WARNINGS
QT prolongation, ventricular tachycardia, and torsades de pointes have been reported with macrolides, including erythromycin (see the sections SIDE EFFECTS and PRECAUTIONS, DRUG INTERACTIONS).
ERTHROMYCIN ORAL should be administered with caution to any patient who has demonstrated some form of allergy to drugs. If an allergic reaction to erythromycin occurs, administration of the drug should be discontinued. Serious hypersensitivity reactions may require epinephrine, antihistamines, or corticosteroids.
Infants born to women treated during pregnancy with oral erythromycin for early syphilis should be treated with an appropriate penicillin regimen since erythromycin does not reach the fetus in adequate concentration.
There have been reports of hepatic dysfunction, with or without jaundice, occurring in patients receiving erythromycin products, particularly erythromycin estolate. If findings suggestive of significant hepatic dysfunction occur, therapy with erythromycin products should be discontinued
USES
ERTHROMYCIN ORAL is used to treat the following infections caused by susceptible strains of the designated microorganisms:
· Upper Respiratory Tract Infections: those of mild to moderate severity caused by Streptococcus pyogenes (group A beta-hemolytic streptococci); Streptococcus pneumoniae (Diplococcus pneumoniae); and Hemophilus influenzae. Not all strains of Hemophilus influenzae are susceptible to erythromycin with usual therapeutic doses.
· Lower Respiratory Tract Infections: those of mild to moderate severity when caused by Streptococcus pyogenes (group A beta-hemolytic streptococci); Streptococcus pneumoniae ( Diplococcus pneumoniae); and Mycoplasma pneumoniae (Eaton's agent).
· Pertussis (Whooping Cough): caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals.
· Diphtheria: As an adjunct to antitoxin in infections due to Corynebacterium diphtheriae, to prevent establishment of carriers and to eradicate the organism in carriers.
· Legionnaires' Disease: caused by Legionella pneumophila. Controlled clinical efficacy studies have not been conducted. In vitro and limited preliminary clinical data suggest that erythromycin can be effective in the treatment of Legionnaires' disease.
· Skin and Soft Tissue Infections: those of mild to moderate severity when caused by Streptococcus pyogenes and Staphylococcus aureus (resistance of staphylococci may emerge during treatment). Erythrasma: in the treatment of infections due to Corynebacterium minutissimum. The treatment of Acne vulgaris.
· Sexually Transmitted Diseases: Primary Syphilis: caused by Treponema pallidum. Erythromycin is an alternate choice for treatment for primary syphilis in patients allergic to the penicillins. Spinal fluid should be examined before treatment and as part of the follow-up after therapy.
Chlamydia Trachomatis Infection: Erythromycin is an alternate choice in the treatment of the following infections when caused by Chlamydia trachomatis: a) In infants and children (9 years and older) for conjunctivitis. NOTE: Topical therapy alone for conjunctivitis is NOT adequate. b) In pregnant women and nursing mothers for urethral, endocervical or rectal infections. c) In youths and adults, for urethral, endocervical or rectal infections.
Specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify the causative organisms and to determine their susceptibility to erythromycin. Therapy may be instituted before results of susceptibility studies are known; however, antibiotic treatment should be re-evaluated when the results become available or if the clinical response is not adequate.
HOW TO USE
Adults: The usual dose is 250 mg every 6 hours or 333 mg every 8 hours. If twice-a-day dosage is desired, the recommended dose is 500 mg every 12 hours. Dosage may be increased up to 4 g per day, depending on the severity of infection. Twice-a-day dosing is not recommended when doses larger than 1 g daily are administered.
Children: Age, weight, and severity of the infection are important factors in determining the proper dosage. The usual dosage is 30-50 mg/kg/day in equally divided doses. For the treatment of more severe infections, this dosage may be doubled.
Erythromycin may cause side effects. If they occur, they are likely to be minor and temporary. However, some may be serious and need medical attention.
Erythromycin may cause:
· liver problems and liver dysfunction with symptoms such as
nausea,
vomiting,
abdominal pain and discomfort,
jaundice (yellowing of the skin and eyes),
diarrhea,
inflammation of the pancreas,
itching and skin rashes,
hearing problems (associated with very high doses),
confusion,
hallucinations,
vertigo (dizziness, balance problem) and seizure,
· irregularities of the heartbeat (palpitations),
· hypersensitivity (allergic reaction) with symptoms such as swollen mouth, throat, lips, difficulty breathing, skin reactions (rash, blisters, hives.)
· Long-term use of erythromycin has been associated with the growth of not sensitive bacteria or fungi and bacteria initially sensitive to erythromycin. If such infections occur, stop taking erythromycin and call your doctor or pharmacist.
General information about ERTHROMYCIN ORAL
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ERTHROMYCIN ORAL for a condition for which it was not prescribed. Do not give ERTHROMYCIN ORAL to other people, even if they have the same condition. It may harm them. This Medication Guide summarizes the most important information about ERTHROMYCIN ORAL . If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ERTHROMYCIN ORAL that was written for healthcare professionals.
Active ingredient: erythromycin
Inactive ingredients: microcrystalline cellulose, croscarmellose sodium, steraic acid, magnesium stearate, colloidal silicon dioxide, Hydroxypropyl methylcellose 2910 E5, polyethylene glycol 3350, titanium dioxide, carnuba wax and D &C Red #30 Aluminum Lake
OVERDOSE
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
MISSED DOSE
If you have missed a dose, take it as soon as you remember unless it is time to take the next one. Continue with the remaining doses as before. Do not take more than one dose at a time.
STORAGE
Store at room temperature 59-degrees F to 86-degrees F (15-degrees C to 30-degrees C) in a tightly closed container.
