Ery-Tab

Name: Ery-Tab

Clinical pharmacology

Orally administered erythromycin base and its salts are readily absorbed in the microbiologically active form. Interindividual variations in the absorption of erythromycin are, however, observed, and some patients do not achieve optimal serum levels. 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, but fetal plasma levels are low. The drug 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 the liver and is excreted in the bile; the effect of hepatic dysfunction on biliary excretion 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.

ERY-TAB (erythromycin delayed release tablets) tablets are coated with a polymer whose dissolution is pH dependent. This coating allows for minimal release of erythromycin in acidic environments, e.g. stomach. The tablets are designed for optimal drug release and absorption in the small intestine. In multiple-dose, steady-state studies, ERY-TAB (erythromycin delayed release tablets) tablets have demonstrated adequate drug delivery in both fasting and non-fasting conditions. Bioavailability data are available from Abbott Laboratories, Dept. 422.

Microbiology

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.

Many strains of Haemophilus influenzae are resistant to erythromycin alone, but are susceptible to erythromycin and sulfonamides used concomitantly.

Staphylococci resistant to erythromycin may emerge during a course of erythromycin therapy. Erythromycin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.

Gram-positive organisms

Corynebacterium diphtheriae
Corynebacterium minutissimum

Listeria monocytogenes

Staphylococcus aureus
(resistant organisms may emerge during treatment)
Streptococcus pneumoniae

Streptococcus pyogenes

Gram-negative organisms

Bordetella pertussis
Legionella pneumophila

Neisseria gonorrhoeae

Other microorganisms

Chlamydia trachomatis
Entamoeba histolytica

Mycoplasma pneumoniae

Treponema pallidum

Ureaplasma urealyticum

The following in vitro data are available, but their clinical significance is unknown.

Erythromycin exhibits in vitro minimal inhibitory concentrations (MIC's) of 0.5 mcg/mL or less against most ( ≥ 90%) strains of the following microorganisms; however, the safety and effectiveness of erythromycin in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.

Gram-positive organisms

Viridans group streptococci

Gram-negative organisms

Moraxella catarrhalis

Susceptibility Tests

Dilution Techniques

Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MIC's). These MIC's provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MIC's should be determined using a standardized procedure. Standardized procedures are based on a dilution method1 (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of erythromycin powder. The MIC values should be interpreted according to the following criteria:

MIC (mcg/mL) Interpretation
≤ 0.5 Susceptible(S)
1-4 Intermediate(I)
≥ 8 Resistant(R)

A report of “Susceptible” indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of “Intermediate” indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of “Resistant” indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.

Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. Standard erythromycin powder should provide the following MIC values:

Microorganism MIC (mcg/mL)
S. aureus ATCC 29213 0.12-0.5
E. faecalis ATCC 29212 1-4

Diffusion Techniques

Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure2 requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 15-mcg erythromycin to test the susceptibility of microorganisms to erythromycin.

Reports from the laboratory providing results of the standard single-disk susceptibility test with a 15-mcg erythromycin disk should be interpreted according to the following criteria:

Zone Diameter (mm) Interpretation
≥ 23 Susceptible(S)
14-22 Intermediate(I)
≤ 13 Resistant(R)

Interpretation should be as stated above for results using dilution techniques. Interpretation involves correlation of the diameter obtained in the disk test with the MIC for erythromycin.

As with standardized dilution techniques, diffusion methods require the use of laboratory control microorganisms that are used to control the technical aspects of the laboratory procedures. For the diffusion technique, the 15-mcg erythromycin disk should provide the following zone diameters in these laboratory test quality control strains:

Microorganism Zone Diameter (mm)
S. aureus ATCC 25923 22-30

REFERENCES

1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically, Third Edition. Approved Standard NCCLS Document M7-A3, Vol. 13, No. 25 NCCLS, Villanova, PA, December 1993.

2. National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Disk Susceptibility Tests, Fifth Edition. Approved Standard NCCLS Document M2-A5, Vol. 13, No. 24 NCCLS, Villanova, PA, December 1993.

Uses of Ery-Tab

Oral:

Oral erythromycin is a prescription medication used to treat infections caused by bacteria, such as respiratory tract infections, intestinal infections, ear infections, urinary tract infections, skin infections, and venereal disease.

 

Topical:

Topical erythromycin is a prescription medication used to treat acne vulgaris. The ophthalmic ointment is used to treat infections of the eye.

 

Injectable:

Injectable erythromycin is a prescription medication used to treat infections caused by bacteria, such as respiratory tract infections, intestinal infections, urinary tract infections, skin infections, and venereal disease.

 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Ery-Tab Precautions

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)

Ery-Tab and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed.

Erythromycin has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from erythromycin, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

What are some things I need to know or do while I take Ery-Tab?

