Dosing and uses of Pediazole (erythromycin base/sulfisoxazole)
Adult dosage forms and strengths
Not prescribed for adults
Pediatric dosage forms and strengths
erythromycin/sulfisoxazole
oral suspension
- (200mg/600mg)/5mL
H. influenzae Acute Otitis Media
<2 months: Contraindicated
>2 months: 50 mg/kg/day (erythromycin) or 150 mg/kg/day (sulfisoxazole) PO divided q6-8hr for10 days
Not to exceed 6 g/day sulfisoxazole
Pediazole (erythromycin base/sulfisoxazole) adverse (side) effects
Frequency not defined
Abdominal pain and discomfort
Diarrhea
Lack or loss of appetite
Nausea
Vomiting
Anxiety
Arrythmia
Blood disorders
Blood or stone formation in urine
Bluish discoloration of skin
Chills
Colitis
Convulsions
Cough
Melena
Depression
Dermatitis
Difficulty/inability to urinate
Disorientation
Dizziness
Drowsiness
Dystonia
Exhaustion
Fainting
Fatigue
Fluid retention
Flushing
Fever
Gas
GI bleeding
Hallucinations
Headache
Hepatitis
Hives
Hypoglycemia
Insomnia
Itching
Polyuria
Stoamtitis
Redness & swelling of tongue
Tinnitus
Sensitivity to light
Severe allergic reactions
Severe skin welts or swelling
Shortness of breath
Skin rash
Stevens-Johnson syndrome
Swelling around the eye
Temporary hearing loss
Vertigo
Weakness
Warnings
Contraindications
Hypersensitivity to macrolides, sulfonamides, sulfonylureas, thiazides
Term pregnancy
Lactation
Age <2 months
Porphyria
G-6-PD deficiency
Severe hepatic or renal impairment (CrCl <15 mL/min), documented megaloblastic or folate deficiency anemia, obstructive uropathy
Pregnancy and lactation
Pregnancy category: C
Lactation: enters breast milk
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Pediazole (erythromycin base/sulfisoxazole)
Half-Life: 1-1.5 hr (erythromycin); 4.6-7.8 hr (sulfisoxazole)
Protein bound: 75-90% (erythromycin); 855 (sulfisoxazole)
Protein Bound: 75-90%
Peak Plasma Time of erythromycin: base: 4 hr; ethylsuccinate: 0.5-2.5 hr; delayed with food due to differences in absorption
Metabolized: in liver by demethylation (erythromycin); conjugated in liver (sulfisoxazole)
Excretion
Erythromycin
- Unchanged drug excreted and concentrated in bile
- Urine: <5%
Sulfisoxazole
- Urine: 50% in urine as unchanged drug
Mechanism of action
Erythromycin: Erythromycin: Macrolide antibiotic; iInhibits bacterial growth, possibly by blocking dissociation of peptidyl tRNA from ribosomes, causing RNA-dependent protein synthesis to arrest
Sulfisoxazole: Sulfonamide derivative; exerts bacteriostatic action by antagonizing para-aminobenzoic acid (PABA), an essential component in folic acid synthesis