Eryc

Eryc is a prescription medication used to treat infections caused by bacteria. Eryc belongs to a group of drugs called macrolide antibiotics. These work by killing or stopping the growth of the bacteria that cause infections.

This medication comes as a long-acting capsule for oral use. It is usually taken 2 to 4 times daily.

Do not chew, divide, or break the long-acting capsules. Swallow these whole and take with a full glass of water.

Common side effects of Eryc include nausea, diarrhea, vomiting, and stomach pain.

Oral:

Serious side effects have been reported with erythromycin including the following:

• Severe skin rash
• Itching
• Hives
• Difficulty breathing or swallowing
• Wheezing
• Yellowing of the skin or eyes
• Dark skin
• Pale stools
• Unusual tiredness
• Vaginal infections

Topical:

Serious side effects have been reported with erythromycin including the following:

• Irritation at the site of application, including dryness, redness, itching, and burning
• Redness, itching, stinging, or burning of the eye

Ophthalmic erythromycin can also cause blurred vision. Do not drive or operate heavy machinery until you know how erythromycin affects you.

Injectable:

Serious side effects have been reported with erythromycin including the following:

• Cardiac complications, including QT prolongation and ventricular arrhythmias
• Allergic reactions with skin reactions ranging from mild rash to widespread redness, necrosis, and detachment of the epidermis

Do not take erythromycin if you:

• are allergic to erythromycin or to any of its ingredients
• are taking terfenadine (Seldane)
• are taking astemizole (Hismanal)

If you take too much erythromycin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If erythromycin is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

You should not take erythromycin if you are allergic to it, or if you are also using cisapride (Propulsid), dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, Cafergot, Migergot), or pimozide (Orap). Erythromycin may interact with these medicines and could cause dangerous or life-threatening heart rhythm disorders.

Before you take erythromycin, tell your doctor if you have liver disease, myasthenia gravis, a heart rhythm disorder, a history of Long QT syndrome, or low levels of potassium or magnesium in your blood.

Take this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Erythromycin will not treat a viral infection such as the common cold or flu.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking erythromycin and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

This section provides information on the proper use of a number of products that contain erythromycin. It may not be specific to Eryc. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Take this medicine with or without food.

Measure the mixed suspension with a marked measuring spoon, oral syringe, or medicine cup.

Keep using the medicine for the full time of treatment, even if you or your child begin to feel better after the first few doses. Your infection may not go away if you stop using the medicine too soon.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (granules for suspension, suspension, and tablets):
  • For treatment of bacterial infections:
    • Adults—400 milligrams (mg) every 6 hours or 800 mg every 12 hours. Depending on the severity of your infection, your doctor may increase your dose as needed up to 4000 mg per day.
    • Children—Dose is based on body weight and must be determined by your doctor. The dose is usually 30 to 50 milligrams (mg) per kilogram (kg) of body weight per day, divided in equal doses and taken every 6 hours. Depending on the severity of your infection, your doctor may increase your dose as needed.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the mixed E.E.S.® suspension in the refrigerator. Throw away any unused medicine within 10 days.

Store the mixed Ery-Ped® suspension at room temperature. Throw away any unused medicine within 35 days.

It is very important that your doctor check the progress of you or your child at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects. If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Do not use this medicine if you or your child are also using astemizole (Hismanal®), cisapride (Propulsid®), pimozide (Orap®), or terfenadine (Seldane®). Using these medicines together may increase risk for more serious side effects.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you or your child have worsening symptoms of heart rhythm problems, such as fast, pounding, or uneven heartbeats.

Make sure your doctor knows if you are pregnant or may be pregnant before taking this medicine.

Erythromycin may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop using this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Before you have any medical tests, tell the medical doctor in charge that you or your child are using this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Erythromycin is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below:

Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae, or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information).

Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes.

Listeriosis caused by Listeria monocytogenes.

Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the pro-phylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae.

Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment).

Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers.

Erythrasma: In the treatment of infections due to Corynebacterium minutissimum.

Syphilis caused by Treponema pallidum: Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy.

Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents.

Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythromycin lactobionate for injection, USP followed by erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months.

Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis.

When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongono-coccal urethritis caused by Ureaplasma urealyticum.

Legionnaires’ Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires’ Disease.

Prophylaxis:

Prevention of Initial Attacks of Rheumatic Fever: Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for ten days.

Prevention of Recurrent Attacks of Rheumatic Fever: Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Eryc and other antibacterial drugs, Eryc should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Erythromycin is contraindicated in patients with known hypersensitivity to this antibiotic.