For all patients taking this medicine:

  • Tell all of your health care providers that you take Ery-Tab. This includes your doctors, nurses, pharmacists, and dentists.
  • Have your blood work checked if you are on this medicine for a long time. Talk with your doctor.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Ery-Tab.
  • Do not use longer than you have been told. A second infection may happen.
  • If you are on a low-salt or salt-free diet, talk with your doctor.
  • Hearing loss has rarely happened in people taking this medicine. This most often goes back to normal. The chance may be higher if you have kidney problems or if you take high doses of Ery-Tab. Call your doctor right away if you have hearing problems like hearing loss.
  • If you have myasthenia gravis, talk with your doctor. Call your doctor if your signs get worse. Signs of myasthenia gravis have also happened in people who do not have it. Call your doctor right away if you have new or worse muscle weakness, trouble chewing or swallowing, trouble breathing, droopy eyelids, or change in eyesight like blurred eyesight or seeing double.
  • This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this medicine with your other drugs.
  • If you are 65 or older, use Ery-Tab with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Newborns:

  • A very bad stomach problem has happened in newborns taking Ery-Tab (erythromycin delayed-release tablets and capsules). Call the doctor right away if your child throws up or gets irritable with feeding.

Ery-Tab Description

Ery-Tab® (erythromycin delayed-release tablets) is an antibacterial product containing erythromycin base in a specially enteric-coated tablet. The coating protects the antibiotic from the inactivating effects of gastric acidity and permits efficient absorption of the antibiotic in the small intestine. Ery-Tab® tablets for oral administration are available in three dosage strengths, each white oval tablet containing either 250 mg, 333 mg, or 500 mg of erythromycin as the free base. Ery-Tab® tablets comply with USP Dissolution Test 1.

Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, and soluble in alcohol, chloroform, and ether. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*,13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α -L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihdroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C37H67NO13, and the molecular weight is 733.94. The structural formula is:

Inactive Ingredients

Ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, crospovidone, diacetylated monoglycerides, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, povidone, propylene glycol, sodium citrate, sorbitan monooleate, talc, and titanium dioxide.

Ery-Tab Dosage and Administration

In most patients, Ery-Tab® (erythromycin delayed-release tablets) are well absorbed and may be dosed orally without regard to meals. However, optimal blood levels are obtained when Ery-Tab® 250 mg, Ery-Tab® 333 mg or Ery-Tab® 500 mg tablets are given in the fasting state (at least 1/2 hour and preferably 2 hours before meals).

Adults

The usual dose is 250 mg four times daily in equally spaced doses. The 333 mg tablet is recommended if dosage is desired 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 according to the severity of the infection. However, 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 to 50 mg/kg/day, in equally divided doses. For more severe infections, this dose may be doubled but should not exceed 4 g per day.

In the treatment of streptococcal infections of the upper respiratory tract (e.g., tonsillitis or pharyngitis), the therapeutic dosage of erythromycin should be administered for at least ten days.

The American Heart Association suggests a dosage of 250 mg of erythromycin orally, twice a day in long-term prophylaxis of streptococcal upper respiratory tract infections for the prevention of recurring attacks of rheumatic fever in patients allergic to penicillin and sulfonamides.4

Conjunctivitis of the Newborn Caused by Chlamydia trachomatis

Oral erythromycin suspension 50 mg/kg/day in 4 divided doses for at least 2 weeks.4

Pneumonia of Infancy Caused by Chlamydia trachomatis

Although the optimal duration of therapy has not been established, the recommended therapy is oral erythromycin suspension 50 mg/kg/day in 4 divided doses for at least 3 weeks.

Urogenital Infections During Pregnancy Due to Chlamydia trachomatis

Although the optimal dose and duration of therapy have not been established, the suggested treatment is 500 mg of erythromycin by mouth four times a day or two erythromycin 333 mg tablets orally every 8 hours on an empty stomach for at least 7 days. For women who cannot tolerate this regimen, a decreased dose of one erythromycin 500 mg tablet orally every 12 hours, one 333 mg tablet orally every 8 hours or 250 mg by mouth four times a day should be used for at least 14 days.6

For adults with uncomplicated urethral, endocervical, or rectal infections caused by Chlamydia trachomatis, when tetracycline is contraindicated or not tolerated

500 mg of erythromycin by mouth four times a day or two 333 mg tablets orally every 8 hours for at least 7 days.6

For patients with nongonococcal urethritis caused by Ureaplasma urealyticum when tetracycline is contraindicated or not tolerated

500 mg of erythromycin by mouth four times a day or two 333 mg tablets orally every 8 hours for at least seven days.6

Primary Syphilis

30 to 40 g given in divided doses over a period of 10 to 15 days.

Acute pelvic inflammatory disease caused by N. gonorrhoeae

500 mg Erythrocin Lactobionate-I.V. (erythromycin lactobionate for injection, USP) every 6 hours for 3 days, followed by 500 mg of erythromycin base orally every 12 hours, or 333 mg of erythromycin base orally every 8 hours for 7 days.

Intestinal Amebiasis

Adults

500 mg every 12 hours, 333 mg every 8 hours or 250 mg every 6 hours for 10 to 14 days.

Children

30 to 50 mg/kg/day in divided doses for 10 to 14 days.

