ILOSONE Erythromycin Estolate 100mg / mL Suspension (Oral Drops) 10mL Orange

Treatment of the following conditions in children and adults (culture and susceptibility testing should be done): Upper respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenes, viridans group streptococci, Streptococcus pneumoniae or Haemophilus influenzae (when erythromycin is used concomitantly with adequate doses of sulfonamides, since not all strains of H. influenzae are susceptible at the erythromycin concentrations ordinarily achieved).
Lower respiratory tract infections of mild to moderate severity caused by S. pyogenes, S. pneumoniae, Mycoplasma pneumoniae or Legionella pneumophila.
Primary syphilis caused by Treponema pallidum. Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examination should be done before treatment and as part of follow up after therapy.
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. Extraenteric amebiasis requires treatment with other agents.
Infections due to Listeria monocytogenes.
Skin and soft tissue infections of mild to moderate severity caused by S. pyogenes or Staphylococcus aureus (resistant staphylococci may develop during treatment).
Pertussis Caused by Bordetella pertussis: Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them non-infectious. Some clinical studies suggests that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals.
Conjunctivitis of the newborn, pneumonia of infancy and urogenital infections during pregnancy caused by Chlamydia trachomatis (see Precautions). When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of adults with uncomplicated urethral, endocervical or rectal infections due to C. trachomatis.

Adults: Usual Dose: 250 mg every 6 hrs. This may be increased up to ≥4 g daily according to the severity of the infection.
Children: Age, weight and severity of the infection are important factors in determining the proper dosage. The usual regimen is 30-50 mg/kg/day in divided doses. For more severe infections, this dosage may be doubled.
If administration is desired on a twice-a-day schedule in either adults or children, ½ of the total daily dose may be given every 12 hrs. Twice-a-day dosing is not recommended with doses >1 g daily are administered.
Streptococcal Infections: For the treatment of streptococcal pharyngitis and tonsillitis, the usual dosage range is 20-50 mg/kg/day in divided doses (see table).

In the treatment of group A β-hemolytic streptococcal infections, a therapeutic dosage of erythromycin should be administered for at least 10 days.
In continuous prophylaxis of streptococcal infections in persons with a history of rheumatic heart disease, the dosage is 250 mg twice a day.
For prophylaxis against bacterial endocarditis in penicillin allergic patients with congenital heart disease, rheumatic or other acquired valvular heart disease when undergoing dental procedures or surgical procedures of the upper respiratory tract. The dosage schedule for adults is 1 g (20 mg/kg for children) orally 1 hr before the procedure and then 500 mg (10 mg/kg for children) orally 6 hrs later.
Primary Syphilis: A regimen of erythromycin estolate 20 g in divided doses over a period of 10 days has been shown to be effective in the treatment of primary syphilis.
Dysenteric Amebiasis: Adults: 250 mg 4 times daily for 10-14 days. Children: 30-50 mg/kg/day in divided doses for 10-14 days.
Pertussis: Although optimum dosage and duration of treatment have not been established, dosage of erythromycin utilized in reported clinical studies was 40-50 mg/kg/day, given in divided doses for 5-14 days.
Legionnaire's Disease: Although optimum doses have not been established, doses utilized in reported clinical data were those recommended (1-4 g erythromycin estolate daily in divided doses).
Conjunctivitis of the Newborn Caused by C. trachomatis: Oral erythromycin suspension, 50 mg/kg/day in 4 divided doses for at least 2 weeks.
Pneumonia of Infancy Caused by C. trachomatis: Although the optimum duration of therapy has not been established, the recommended therapy is oral erythromycin suspension, 50 mg/kg/day in 4 divided doses for at least 3 weeks.
Urogenital Infections During Pregnancy Due to C. trachomatis: Although the optimum dose and duration of therapy have not been established, the suggested treatment is erythromycin, 500 mg orally 4 times a day for at least 7 days. For women who cannot tolerate this regimen, a decreased dose of 250 mg orally 4 times a day should be used for at least 14 days.
For adults with uncomplicated urethral, endocervical or rectal infections caused by C. trachomatis in whom tetracyclines are contraindicated or not tolerated, 500 mg orally 4 times a day for at least 7 days.

Should be taken on an empty stomach: Best taken 1 hr before or 2 hr after meals. May be taken w/ meals to reduce GI discomfort.

Patients with known hypersensitivity to erythromycin. Patients taking terfenadine, astemizole, cisapride, pimozide, verapamil or diltiazem (see Interactions).
Patients with known history of sensitivity to erythromycin estolate and for those with preexisting liver disease.

