Drugs Details

Drugs Info of Pediazole
Drugs Details
  • Drugs Type  : Multum
  • Date : 7th Feb 2015 03:57 am
  • Brand Name : Pediazole
  • Generic Name : erythromycin and sulfisoxazole (Pronunciation: ee RITH roe MYE sin and SUL fa SOX i zole)
Descriptions

Pediazole (erythromycin and sulfisoxazole) is a combination of erythromycinethylsuccinate, USP, and sulfisoxazole acetyl, USP. When reconstituted with water as directed on the label, the granules form a white, strawberry-banana flavor 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'-(ethyl succinate).

Sulfisoxazole acetyl or N 1 -acetyl sulfisoxazole is an ester of sulfisoxazole. Chemically, sulfisoxazole is N-(3,4-Dimethyl-5-isoxazolyl)-N-sulfanilylacetamide.

Inactive Ingredients:   Citric acid, magnesium aluminum silicate, poloxamer,sodium carboxymethylcellulose, sodium citrate, sucrose and artificial flavoring.

 

What are the possible side effects of erythromycin and sulfisoxazole (Pediazole)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • dizziness, fainting, fast or pounding heartbeat;
  • diarrhea that is watery or bloody;
  • confusion, hallucinations;
  • muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine;
  • white patches or sores inside your mouth or on your lips;
  • fever, sore throat, and...

Read All Potential Side Effects and See Pictures of Pediazole »

What are the precautions when taking erythromycin and sulfisoxazole (Pediazole)?

Before taking erythromycin with sulfisoxazole, tell the doctor or pharmacist if your child is allergic to it; or to other macrolide antibiotics (such as azithromycin, clarithromycin) or sulfa medications; or if your child has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your child's pharmacist for more details.

Before using this medication, tell the doctor or pharmacist your child's medical history, especially of: severe allergies, asthma, blood disorders (such as porphyria, bone marrow suppression/low blood cell counts), a certain genetic condition (glucose-6-phosphate dehydrogenase/G6PD deficiency), kidney disease, liver disease, a certain type of muscle disease (myasthenia...

Read All Potential Precautions of Pediazole »

 

This monograph has been modified to include the generic and brand name in many instances.

Indications

For treatment of ACUTE OTITIS MEDIA in children that is caused by susceptible strains of Haemophilus influenzae.

Dosage Administration

PEDIAZOLE (erythromycin and sulfisoxazole) SHOULD NOT BE ADMINISTERED TO INFANTS UNDER 2 MONTHS OF AGE BECAUSE OF CONTRAINDICATIONS OF SYSTEMIC SULFONAMIDES IN THIS AGE GROUP.

For Acute Otitis Media in Children:   The dose of Pediazole (erythromycin and sulfisoxazole) can be calculated based on the erythromycin component (50 mg/kg/day) or the sulfisoxazole component (150 mg/kg/day to a maximum of 6 g/day). The total daily dose of Pediazole (erythromycin and sulfisoxazole) should be administered in equally divided doses three or four times a day for 10 days.Pediazole (erythromycin and sulfisoxazole) may be administered without regard to meals. 

The following approximate dosage schedules are recommended for using Pediazole (erythromycin and sulfisoxazole) : 

Children: Two months of age or older

FOUR-TIMES-A-DAY SCHEDULE 

Weight Dose--every 6 hours
Less than 8 kg (<18 lbs) Adjust dosage by body weight
8 kg (18 lbs) 1 / 2 teaspoonful (2.5 mL)
16 kg (35 lbs) 1 teaspoonful (5 mL)
24 kg (53 lbs) 1 1 / 2 teaspoonfuls (7.5 mL)
Over 32 kg (over 70 lbs) 2 teaspoonfuls (10 mL)


 

THREE-TIMES-A-DAY SCHEDULE 

Weight Dose--every 8 hours
Less than 6 kg (<13 lbs) Adjust dosage by body weight
6 kg (13 lbs) 1 / 2 teaspoonful (2.5 mL)
12 kg (26 lbs) 1 teaspoonful (5 mL)
18 kg (40 lbs) 1 1 / 2 teaspoonfuls (7.5 mL)
24 kg (53 lbs) 2 teaspoonfuls (10 mL)
Over 30 kg (over 66 lbs) 2 1 / 2 teaspoonfuls (12.5 mL)

 

TO PATIENT: Shake before using. Oversize bottle provides shake space. Keep tightly closed. Store in the refrigerator. Use within 14 days. Unused portion should be discarded after 14 days.

How Supplied

Pediazole (erythromycin and sulfisoxazole) Suspension is available for teaspoondosage in 100-mL ( NDC 0074-8030-13), 150-mL ( NDC 0074-8030-43), 200-mL (NDC 0074-8030-53) and 250-mL ( NDC 0074-8030-73) bottles, in the form of granules to be reconstituted with water. The suspension provides erythromycin ethylsuccinate equivalent to 200 mg erythromycin activity and sulfisoxazole acetyl equivalent to 600 mg sulfisoxazole per teaspoonful (5 mL).

Before mixing, store below 86°F (30°C).

 

REFERENCES

 

  1. Biovert A, Barbeau G, Belanger PM: Pharmacokinetics of sulfisoxazole in young and elderly subjects. Gerontology 1984;30:125-131.
  2. Oie S, Gambertoglio JG, Fleckenstein L: Comparison of the disposition of total and unbound sulfisoxazole after single and multiple dosing. J Pharmacokinet Biopharm 1982;10:157-172.
  3. National Committee for Clinical Laboratory Standards: Performance Standards for Antimicrobial Disk Susceptibility Tests, ed. 4. Approved Standard NCCLS Document M2-A4, Vol 10, No. 7. Villanova, Pa: NCCLS, 1990.

