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Miocamycin

A Review of its Antimicrobial Activity, Pharmacokinetic Properties and Therapeutic Potential

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Abstract

Synopsis

Miocamycin is an orally administered 16-membered macrolide antimicrobial drug. It has a spectrum of in vitro activity similar to that of erythromycin, inhibiting a range of Gram-positive and Gram-negative organisms, atypical microbes and some anaerobes. Importantly, miocamycin demonstrates greater in vitro potency than erythromycin against several pathogens including Legionella pneumophila, Mycoplasma hominis, and Ureaplasma urealyticum. Equally noteworthy is its activity against erythromycin-resistant staphylococcal and streptococcal species expressing inducible-type resistance. Miocamycin possesses poor overall activity against Haemophilias influenzae and is inactive against Enterobacteriaceae.

Penetration of miocamycin into body tissues and fluids is both rapid and extensive. The 3 major metabolites of miocamycin possess antimicrobial activity and may contribute to the therapeutic efficacy of the drug.

Clinical data indicate that miocamycin is useful in the treatment of upper and lower respiratory tract infections in both adult and paediatric patients. Miocamycin is also effective in the treatment of urogenital tract infections caused by Chlamydia trachomatis or U. urealyticum. Several studies suggest that miocamycin is at least as effective as erythromycin in these indications; however, comparisons with newer macrolide agents have yet to be performed. In other studies, miocamycin proved to be a useful agent in the treatment of periodontal infections and as anti-infective prophylaxis in dental surgery.

Miocamycin appears to have a tolerability profile qualitatively similar to that of other macrolides, with gastrointestinal and skin disorders being the most commonly reported adverse events. Current data suggest that the potential for drug interactions with miocamycin is low, with the possible exceptions of carbamazepine and cyclosporin.

Thus, although further confirmation and elaboration of various aspects of its efficacy and tolerability profile is needed, at this stage miocamycin offers a useful alternative oral therapy to erythromycin for the treatment of uncomplicated community-acquired respiratory tract infections and nongonococcal urethritis.

Antimicrobial Activity

The in vitro activity spectrum of miocamycin is similar to that of erythromycin. While it is generally less potent in vitro than erythromycin, differences in potency between the 2 drugs have been demonstrated for particular organisms.

Miocamycin is active against Streptococcus pneumoniae, S. pyogenes and S. agalactiae. It is also active against erythromycin-sensitive strains of Staphylococcus aureus and Enterococcus faecalis, and, in contrast to the 14-membered and 15-membered macrolide agents, is active against erythromycin-resistant strains expressing inducible-type resistance. The atypical respiratory tract pathogens Bordetella pertussis, Legionella pneumophila, Mycoplasma pneumoniae and Moraxella catarrhalis are susceptible to miocamycin, although the drug generally showed low activity against Haemophilus influenzae. Miocamycin is active against the commonly isolated urogenital pathogens Chlamydia trachomatis, Gardnerella vaginalis, Ureaplasma urealyticum and M. hominis. Miocamycin is also active against several anaerobic bacteria. Enterobacteriaceae are resistant to miocamycin.

The antimicrobial activity of miocamycin, as with other macrolides, is apparently achieved through protein synthesis inhibition. The in vivo efficacy of the drug appears to be greater than its in vitro antimicrobial activity would suggest. This observation may be explained by the high tissue concentrations achieved by miocamycin, its postantibiotic effect and potential beneficial effects on the immune system, and the formation of metabolites with antimicrobial activity.

Pharmacokinetic Properties

Mean peak serum concentrations of approximately 1.8 mg/L are attained in adults with normal renal and hepatic function within 0.5 to 1 hour of receiving a single dose of miocamycin 600mg. Food does not appear to affect the absorption of miocamycin. Elimination of miocamycin is primarily by hepatic metabolism and biliary excretion, and its elimination half-life is approximately 1 hour. The pharmacokinetic profile of miocamycin in children appears similar to that in adults. Peak plasma concentrations of the 3 major metabolites were in the range 0.5 to 1.8 mg/ L in healthy adult volunteers after a 1200mg dose of miocamycin.

Miocamycin has a large apparent volume of distribution (228 to 329L) and is not highly plasma protein bound (47%), indicating extensive tissue penetration. The drug distributes rapidly into tissues and tissue fluids, and achieves concentrations in the range of the minimum inhibitory concentrations (MIC) for most susceptible organisms in all tissues analysed.

Therapeutic Efficacy

The clinical efficacy of miocamycin has been assessed in both adult and paediatric patients with respiratory or urogenital tract infections in trials conducted in Japan and Italy. Many of the studies were noncomparative, while the majority of comparative studies were nonblinded. Study methodologies, particularly patient inclusion criteria, were generally lacking. Definitions of clinical cure or improvement varied considerably between studies and lower dosages were used in Japanese versus non-Japanese studies. Consequently, ratings of clinical efficacy varied widely among studies.

