Pce

Erythromycin is a prescription medication used to treat infections caused by bacteria.

Erythromycin 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 in capsule, tablet, long-acting capsule, long-acting tablet, chewable tablet, suspension, and pediatric drop forms for oral use. It is usually taken 3 to 4 times daily.

This medication also comes in topical solution and gel forms and as an ophthalmic ointment.

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

This medication is also available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of erythromycin include stomach upset, diarrhea, vomiting, stomach cramps, mild skin rash, and stomach pain.

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

• Abbott Pharmaceutical

• Arbor Pharmaceuticals, Inc.

• Cheshire Pharm. Systems

• PD-Rx Pharmaceuticals, Inc.

• Pharma Pac (A Service Of H.J. Harkins Co., Inc.)

• Quality Care Pharmaceuticals

Pce is part of the drug classes:

• Antiinfectives for treatment of acne

• Macrolides

Serious side effects have been reported with erythromycin. See the “Erythromycin Precautions” section.

Oral:

• Common side effects of oral erythromycin include the following:
• Upset stomach
• Diarrhea
• Vomiting
• Stomach cramps
• Mild skin rash
• Stomach pain

Topical:

Common side effects of topical erythromycin include the following:

• Irritation at the site of application, including dryness, redness, itching, and burning

Injectable:

Common side effects of oral injectable erythromycin include the following:

• Irritation at the injection site
• Skin rash

This is not a complete list of erythromycin side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Oral:

Take erythromycin exactly as prescribed.

This medication comes in capsule, tablet, long-acting capsule, long-acting tablet, chewable tablet, suspension, and pediatric drop forms for oral use. It is usually taken 3 to 4 times daily.

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

Topical:

This medication also comes in topical solution and gel forms and as an ophthalmic ointment.

Injectable:

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of erythromycin at the same time.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of erythromycin in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of erythromycin in the elderly. However, elderly patients are more likely to have erythromycin-induced hearing loss, heart rhythm problems, and bleeding problems.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amifampridine
• Amisulpride
• Astemizole
• Bepridil
• Cisapride
• Colchicine
• Dihydroergotamine
• Dronedarone
• Ergoloid Mesylates
• Ergonovine
• Ergotamine
• Flibanserin
• Fluconazole
• Grepafloxacin
• Levomethadyl
• Lomitapide
• Lovastatin
• Mesoridazine
• Methylergonovine
• Methysergide
• Pimozide
• Piperaquine
• Posaconazole
• Saquinavir
• Simvastatin
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acecainide
• Afatinib
• Ajmaline
• Amiodarone
• Amitriptyline
• Amoxapine
• Anagrelide
• Apixaban
• Apomorphine
• Aprepitant
• Aprindine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Atorvastatin
• Azimilide
• Azithromycin
• Bedaquiline
• Bosutinib
• Bretylium
• Brexpiprazole
• Buserelin
• Carbamazepine
• Ceritinib
• Cerivastatin
• Chloral Hydrate
• Chloroquine
• Chlorpromazine
• Cholera Vaccine, Live
• Cilostazol
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clindamycin
• Clomipramine
• Clozapine
• Cobicistat
• Cobimetinib
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Darunavir
• Dasatinib
• Deflazacort
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dibenzepin
• Digoxin
• Diltiazem
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Droperidol
• Efavirenz
• Eliglustat
• Encainide
• Enflurane
• Eplerenone
• Escitalopram
• Fingolimod
• Flecainide
• Fluoxetine
• Fosaprepitant
• Foscarnet
• Gatifloxacin
• Gemifloxacin
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Halothane
• Histrelin
• Hydrocodone
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibrutinib
• Ibutilide
• Idelalisib
• Ifosfamide
• Iloperidone
• Imipramine
• Isoflurane
• Isradipine
• Ivabradine
• Ivacaftor
• Ketoconazole
• Lapatinib
• Leuprolide
• Levofloxacin
• Lidoflazine
• Lopinavir
• Lorcainide
• Lumacaftor
• Lumefantrine
• Lurasidone
• Mefloquine
• Methadone
• Metronidazole
• Mifepristone
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Naloxegol
• Netupitant
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olaparib
• Ondansetron
• Oxycodone
• Paliperidone
• Panobinostat
• Pasireotide
• Pazopanib
• Pentamidine
• Pimavanserin
• Pirmenol
• Pitavastatin
• Pitolisant
• Pixantrone
• Prajmaline
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Ribociclib
• Risperidone
• Sematilide
• Sertindole
• Sevoflurane
• Simeprevir
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sonidegib
• Sorafenib
• Sotalol
• Spiramycin
• Sulfamethoxazole
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tadalafil
• Tedisamil
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Theophylline
• Tizanidine
• Tolvaptan
• Topotecan
• Toremifene
• Trazodone
• Trifluoperazine
• Trimethoprim
• Trimipramine
• Triptorelin
• Troleandomycin
• Vandetanib
• Vardenafil
• Vasopressin
• Vemurafenib
• Venetoclax
• Verapamil
• Vinblastine
• Vincristine
• Vincristine Sulfate Liposome
• Vinflunine
• Voriconazole
• Warfarin
• Zolmitriptan
• Zotepine
• Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil
• Alprazolam
• Anisindione
• Avanafil
• Bexarotene
• Budesonide
• Buspirone
• Cyclosporine
• Diazepam
• Dicumarol
• Methylprednisolone
• Midazolam
• Phenprocoumon
• Roflumilast
• Salmeterol
• Sildenafil
• Sirolimus
• Suvorexant
• Tolterodine
• Triazolam
• Trimetrexate
• Valproic Acid
• Zafirlukast