July, 1994

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Erythromycin ethylsuccinate:   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 hepaticdysfunction and/or abnormal liver-function test results may occur (seeWARNINGS section). Pseudomembranous colitis has been rarely reported in association with erythromycin therapy.

Allergic reactions ranging from urticaria and mild skin eruptions to anaphylaxishave occurred.

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

Onset of pseudomembranous colitis symptoms may occur during or afterantibiotic treatment. (See WARNINGS .)

Sulfisoxazole acetyl:   Included in the listing that follows are adverse reactions that have been reported with other sulfonamide products: pharmacologic similarities require that each of the reactions be considered with Pediazole (erythromycin and sulfisoxazole) administration.

Allergic/Dermatologic:   Anaphylaxis, erythema multiforme (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis,angioedema, arteritis, vasculitis, allergic myocarditis, serum sickness, rash, urticaria, pruritus, photosensitivity, and conjunctival and scleral injection. In addition, periarteritis nodosa and systemic lupus erythematosus have been reported. (See WARNINGS.)

Cardiovascular:   Tachycardia, palpitations, syncope, and cyanosis.

Rarely, erythromycin has been associated with the production of ventricular arrhythmias, including ventricular tachycardia and torsade de pointes, in individuals with prolonged QT intervals.

Endocrine:   The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides) and oral hypoglycemicagents. Cross-sensitivity may exist with these agents. Developments of goiter,diuresis, and hypoglycemia have occurred rarely in patients receiving sulfonamides.

Gastrointestinal:   Hepatitis, hepatocellular necrosis, jaundice, pseudomembranous colitis, nausea, emesis, anorexia, abdominal pain, diarrhea, gastrointestinal hemorrhage, melena, flatulence, glossitis, stomatitis, salivary gland enlargement, and pancreatitis. Onset of pseudomembranous colitis symptoms may occur during or after treatment with sulfisoxazole, a component of Pediazole. (See WARNINGS.)

The sulfisoxazole acetyl component of Pediazole (erythromycin and sulfisoxazole) has been reported to cause increased elevation of liver-associated enzymes in patients with hepatitis.

Genitourinary:   Crystalluria, hematuria, BUN and creatinine elevations, nephritis, and toxic nephrosis with oliguria and anuria. Acute renal failure and urinaryretention have also been reported.

The frequency of renal complications, commonly associated with some sulfonamides, is lower in patients receiving the more soluble sulfonamides such as sulfisoxazole.

Hematologic:   Leukopenia, agranulocytosis, aplastic anemia, thrombocytopenia,purpura, hemolytic anemia, anemia, eosinophilia, clotting disorders including hypoprothrombinemia and hypofibrinogenemia, sulfhemoglobinemia, andmethemoglobinemia.

Neurologic:   Headache, dizziness, peripheral neuritis, paresthesia, convulsions,tinnitus, vertigo, ataxia, and intracranial hypertension.

Psychiatric:   Psychosis, hallucinations, disorientation, depression, and anxiety.

Respiratory:   Cough, shortness of breath, and pulmonary infiltrates. (SeeWARNINGS.)

Vascular:   Angioedema, arteritis, and vasculitis.

Miscellaneous:   Edema (including periorbital), pyrexia, drowsiness, weakness,fatigue, lassitude, rigors, flushing, hearing loss, insomnia, and pneumonitis.

 

Read the Pediazole (erythromycin and sulfisoxazole) Side Effects Center for a complete guide to possible side effects

Learn More »
 
 
 

Interactions

Drug Interactions:   Erythromycin use in patients who are receiving high doses of theophylline may be associated with an increase in serum theophylline levels and potential theophylline toxicity. In case of theophylline toxicity and/or elevated serum theophylline levels, the dose of theophylline should be reduced while the patient is receiving concomitant erythromycin therapy.

Concomitant administration of erythromycin and digoxin has been reported to result in elevated digoxin serum levels.

There have been reports of increased anticoagulant effects when erythromycin and oral anticoagulants were used concomitantly. Increased anticoagulation effects due to this drug may be more pronounced in the elderly.

Concurrent use of erythromycin and ergotamine or dihydroergotamine has been associated in some patients with acute ergot toxicity characterized by severe peripheral vasospasm and dysesthesia.

Erythromycin has been reported to decrease the clearance of triazolam and midazolam and thus may increase the pharmacologic effect of thesebenzodiazepines.

The use of erythromycin in patients concurrently taking drugs metabolized by the cytochrome P450 system may be associated with elevations in serum levels of these other drugs. There have been reports of interactions of erythromycin with carbamazepine, cyclosporine, hexobarbital, phenytoin, alfentanil, diisopyramide, lovastatin, and bromocriptine. Serum concentrations of drugs metabolized by the cytochrome P450 system should be monitored closely in patients concurrently receiving erythromycin.

Erythromycin significantly alters the metabolism of terfenadine when taken concomitantly. Rare cases of serious cardiovascular adverse events, including death, cardiac arrest, torsades de pointes, and other ventricular arrhythmias, have been observed. (See CONTRAINDICATIONS.)

