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erythromycin base/sulfisoxazole (Pediazole)

 

Classes: Sulfonamides

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