ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL granule, for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ERYTHROMYCIN ETHYLSUCCINATE (UNII: 1014KSJ86F) (ERYTHROMYCIN - UNII:63937KV33D), SULFISOXAZOLE ACETYL (UNII: WBT5QH3KED) (SULFISOXAZOLE - UNII:740T4C525W)

Available from:

Physicians Total Care, Inc.

INN (International Name):

ERYTHROMYCIN ETHYLSUCCINATE

Composition:

ERYTHROMYCIN ETHYLSUCCINATE 200 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For treatment of ACUTE OTITIS MEDIA in children that is caused by susceptible strains of Haemophilus influenzae . Erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension is contraindicated in the following patient populations: Use in pregnant women at term, in children less than 2 months of age, and in mothers nursing infants less than 2 months of age is contraindicated because sulfonamides may promote kernicterus in the newborn by displacing bilirubin from plasma proteins. Erythromycin is contraindicated in patients taking terfenadine. (See PRECAUTIONS, Drug Interactions:.)

Product summary:

Erythromycin Ethylsuccinate and Sulfisoxazole Acetyl for Oral Suspension is available for teaspoon dosage in 100 mL (NDC 54868-0971-1) bottles, in the form of granules to be reconstituted with water. The suspension provides erythromycin ethylsuccinate equivalent to 200 mg erythromycin activity and sulfisoxazole acetyl equivalent to 600 mg sulfisoxazole per teaspoonful (5 mL). Store at room temperature in dry form.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL - ERYTHROMYCIN
ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL GRANULE, FOR SUSPENSION
PHYSICIANS TOTAL CARE, INC.
----------
ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL FOR ORAL
SUSPENSION, USP
Revised MARCH 2007
11001190
Rx only
DESCRIPTION:
Erythromycin ethylsuccinate and sulfisoxazole acetyl, when
reconstituted with water as directed on the
label, the granules form a white, cherry flavored suspension that
provides the equivalent of 200 mg
erythromycin activity and the equivalent of 600 mg of sulfisoxazole
activity per teaspoonful (5 mL).
Erythromycin is produced by a strain of _Saccaropolyspora erythraea_
and belongs to the macrolide group
of antibiotics. It is basic and readily forms salts and esters.
Erythromycin ethylsuccinate is the 2’-
ethylsuccinyl ester of erythromycin. It is essentially a tasteless
form of the antibiotic suitable for oral
administration, particularly in suspension dosage forms. The chemical
name is erythromycin 2’-
(ethylsuccinate). Erythromycin ethylsuccinate has the following
structural formula:
C
H NO MOLECULAR WEIG HT: 862.06
Sulfisoxazole acetyl or _N_ -acetyl sulfisoxazole is an ester of
sulfisoxazole. Chemically, sulfisoxazole
is _N_ -(3,4-dimethyl-5-isoxazotyl) sulfanilamide. Sulfisoxazole
acetyl has the following structural
formula:
C H N O S MOLECULAR WEIG HT: 309.34
4 5
75
16
_1_
_1_
C H N O S MOLECULAR WEIG HT: 309.34
INACTIVE INGREDIENTS:
Artificial flavor, lactose anhydrous, methylparaben, polysorbate 80,
povidone, simethicone, sodium
citrate anhydrous and sucrose.
CLINICAL PHARMACOLOGY:
Orally administered erythromycin ethylsuccinate suspensions are
readily and reliably absorbed.
Erythromycin ethylsuccinate products have demonstrated rapid and
consistent absorption in both fasting
and nonfasting conditions. However, higher serum concentrations are
obtained when these products are
given with food. Erythromycin is largely bound to plasma proteins.
After absorption, erythromycin
diffuses readily into most body fluid