It has been reported that sulfisoxazole may prolong the prothrombin time in patients who are receiving the anticoagulant warfarin. This interaction should be kept in mind when Pediazole (erythromycin and sulfisoxazole) is given to patients already on anticoagulant therapy, and the coagulation time should be reassessed.

It has been proposed that sulfisoxazole competes with thiopental for plasmaprotein binding. In one study involving 48 patients, intravenous sulfisoxazole resulted in a decrease in the amount of thiopental required for anesthesia and in a shortening of the awakening time. It is not known whether chronic oral doses of sulfisoxazole have a similar effect. Until more is known about this interaction, physicians should be aware that patients receiving sulfisoxazole might require less thiopental for anesthesia.

Sulfonamides can displace methotrexate from plasma protein binding sites, thus increasing free methotrexate concentrations. Studies in man have shown sulfisoxazole infusions to decrease plasma protein-bound methotrexate by one fourth.

Sulfisoxazole can also potentiate the blood-sugar-lowering activity of sulfonylureas.

Read the Pediazole Drug Interactions Center for a complete guide to possible interactions

Learn More »
 

This monograph has been modified to include the generic and brand name in many instances.

Warnings

FATALITIES ASSOCIATED WITH THE ADMINISTRATION OFSULFONAMIDES, ALTHOUGH RARE, HAVE OCCURRED DUE TO SEVERE REACTIONS INCLUDING STEVENS-JOHNSON SYNDROME, TOXICEPIDERMAL NECROLYSIS, FULMINANT HEPATIC NECROSIS,AGRANULOCYTOSIS, APLASTIC ANEMIA, AND OTHER BLOODDYSCRASIAS.

SULFONAMIDES, INCLUDING SULFONAMIDE-CONTAINING PRODUCTS SUCH AS PEDIAZOLE (erythromycin and sulfisoxazole) , SHOULD BE DISCONTINUED AT THE FIRST APPEARANCE OF SKIN RASH OR ANYSIGN OF ADVERSE REACTION. In rare instances, a skin rash may be followed by a more severe reaction, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, hepatic necrosis, and serious blood disorders. (See

PRECAUTIONS

.)

 

Clinical signs such as sore throat, fever, pallor, rash, purpura, or jaundice may be early indications of serious reactions.

There have been reports of hepatic dysfunction with or without jaundice, occurring in patients receiving oral erythromycin products.

Cough, shortness of breath, and pulmonary infiltrates are hypersensitivity reactions of the respiratory tract that have been reported in association with sulfonamide treatment.

The sulfonamides should not be used for the treatment of group A beta-hemolytic streptococcal infections. In an established infection, they will not eradicate thestreptococcus and, therefore, will not prevent sequelae such as rheumatic fever.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including Pediazole (erythromycin and sulfisoxazole) , and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced byClostridium difficile is one primary cause of "antibiotic-associated colitis."

After diagnosis of pseudomembranous colitis has been established, therapeuticmeasures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, proteinsupplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.

There have been reports suggesting that erythromycin does not reach the fetus in adequate concentration to prevent congenital syphilis. Infants born to women treated during pregnancy with erythromycin for early syphilis should be treated with an appropriate penicillin regimen.

Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving erythromycin concomitantly with lovastatin. Therefore, patients receiving concomitant lovastatin and erythromycin should be carefully monitored for creatine kinase (CK) and serum transaminase levels. (See package insert for lovastatin.)

 

Precautions

General: Erythromycin is principally excreted by the liver. Caution should be exercised when erythromycin is administered to patients with impaired hepatic function. (See CLINICAL PHARMACOLOGY and WARNING sections.)

Prolonged or repeated use of erythromycin may result in an overgrowth of nonsusceptible bacteria or fungi. If superinfection occurs, erythromycin should be discontinued and appropriate therapy instituted.

There have been reports that erythromycin may aggravate the weakness of patients with myasthenia gravis.

When indicated, incision and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy.

Sulfonamides should be given with caution to patients with impaired renal or hepatic function and to those with severe allergy or bronchial asthma. In glucose-6-phosphate dehydrogenase-deficient individuals, hemolysis may occur; this reaction is frequently dose-related.

Information for Patients:   Patients should maintain an adequate fluid intake to prevent crystalluria and stone formation.

Laboratory Tests:   Complete blood counts should be done frequently in patients receiving sulfonamides. If a significant reduction in the count of any formed blood element is noted, Pediazole (erythromycin and sulfisoxazole) should be discontinued. Urinalysis with careful microscopic examination and renal function tests should be performed during therapy, particularly for those patients with impaired renal function. Blood levels should be measured in patients receiving a sulfonamide for serious infections. (See INDICATIONS AND USAGE.)

Drug/laboratory Test Interactions:   Erythromycin interferes with the fluorometric determination of urinary catecholamines.

 

Drug Interactions:   Erythromycin use in patients who are receiving high doses of theophylline may be associated with an increase in serum theophylline levels and potential theophylline toxicity. In case of theophylline toxicity and/or elevated serum theophylline levels, the dose of theophylline should be reduced while the patient is receiving concomitant erythromycin therapy.

Concomitant administration of erythromycin and digoxin has been reported to result in elevated digoxin serum levels.

There have been reports of increased anticoagulant effects when erythromycin and oral anticoagulants were used concomitantly. Increased anticoagulation effects due to this drug may be more pronounced in the elderly.

Concurrent use of erythromycin and ergotamine or dihydroergotamine has been associated in some patients with acute ergot toxicity characterized by severeperipheral vasospasm and dysesthesia.

