORAL SUSPENSION, USP, 200 MG/5 ML AND
400
MG/5 ML 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, USP 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, USP is an ester of
erythromycin, USP
suitable for oral administration. Erythromycin ethylsuccinate, USP is
known chemically as
erythromycin 2′-(ethyl succinate). The molecular formula is C
H
NO
and the
molecular weight is 862.06. The structural formula is:
Erythromycin ethylsuccinate for oral suspension, USP, 200 mg/5 mL when
reconstituted
with water, forms a suspension containing erythromycin ethylsuccinate,
USP equivalent
43
75
16
with water, forms a suspension containing erythromycin ethylsuccinate,
USP equivalent
to 200 mg erythromycin, USP per 5 mL (teaspoonful) or 100 mg per 2.5
mL
(dropperful) with an appealing fruit flavor. Erythromycin
ethylsuccinate for oral
suspension, USP, 400 mg/5 mL when reconstituted with water, forms a
suspension
containing erythromycin ethylsuccinate, USP equivalent to 400 mg of
erythromycin, USP
per 5 mL (teaspoonful) with an appealing banana flavor.
These products are intended primarily for pediatric use but can also
be used in adults.
_INACTIVE INGREDIENTS_
Erythromycin ethylsuccinate for oral suspension, USP, 200 mg/5 mL
contains caramel
flavor, mixed fruit flavor, polysorbate 80, sodium citrate dihydrate,
sucrose, and
xanthan gum. Erythromycin ethylsuccinate for oral suspension, USP 400
mg/