PCE (Erythromycin Base Particles) - Summary

PCE SUMMARY

PCE (erythromycin particles in tablets) is 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.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of PCE and other antibacterial drugs, PCE 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.

PCE tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below:

Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes; Streptococcus pneumoniae; 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 pyogenes or Streptococcus pneumoniae.

Listeriosis caused by Listeria monocytogenes.

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).

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 prophylaxis of pertussis in exposed susceptible individuals.

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.

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

Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythrocin® Lactobionate-I.V. (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 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 nongonococcal urethritis caused by Ureaplasma urealyticum.

Primary syphilis caused by Treponema pallidum. Erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the follow-up after therapy.

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.

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).³ Erythromycin is indicated for the treatment of penicillin-allergic patients. 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

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NEWS HIGHLIGHTS

Media Articles Related to PCE (Erythromycin)

PCE Exposure Increases Risk Of Birth Defects
Source: Cleft Palate News From Medical News Today [2009.09.24]
Exposure to tetrachloroethylene (also known as perchlorethylene, PCE) may cause congenital birth defects. A study of expectant women exposed to PCE in drinking water, published in BioMed Central's open access journal Environmental Health, found an increased risk of oral clefts and neural tube defects in their children.

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Published Studies Related to PCE (Erythromycin)

Erythromycin establishes early oral feeding in neonates operated for congenital intestinal atresias. [2009.04]
PURPOSE: The recovery of gastrointestinal function following surgery for congenital intestinal atresias can be prolonged and may increase morbidity and hospital stay. This study was conducted to investigate the prokinetic effect of erythromycin in neonates undergoing surgery for small bowel atresias... CONCLUSION: The administration of oral erythromycin following primary anastomosis for small intestinal atresias results in early recovery of intestinal function, fewer days on TPN and a trend for shorter hospital stay.

Effect of oral erythromycin therapy in patients with aseptic loosening of joint prostheses. [2009.04]
There is currently no cure for aseptic loosening (AL) of total joint replacement (TJR) except surgical revision. The purpose of this study was to determine whether oral EM could improve the periprosthetic tissue profiles and reduce serum cytokine production in AL patients who are candidates for surgical revision...

Long-term erythromycin therapy is associated with decreased chronic obstructive pulmonary disease exacerbations. [2008.12.01]
RATIONALE: Frequent chronic obstructive pulmonary disease (COPD) exacerbations are a major cause of hospital admission and mortality and are associated with increased airway inflammation. Macrolides have airway antiinflammatory actions and may reduce the incidence of COPD exacerbations. OBJECTIVES: To determine whether regular therapy with macrolides reduces exacerbation frequency... CONCLUSIONS: Macrolide therapy was associated with a significant reduction in exacerbations compared with placebo and may be useful in decreasing the excessive disease burden in this important patient population. Clinical trial registered with www.clinicaltrials.gov (NCT 00147667).

Oral amoxicillin vs. oral erythromycin in the treatment of pyoderma in Bamako, Mali: an open randomized trial. [2007.10]
BACKGROUND: Pyoderma (bacterial superficial skin infection) is an extremely common disorder in tropical developing countries. In these settings, Streptococcus pyogenes is considered to be the main etiological agent. Apart from epidemics of poststreptococcal glomerulonephritis where mass treatment with intramuscular benzathine-penicillin is recommended, no recommendation exists for the treatment of pyoderma in this setting. The aim of this study was to evaluate the efficacy of oral amoxicillin in the treatment of pyoderma in Mali, by comparison with oral erythromycin... CONCLUSIONS: Amoxicillin was as efficacious as erythromycin in the treatment of severe pyoderma in Mali. Owing to its efficacy, added to high availability and low cost, this compound should be considered a first-line treatment of this disorder in this country, and perhaps in other countries where this condition presents in a similar way.

Oral erythromycin accelerates impaired gastrointestinal motility after endoscopic mucosal resection. [2007.09]
Gastrointestinal motility may be impaired after endoscopic mucosal resection of gastric lesions. We investigated whether oral erythromycin could improve motility... Postprandial and fasting gastrointestinal motility were impaired after endoscopic resection, and postprandial as well as fasting motility were improved by oral erythromycin.