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bradycardia (slow heartbeat) or
• Heart rhythm problems (e.g., QT prolongation) or
• Hypokalemia (low potassium in the blood), uncorrected or
• Hypomagnesemia (low magnesium in the blood), uncorrected—Use is not recommended in patients with these conditions.

• Congestive heart failure—The granules and tablet dosage forms of this medicine contains sodium, which can make this condition worse.

• Elevated liver enzymes or
• Liver disease (including cholestatic hepatitis) or
• Myasthenia gravis (severe muscle weakness)—Use with caution. May make these conditions worse.

1. Clinical and Laboratory Standards Institute. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically, 7th ed. Approved Standard, CLSI Document M07-A7, Vol. 26(2). CLSI, Wayne, PA, Jan. 2006.
2. Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Susceptibility Testing, 18th Informational Supplement, CLSI Document M100-S18, Vol 28(1). CLSI, Wayne, PA, Jan. 2008.
3. Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Disk Susceptibility Tests, 9th ed. Approved Standard CLSI Document M02-A9, Vol. 26(1). CLSI, Wayne, PA, Jan. 2006.
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.

03-A549-R1, Revised January, 2012

Arbor Pharmaceuticals
Atlanta, GA 30328

www.arborpharma.com

(Nos. 3389, 6290)

NDC 24338-114-13
100 Tablets

PCE®
500 mg
TABLETS

erythromycin
particles in tablets

Rx only

arbor™
PHARMACEUTICALS, LLC.

Applies to erythromycin: oral capsule, oral capsule delayed release, oral powder for suspension, oral suspension, oral tablet, oral tablet chewable, oral tablet delayed release, oral tablet enteric coated

Other dosage forms:

• intravenous powder for solution

Along with its needed effects, erythromycin (the active ingredient contained in PCE Dispertab) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

• Blistering, peeling, or loosening of the skin
• chills
• cough
• diarrhea
• difficulty with swallowing
• dizziness
• fast heartbeat
• hives or welts
• joint or muscle pain
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red, irritated eyes
• red skin lesions, often with a purple center
• redness of the skin
• skin rash
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• tightness in the chest
• unusual tiredness or weakness
• wheezing

• Abdominal or stomach cramps or tenderness
• bloating
• bloody or cloudy urine
• chest pain or discomfort
• dark urine
• diarrhea, watery and severe, which may also be bloody
• fainting
• fever
• general tiredness and weakness
• greatly decreased frequency of urination or amount of urine
• hearing loss
• increased thirst
• irregular heartbeat recurrent
• irregular or slow heart rate
• light-colored stools
• nausea and vomiting
• pain
• swelling of the feet or lower legs
• unusual weight loss
• upper right abdominal or stomach pain
• yellow eyes and skin

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

• Abdominal or stomach pain
• diarrhea (mild)
• loss of appetite
• weight loss

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