Erythromycin and Sulfisoxazole (Systemic)


VA CLASSIFICATION
Primary: AM900

Commonly used brand name(s): Eryzole; Pediazole.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antibacterial (systemic)—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Otitis media, acute (treatment)—Erythromycin and sulfisoxazole combination is indicated in the treatment of acute otitis media caused by Haemophilus influenzae {13}, [pneumococci, group A streptococci, and Branhamella catarrhalis] in children. {10}

[Sinusitis (treatment)]1—Erythromycin and sulfisoxazole combination is used in the treatment of acute sinusitis caused by H. influenzae , pneumococci, group A streptococci, and B. catarrhalis in children.

—Not all species or strains of a particular organism may be susceptible to erythromycin and sulfisoxazole combination.

1 Not included in Canadian product labeling.



Pharmacology/Pharmacokinetics

Erythromycin—See Erythromycins (Systemic).

Sulfisoxazole—See Sulfonamides (Systemic).


Precautions to Consider

Erythromycin—See Erythromycins (Systemic).

Sulfisoxazole—See Sulfonamides (Systemic).


Side/Adverse Effects
Erythromycin—See Erythromycins (Systemic).
Sulfisoxazole—See Sulfonamides (Systemic).



Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Erythromycin and Sulfisoxazole (Systemic) .

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Allergy to erythromycins or sulfonamides; patients allergic to furosemide, thiazide diuretics, sulfonylureas, or carbonic anhydrase inhibitors may also be allergic to this medication

Pregnancy—Erythromycin crosses the placenta; sulfisoxazole also crosses the placenta and should not be used at term because it may cause kernicterus in the infant; it has also been associated with cleft palates and skeletal defects in the offspring of mice and rats





Breast-feeding—Erythromycins are distributed into breast milk in concentrations that may exceed maternal serum concentrations; sulfisoxazole is also distributed into breast-milk and is not recommended in nursing women since sulfonamides may cause kernicterus in nursing infants





Use in children—Sulfonamides should not be used in children up to 2 months of age because they may cause kernicterus






Dental—Systemic erythromycins may cause oral candidiasis; the leukopenic and thrombocytopenic effects of sulfonamides may result in an increased incidence of certain microbial infections, delayed healing, and gingival bleeding
Other medications, especially alfentanil; astemizole; coumarin- or indanedione-derivative anticoagulants; hydantoin anticonvulsants; oral antidiabetic agents; carbamazepine; chloramphenicol; cyclosporine; other hemolytics; other hepatotoxic medications; clindamycin; lincomycin; methenamine; methotrexate; terfenadine; or xanthines, especially theophylline
Other medical problems, especially blood dyscrasias, a history of cardiac arrythmias or QT prolongation, glucose-6-phosphate dehydrogenase (G6PD) deficiency, hepatic function impairment, loss of hearing, megaloblastic anemia, porphyria, or renal function impairment

Proper use of this medication
» Maintaining adequate fluid intake; may be taken with food

» Not giving to infants under 2 months of age

Using specially marked measuring spoon or other device to measure dose

Proper administration technique for oral liquids; not using after expiration date

» Compliance with full course of therapy

» Importance of not missing doses, and taking at evenly spaced times

» Proper dosing
Missed dose: Taking as soon as possible; not taking if almost time for next dose; not doubling dose

» Proper storage

Precautions while using this medication
» Regular visits to physician to check blood counts, especially in long-term therapy

Checking with physician if no improvement within a few days

» Possible photosensitivity reactions

Using caution in use of regular toothbrushes, dental floss, and toothpicks; delaying dental work until blood counts have returned to normal; checking with physician or dentist concerning proper oral hygiene


Side/adverse effects
Signs of potential side effects, especially blood dyscrasias, cardiac toxicity, crystalluria, goiter, hematuria, hepatotoxicity, hypersensitivity reactions, interstitial nephritis, loss of hearing, Lyell's syndrome, pancreatitis, Stevens-Johnson syndrome, thyroid function disturbance, and tubular necrosis


General Dosing Information
Erythromycin and sulfisoxazole combination may be taken with food. {10}

Because of its relatively high solubility even in acid urine, the risk of crystalluria with sulfisoxazole is low and alkalinization of the urine is usually unnecessary.

Patients with impaired renal function may require a reduction in dose.

As with other antibacterials, the possibility of superinfection with mycotic or bacterial pathogens should be kept in mind during prolonged or repeated therapy with erythromycin and sulfisoxazole. If superinfection occurs, the medication should be discontinued and appropriate treatment instituted. {13}

For treatment of adverse effects
For antibiotic-associated pseudomembranous colitis (AAPMC):

• Some patients may develop AAPMC, caused by Clostridium difficile toxin, during or following administration of erythromycin and sulfisoxazole. Mild cases may respond to discontinuation of the medication alone. Moderate to severe cases may require fluid, electrolyte, and protein replacement. In patients not responding to the above measures or in more severe cases, treatment with an antibacterial medication effective against AAPMC may be necessary. {13}



Oral Dosage Forms

ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL FOR ORAL SUSPENSION USP

Usual adult and adolescent dose
Use is not indicated in adults.