Erythromycin has been reported to decrease the clearance of triazolam and midazolam and thus may increase the pharmacologic effect of thesebenzodiazepines.

The use of erythromycin in patients concurrently taking drugs metabolized by the cytochrome P450 system may be associated with elevations in serum levels of these other drugs. There have been reports of interactions of erythromycin with carbamazepine, cyclosporine, hexobarbital, phenytoin, alfentanil, diisopyramide, lovastatin, and bromocriptine. Serum concentrations of drugs metabolized by the cytochrome P450 system should be monitored closely in patients concurrently receiving erythromycin.

Erythromycin significantly alters the metabolism of terfenadine when taken concomitantly. Rare cases of serious cardiovascular adverse events, including death, cardiac arrest, torsades de pointes, and other ventricular arrhythmias, have been observed. (See CONTRAINDICATIONS.)

It has been reported that sulfisoxazole may prolong the prothrombin time in patients who are receiving the anticoagulant warfarin. This interaction should be kept in mind when Pediazole (erythromycin and sulfisoxazole) is given to patients already on anticoagulant therapy, and the coagulation time should be reassessed.

It has been proposed that sulfisoxazole competes with thiopental for plasmaprotein binding. In one study involving 48 patients, intravenous sulfisoxazole resulted in a decrease in the amount of thiopental required for anesthesia and in a shortening of the awakening time. It is not known whether chronic oral doses of sulfisoxazole have a similar effect. Until more is known about this interaction, physicians should be aware that patients receiving sulfisoxazole might require less thiopental for anesthesia.

Sulfonamides can displace methotrexate from plasma protein binding sites, thus increasing free methotrexate concentrations. Studies in man have shown sulfisoxazole infusions to decrease plasma protein-bound methotrexate by one fourth.

Sulfisoxazole can also potentiate the blood-sugar-lowering activity of sulfonylureas.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Carcinogenesis:  Pediazole (erythromycin and sulfisoxazole) has not undergone adequate trials relating to carcinogenicity; each component, however, has been evaluated separately. Long-term (21 month) oral studies conducted in rats with erythromycin ethylsuccinate did not provide evidence of tumorigenicity. Sulfisoxazole was not carcinogenic in either sex when administered to mice by gavage for 103 weeks at dosages up to approximately 18 times the recommended human dose or to rats at 4 times the human dose. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides, and long-term administration of sulfonamides has resulted in thyroid malignancies in this species.

Mutagenesis:  There are no studies available that adequately evaluate the mutagenic potential of Pediazole (erythromycin and sulfisoxazole) or either of its components. However, sulfisoxazole was not observed to be mutagenic in E. coli Sd-4-73 when tested in the absence of a metabolic activating system. There was no apparent effect on male or female fertility in rats fed erythromycin (base) at levels up to 0.25% of diet.

Impairment of Fertility:  Pediazole (erythromycin and sulfisoxazole) has not undergone adequate trials relating to impairment of fertility. In a reproduction study in rats given 7 times the human dose per day of sulfisoxazole, no effects were observed regarding mating behavior, conception rate or fertility index (percentpregnant).

Pregnancy:   Teratogenic Effects. Pregnancy Category C. At dosages 7 times the human daily dose, sulfisoxazole was not teratogenic in either rats or rabbits. However, in two other teratogenicity studies, cleft palates developed in both rats and mice after administration of 5 to 9 times the human therapeutic dose of sulfisoxazole.

There is no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed erythromycin base (up to 0.25% of diet) prior to and during mating, during gestation, and through weaning of two successive litters. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Erythromycin has been reported to cross the placental barrier in humans, but fetal plasma levels are generally low.

There are no adequate or well-controlled studies of Pediazole (erythromycin and sulfisoxazole) in either laboratory animals or in pregnant women. It is not known whether Pediazole (erythromycin and sulfisoxazole) can cause fetal harm when administered to a pregnant woman prior to term or can affect reproduction capacity. Pediazole (erythromycin and sulfisoxazole) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects:  Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with sulfonamides. (SeeCONTRAINDICATIONS.)

Labor and Delivery:   The effects of erythromycin and sulfisoxazole on labor and delivery are unknown.

Nursing Mothers:   Both erythromycin and sulfisoxazole are excreted in human milk. Because of the potential for the development of kernicterus in neonates due to the displacement of bilirubin from plasma proteins by sulfisoxazole, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. (SeeCONTRAINDICATIONS .)

Pediatric Use:   See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections. Not for use in children under 2 months of age. (SeeCONTRAINDICATIONS.)

 

 

 

This monograph has been modified to include the generic and brand name in many instances.

OverDose

No information is available on a specific result of overdose with Pediazole (erythromycin and sulfisoxazole) . Overdosage of erythromycin should be handled with the prompt elimination of unabsorbed drug and all other appropriate measures. Erythromycin is not removed by peritoneal dialysis or hemodialysis.

The amount of a single dose of sulfisoxazole that is either associated with symptoms of overdosage or is likely to be life-threatening has not been reported. Signs and symptoms of overdosage reported with sulfonamides include anorexia,colic, nausea, vomiting, dizziness, headache, drowsiness and unconsciousness. Pyrexia, hematuria and crystalluria may be noted. Blood dyscrasias and jaundiceare potential late manifestations of overdosage.

