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PubMed1984

Toxicological studies on a new macrolide antibiotic, midecamycin acetate (miocamycin). Part IV-1. Toxicity of metabolites of miocamycin: acute toxicity of Mb1 in mice.

Miocamycin (MOM) is a derivative of midecamycin, a macrolide antibiotic isolated from a culture broth of Streptomyces mycarofaciens. MOM is metabolized into 4 main metabolites of Mb1, Mb2, Mb6 and Mb12. The object of this study was to evaluate acute toxicity in male and female mice after single oral administration of Mb1, a metabolite of MOM, at a dose level of 5,000 mg/kg as the maximum physically applicable dose. Observations were kept for 1 week after administration. In conclusion, Mb1 exhibited no acute toxicity in present study. The LD0 values were estimated as more than 5,000 mg/kg.

Administration, Oral↗

PubMed1984

Toxicological studies on a new macrolide antibiotic, midecamycin acetate (miocamycin). Part IV-2. Toxicity of metabolites of miocamycin: acute toxicity of Mb1 in rats.

Acute toxicity studies on miocamycin (MOM), non-crystalline solid, and its metabolite Mb1 were performed in mice in the previous studies. In the present studies, we evaluated acute toxicity of Mb1 in male and female rats after single oral administration at the maximum physically applicable dose of 5,000 mg/kg. Observations were continued for 1 week after treatment. It is concluded that LD0 values of Mb1 were estimated more than 5,000 mg/kg.

Animals↗

PubMed1984

Toxicological studies on a new macrolide antibiotic, midecamycin acetate (miocamycin). Part IV-3. Toxicity of metabolites of miocamycin: subacute toxicity of Mb1 in rats.

Miocamycin (MOM) is a derivative of midecamycin, a macrolide antibiotic and is metabolized into 4 main metabolites of Mb1, Mb2, Mb6 and Mb12. In the previous study, LD0 values of Mb1 were estimated more than 5,000 mg/kg in male and female rats as Mb1 did not exhibited any lethal toxicity even at the maximum physically applicable dose of 5,000 mg/kg. The object of this study was to examine subacute toxicity in male and female rats after repeated p.o. administration of Mb1 for 5 weeks at a daily dosage of 125, 250, 500 and 1,000 mg/kg. It is concluded that no manifest toxicity was observed in this subacute toxicity study on Mb1 in rats.

Animals↗

PubMed1984

Toxicological studies on a new macrolide antibiotic, midecamycin acetate (miocamycin). Part IV-4. Toxicity of metabolites of miocamycin: acute toxicity of Mb2 in mice.

Miocamycin (MOM) is a derivative of midecamycin and is metabolized into 4 main metabolites. At previous study, LD0 values of Mb1 were estimated more than 5,000 mg/kg in male and female mice. The object of this study was to evaluate acute toxicity in male and female mice after single oral administration of Mb2, a metabolite of MOM, at a dose level of 5,000 mg/kg as the maximum physically applicable dose. It is concluded that LD0 values of Mb2 were estimated more than 5,000 mg/kg.

Animals↗

PubMed1984

Toxicological studies on a new macrolide antibiotic, midecamycin acetate (miocamycin). Part IV-5. Toxicity of metabolites of miocamycin: acute toxicity of Mb2 in rats.

Miocamycin (MOM) is a derivative of midecamycin and is metabolized into 4 main metabolites. At previous study, LD0 values of Mb1 were estimated more than 5,000 mg/kg in male and female rats. The object of this study was to evaluate acute toxicity in male and female rats after single oral administration of Mb2, a metabolite of MOM. It is concluded that LD0 values of Mb2 were estimated more than 5,000 mg/kg.

Animals↗

PubMed1984

Toxicological studies on a new macrolide antibiotic, midecamycin acetate (miocamycin). Part IV-6. Toxicity of metabolites of miocamycin: subacute toxicity of Mb2 in rats.

