Erythromycin Ethylsuccinate / Sulfisoxazole

Trade Names:
E. S. P.
- Granules for oral suspension Erythromycin ethylsuccinate (equivalent to 200 mg erythromycin activity) and sulfisoxazole acetyl (equivalent to 600 mg sulfisoxazole) per 5 mL when reconstituted

Pharmacology

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Erythromycin suppresses bacterial protein synthesis; sulfonamides interfere with bacterial folic acid synthesis.

Pharmacokinetics

Absorption

C _max is 0.3 to 2 mcg/mL. T _max is 1.6 h.

Distribution

Largely bound to plasma proteins. Diffuses into most body fluids. Passage across the blood-brain barrier increases in meningitis. Crosses the placenta and is excreted in breast milk.

Metabolism

Metabolized in the liver by demethylation.

Elimination

Mostly excreted in the bile; less than 5% recovered in the active form in the urine.

Indications and Usage

Treatment of acute otitis media in children caused by susceptible strains of Haemophilus influenzae .

Contraindications

Hypersensitivity to chemically related drugs (eg, sulfonylureas, thiazide and loop diuretics, carbonic anhydrase inhibitors, sunscreens containing PABA, local anesthetics) or salicylates; patients taking terfenadine or astemizole; porphyria; use in infants younger than 20 mo of age, pregnant women at term and women breast-feeding infants younger than 2 mo of age.

Dosage and Administration

PO 50 mg/kg/day erythromycin and 150 mg/kg/day (max 6 g/day) sulfisoxazole in equally divided doses 4 times daily for 10 days.

General Advice

• Give with full glass of water 1 h before or 2 h after meals.
• If GI upset is significant, administer with food or milk.
• Shake oral suspension well.

Storage/Stability

Refrigerate after opening. Discard unused portion after 14 days.

Drug Interactions

May increase anticoagulant effects.

Erythromycin significantly alters metabolism of terfenadine. Rare cases of serious CV events including death have been reported.

May cause decreased metabolism and increased concentrations of these drugs.

Erythromycin may interfere with metabolism while sulfonamides may decrease cyclosporine levels; both increase risk of nephrotoxicity.

May increase digoxin levels.

Severe myopathy or rhabdomyolysis may occur.

Sulfonamides can displace methotrexate from protein-binding sites and increase free methotrexate levels.

Sulfisoxazole may potentiate hypoglycemic effects.

May increase theophylline plasma concentrations.

May enhance anesthetic effects of thiopental.

Laboratory Test Interactions

Sulfisoxazole may produce false-positive results.

Sulfonamides may produce false-positive results when performed by Benedict's method.

Sulfisoxazole may interfere with test results.

Adverse Reactions

CNS

Headache; peripheral neuropathy; dizziness; psychosis; hallucinations; depression; convulsions.

Dermatologic

Urticaria; skin eruptions; pruritus; photosensitivity; anaphylaxis; erythema multiforme; toxic epidermal necrolysis; exfoliative dermatitis; angioedema; arteritis; vasculitis.

EENT

Hearing loss (associated with high doses erythromycin and renal insufficiency).

GI

Nausea; vomiting; abdominal pain/cramping; diarrhea; anorexia.

Genitourinary

Crystalluria; hematuria; increased BUN and creatinine; nephritis; toxic nephrosis with oliguria.

Hepatic

Hepatic dysfunction; abnormal LFT results; pseudomembranous colitis; GI hemorrhage; pancreatitis.

Hematologic

Leukopenia; agranulocytosis; aplastic anemia; thrombocytopenia; hemolytic anemia; purpura; eosinophilia; clotting disorders; methemoglobinemia.

Miscellaneous

Fever; chills; arthralgias; myalgias; periarteritis nodosum; systemic lupus erythematosus; serum sickness.

Precautions

Pregnancy

Category C .

Lactation

Both erythromycin and sulfisoxazole are excreted in breast milk.

Children

Do not expose children younger than 2 mo of age (directly or through breast milk) to sulfonamides because of risk of kernicterus.

Renal Function

Use drug with caution in patients with renal function impairment. Hepatotoxicity has been associated with erythromycin.

Hepatic Function

Use drug with caution in patients with hepatic function impairment. Hepatotoxicity has been associated with erythromycin.

Special Risk Patients

May aggravate weakness in patients with myasthenia gravis. Use drug with caution in patients with severe allergies or bronchial asthma. Dose-related hemolytic anemia may occur in patients with G-6-PD deficiency.

Superinfection

Prolonged use may result in bacterial or fungal overgrowth of nonsusceptible microorganisms.

Fatalities

Rare fatalities from severe reactions associated with hypersensitivity, agranulocytosis, aplastic anemia, blood dyscrasias, renal and hepatic damage, irreversible neuromuscular and CNS changes, and fibrosing alveolitis have been reported with sulfonamides.

Ototoxicity

May occur, especially in patients with renal or hepatic insufficiency and elderly patients and with administration of large doses.

Pseudomembranous colitis

Consider possibility in patients with diarrhea.

Overdosage

Symptoms

Nausea, vomiting, diarrhea, hearing loss, vertigo, dizziness, headache, drowsiness, unconsciousness, toxic fever, acidosis, hemolytic anemia.

Patient Information

• Instruct patient/family to follow complete course of therapy.
• Advise patient to shake suspension well before using and refrigerate after opening.
• Tell patient to take drug with full glass of water 1 h before or 2 h after meals. If GI distress occurs, take with food or milk.
• Instruct patient to report these symptoms to health care provider: tachycardia, palpitations, syncope, cyanosis, seizures, hallucinations, shortness of breath, rash, bleeding, diarrhea, inability to void, urticaria, abdominal pain, signs of superinfection.
• Caution patient to avoid exposure to sunlight and to use sunscreen or wear protective clothing to avoid photosensitivity reaction.

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