General principles of treatment include the immediate discontinuation of the drug, instituting gastric lavage or emesis, forcing oral fluids, and administeringintravenous fluids if urine output is low and renal function is normal. The patient should be monitored with blood counts and appropriate blood chemistries, including electrolytes. If the patient becomes cyanotic, the possibility ofmethemoglobinemia should be considered and, if present, the condition should be treated appropriately with intravenous 1% methylene blue. If a significant blood dyscrasia or jaundice occurs, specific therapy should be instituted for these complications. Peritoneal dialysis is not effective, and hemodialysis is only moderately effective in removing sulfonamides.

The acute toxicity of sulfisoxazole in animals is as follows:

 

 

 
    Species LD 50 ± S.E. 
· (mg/kg)
    mouse 5700 ± 235
    rats >10,000
    rabbits >2000

 

 
 

ContrainDications

Pediazole (erythromycin and sulfisoxazole) is contraindicated in the following patient populations:

Patients with a known hypersensitivity to either of its components, children younger than 2 months, pregnant women at term, and mothers nursing infants less than 2 months of age.

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 fromplasma proteins.

Erythromycin is contraindicated in patients taking terfenadine. ( SeePRECAUTIONS -- Drug Interactions. )

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Orally administered erythromycin ethylsuccinate suspensions are readily and reliably absorbed. Erythromycin ethylsuccinate products have demonstrated rapid and consistent absorption in both fasting and nonfasting conditions. However, higher serum concentrations are obtained when these products are given with food. Bioavailability data are available from Ross Products Division. Erythromycin is largely bound to plasma proteins. After absorption, erythromycin diffuses readily into most body fluids. In the absence of meningeal inflammation, low concentrations are normally achieved in the spinal fluid, but the passage of the drug across the blood-brain barrier increases in meningitis. Erythromycin crosses the placental barrier and is excreted in human milk. Erythromycin is not removed by peritoneal dialysis or hemodialysis.

In the presence of normal hepatic function, erythromycin is concentrated in theliver and is excreted in the bile; the effect of hepatic dysfunction on biliaryexcretion of erythromycin is not known. After oral administration, less than 5% of the administered dose can be recovered in the active form in the urine.

Wide variation in blood levels may result following identical doses of a sulfonamide. Blood levels should be measured in patients receiving these drugs for serious infections. Free sulfonamide blood levels of 50 to 150 mcg/mL may be considered therapeutically effective for most infections, with blood levels of 120 to 150 mcg/mL being optimal for serious infections. The maximum sulfonamide level should be 200 mcg/mL, because adverse reactions occur more frequently above this concentration.

Following oral administration, sulfisoxazole is rapidly and completely absorbed; thesmall intestine is the major site of absorption, but some of the drug is absorbed from the stomach. Sulfonamides are present in the blood as free, conjugated (acetylated and possibly other forms), and protein-bound forms. The amount present as "free" drug is considered to be the therapeutically active form. Approximately 85% of a dose of sulfisoxazole is bound to plasma proteins, primarily to albumin; 65% to 72% of the unbound portion is in the nonacetylated form.

Maximum plasma concentrations of intact sulfisoxazole following a single 2-g oral dose of sulfisoxazole to healthy adult volunteers ranged from 127 to 211 mcg/mL (mean, 169 mcg/mL), and the time of peak plasma concentration ranged from 1 to 4 hours (mean, 2.5 hours). The elimination half-life of sulfisoxazole ranged from 4.6 to 7.8 hours after oral administration. The elimination of sulfisoxazole has been shown to be slower in elderly subjects (63 to 75 years) with diminished renalfunction (creatine clearance 37 to 68 mL/min). 1 After multiple-dose oral administration of 500 mg q.i.d. to healthy volunteers, the average steady-state plasma concentrations of intact sulfisoxazole ranged from 49.9 to 88.8 mcg/mL (mean, 63.4 mcg/mL). 2

Sulfisoxazole and its acetylated metabolites are excreted primarily by the kidneys through glomerular filtration. Concentrations of sulfisoxazole are considerably higher in the urine than in the blood. The mean urinary recovery following oral administration of sulfisoxazole is 97% within 48 hours; 52% of this is intact drug, and the remainder is the N 4 -acetylated metabolite.

Sulfisoxazole is distributed only in extracellular body fluids. It is excreted in human milk. It readily crosses the placental barrier. In healthy subjects, cerebrospinal fluidconcentrations of sulfisoxazole vary; in patients with meningitis, however, concentrations of free drug in cerebrospinal fluid as high as 94 mcg/mL have been reported.

Microbiology:

Pediazole (erythromycin and sulfisoxazole) has been formulated to contain sulfisoxazole for concomitant use with erythromycin.

Erythromycin acts by inhibition of protein synthesis by binding 50 S ribosomal subunits of susceptible organisms. It does not affect nucleic acid synthesis. Antagonism has been demonstrated in vitro between erythromycin and clindamycin, lincomycin, and chloramphenicol.

The sulfonamides are bacteriostatic agents, and the spectrum of activity is similar for all. Sulfonamides inhibit bacterial synthesis of dihydrofolic acid by preventing the condensation of the pteridine with para -aminobenzoic acid through competitive inhibition of the enzyme dihydropteroate synthetase. Resistant strains have altered dihydropteroate synthetase with reduced affinity for sulfonamides or produce increased quantities of para -aminobenzoic acid.

Susceptibility Testing:

Quantitative methods that require measurement of zone diameter give the most precise estimates of the susceptibility of bacteria to antimicrobial agents. One such standardized single-disc procedure 3 has been recommended for use with discs to test susceptibility to erythromycin and sulfisoxazole. Interpretation involves correlation of the zone diameters obtained in the disc test with minimal inhibitory concentration (MIC) values for erythromycin and sulfisoxazole.