Since erythromycin is excreted principally by the liver, caution should be exercised in administering the antibiotic to patients with impaired hepatic function. When indicated, incision and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy.
Carcinogenicity & Mutagenicity: 2-year oral studies conducted in rats with erythromycin did not provide evidence of tumorigenicity or mutagenicity.
Use in pregnancy: Reproduction studies have been performed in rats, mice and rabbits, using erythromycin and its various salts and esters of doses several times the usual human dose. No evidence of impaired fertility or harm to the fetus that appeared to be related to erythromycin was reported in 3 studies. There are however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response this drug should be used during pregnancy only if clearly needed.
Labor and Delivery: The effect of erythromycin estolate on labor and delivery is unknown.
Use in lactation: Erythromycin is excreted in human milk. Caution should be exercised when erythromycin is administered to a nursing woman.
Use in children: Several reports of infantile hypertrophic pyloric stenosis have been reported in newborn infants receiving various erythromycin products, including erythromycin estolate. Erythromycin should be used cautiously in the first 3 months of life (see Indications and Dosage & Administration).

The most frequent side effects of erythromycin preparations are gastrointestinal (eg, abdominal cramping and discomfort) and are dose-related. Nausea, vomiting and diarrhea occur frequently with usual oral doses. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see Warnings).
During prolonged or repeated therapy, there is a possibility of overgrowth of nonsusceptible bacteria or fungi. If such infections arise, the drug should be discontinued and appropriate therapy instituted.
Mild allergic reactions eg, urticaria and other skin rashes have occurred. Serious allergic reactions, including anaphylaxis, have been reported.
There have been isolated reports of hearing loss and/or tinnitus in patients receiving erythromycin. The ototoxic effect of the drug is usually reversible with drug discontinuance. However, in rare instances involving IV administration, the ototoxic effect has been irreversible. Ototoxic effects occur chiefly in patients with renal or hepatic insufficiency and in patients receiving high doses of erythromycin.
Very rarely erythromycin has been associated with QT prolongation and ventricular arrhythmias, including ventricular tachycardia and torsade des pointes.
Several reports of infantile hypertrophic pyloric stenosis have been reported in newborn infants receiving various erythromycin products, including erythromycin estolate. Erythromycin should be used cautiously in the first 3 months of life.

Erythromycin significantly alters the metabolism of terfenadine when taken concomitantly. Rare cases of serious cardiovascular adverse events, including death, cardiac arrest, Torsades de pointes and other ventricular arrhythmias, have been observed (see Contraindications).
Since probenecid inhibits tubular reabsorption of erythromycin in animals, it prolongs maintenance of plasma levels.
Lincomycin or clindamycin therapy should be avoided in treatment of infections due to erythromycin-resistant organisms.
Erythromycin use in patients who are receiving high doses of theophylline may be associated with increase in serum theophylline levels and potential theophylline toxicity. In case of theophylline toxicity and/or elevated serum theophylline levels, the dose of theophylline should be reduced while the patient is receiving concomitant erythromycin therapy.
Concomitant administration of erythromycin and digoxin has been reported to result in elevated digoxin serum levels.
There have been reports of increased anticoagulant effects when erythromycin and oral anticoagulants were used concomitantly. Increased anticoagulation effects due to this drug interaction may be more pronounced in the elderly.
Concurrent use of erythromycin and ergotamine or dihydroergotamine has been associated in some patients with acute ergot toxicity characterized by severe peripheral vasospasm and dysesthesia.
Erythromycin has been reported to decrease the clearance of triazolam and midazolam and thus may increase the pharmacologic effect of these benzodiazepines.
The use of erythromycin in patients concurrently taking drugs metabolized by the cytochrome P-450 system may be associated with elevations in serum concentrations of these other drugs. Elevated serum concentrations of the following drugs have been reported or may occur when administered concurrently with erythromycin: Carbamazepine, cyclosporine, hexobarbital, phenytoin, alfentanyl, disopyramide, quinidine; HMG-CoA reductase inhibitors eg, simvastatin and lovastatin, bromocriptine, PDE5 inhibitors eg, sildenafil, tadalafil and vardenafil. Serum concentrations, when available and appropriate, of these and other drugs metabolized by the cytochrome P-450 system should be monitored closely in patients concurrently receiving erythromycin and dosage adjustments made as needed. Elevated cisapride levels have been reported in patients receiving erythromycin and cisapride concomitantly. This may result in QT prolongation and lead to serious cardiac arrhythmias, including Torsades de pointes, ventricular tachycardia and ventricular fibrillation. Fatalities have been reported (see Contraindications).
Laboratory Tests: Erythromycin may interfere with AST (SGOT) determinations if a zone-fast violet B or diphenylhydrazine colorimetric determinations are used.
Erythromycin interferes with the fluorometric determination of urinary catecholamine.

Macrolides