Erythrocin Stearate (Erythromycin Stearate) - Summary

SUMMARY

ERYTHROCIN STEARATE Filmtab tablets (erythromycin stearate tablets, USP) are an antibacterial product containing the stearate salt of erythromycin in a unique film coating.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ERYTHROCIN STEARATE Filmtab tablets and other antibacterial drugs, ERYTHROCIN STEARATE Filmtab tablets 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.

ERYTHROCIN STEARATE 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

Published Studies Related to Erythrocin Stearate (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 Erythrocin Stearate (Erythromycin)

The Effect of Concomitant Administration of Erythromycin and Diltiazem on CYP3A Activity in Healthy Volunteers [Completed]
We, the researchers at the Indiana University School of Medicine, are doing this study to better understand how the effects of certain medications are altered when taken simultaneously, or in combination with each other. We will also look at how each volunteer's genes (DNA) may affect the way these medications are metabolized.

Hypothesis:

We will test the hypothesis that the extent of drug-drug interaction caused by the combination of erythromycin and diltiazem is not predictable from the extent of interaction produced by each inhibitor alone. Specifically we will test the hypothesis that the combination of erythromycin and diltiazem will cause a greater decrease in midazolam intravenous and oral clearance than the sum of the decreases caused by each inhibitor alone.

An Open, Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Intravenous Followed by Oral Azithromycin Versus Cefuroxime Alone or With Oral Erythromycin for the Treatment of Chinese Patients Who Were Hospitalized for Pneumonia [Completed]
To validate the efficacy and safety of azithromycin for the treatment of Chinese patients hospitalized with community-acquired pneumonia (CAP), compared with cefuroxime or the combination of cefuroxime plus oral erythromycin.

The Effect of Intravenous Erythromycin on Gastric Emptying in Non-Fasted Patients Before Emergency Total Anesthesia [Recruiting]
Urgent or emergency surgery requires that fasting rules observed in elective settings are not respected. Patients in the emergency situation have often ingested food or liquids in their stomach and may have swallowed blood from oral or nasal injuries. Also, gastric emptying is delayed due to the stress of trauma. Patients who are anesthetized in such conditions are at risk of "vomiting" (regurgitation) during the start of anesthesia and that the content of the stomach reaches the trachea and lungs (this is called bronchoaspiration). Fortunately the incidence of aspiration is low, about 1. 4 to 6 in 10'000 anaesthetics, and about 1 in 100'000 patients is likely to die due to aspiration. Thus, although episodes of broncho-aspiration are rare, efficacious prevention of this potentially lethal complication is important. One method to reduce the risk of broncho-aspiration during induction of anaesthesia is the pharmacological reduction of the gastric content (i. e. pre-treatment). The intention of this study is to investigate the efficacy of erythromycin in emptying the stomach of non-fasted surgical patients before induction of anaesthesia in the emergency setting.

Use of Erythromycin in Mustard-Induced Bronchiolitis [Completed]
We looked for the effectiveness of low-dose long-term prescription of erythromycin in mustard-induced bronchiolitis obliterans

Effectiveness of Antibiotic Treatment for Reducing Binge Eating and Improving Digestive Function in People With Bulimia Nervosa [Recruiting]
This study will determine the effectiveness of the antibiotic erythromycin in enhancing gastrointestinal function and decreasing the frequency of binge eating in people with bulimia nervosa.

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