Miocamycin (MOM) is a derivative of midecamycin, a macrolide antibiotic and is metabolized into 4 main metabolites of Mb1, Mb2, Mb6 and Mb12. At previous study, the acute and subacute toxicity of Mb1 and acute toxicity of Mb2 were performed that those metabolites did not exhibit any lethal toxicity even at the maximum physically applicable dose. The object of this study was to examine subacute toxicity in male and female rats after repeated p.o. administration of Mb2 for 5 weeks at a daily dosage of 125, 250, 500 and 1,000 mg/kg. It is, therefore, concluded that Mb2 exerted no toxic effects in this subacute toxicity.

Animals↗

PubMed1984

Toxicological studies on a new macrolide antibiotic, midecamycin acetate (miocamycin). Part IV-7. Toxicity of metabolites of miocamycin: acute toxicity of Mb6 in mice.

Miocamycin (MOM) is a derivative of midecamycin and is metabolized into 4 main metabolites. In the present studies, we evaluated acute toxicity and estimated LD50 values of Mb6, one of the main metabolites of MOM, in male and female mice after single oral administration. Observations were continued for 1 week after treatment. The LD50 values were calculated according to Litchfield-Wilcoxon's method. It is concluded that LD50 values of Mb6 were 4,150 mg/kg (3,577.6 approximately 4,814.0 mg/kg) in male mice and 4,000 mg/kg (3,389.8 approximately 4,720.0 mg/kg) in female mice, respectively.

Animals↗

PubMed1984

Toxicological studies on a new macrolide antibiotic, midecamycin acetate (miocamycin). Part IV-8. Toxicity of metabolites of miocamycin: acute toxicity of Mb6 in rats.

Miocamycin (MOM) is a derivative of midecamycin and is metabolized into 4 main metabolites of Mb1, Mb2, Mb6 and Mb12. In the previous studies, we estimated LD50 values of Mb6 in male and female mice after single oral administration. The LD50 values were 4,150 mg/kg in male mice and 4,000 mg/kg in female mice, respectively. In the present studies, we evaluated acute toxicity and estimated LD50 values of Mb6 in male and female rats after single oral administration. Observations were continued for 1 week after treatment. It is concluded that LD0 values of Mb6 in male and female rats, were estimated more than 5,000 mg/kg as Mb6 did not exhibit any manifest acute toxicity even at the maximum physically applicable dose of 5,000 mg/kg.

Animals↗

PubMed1984

Toxicological studies on a new macrolide antibiotic, midecamycin acetate (miocamycin). Part IV-9. Toxicity of metabolites of miocamycin: subacute toxicity of Mb6 in rats.

Miocamycin (MOM) is a derivative of midecamycin and is metabolized into 4 main metabolites of Mb1, Mb2, Mb6 and Mb12. It is also known that LD50 values of Mb6 were 4,150 mg/kg in male mice and 4,000 mg/kg in female mice but LD0 values in male and female rats were estimated more than 5,000 mg/kg. The object of this study was to examine subacute toxicological effects in male and female rats after repeated oral administration of Mb6 for 5 weeks at a daily dosage of 125, 250, 500 and 1,000 mg/kg. It is concluded that no manifest toxicity was observed in this study with Mb6 in male and female rats after oral administration at dosage levels of 125, 250, 500 and 1,000 mg/kg for 5 weeks.

Animals↗

PubMed1984

Toxicological studies on a new macrolide antibiotic, midecamycin acetate (miocamycin). Part IV-11. Toxicity of metabolites of miocamycin: acute toxicity of Mb12 in rats.

Miocamycin (MOM) is a derivative of midecamycin and is metabolized into 4 main metabolites of Mb1, Mb2, Mb6 and Mb12. In the previous studies, LD50 values of Mb12 were 5,750 mg/kg in male mice and 4,950 mg/kg in female mice, respectively. The object of this study was to evaluate acute toxicity in male and female rats after single oral administration of Mb12. Observations were continued for 1 week after treatment. It is concluded that LD0 values of Mb12 were estimated more than 5,000 mg/kg.

Animals↗

PubMed1984

Toxicological studies on a new macrolide antibiotic, midecamycin acetate (miocamycin). Part IV-12. Toxicity of metabolites of miocamycin: subacute toxicity of Mb12 in rats.