Pertussis

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

Legionnaires' Disease

Although optimal dosage has not been established, doses utilized in reported clinical data were 1 to 4 g daily in divided doses.

Preoperative Prophylaxis for Elective Colorectal Surgery

Listed below is an example of a recommended bowel preparation regimen.

A proposed surgery time of 8:00 a.m. has been used.

Pre-op Day 3

Minimum residue or clear liquid diet. Bisacodyl, 1 tablet orally at 6:00 p.m.

Pre-op Day 2

Minimum residue or clear liquid diet. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m., 2:00 p.m. and 6:00 p.m. Enema at 7:00 p.m. and 8:00 p.m.

Pre-op Day 1

Clear liquid diet. Supplemental (IV) fluids as needed. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m. and 2:00 p.m. Neomycin sulfate (1.0 g) and erythromycin base (two 500 mg tablets, three 333 mg tablets or four 250 mg tablets) orally at 1:00 p.m., 2:00 p.m. and 11:00 p.m. No enema.

Day of Operation

Patient evacuates rectum at 6:30 a.m. for scheduled operation at 8:00 a.m.

How is Ery-Tab Supplied

Ery-Tab® (erythromycin delayed-release tablets, USP) are supplied as white oval enteric-coated tablets debossed on one side with the Arbor logo, A, and on the other side with a two letter Code designation, EC for the 250 mg tablets, EH for the 333 mg tablets, and ED for the 500 mg tablets, in the following package sizes:

250 mg tablets: bottles of 100 (NDC 24338-122-13)
333 mg tablets: bottles of 100 (NDC 24338-124-13)
500 mg tablets: bottles of 100 (NDC 24338-126-13).

Recommended Storage

Store below 86°F (30°C).

References

  1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically, Approved Standard – Ninth Edition. CLSI document M07-A9, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.
  2. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing: Twenty-third Informational Supplement. CLSI document M100-S23, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2013.
  3. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard – Eleventh Edition CLSI document M02-A11. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.
  4. Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease of the Council on Cardiovascular Disease in the Young, the American Heart Association: Prevention of Rheumatic Fever. Circulation. 78(4):1082-1086, October 1988.
  5. Honein, M.A., et. al.: Infantile hypertrophic pyloric stenosis after pertussis prophylaxis with erythromycin: a case review and cohort study. The Lancet 1999:354 (9196): 2101-5.
  6. Data on file, Arbor Pharmaceuticals, LLC.

03-A919-R2
Revised: July, 2013

Arbor Pharmaceuticals, LLC
Atlanta, GA 30328 USA

(List 6304, 6320, 6321)

Before taking this medicine

You should not take Ery-Tab if you are allergic to it.

Some medicines can cause unwanted or dangerous effects when used with Ery-Tab. Your doctor may need to change your treatment plan if you use any of the following drugs:

  • cisapride;

  • pimozide;

  • ergotamine; or

  • dihydroergotamine.

To make sure Ery-Tab is safe for you, tell your doctor if you have:

  • liver or kidney disease;

  • myasthenia gravis;

  • a heart rhythm disorder;

  • an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

  • a history of Long QT syndrome; or

  • if you take medicine to treat a heart rhythm disorder.

FDA pregnancy category B. Ery-Tab is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Erythromycin can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to a child without a doctor's advice.

Ery-Tab side effects

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

Call your doctor at once if you have:

  • diarrhea that is watery or bloody;

  • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

  • hearing problems (rare);

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Older adults may be more likely to have serious side effects from Ery-Tab, including hearing loss, or a life-threatening fast heart rate.

Common Ery-Tab side effects may include:

  • mild diarrhea; or

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

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.

For Healthcare Professionals

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 Ery-Tab) 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 Ery-Tab) 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 Ery-Tab) (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 Ery-Tab may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Before taking this medicine

You should not take erythromycin if you are allergic to it.

Some medicines can cause unwanted or dangerous effects when used with erythromycin. Your doctor may need to change your treatment plan if you use any of the following drugs:

  • cisapride;

  • pimozide;

  • ergotamine; or

  • dihydroergotamine.

To make sure erythromycin is safe for you, tell your doctor if you have:

  • liver or kidney disease;

  • myasthenia gravis;

  • a heart rhythm disorder;

  • an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

  • a history of Long QT syndrome; or

  • if you take medicine to treat a heart rhythm disorder.

FDA pregnancy category B. Erythromycin is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Erythromycin can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to a child without a doctor's advice.

What other drugs will affect erythromycin?

Many drugs can interact with erythromycin. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with erythromycin, especially:

  • antiviral medicine (drugs to treat hepatitis, or HIV/AIDS);

  • antifungal medicine;

  • any other antibiotic medicines;

  • cancer medicine;

  • drugs that lower cholesterol or triglycerides;

  • drugs to treat or prevent malaria;

  • drugs to treat pulmonary arterial hypertension;

  • heart or blood pressure medication;

  • medicine to prevent organ transplant rejection; or

  • medicine to treat depression or mental illness.

This list is not complete and many other drugs can interact with erythromycin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

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