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Clinical Trials Related to PCE (Erythromycin)

Detection of Circulating Endothelial Progenitors Cells (EPCs) in Non-small Cell Lung Cancer (NSCLC) [Recruiting]
Bone-marrow-derived progenitor cells (EPCS) play an important role in neovascularization and tumor growth. In lung cancer, angiogenesis is an important event in mechanisms of tumor proliferation and metastasis. Recent evidences suggest that EPCS can be recruited and differentiate in mature endothelial cells to form new blood vessels. The role of EPCs in NSCLC is unclear. In contrast, angiogenic drugs are proposed combined to systemic chemotherapy in NSCLC. The aim of this study is to identify EPCs in peripheral blood from patients with NSCLC, by comparison to Chronic Pulmonary Obstructive Disease (COPD), an inflammatory disease.

TempTouch IR Thermometry & Diabetic Patient Self-Care [Completed]
Foot ulcers develop in diabetics with neuropathy because of cumulative injury over the course of several days. These patients do not feel pain, and do not recognize their foot is being injured until a wound develops. Areas about to ulcerate become inflamed and “hot spots” can be identified. This study’s purpose is to evaluate the effectiveness of a home infrared temperature probe designed to forewarn patients that an area on the foot is inflamed so they can take preventive measures. The study will evaluate the incidence of diabetic foot ulcers among high-risk patients, evaluate the cost of home temperature monitoring compared to standard therapy, and evaluate patient satisfaction. 180 diabetics at high-risk of having foot complications will be randomized into 3 treatment arms: 1) standard therapy consisting of regular foot care; 2) standard therapy plus recording of a structured foot evaluation using a hand mirror; and 3) standard therapy plus infrared home temperature assessment to identify “hot spots.” Device patients will measure temperatures at 6 sites on the foot each day. When temperatures are elevated >4°F patients will contact the research nurse and decrease activity. The primary study outcome will be incident foot ulcers and Charcot fractures.

Nutrition Intervention in Drug Naive HIV-infected Kenyan Women and Their Children [Recruiting]
Many of the 28 million people with immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS) estimated to be living in sub-Saharan Africa also suffer from malnutrition. Reproductive age women, their infants and young children are among the most vulnerable for malnutrition and progression of HIV to AIDS and mortality is increased in the malnourished, as seen in Eastern and Southern Africa. The HIV Nutrition Project (HNP) research evaluates the effect of protein and micronutrients in meat on the health and nutritional well being of Kenyan women living with HIV in rural Kenya and the health and development of their children, by means of a randomized nutrition intervention. We will determine if meat in the diets of HIV- infected women and their children (1) protects the immune system and prevents severe infection, (2) prevents the loss of body mass and enhances the quality of life among drug naïve women not yet ill enough to warrant antiretroviral drugs and (3) positively impacts growth and development of vulnerable children of the HIV-infected women when compared to those given supplements with the same amount of energy but with either soya or wheat protein. The intervention food with beef protein provides significant vitamin B12, lysine and bio-available iron, zinc and selenium when compared to the soya and wheat supplements. Deficiencies of these nutrients may hasten HIV disease progression.

The findings from our project may have implications for the development of initiatives that are either sustainable or subsidized by the local, regional and/or global economies that ensure that all HIV-infected individuals have access to adequate nutrition support that includes foods that provide enough nutrients that are needed to optimize health and well-being. The knowledge gained may significantly impact other populations at high risk for decreased immune function such as those with tuberculosis and malaria.

This is a 3 arm randomized design where 225 HIV-infected rural Kenyan mothers with a CD4 between 250 and 500, WHO Stage 1 or 2, and with no co-existing infections, receive with their child, a nutrition biscuit supplement daily (5 days/week) for 12 months. These women are not yet ill enough to warrant treatment with antiretroviral drugs in Kenya and therefore a food intervention may keep them healthy longer and delay the need for drugs.

High-Dose Methotrexate in Treating Young Patients With Solid Tumors [Suspended]
RATIONALE: Drugs used in chemotherapy, such as high-dose methotrexate work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as leucovorin calcium, may protect normal cells from the side effects of chemotherapy.

PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of high-dose methotrexate in treating patients with solid tumors.

CYP3A5 Gene as a Risk Factor for Kidney Damage in Young Patients With Cancer Treated With Ifosfamide [Recruiting]
RATIONALE: Studying the genes expressed in samples of blood from young patients with cancer treated with ifosfamide may help doctors identify risk factors for kidney damage.

PURPOSE: This clinical trial is looking at the CYP3A5 gene to see if having the gene may be a risk factor for kidney damage in young patients with cancer treated with ifosfamide.

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