Miocamycin (MOM) is a derivative of midecamycin and is metabolized into 4 main metabolites of Mb1, Mb2, Mb6 and Mb12. In the previous study, LD0 values of Mb12 in male and female rats were estimated more than 5,000 mg/kg. The object of this study was to evaluate subacute toxicity in male and female rats after repeated oral administration of Mb12 for 5 weeks at a daily dosage of 125, 250, 500 and 1,000 mg/kg. It is concluded that no manifest toxic effects were caused by Mb12 even at the highest dosage level of 1,000 mg/kg/day for 5 weeks to male and female rats.

Animals↗

PubMed1984

Toxicological studies on a new macrolide antibiotic, midecamycin acetate (miocamycin). Part IV-10. Toxicity of metabolites of miocamycin: acute toxicity of Mb12 in mice.

We evaluated acute toxicity and estimated LD50 values of Mb12, one of the main metabolites of MOM, in male and female mice after single oral administration. Observations were continued for 1 week after treatment. The LD50 values were calculated according to Litchfield-Wilcoxon's method. It is concluded that LD50 values of Mb12 were 5,750 mg/kg (4,914.5-6,727.5 mg/kg) in male mice and 4,950 mg/kg (4,194.9-5,841.0 mg/kg) in female mice, respectively.

Animals↗

PubMed1993

Miocamycin. A review of its antimicrobial activity, pharmacokinetic properties and therapeutic potential.

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 Haemophilus 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.

Adult↗

PubMed1990

Miocamycin distribution in tonsillar and pulmonary tissues after repeated administration.

Twenty patients undergoing tonsillectomy were treated with a peroral administration of 600 mg of miocamycin every 12 hours for 4 days. On the 5th day, after a last administration of a dose of 600 mg the ablation of the tonsils was carried out on groups of 4 subjects, each one at the following times after oral intake of the drug: 2, 4, 6, 8, 12 h. Twenty-nine patients, admitted to hospital to undergo lung resection were treated with peroral administration of miocamycin in accordance with the above mentioned dose scheme. The operation was carried out on groups of 5 subjects, each on the fifth day at the following times after the last administration: 2, 3, 4, 6, 8 and 12 h (4 subjects). Simultaneously blood was withdrawn for the determination of miocamycin in serum. Miocamycin was measured by a microbiological procedure using Sarcina lutea ATCC 9341. The highest levels of miocamycin were observed after 2h in tonsils (3.2 +/- 0.82 mg/kg) and serum (1.3 +/- 0.33 mg/l). After 12h miocamycin proved to be still measurable in the tissue (0.12 +/- 0.05 mg/kg), whereas it was not detected in serum. In pulmonary tissue, the highest levels of miocamycin were likewise identified at the 2nd hour (2.82 +/- 0.59 mg/kg), simultaneously with the highest serum levels (2.3 +/- 0.61 mg/l). At the 12th hour miocamycin could still be dosed in 3 tissue samples, with values between 0.1 and 0.2 mg/kg and was found just at dosing limits in only one serum sample.

Adolescent↗

PubMed1991

Kinetic profile of miocamycin in middle ear fluid and mucosa.

A group of 18 patients, before undergoing otoplastic surgery, was treated with miocamycin 600 mg in a single dose; middle ear tissue samples were collected at 2, 3, 4 and 6 h. A group of 20 patients suffering from secretory otitis media (SOM) was also treated with 600 mg of miocamycin in a single dose; collections of middle ear fluid (MEF) were performed at 1, 2, 4 and 6 h. Blood withdrawals from all patients occurred at the same time intervals. The miocamycin determination was performed by means of a microbiological method employing Sarcina lutea ATCC 9341. The highest serum levels (1.06 +/- 0.13 mg/l) were found at 2 h in the group from which middle ear mucosa had been withdrawn and at 1 h (2.2 +/- 0.5 mg/l) in the group from which the MEF had been collected; at 6 h miocamycin could be determined in both groups, with values ranging from 0.1 to 0.2 mg/l. In middle ear mucosa the miocamycin concentration was 1.52 +/- 0.27 mg/kg at 2 h and 0.2 +/- 0.09 mg/kg at 6 h. In MEF, the miocamycin concentration was 2.1 +/- 0.27 mg/l at 1 h and 0.24 +/- 0.05 mg/l at 6 h. The miocamycin concentration determined at 1 h in MEF was virtually equal to that in serum at the same time. At the following experimental times of withdrawal, the miocamycin concentration in mucosa specimens, as well as in MEF samples, proved to be markedly higher than values simultaneously found in serum.