If the standardized procedure of disc susceptibility is used, a 15-mcg erythromycin disc should give a zone diameter of at least 18 mm when tested against an erythromycin-susceptible bacterial strain, and a 250-300 mcg sulfisoxazole disc should give a zone diameter of at least 17 mm when tested against a sulfisoxazole-susceptible bacterial strain.

In vitro sulfonamide susceptibility tests are not always reliable because media containing excessive amounts of thymidine are capable of reversing the inhibitory effect of sulfonamides, which may result in false resistant reports. The tests must be carefully coordinated with bacteriological and clinical responses. When the patient is already taking sulfonamides, follow-up cultures should have aminobenzoic acid added to the isolation media but not to subsequent susceptibility test media.

This monograph has been modified to include the generic and brand name in many instances.

 

Patient Information

Patients should maintain an adequate fluid intake to prevent crystalluria and stone formation.

Laboratory Tests:   Complete blood counts should be done frequently in patients receiving sulfonamides. If a significant reduction in the count of any formed blood element is noted, Pediazole (erythromycin and sulfisoxazole) should be discontinued. Urinalysis with careful microscopic examination and renal function tests should be performed during therapy, particularly for those patients with impaired renal function. Blood levels should be measured in patients receiving a sulfonamide for serious infections. (See INDICATIONS AND USAGE .)

Drug/laboratory Test Interactions:   Erythromycin interferes with the fluorometric determination of urinary catecholamines.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

ERYTHROMYCIN/SULFISOXAZOLE SUSPENSION - ORAL

 

(e-RITH-roe-MYE-sin /SUL-fi-SOX-a-zole)

 

COMMON BRAND NAME(S): Pediazole

 

USES: Erythromycin/sulfisoxazole is a combination antibiotic used to treat middle ear infections in children. This product contains a macrolide (erythromycin) and a sulfa-type (sulfisoxazole) antibiotic. It works by stopping the growth of bacteria.

This antibiotic combination treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

This medication should not be used by children younger than 2 months of age due to the risk of serious side effects.

 

HOW TO USE: Give this medication by mouth with or without food as directed by the doctor, usually 3 or 4 times a day. If nausea occurs, giving this medication with food or milk may reduce this side effect.

Shake the bottle well before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

To prevent kidney stones from forming, your child should drink plenty of liquids while taking this medication unless the doctor instructs you otherwise.

The dosage is based on your child's medical condition, weight, and response to treatment.

Antibiotics work best when the amount of medicine in the body is kept at a constant level. Therefore, give this medication at evenly spaced intervals. To help you remember, give the medication at the same times each day.

Continue to give this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.

Tell the doctor if your child's condition persists or worsens.

Consumer Overview Side Effect

SIDE EFFECTS: Nausea, vomiting, diarrhea, stomach pain/cramping, and loss of appetite may occur. Giving this medication with food may lessen these symptoms. Headache and dizziness may also occur. If any of these effects persist or worsen, tell the doctor or pharmacist promptly.

Remember that the doctor has prescribed this medication because he or she has judged that the benefit to your child is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell the doctor right away if your child has any serious side effects, including: sun sensitivity (sunburn), muscle weakness, slurred speech, blurred vision, drooping eyelids, eye redness, hearing loss, joint pain/aches, new lump/growth in the neck (goiter), change in the amount of urine, painful urination, pink/bloody urine, mental/mood changes (such as confusion), numbness or tingling of the hands/feet.

This medication may rarely decrease bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease the body's ability to fight an infection, or cause easy bruising/bleeding. Tell the doctor immediately if your child develops any of the following rare (possibly fatal) symptoms: unusual tiredness, pale skin, signs of infection (such as fever, chills, persistent sore throat), easy bleeding/bruising.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Tell the doctor right away if your child develops: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in stool.

Do not use anti-diarrhea products or narcotic pain medications if your child has any of these symptoms because these products may make them worse.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact the doctor if you notice white patches in your child's mouth, a change in vaginal discharge, or other new symptoms.

This medication may rarely cause very serious (possibly fatal) side effects. Get medical help right away if your child has any very serious side effects, including: severe dizziness, fainting, fast/irregular heartbeat, signs of lung injury (such as persistent cough), seizures, blue lips/skin, signs of liver disease (such as persistent nausea/vomiting, yellowing eyes or skin, dark urine, severe stomach/abdominal pain).

A very serious (possibly fatal) allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your child's doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Pediazole (erythromycin and sulfisoxazole) Side Effects Center for a complete guide to possible side effects

Learn More »
 

PRECAUTIONS: Before taking erythromycin with sulfisoxazole, tell the doctor or pharmacist if your child is allergic to it; or to other macrolide antibiotics (such as azithromycin, clarithromycin) or sulfa medications; or if your child has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your child's pharmacist for more details.

Before using this medication, tell the doctor or pharmacist your child's medical history, especially of: severe allergies, asthma, blood disorders (such as porphyria, bone marrow suppression/low blood cell counts), a certain genetic condition (glucose-6-phosphate dehydrogenase/G6PD deficiency), kidney disease, liver disease, a certain type of muscle disease (myasthenia gravis).

Erythromycin/sulfisoxazole may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if your child has certain medical conditions or is taking other drugs that may cause QT prolongation. Before using erythromycin/sulfisoxazole, tell the doctor or pharmacist of all the drugs your child takes and if your child has any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your child's risk of QT prolongation. This risk may increase if your child uses certain drugs (such as diuretics/"water pills") or if your child has conditions such as severe sweating, diarrhea, or vomiting. Talk to the doctor about using erythromycin/sulfisoxazole safely.

