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  • Erythromycin Ethylsuccinate and Sulfisoxazole Acetyl
    (Sulfisoxazole Acetyl, Erythromycin Ethylsuccinate) - Various

    THERAPEUTIC CLASS

    Macrolide/sulfonamide

    DEA CLASS

    RX

    INDICATIONS

    Acute otitis media caused by H.influenzae.

    PEDIATRIC DOSAGE

    Pediatrics: ≥2 months: Dose based on 50mg/kg/day erythromycin or 150mg/kg/day sulfisoxazole. Total daily dose should be given in equally divided doses, tid-qid for 10 days. Max: 6g/day sulfisoxazole. Refer to PI for further dosing schedule information.

    HOW SUPPLIED

    Sus: (Erythromycin Ethylsuccinate-Sulfisoxazole Acetyl) 200mg-600mg/5mL [100mL, 150mL, 200mL]

    CONTRAINDICATIONS

    Pediatrics <2 months old, pregnant women at term, mothers nursing infants <2 months old, concomitant terfenadine.

    WARNINGS/PRECAUTIONS

    Fatalities due to severe reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dycrasias reported; d/c at first appearance of skin rash or if any adverse reaction develops. Hepatic dysfunction with or without jaundice reported. Hypersensitivity reactions of the respiratory tract reported. Sulfonamides should not be used for the treatment of group A beta-hemolytic streptococcal infections. Pseudomembranous colitis reported. Erythromycin does not reach the fetus in adequate concentrations to prevent congenital syphilis. Caution with impaired renal or hepatic function and in patients with severe allergy or bronchial asthma. May result in bacterial resistance with prolonged use or use in the absence of a proven/suspected bacterial infection or a prophylactic indication; take appropriate measures if superinfection develops. May aggravate weakness in patients with myasthenia gravis. Hemolysis may occur in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Monitor CBC frequently; d/c if significant reduction in any count develops. Urinalysis with careful microscopic examination and renal function tests should be performed during therapy. Blood levels should be measured in patients receiving a sulfonamide for a serious infection.

    ADVERSE REACTIONS

    N/V, abdominal pain, diarrhea, anorexia, hepatic dysfunction, leukopenia, psychosis, allergic reactions, tachycardia, syncope, edema, headache, cough, angioedema.

    DRUG INTERACTIONS

    See Contraindications. Erythromycin: Concomitant use with high doses of theophylline may increase theophylline levels and cause toxicity. May increase levels of digoxin and drugs metabolized by CYP450 (eg, carbamazepine, cyclosporine, hexobarbital, phenytoin, alfentanil, disopyramide, lovastatin, bromocriptine). May increase the effects of oral anticoagulants. Acute ergot toxicity may occur when used concomitantly with ergotamine or dihydroergotamine. May decrease the clearance of triazolam and midazolam. Rhabdomyolysis reported with or without renal impairment in seriously ill patients receiving concomitant therapy with lovastatin. Sulfisoxazole: May prolong PT when used concomitantly with warfarin. May compete with thiopental for plasma protein binding; concomitant use may require less thiopental for anesthesia. Concomitant use with methotrexate may displace methotrexate from plasma protein binding sites. May potentiate blood sugar lowering effects of sulfonylureas.

    PREGNANCY

    Category C, not for use in nursing.

    MECHANISM OF ACTION

    Erythromycin: Macrolide; acts by inhibition of protein synthesis by binding 50s ribosomal sub-units of susceptible organisms. Sulfisoxazole: Sulfonamide; bacteriostatic agents. Inhibits bacterial synthesis of dihydrofolic acid by preventing the condensation of the pteridine with para-aminobenzoic acid through competitive inhibition of the enzyme dihydropteroate synthetase.

    PHARMACOKINETICS

    Absorption: (Erythromycin) Rapid. (Sulfisoxazole) Rapid and complete; (2g PO dose) Cmax=127-211mcg/mL; Tmax=1-4 hrs. Distribution: Crosses placental barrier and found in breast milk. (Sulfisoxazole) Plasma protein binding (85%). Elimination: (Erythromycin) Urine (<5% active form). (Sulfisoxazole) Urine (97%); T1/2= 4.6-7.8 hrs.

    ASSESSMENT

    Assess for proper diagnosis of causative organism. Assess age of patient, conditions such as myasthenia gravis, arrhythmias, G6PD deficiency, severe allergy or bronchial asthma, and hepatic/renal function. Note other diseases/conditions and drug therapies. Obtain baseline CBC.

    MONITORING

    Monitor for signs and symptoms of a severe reaction (eg, SJS, TEN, fulminant hepatic necrosis, agranulocytosis, aplastic anemia or other blood dyscrasias), hypersensitivity reactions of the respiratory tract, pseudomembranous colitis, and for superinfection. Monitor for aggravation of weakness in patients with myasthenia gravis. In G6PD deficiency, monitor for hemolysis. Perform frequent monitoring of CBC. Monitor LFTs and renal function. Perform urinalysis with careful microscopic examination. In patients with a serious infection, measure drug levels.

    PATIENT COUNSELING

    Inform of risks and benefits of therapy. Notify physician if pregnant or nursing and of all current medications. Advise to maintain an adequate fluid intake to prevent crystalluria and stone formation. Contact physician if any adverse reactions develop.

    ADMINISTRATION/STORAGE

    Administration: Oral route. Storage: (Dry form) Room temperature.