NOTES
Medication Guide: revision date 01/2014
Prescribing Information: revision date 01/2014
DRUG INTERACTIONS
Terfenadine: Terfenadine undergoes metabolism in the liver by a specific cytochrome P450 isoenzyme. This metabolic pathway may be impaired in patients who are taking erythromycin, an inhibitor of this isoenzyme. Interference with this enzyme can lead to elevated terfenadine plasma levels which may be associated with QT prolongation, and increased risk of ventricular tachyarrythmias (such as torsades de pointes, ventricular tachycardia, and ventricular fibrillation).
Astemizole: Concomitant administration of astemizole with erythromycin is contraindicated because erythromycin is known to impair the Cytochrome P450 enzyme system which also influences astemizole metabolism. There have been two reports to date of syncope with torsades de pointes requiring hospitalization in patients taking astemizole with erythromycin. In each case the QT intervals were prolonged beyond 650 milliseconds at the time of the event; one patient also received ketoconazole and the other patient also had hypokalemia.
Rare cases of serious cardiovascular adverse events, including death, cardiac arrest and other ventricular arrhythmias have been observed.
Theophylline: The concomitant administration of erythromycin and high doses of theophylline may be associated with increased serum theophylline levels and possible theophylline toxicity. The dose of theophylline may require reduction while patients are receiving erythromycin. Carbamazepine: Erythromycin administration in patients receiving carbamazepine has been reported to cause increased serum levels of carbamazepine with subsequent development of signs of carbamazepine toxicity. Digoxin/Phenytoin: Concomitant administration of erythromycin and digoxin or phenytoin has been reported to result in elevated serum levels of these agents, leading to toxicity in some patients. Oral Anticoagulants: There have been reports of increased prothrombin time when erythromycin and oral anticoagulants were used concomitantly. Increased anticoagulation effects due to this drug may be more pronounced in the elderly (see the section PRECAUTIONS).
Ergotamine/dihydroergotamine: There are reports that ischemic reactions may occur when erythromycin is given concurrently with ergotamine-containing drugs. Cyclosporin: A rise in plasma cyclosporin levels has been reported during concomitant administration of erythromycin. Lincomycin/Clindamycin/Chloramphenicol: Erythromycin should be used with caution if administered concomitantly with lincomycin, clindamycin, or chloramphenicol. In vitro experiments have demonstrated that binding sites for erythromycin, lincomycin, clindamycin and chloramphenicol overlap and competitive inhibition may occur. Triazolam/Midazolam: Erythromycin has been reported to decrease the clearance of triazolam and midazolam and thus may increase the pharmacologic effect of these drugs.
Alfentanil: The concomitant use of erythromycin with alfentanil can significantly inhibit the clearance of alfentanil and may increase the risk of prolonged or delayed respiratory depression. Lovastatin: Patients receiving concomitant lovastatin and erythromycin should be carefully monitored; cases of rhabdomyolysis have been reported in seriously ill patients. Cisapride/Pimozide: Rare cases of serious cardiovascular adverse events, including death, cardiac arrest, torsades de pointes, and other ventricular arrhythmias have been observed in patients taking cisapride concomitantly with macrolide antibiotics including erythromycin. Atorvastatin: In healthy individuals, coadministration of erythromycin (500 mg QID) was associated with higher plasma concentrations of atorvastatin.
Quinidine: Drug interaction occurring with the concomitant administration of erythromycin and quinidine in their usual oral forms, resulting in QT prolongation, torsades de pointes and cardiac arrest has been reported. Caution and close monitoring is recommended when the drugs are administered concomitantly. The use of erythromycin in patients taking concurrent drugs which are metabolized by cytochrome P450 (3A4) system may be associated with elevations in serum levels of these other drugs (e.g. pimozide, ergotamine, dihydroergotamine). There have been reports of interactions of erythromycin with cyclosporine, tacrolimus, hexobarbital and phenytoin. Serum concentrations of drugs metabolized by the cytochrome P450 system should be monitored closely in patients concurrently receiving erythromycin.
Pregnancy The safety of erythromycin for use during pregnancy has not been established. Erythromycin crosses the placental barrier.
Nursing Mothers The safety of erythromycin for use during breast feeding has not been established. Erythromycin is excreted in breast milk.
Neonates The safety of erythromycin for use in neonates has not been established. Geriatrics: Clinical studies with erythromycin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of the decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. There have been reports of prolonged QT syndrome in geriatric patients receiving erythromycin products. Elderly patients may experience increased effects of oral anticoagulant therapy while undergoing treatment with erythromycin (see the section PRECAUTIONS).
Prolonged or repeated use of erythromycin may result in an overgrowth of non-susceptible bacteria or fungi and organisms initially sensitive to erythromycin. If superinfection occurs, erythromycin should be discontinued and appropriate therapy instituted. Exacerbation of symptoms of myasthenia gravis and new onset of symptoms of myasthenic syndrome has been reported in patients receiving erythromycin therapy. Since erythromycin is principally excreted by the liver, caution should be exercised when erythromycin is administered to patients with impaired hepatic function. Laboratory Tests: Erythromycin interferes with the fluorometric determination of urinary catecholamines.
Erythromycin Oral should be administered with caution to any patient who has demonstrated some form of allergy to drugs. If an allergic reaction to erythromycin occurs, administration of the drug should be discontinued. Serious hypersensitivity reactions may require epinephrine, antihistamines, or corticosteroids. Infants born to women treated during pregnancy with oral erythromycin for early syphilis should be treated with an appropriate penicillin regimen since erythromycin does not reach the fetus in adequate concentration.
