PCE

DRUG DESCRIPTION

PCE tablets (erythromycin particles in tablets) are an antibacterial product containing specially coated erythromycin base particles for oral administration. The coating protects the antibiotic from the inactivating effects of gastric acidity and permits efficient absorption of the antibiotic in the small intestine. PCE tablets are available in two strengths containing either 333 mg or 500 mg of erythromycin base. PCE tablets 500 mg tablets contain no synthetic dyes or artificial colors.

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-?L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6trideoxy-3-(dimethylamino)-?-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C37H67NO13, and the molecular weight is 733.94. The structural formula is:

PCE  (erythromycin) Structural Formula Illustration

Inactive Ingredients

PCE 333 mg Tablets

Cellulosic polymers, citrate ester, colloidal silicon dioxide, D&C Red No. 30, hydrogenated vegetable oil wax, lactose, magnesium stearate, microcrystalline cellulose, povidone, propylene glycol, sodium starch glycolate, stearic acid and vanillin.

PCE 500 mg Tablets

Cellulosic polymers, citrate ester, colloidal silicon dioxide, crospovidone, hydrogenated vegetable oil wax, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, stearic acid, talc, titanium dioxide and vanillin. PCE 500 mg tablets contain no synthetic dyes or artificial colors.

What are the precautions when taking erythromycin pce (PCE)?

Before taking erythromycin, tell your doctor or pharmacist if you are allergic to it; or to other macrolide antibiotics (e.g., azithromycin, clarithromycin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, a certain type of muscle disease (myasthenia gravis).

Erythromycin 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 require immediate medical...

Read All Potential Precautions of PCE


PCE Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, diarrhea, stomach pain/cramping, loss of appetite, and mild heartburn may occur. Taking this medication with food may lessen these symptoms. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

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

Tell your doctor immediately if this unlikely but serious side effect occurs: mouth sores.

Tell your doctor immediately if any of these rare but very serious side effects occur: persistent nausea/vomiting, severe stomach/abdominal pain, unusual fatigue, dark urine, yellowing eyes or skin, muscle weakness, hearing problems (e.g., hearing loss).

Seek immediate medical attention if any of these rare but very serious side effects occur: severe dizziness, fainting, fast/irregular heartbeat, seizures.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

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

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 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.

PRECAUTIONS: Before taking erythromycin, tell your doctor or pharmacist if you are allergic to it; or to other macrolide antibiotics (e.g., azithromycin, clarithromycin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, a certain type of muscle disease (myasthenia gravis).

Erythromycin 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 require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using erythromycin, tell your doctor or pharmacist if you have 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 risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using erythromycin safely.

Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially hearing loss and irregular heartbeat.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.



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