Adult Dosing

Bacterial infections

• 40-50 mg/kg/day PO div q6-8h based on erythomycin component
• MAX: 2 gm/day based on erythomycin component

Pediatric Dosing

Acute otitis media, sinusitis, pharyngitis, bronchitis

Child >2 month

• 40-50 mg/kg/day PO divided q6-8 hours based on erythomycin component
• MAX: 2 gm/day based on erythomycin component

[Outline]

• Adult Dosing
• Pediatric Dosing

• Acute otitis media in children caused by susceptible strains of Haemophilus influenzae
• Sinusitis, pharyngitis, and bronchitis associated bacterial infections in children
• Bacterial infections

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to sulfonamides
• Patients <2 months
• Pregnancy near-term
• Breastfeeding with infant <2 months
• BCG live intravesical, cisapride, dofetilide, dronedarone, eletriptan, ergot alkaloids, ergotamine/caffeine, methenamine, phenothiazines, pimozide, saquinavir, toremifene

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined, caution advised

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined, caution advised

• Fatal severe reactions may occur with the administration of sulfonamides. Suspend therapy at the first appearance of skin rash or any sign of adverse reaction
• Oral erythromycin may cause hepatic dysfunction, with or without jaundice
• The sulfonamides should not be used for the treatment of group A beta-hemolytic streptococcal infections
• Combination therapy may cause mild to life-threatening pseudomembranous colitis. Therefore do not administer in patients with history of diarrhea
• Carefully monitor creatine kinase (CK) and serum transaminase levels in patients receiving concomitant lovastatin and erythromycin because it may cause rhabdomyolysis with or without renal impairment
• As erythromycin is principally excreted by the liver, it should be cautiously administer in patients with impaired hepatic function
• Erythromycin may aggravate the weakness of patients with myasthenia gravis
• Sulfonamides should be given with caution to patients with impaired renal or hepatic function and to those with severe allergy or bronchial asthma
• Freqent dosing may cause hemolysis in glucose-6-phosphate dehydrogenase-deficient individuals

Caution: Use cautiously in

• Renal impairment
• Hepatic impairment
• Myasthenia gravis
• Severe allergies
• Asthma
• G6PD deficiency
• QT prolongation
• Hypokalemia
• Hypomagnesemia
• Bradycardia
• Cardiomyopathy
• Myocardial ischemia or MI

Pregnancy Category:C

Breastfeeding: Erythromycin: Excreted in breastmilk in small quantities and safely administered directly to infants, hence not expected to cause adverse events in the breastfed infant. Monitor the infant for irritability, diarrhea and candidiasis. As per one case report and unconfirmed epidemiologic evidence the risk of hypertrophic pyloric stenosis in infants might increase by maternal use of erythromycin during breastfeeding. Sulfisoxazole: In full term healthy infants, sulfisoxazole is considered acceptable for use, after the new born period. However alternative agents may be preferred in stressed, premature, jaundiced infants due to the risk of bilirubin displacement and kernicterus. This drug should be avoided while breastfeeding a G6PD-deficient infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 25 February 2011). According to manufacturer data a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother, because of the potential for the development of kernicterusin neonates due to the displacement of bilirubin from plasma proteins by sulfisoxazole.Erythromycin: This drug is compatible and considered safe with breastfeeding based upon data from AAP Policy Guidelines (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776 last accessed February 2011)

• CNS: Convulsions, myasthenia gravis exacerbation, kernicterus
• CV: QT prolongation, ventricular arrhythmias, anorexia, torsades de pointes, vasculitis
• GI: Nausea, vomiting, abdominal pain, diarrhea, pseudomembranous colitis, infantile hypertrophic pyloric stenosis, pancreatitis
• RESP: Pulmonary hypersensitivity
• EENT: Reversible hearing loss
• DERM: Rash, urticaria, pruritus, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity, lupus erythematosus
• HEMA: Leukopenia, thrombocytopenia, agranulocytosis, aplastic anemia, blood dyscrasias
• GU: Nephritis, acute renal failure, crystalluria
• HEPA: Hepatic impairment, hepatic necrosis, fulminant, elevated liver transaminases, jaundice
• MISC: Superinfection, anaphylaxis, angioedema

Erythromycin

• Macrolide; penetrates the bacterial cell membrane and reversibly binds to the 50 S subunit of bacterial ribosomes resulting in the inhibition of protein synthesis
• Extensively metabolized by liver; CYP450: 3A4 substrate
• Excretion: Primarily excreted in bile; <5% in urine
• Half-life: 0.8-3 hrs

Sulfisoxazole

• Sulfonamide; bacteriostatic action, Interferes with bacterial folic acid synthesis
• Sulfisoxazole is rapidly and completely absorbed
• Metabolized by liver; CYP450: Unknown
• Renally excreted
• Half-life: 4.5-7.8 hrs

US Trade Name(s)

• Only generic available

US Availability

erythromycin/sulfisoxazole (generic)

• SUSP: [200 mg/600 mg]/5 mL

Canadian Trade Name(s)

• Only generic available

Canadian Availability

Pediazole

• SUSP: [200 mg/600 mg]/5 mL

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Antimicrobials

Antibiotic Combinations

Infectious Disease

Antibiotic Combinations