This medication may make your child more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Have your child use a sunscreen and wear protective clothing when outdoors.

Erythromycin/sulfisoxazole may cause live bacterial vaccines (such as typhoid vaccine) not to work as well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your child's doctor.

Before having surgery, tell your child's doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially hearing loss and QT prolongation (see above).

Infants may be more sensitive to the side effects of this drug, especially a stomach problem called IHPS (infantile hypertrophic pyloric stenosis). Contact your child's doctor immediately if your child has persistent vomiting or increased irritability with feeding.

During pregnancy, this medication should be used only when clearly needed. This medication must not be used near the time of delivery because of possible harm to the unborn baby. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. It may have undesirable effects on infants who are ill or premature or have certain disorders (jaundice, high blood levels of bilirubin, G6PD deficiency). Therefore, breast-feeding is not recommended for infants with these conditions. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how medications work or increase your child's risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products your child uses (including prescription/nonprescription drugs and herbal products) and share it with your child's doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without the doctor's approval.

Some products that may interact with this drug include: clindamycin, digoxin, methenamine, methotrexate, tretinoin.

Many drugs besides erythromycin may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, cisapride, pimozide, procainamide, propafenone, quinidine, sotalol, among others.

Other medications can affect the removal of erythromycin from your child's body, which may affect how erythromycin works. Examples include azole antifungals (such as itraconazole, ketoconazole), certain calcium channel blockers (such as diltiazem, verapamil), certain anti-seizure medications (such as carbamazepine, phenytoin), quinupristin-dalfopristin, among others.

Erythromycin can slow down the removal of other drugs from your child's body, which may affect how they work. Examples of affected drugs include bromocriptine, colchicine, certain benzodiazepines (such as midazolam, triazolam), eletriptan, ergot alkaloids (such as ergotamine, dihydroergotamine), certain drugs to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, tadalafil), certain "statin" drugs (such as lovastatin, simvastatin), vinblastine, among others.

Although most antibiotics probably do not affect hormonal birth control such as pills, patch, or ring, some antibiotics may decrease their effectiveness. This could cause pregnancy. Examples include rifamycins such as rifampin or rifabutin. Be sure to ask the doctor or pharmacist if your child should use additional reliable birth control methods while using this antibiotic.

This medication may interfere with certain laboratory tests (urine tests), possibly causing false test results. Make sure laboratory personnel and all doctors know your child is using this drug.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

This medication has been prescribed for your child's current condition only. Do not use it later for another infection unless your child's doctor directs you to do so. A different medication may be necessary in that case.

If this medication is used for an extended period, laboratory tests (such as blood counts) may be performed periodically to monitor your child's progress or check for side effects. Consult your child's doctor for more details.

 

MISSED DOSE: If your child misses a dose, give it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your child's usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store in the refrigerator. Throw away any unused medication after 14 days. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult the pharmacist or local waste disposal company.

 

Information last revised April 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Pediazole

Generic Name: erythromycin and sulfisoxazole (Pronunciation: ee RITH roe MYE sin and SUL fa SOX i zole)

  • What is erythromycin and sulfisoxazole (Pediazole)?
  • What are the possible side effects of erythromycin and sulfisoxazole (Pediazole)?
  • What is the most important information I should know about erythromycin and sulfisoxazole (Pediazole)?
  • What should I discuss with my healthcare provider before taking erythromycin and sulfisoxazole (Pediazole)?
  • How should I take erythromycin and sulfisoxazole (Pediazole)?
  • What happens if I miss a dose (Pediazole)?
  • What happens if I overdose (Pediazole)?
  • What should I avoid while taking erythromycin and sulfisoxazole (Pediazole)?
  • What other drugs will affect erythromycin and sulfisoxazole (Pediazole)?
  • Where can I get more information?

What is erythromycin and sulfisoxazole (Pediazole)?

 

Erythromycin is in a group of drugs called macrolide antibiotics. Erythromycin fights bacteria in the body.

Sulfisoxazole is a sulfa drug that also fights bacteria in the body.

The combination of erythromycin and sulfisoxazole is used to ear infections in children.

Erythromycin and sulfisoxazole may also be used for other purposes not listed in this medication guide.

What are the possible side effects of erythromycin and sulfisoxazole (Pediazole)?

 

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • dizziness, fainting, fast or pounding heartbeat;
  • diarrhea that is watery or bloody;
  • confusion, hallucinations;
  • muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine;
  • white patches or sores inside your mouth or on your lips;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • the first sign of any skin rash, no matter how mild;
  • pale skin, easy bruising or bleeding;
  • ringing in your ears, or problems with hearing;
  • numbness or tingly feeling in your hands or feet;
  • sore throat, swelling or lump in your throat or neck;
  • cough, feeling short of breath;
  • blood in your urine, pain in your side or lower back, pain when you urinate;
  • urinating less than usual or not at all; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild nausea, vomiting, diarrhea, or stomach pain;
  • headache, mild dizziness, spinning sensation; or
  • vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Pediazole (erythromycin and sulfisoxazole) Side Effects Center for a complete guide to possible side effects

Learn More »
 

What is the most important information I should know about erythromycin and sulfisoxazole (Pediazole)?