Miocamycin 600 to 1200 mg/day administered for 2 to 3 weeks produced clinical cure/improvement rates of 76 to 100% in clinical trials in adult patients with mainly acute exacerbations of bronchitis, or pneumonia. Miocamycin 50 mg/day administered for 10 days was effective in the treatment of bronchitis/pneumonia or pharyngitis/tonsillitis in children (cure rates 72 to 100%). Limited comparative studies indicate that miocamycin 1200 mg/day is at least as effective as erythromycin 1500 to 2000 mg/day, and has similar efficacy to dirithromycin 500 mg/day or josamycin 1500 mg/day, in adult patients with respiratory tract infections.

In 2 comparative studies in paediatric patients with upper or lower respiratory tract infections, miocamycin 50 mg/kg/day administered for 10 days was at least as effective as erythromycin 50 mg/kg/day and showed similar efficacy to amoxicillin 60 mg/kg/day.

Cure rates (combined clinical/micro-organism eradication) of 72 to 100% were achieved in adult patients with mainly acute urogenital tract infections caused by C. trachomatis or U. urealyticum after treatment with miocamycin 1200 or 1800 mg/day for up to 20 days. Miocamycin 1800 mg/day was at least as effective as erythromycin 2000 mg/day in 2 comparative studies in this indication.

In noncomparative clinical trials, miocamycin 1200 to 1800 mg/day was effective in the treatment of periodontal infections while various regimens provided adequate anti-infective prophylaxis in patients undergoing dental surgery.

Clinical Tolerability

The tolerability profile of miocamycin appears similar to that of other macrolide antimicrobial drugs. Limited data in adult patients indicate that miocamycin is generally well tolerated. Most adverse events were transient gastrointestinal tract or skin disorders of mild to moderate severity. A large Japanese postmarketing surveillance study in 12 053 paediatric patients confirmed this favourable tolerability profile, although these children received lower dosages than are generally used outside Japan. There are preliminary data suggesting that miocamycin has a lower stimulatory effect on gastrointestinal motility than erythromycin and other 14-membered macrolide agents; however, these findings are of uncertain clinical significance.

The overall potential for drug interactions with miocamycin would appear to be low. Studies in small numbers of patients and healthy volunteers indicate that miocamycin has little or no propensity to interact with theophylline. However, limited data in healthy volunteers and patients, respectively, suggest that miocamycin may significantly impair the elimination pharmacokinetics of carbamazepine and cyclosporin.

Dosage and Administration

Dosages vary between countries. The recommended oral dosage for adults is 600mg twice or 3 times daily in Italy and 800mg twice daily in France. In Italy, a regimen of 50 mg/kg/day in 2 or 3 divided administrations is recommended for children. Lower dosages have generally been used in Japan with 300mg 3 times daily and 20 to 40 mg/kg/day in 3 divided doses being the most frequently used adult and paediatric dosages, respectively, in clinical trials. Miocamycin is available in tablet or syrup formulations.

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    Stephen M. Holliday & Diana Faulds

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Various sections of the manuscript reviewed by: D. Felmingham, Department of Clinical Microbiology, University College Hospital, London, England; P.C. Fuchs, St. Vincent Hospital and Medical Center, Portland, Oregon, USA; F. Fraschini, Department of Medical Pharmacology, Chemotherapy and Toxicology, University of Milan, Milan, Italy; J.M.T. Hamilton-Miller, Department of Medical Microbiology, Royal Free Hospital School of Medicine, London, England; M.G. Martens, Department of Obstetrics and Gynecology, Division of Infectious Diseases, University of Texas Medical Branch at Galveston, Galveston, Texas, USA; P. Periti, Department of Preclinical and Clinical Pharmacology, University of Florence, Florence, Italy; E. Pozzi, Department of Clinical and Biological Sciences, Respiratory Disease Division, University of Turin, Turin, Italy; R.A. Robson, Department of Nephrology, Christchurch Hospital, Christchurch, New Zealand; R. Soejima, Department of Medicine, Division of Respiratory Diseases, Kawasaki Medical School, Okayama, Japan; R. Wise, Department of Microbiology, Dudley Road Hospital, Birmingham, England; M.J. Wood, Department of Communicable Diseases and Tropical Medicine, East Birmingham Hospital, Birmingham, England.

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Holliday, S.M., Faulds, D. Miocamycin. Drugs 46, 720–745 (1993). https://doi.org/10.2165/00003495-199346040-00008

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