Usual pediatric dose
Antibacterial


Infants up to 2 months of age:
Use is contraindicated since sulfonamides may cause kernicterus in neonates. {10} {13}



Infants and children 2 months of age and over:


The dose can be calculated, based on either the equivalent of erythromycin or sulfisoxazole base, as follows {13}
Oral, 50 mg (erythromycin) per kg of body weight per day in three or four divided doses for ten days; or

Oral, 150 mg (sulfisoxazole) per kg of body weight per day in three or four divided doses for ten days.




The following dosage schedules can also be used:
Four-times-a-day dosing schedule {13}:


Body Weight
Dose
(Every 6 hours for ten days)
Less than 8 kg
(Less than 18 lb)
Adjust dosage by body weight
8 kg (18 lb)
1/2 teaspoonful (2.5 mL)
16 kg (35 lb)
1 teaspoonful (5 mL)
24 kg (53 lb)
1 1/2 teaspoonfuls (7.5 mL)
Over 32 kg
(over 70 lb)
2 teaspoonfuls (10 mL)

Note: The maximum dose for children should not exceed 6 grams (sulfisoxazole) daily.

Three-times-a-day dosing schedule {13}:


Body Weight
Dose
(Every 8 hours for ten days)
Less than 6 kg
(Less than 13 lb)
Adjust dosage by body weight
6 kg (13 lb)
1/2 teaspoonful (2.5 mL)
12 kg (26 lb)
1 teaspoonful (5 mL)
18 kg (40 lb)
1 1/2 teaspoonfuls (7.5 mL)
24 kg (53 lb)
2 teaspoonfuls (10 mL)
Over 30 kg
(over 66 lb)
2 1/2 teaspoonfuls (12.5 mL)

Note: The maximum dose for children should not exceed 6 grams (sulfisoxazole) daily.




Strength(s) usually available
U.S.—


200 mg of erythromycin and 600 mg of sulfisoxazole per 5 mL (when reconstituted according to manufacturer's instructions) (Rx) [Eryzole{14}] [Pediazole{13} (sucrose)][Generic]

Canada—


200 mg of erythromycin and 600 mg of sulfisoxazole per 5 mL (when reconstituted according to manufacturer's instructions) (Rx) [Pediazole{15}]

Packaging and storage:
Prior to reconstitution, store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Stability:
After reconstitution, suspensions retain their potency for 14 days if refrigerated. {11}

Auxiliary labeling:
   • Refrigerate.
   • Shake well.
   • Take with water.
   • Avoid too much sun or use of sunlamp.
   • Continue medicine for full time of treatment.
   • Beyond-use date.

Note: When dispensing, include a calibrated liquid-measuring device.




Revised: 06/14/1999



References
  1. McEvoy GK, editor. AHFS Drug information 88. Bethesda, MD: American Society of Hospital Pharmacists, 1988: 431.
  1. Yoshikawa TT, Chow AW, Guze LB, editors. Infectious disease. Boston: Houghton Mifflin Professional Publications, 1980: 713-4.
  1. Fansidar package insert (Roche—US), Rev 5/87, Rec 9/87.
  1. Gantrisin (Roche). In: PDR Physicians' desk reference. 42nd ed. 1988. Oradell, NJ: Medical Economics Company, 1988: 1724-5.
  1. Red book 1991. Montvale, NJ: Medical Economics Data, 1989: 279-80.
  1. USP DI 1989, VA Medication Classification System: 2472.
  1. Red book 1989. Montvale, NJ: Medical Economics Data, 1989: 317-8.
  1. Red book 1989. Montvale, NJ: Medical Economics Data, 1989: 543.
  1. Pediazole (Abbott). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 23rd ed. Ottawa: Canadian Pharmaceutical Association, 1988: 690.
  1. Erythromycin ethylsuccinate and sulfisoxazole acetyl package insert (Lederle—US), Rev 8/88, Rec 12/88.
  1. Panel comment, 6/4/84.
  1. USP Requirements, USP DI 1989, Vol III, IV/35.
  1. Pediazole (Ross). In: PDR Physicians' desk reference. 53rd ed. 1999. Montvale, NJ: Medical Economics Company; 1999. p. 2737-9.
  1. Eryzole (Alra). In: PDR Physicians' desk reference. 53rd ed. 1999. Montvale, NJ: Medical Economics Company; 1999. p. 510.
  1. Pediazole (Abbott). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ottawa: Canadian Pharmacists Association; 1998. p. 1280-1.
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