 

Do not take this medication if you are allergic to erythromycin or sulfisoxazole, if you are in your 9th month of pregnancy, or if you are breast-feeding a baby younger than 2 months old.

Before taking erythromycin and sulfisoxazole, tell your doctor if you have liver or kidney disease, diabetes, myasthenia gravis, a history of "Long QT Syndrome," or if you are allergic to sulfa drugs or other antibiotics such as azithromycin (Zithromax) or clarithromycin (Biaxin).

Take this medication for the full prescribed length of time. Your symptoms may get better before the infection is completely cleared. Erythromycin and sulfisoxazole will not treat a viral infection such as the common cold or flu.

Side Effects Centers
  • Pediazole

Patient Detailed How Take

What should I discuss with my healthcare provider before taking erythromycin and sulfisoxazole (Pediazole)?

 

Do not take this medication if you are allergic to erythromycin or sulfisoxazole, or if::

  • you are in your 9th month of pregnancy; or
  • you are breast-feeding a baby younger than 2 months old.

Erythromycin may interact with these medicines and could cause dangerous or life-threatening heart rhythm disorders.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

  • kidney disease;
  • liver disease;
  • diabetes;
  • myasthenia gravis;
  • a history of "Long QT Syndrome"; or
  • if you are allergic to sulfa drugs or other antibiotics such as azithromycin (Zithromax) or clarithromycin (Biaxin).

FDA pregnancy category C. It is not known whether erythromycin and sulfisoxazole is harmful to an unborn baby when taken in early pregnancy. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Do not take erythromycin and sulfisoxazole during late pregnancy.

Erythromycin and sulfisoxazole can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not take erythromycin and sulfisoxazole if you are breast-feeding a baby younger than 2 months old.

Older adults may be more likely to have side effects from this medication.

Do not give this medication to a child younger than 2 months old.

How should I take erythromycin and sulfisoxazole (Pediazole)?

 

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Take erythromycin and sulfisoxazole with a full glass (8 ounces) of water. Drink plenty of fluids every day while taking this medication.

Take this medication with food or milk if it upsets your stomach.

Shake the liquid medicine well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Erythromycin and sulfisoxazole is usually given 3 or 4 times daily. Try to take the medicine at evenly spaced intervals throughout the day.

Take this medication for the full prescribed length of time. Your symptoms may get better before the infection is completely cleared. Erythromycin and sulfisoxazole will not treat a viral infection such as the common cold or flu.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using erythromycin and sulfisoxazole. You may need to stop using the medicine for a short time.

Erythromycin and sulfisoxazole can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using erythromycin.

Store this medication in the refrigerator. Do not freeze. Throw away any unused medicine that is older than 14 days

Side Effects Centers
  • Pediazole

Patient Detailed Avoid Taking

What happens if I miss a dose (Pediazole)?

 

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Pediazole)?

 

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include dizziness, drowsiness, loss of appetite, nausea, vomiting, diarrhea, ringing in your ears, headache, stomach pain, fever, and fainting.

What should I avoid while taking erythromycin and sulfisoxazole (Pediazole)?

 

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, stop taking this medication and call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Avoid exposure to sunlight, sunlamps, or tanning beds. Erythromycin and sulfisoxazole can make your skin more sensitive to sunlight, and a sunburn may result. Wear protective clothing and use sunscreen (SPF 15 or higher) when you are outdoors.

What other drugs will affect erythromycin and sulfisoxazole (Pediazole)?

 

Many drugs can interact with erythromycin. Below is just a partial list. Tell your doctor if you are using:

  • bromocriptine (Parlodel);
  • colchicine (Colcrys);
  • alprazolam (Xanax), midazolam (Versed), or triazolam (Halcion);
  • a blood thinner such as warfarin (Coumadin);
  • cyclosporine (Gengraf, Neoral, Sandimmune);
  • digoxin (Lanoxin);
  • methotrexate (Rheumatrex, Trexall);
  • theophylline (Elixophyllin, Theo-24, Uniphyl);
  • antifungal medication such as itraconazole (Sporanox), fluconazole (Diflucan), ketoconazole (Nizoral), or voriconazole (Vfend);
  • any other antibiotic, especially clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), levofloxacin (Levaquin), moxifloxacin (Avelox), or rifabutin (Mycobutin);
  • a blood thinner such as warfarin (Coumadin);
  • diabetes medication you take by mouth;
  • a diuretic (water pill);
  • a cholesterol-lowering medication such as lovastatin (Mevacor) or simvastatin (Zocor);
  • heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), diltiazem (Cartia, Cardizem), dofetilide (Tikosyn), felodipine (Plendil), nifedipine (Nifedical, Procardia), sotalol (Betapace), or verapamil (Calan, Covera, Isoptin, Verelan);
  • heart rhythm medicine such as disopyramide (Norpace), procainamide (Procan, Pronestyl), propafenone (Rythmol), quinidine (Quinidex, Quin-Release Quin-G);
  • migraine headache medicine such as eletriptan (Relpax), ergotamine (Ercaf, Cafergot, Ergostat, Ergomar) or dihydroergotamine (D.H.E. 45, Migranal); or
  • seizure medication such as carbamazepine (Tegretol), phenytoin (Dilantin), or valproic acid (Depakote, Depakene).

This list is not complete and there are many other drugs that can interact with erythromycin and sulfisoxazole. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?

 

Your pharmacist can provide more information about erythromycin and sulfisoxazole.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 2.02. Revision date: 12/15/2010.

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Side Effects Centers
  • Pediazole

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