Erythromycin and sulfisoxazole

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Itching
• skin rash

• Aching of joints and muscles
• difficulty in swallowing
• nausea or vomiting
• pale skin
• redness, blistering, peeling, or loosening of skin
• skin rash
• sore throat and fever
• stomach pain, severe
• unusual bleeding or bruising
• unusual tiredness or weakness
• yellow eyes or skin

• Blood in urine
• dark or amber urine
• irregular or slow heartbeat
• temporary loss of hearing (with kidney disease and high doses)
• lower back pain
• pain or burning while urinating
• pale stools
• recurrent fainting
• severe stomach pain
• swelling of front part of neck

Check with your doctor as soon as possible if any of the following side effects occur:

• Increased sensitivity to sunlight

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach cramping and discomfort
• diarrhea
• headache
• loss of appetite
• nausea or vomiting

• Sore mouth or tongue

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Erythromycin ethylsuccinate and sulfisoxazole acetyl, when reconstituted with water as directed on the label, the granules form a white, cherry flavored suspension that provides the equivalent of 200 mg erythromycin activity and the equivalent of 600 mg of sulfisoxazole activity per teaspoonful (5 mL).

Erythromycin is produced by a strain of Saccaropolyspora erythraea and belongs to the macrolide group of antibiotics. It is basic and readily forms salts and esters. Erythromycin ethylsuccinate is the 2’-ethylsuccinyl ester of erythromycin. It is essentially a tasteless form of the antibiotic suitable for oral administration, particularly in suspension dosage forms. The chemical name is erythromycin 2’-(ethylsuccinate). Erythromycin ethylsuccinate has the following structural formula:

C45H75NO16 Molecular Weight: 862.06

Sulfisoxazole acetyl or N1-acetyl sulfisoxazole is an ester of sulfisoxazole. Chemically, sulfisoxazole is N1-(3,4-dimethyl-5-isoxazotyl) sulfanilamide. Sulfisoxazole acetyl has the following structural formula:

C13H15N3O4S Molecular Weight: 309.34

Inactive Ingredients:

Artificial flavor, lactose anhydrous, methylparaben, polysorbate 80, povidone, simethicone, sodium citrate anhydrous and sucrose.

Erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension is contraindicated in the following patient populations:

Use in pregnant women at term, in children less than 2 months of age, and in mothers nursing infants less than 2 months of age is contraindicated because sulfonamides may promote kernicterus in the newborn by displacing bilirubin from plasma proteins.

Erythromycin is contraindicated in patients taking terfenadine. (See PRECAUTIONS, Drug Interactions:.)

E.S.P.® 200mg/600mg per 5mL Reconstituted, 100 mL Label Text

NDC 51285-445-22

E.S.P.®

Erythromycin Ethylsuccinate
and Sulfisoxazole Acetyl
for Oral Suspension, USP

200 mg erythromycin activity
and the equivalent of

600 mg sulfisoxazole
per 5 mL reconstituted
100 mL

(when mixed)

DURAMED® Rx only

Hypersensitivity to erythromycin, sulfonamides, or any component of the formulation; pregnant women at term; nursing mothers of infants <2 months of age; infants <2 months of age (sulfas compete with bilirubin for binding sites)

Note: Although the FDA approved product labeling states this medication is contraindicated with other sulfonamide-containing drug classes, the scientific basis of this statement has been challenged. See “Warnings/Precautions” for more detail.

No dosage adjustment provided in the manufacturer’s labeling.

No dosage adjustment provided in manufacturer's labeling; use with caution.

Reconstitute granules for oral suspension with appropriate amount of water as specified on the bottle. Shake well until suspended. Discard unused suspension after 14 days.

Administer without regard to meals. Shake well before use.

Prior to reconstitution, store at room temperature. After reconstitution, store in refrigerator for up to 14 days.