Erythromycin is contraindicated in patients taking terfenadine or astemizole. (SeePRECAUTIONS, Drug interactions).

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

Erythromycin is not removed by peritoneal dialysis or hemodialysis.

Applies to erythromycin: compounding powder, injectable powder for injection, oral capsule, oral delayed release capsule, oral delayed release tablet, oral granule for reconstitution, oral suspension, oral tablet, oral tablet chewable, oral tablet coated particles

General

The most common side effects associated with oral erythromycin (the active ingredient contained in Eryc) were gastrointestinal and were dose-related.[Ref]

Gastrointestinal

Onset of pseudomembranous colitis symptoms has been reported during or after antibacterial therapy.[Ref]

Rare (less than 0.1%): Pancreatitis, pancreatitis without biliary obstruction
Frequency not reported: Nausea, abdominal pain, diarrhea, vomiting, anorexia, infantile hypertrophic pyloric stenosis, pseudomembranous colitis, Clostridium difficile associated diarrhea (ranging from mild diarrhea to fatal colitis)[Ref]

Cardiovascular

Life-threatening episodes of ventricular tachycardia associated with prolonged QT interval (torsades de pointes) have been reported following IV administration of erythromycin (the active ingredient contained in Eryc) lactobionate.

QT prolongation has been reported both in otherwise healthy patients and in patients with a history of heart disease or who were on other potentially arrhythmogenic drugs. Most affected patients were receiving erythromycin intravenously. In a recent retrospective study of 278 consecutive patients who had received IV erythromycin lactobionate, 39% of 49 evaluable patients developed moderate to severe delay in ventricular repolarization (QTc interval greater than or equal to 500 msec) during treatment. Of the 278 patients, torsade de pointes was observed in one patient (less than 0.4%).

Arrhythmias and hypotension have been reported following IV administration.

One case of erythromycin-related polymorphous ventricular tachycardia reported in a patient treated for pneumonia was characterized by a normal QT interval.[Ref]

Frequency not reported: QT prolongation, ventricular arrhythmias, ventricular tachycardia, torsades de pointes, arrhythmias, hypotension, polymorphous ventricular tachycardia
Postmarketing reports: Torsades de pointes[Ref]

Hepatic

Rare (less than 0.1%): Hepatotoxicity, fulminant hepatic necrosis, false isolated elevations of serum glutamic oxaloacetic transaminase (SGOT) enzymes
Frequency not reported: Hepatic dysfunction (including increased liver enzymes), hepatocellular and/or cholestatic hepatitis (with or without jaundice), transient elevations of liver function tests, hepatitis, abnormal liver function test results, intrahepatic cholestasis[Ref]

Hepatic dysfunction (including increased liver enzymes) and hepatocellular and/or cholestatic hepatitis (with or without jaundice) have been reported with oral erythromycin.[Ref]

Hypersensitivity

Frequency not reported: Allergic reactions (ranging from urticaria to anaphylaxis), hypersensitivity reactions (presented as rash, eosinophilia, fever), hypersensitivity with noninfectious hepatitis[Ref]

Dermatologic

Rare (less than 0.1%): Skin rash, maculopapular rashes (generalized, pruritic)
Frequency not reported: Skin reactions (ranging from mild eruptions to erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)[Ref]

Nervous system

Rare (less than 0.1%): Convulsions, reversible hearing loss, reversible ototoxicity
Frequency not reported: Exacerbation of myasthenia gravis symptoms, new onset of myasthenic syndrome[Ref]

Reversible hearing loss was reported primarily in patients with renal dysfunction and in patients receiving high doses of erythromycin.

Several published reviews have indicated that ototoxicity was associated with erythromycin dosages greater than 4 grams per day, preexisting liver or kidney disease, and advanced age. Recovery generally occurred within two weeks.[Ref]

Hematologic

A case of hemolytic anemia has been reported in a patient with severe underlying diseases and erythromycin-associated hepatitis.[Ref]

Rare (less than 0.1%): Reversible agranulocytosis
Frequency not reported: Hemolytic anemia[Ref]

Renal

Frequency not reported: Interstitial nephritis[Ref]

Psychiatric

Rare (less than 0.1%): Recurrent nightmares[Ref]

Local

Slow infusion of diluted erythromycin (the active ingredient contained in Eryc) (continuously or intermittently over no less than 20 to 60 minutes) almost invariably alleviated venous irritation.[Ref]

Rare (less than 0.1%): Venous irritation with IV administration[Ref]

Some side effects of Eryc may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.