Adult↗

PubMed1993

Clinical efficacy of dirithromycin versus miocamycin in tonsillopharyngitis.

A single-blind, randomized, parallel-group study was conducted to compare the efficacy and safety of dirithromycin with miocamycin in the treatment of streptococcal pharyngitis/tonsillitis caused by Group A streptococci. The study population consisted of 60 patients: 30 were randomized to receive 500 mg dirithromycin od and 30 to receive 600 mg miocamycin bd. All 30 dirithromycin-treated patients were eligible for efficacy analysis. A favourable clinical response was observed in 100% of these patients at the post-therapy visit. In the miocamycin-treated group, 28 of 30 (93.3%) patients were eligible for efficacy analysis; a favourable clinical response was observed in 100%. Bacteriological cure of evaluable dirithromycin- and miocamycin-treated patients was 96.7% and 92.9%, respectively. No statistically significant post-therapy differences in clinical or bacteriological response rates were noted between the two groups. Adverse event analysis showed no significant differences between treatment groups. There were no serious adverse events during the study. Two miocamycin-treated patients were prematurely withdrawn from the study due to adverse events (diarrhoea). Analysis of clinical laboratory data revealed no statistically significant differences between the treatment groups that were considered to be drug related. The results of this study suggest that dirithromycin has comparable safety and efficacy to miocamycin in the treatment of streptococcal pharyngitis/tonsillitis infections caused by Group A streptococci.

Adolescent↗

PubMed1993

[Benzathine penicillin G and miocamycin in the treatment of children with streptococcal pharyngitis: a controlled therapeutic trial].

The aim of this study was to compare the clinical and bacteriologic effectiveness of miocamycin (Miocamin, Merck) as compared to benzathine penicillin G in the treatment of streptococcal pharyngitis. One hundred forty nine patients (aged 2 to 15 years) with culture proven Group A streptococcal pharyngitis were randomly assigned to receive miocamycin (15 mg/kg/day bid per os) or one injection of 600,000 or 1,200,000 units of benzathine penicillin G. The clinical response was similar in both groups, in terms of fever duration (16 +/- 14 hours with miocamycin vs 13 +/- 13 hours with penicillin) and normalization of appetite (87.7% of children with miocamycin vs 95.8% of children with penicillin after three days). Bacteriologic eradication of streptococcus was achieved in 66% of children treated with penicillin and 32% of those treated with miocamycin (p < 0.001). We conclude that a single benzathine penicillin is more effective eradicating streptococcus pyogenes than miocamycin in children with streptococcal pharyngitis.

Child↗

PubMed1991

[Effect of miocamycin and erythromycin on the activity of human neutrophils against Staphylococcus aureus].

We evaluate the effect of two macrolide drugs (miocamycin and erythromycin) on human neutrophil cells (PMNs) against S. aureus strains. We studied: a) S. aureus pre-treatment effect, using subinhibitory concentrations of the two drugs, on its phagocytosis by human PMN's; b) effect of the drugs on superoxide production by PMN's; c) intracellular activity of the two drugs against S. aureus. Prior treatment of S. aureus with subinhibitory concentrations (25% of the MIC) increases significantly the phagocytosis of opsonized bacteria by human PMN's. Using non-opsonized bacteria, the registered effect was only statistically significant for miocamycin. Pre-incubation of human PMN's with 1, 10 and 25 mg/L concentrations of each drug did not influence superoxide production of the cells. Both drugs showed slight intracellular activity against S. aureus inside human PMN's, although this only achieves statistically significant difference with higher concentrations (25 mg/L) of miocamycin. In summary, both drugs influence directly human PMN's phagocytosis of S. aureus, changing the opsonic requirements of the microorganism. At therapeutic levels, neither erythromycin nor miocamycin hampered phagocytic and bactericidal mechanisms of human PMN's. At higher concentration, miocamycin showed good intracellular activity against S. aureus.

Erythromycin↗