Erythromycin Oral Suspension

The most frequent side effects of oral erythromycin preparations are gastrointestinal and are dose-related. They include nausea, vomiting, abdominal pain, diarrhea and anorexia. Symptoms of hepatitis, hepatic dysfunction and/or abnormal liver function test results may occur. (See WARNINGS section.)

Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment. (See WARNINGS section.)

Erythromycin has been associated with QT prolongation and ventricular arrhythmias, including ventricular tachycardia and torsades de pointes. (See WARNINGS.)

Allergic reactions ranging from urticaria to anaphylaxis have occurred. Skin reactions ranging from mild eruptions to erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported rarely.

There have been reports of interstitial nephritis coincident with erythromycin use.

There have been rare reports of pancreatitis and convulsions.

There have been isolated reports of reversible hearing loss occurring chiefly in patients with renal insufficiency and in patients receiving high doses of erythromycin.

In case of overdosage, erythromycin should be discontinued. Overdosage should be handled with the prompt elimination of unabsorbed drug and all other appropriate measures should be instituted.

Erythromycin is not removed by peritoneal dialysis or hemodialysis.

Erythromycin ethylsuccinate suspensions may be administered without regard to meals.

Children

Age, weight, and severity of the infection are important factors in determining the proper dosage. In mild to moderate infections the usual dosage of erythromycin ethylsuccinate for children is 30 to 50 mg/kg/day in equally divided doses every 6 hours. For more severe infections this dosage may be doubled. If twice-a-day dosage is desired, one-half of the total daily dose may be given every 12 hours. Doses may also be given three times daily by administering one-third of the total daily dose every 8 hours.

The following dosage schedule is suggested for mild to moderate infections:

Adults

400 mg erythromycin ethylsuccinate every 6 hours is the usual dose. Dosage may be increased up to 4 g per day according to the severity of the infection. If twice-a-day dosage is desired, one-half of the total daily dose may be given every 12 hours. Doses may also be given three times daily by administering one-third of the total daily dose every 8 hours.

For adult dosage calculation, use a ratio of 400 mg of erythromycin activity as the ethylsuccinate to 250 mg of erythromycin activity as the stearate, base or estolate.

In the treatment of streptococcal infections, a therapeutic dosage of erythromycin ethylsuccinate should be administered for at least 10 days. In continuous prophylaxis against recurrences of streptococcal infections in persons with a history of rheumatic heart disease, the usual dosage is 400 mg twice a day.

For Treatment of Urethritis Due to C. trachomatis or U. urealyticum

800 mg three times a day for 7 days.

For Treatment of Primary Syphilis

Adults: 48 to 64 g given in divided doses over a period of 10 to 15 days.

For Intestinal Amebiasis

Adults: 400 mg four times daily for 10 to 14 days. Children: 30 to 50 mg/kg/day in divided doses for 10 to 14 days.

For Use in Pertussis

Although optimal dosage and duration have not been established, doses of erythromycin utilized in reported clinical studies were 40 to 50 mg/kg/day, given in divided doses for 5 to 14 days.

For Treatment of Legionnaires' Disease

Although optimal doses have not been established, doses utilized in reported clinical data were those recommended above (1.6 to 4 g daily in divided doses.)

Directions for Mixing Erythromycin Ethylsuccinate Granules

Add 77 mL water and shake vigorously. This makes 100 mL of suspension.

Add 154 mL water and shake vigorously. This makes 200 mL of suspension.

NDC 52536-134-13
100 mL (when mixed)
For Oral Suspension

Granules

ERYTHROMYCIN
ETHYLSUCCINATE FOR
ORAL SUSPENSION, USP

Erythromycin activity
200 mg per 5 mL

when reconstituted

Rx only

WILSHIRE
PHARMACEUTICALS, INC
www.wilshirerx.com

NDC 52536-136-13
200 mL (when mixed)
For Oral Suspension

Granules

ERYTHROMYCIN
ETHYLSUCCINATE FOR
ORAL SUSPENSION, USP

Erythromycin activity
200 mg per 5 mL

when reconstituted

Rx only

WILSHIRE
PHARMACEUTICALS, INC
www.wilshirerx.com

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• dark urine
• difficulty breathing
• hearing loss
• irregular heartbeat or chest pain
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• severe or watery diarrhea
• unusually weak or tired
• yellowing of eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• loss of appetite
• nausea, vomiting
• stomach pain