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<p><b>Sumamed Information for Physicians and Pharmacists</b></p> |
<p><b>The Application</b></p> |
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<p><b>Absorption<br> |
<p>Numerous clinical trials have confirmed azithromycin's efficacy for many different |
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</b>Sumamed is rapidly absorbed and distributed throughout body tissues and |
indications. At present, azithromycin is used in the treatment of upper respiratory |
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fluids, reaching high and sustained concentrations, that extend the anti-microbial |
tract infections (bacterial pharyngitis/tonsillitis, bacterial sinusitis, bacterial |
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activity of Sumamed well beyond the completion of dosing. Azithromycin's superior |
otitis media), lower respiratory tract infections (bacterial bronchitis, acute |
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absorption, in comparison to erythromycin, is due to its good stability in the |
exacerbation of chronic bronchitis, community acquired pneumonia), sexually |
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acid environment of the stomach. After a single oral dose of 500 mg, peak serum |
transmitted diseases (uncomplicated urethritis, uncomplicated cervicitis), pelvic |
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concentration is reached after two to three hours. Sumamed should be taken one |
inflammatory disease, gastric and duodenal infections caused by <i>Helicobacter |
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hour before or two hours after a meal because food reduces the absorption of |
pylori</i>, skin and soft tissue infections (erysipelas, impetigo, secondary |
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azithromycin by approximately 50%.</p> |
pyoderma, erythema migrans) and prevention of disseminated <i>Mycobacterium |
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<p><b>Distribution</b><br> |
avium</i> complex in persons with advanced HIV infection.</p> |
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As a weak base, it easily penetrates the cell membrane and accumulates within |
<p>Azithromycin's advantage is its activity against gram-negative organisms, particularly |
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the cell, mainly in lysosomes. High concentrations of azithromycin are found |
<i>Haemophilus influenzae</i>, and intracellular and other organisms (<i>Mycoplasma |
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in infected tissues since phagocytes, polymorphonuclear leukocytes and macrophages |
pneumoniae</i>, <i>Chlamydia pneumoniae</i>, <i>Chlamydia trachomatis</i> and |
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deliver azithromycin to the infection site and release it there in the presence |
<i>Legionella pneumophila</i>). Since azithromycin shows a good activity against |
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of bacteria. Following a single 500 mg dose, azithromycin achieves relatively |
the most common pathogens it is used as a choice for empirical therapy.</p> |
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low serum concentrations. As an exceptional advantage in relation to other antibiotics, |
<p><b>The Future</b></p> |
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azithromycin has significantly higher concentrations in tissues than in serum. |
<p>Clinical investigation into new indications is lead by the <i>in vitro</i> |
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Tissue concentrations of azithromycin remain high for five to seven days after |
activity of azithromycin on one hand and unmet medical needs on the other. Potential |
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the completion of dosing, resulting in sustained anti-microbial activity despite |
prospects for azithromycin in clinical usage belong to field of infectious diseases |
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the short dosing regimen.</p> |
and chronic "non-infectious" diseases. Among infectious diseases, azithromycin |
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<p><b>Metabolism<br> |
may have potential uses in the treatment of acute infectious diarrhoea, inclusion |
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</b>The bio-transformation of azithromycin occurs mainly in the liver. Until |
conjunctivitis, dental infections, acne, pertussis, prostatitis, trachoma, toxoplasmosis, |
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now, 10 azithromycin metabolites with no anti-microbial activity have been isolated, |
syphilis, rickettsiosis, leptospirosis and typhoid fever. In field of chronic |
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50% of biliary excreted azithromycin is in the form of the unchanged compound. |
"non-infectious" diseases, new potential indications are atherosclerosis, asthma, |
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</p> |
reactive arthritis, inflammatory bowel disease and some rare diseases.</p> |
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<p><b>Elimination<br> |
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</b>Biliary excretion of azithromycin is a major route of elimination. Only |
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6% of the drug is excreted via urine.</p> |
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<p><b>Terminal half-life</b> is approximately 68 hours.</p> |
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<p><b>Microbiological properties</b><br> |
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Mechanism of <b>action:</b><br> |
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Azithromycin acts by interfering with bacterial DNA synthesis (by binding to |
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the 50S ribosomal subunit). Although this mechanism is considered bacteriostatic |
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concentrations several times higher than minimum inhibitory concentrations (MIC) |
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contribute to the bactericidal activity of azithromycin.<br> |
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Mechanism of<b> resistance:<br> |
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</b>The most common mechanism of resistance to azithromycin is genetically determined |
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biochemical interference with the binding of azithromycin to the 50S ribosomal |
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subunit. Some bacteria, resistant to erythromycin, show cross-resistance to |
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other macrolides. </p> |
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<p><b>Anti-microbial spectrum</b> <br> |
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Sumamed is active against the most common pathogens that cause infections of |
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the respiratory tract, skin and soft tissue, and sexually transmitted diseases. |
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It is also effective in the treatment of gastric and duodenal infections caused |
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by <i>Helicobacter pylori</i>. One advantage is its activity against Gram-negative |
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organisms, particularly <i>Haemophilus influenzae</i>. Sumamed also demonstrates |
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excellent activity against intracellular and other organisms (<i>Mycoplasma |
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pneumoniae, Chlamydia pneumoniae, Chlamydia trachomatis</i> and <i>Legionella |
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pneumophila</i>).</p> |
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<p>Sumamed is active against following:</p> |
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<ul> |
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<li><b>upper respiratory tract infections</b> (<i>Streptococcus pneumoniae, |
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Streptococcus pyogenes, Haemophilus influenzae, Moraxella catarrhalis</i>),</li> |
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<li><b>lower respiratory tract infections</b> (<i>Mycoplasma pneumoniae, Streptococcus |
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pneumoniae, Haemophilus influenzae, Chlamydia pneumoniae, Moraxella catarrhalis</i>),</li> |
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<li><b>sexually transmitted diseases</b> (<i>Chlamydia trachomatis, Neisseria |
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gonorrhoeae, Ureaplasma urealyticum</i>),</li> |
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<li><b>skin and soft tissue infections</b> (<i>Staphylococcus aureus, Streptococcus |
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pyogenes</i>)</li> |
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<li>Sumamed is active against <i>Helicobacter pylori</i>.</li> |
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</ul> |
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<p>These facts make Sumamed a reasonable choice for empirical therapy.</p> |
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<p><b>Clinical efficacy<br> |
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</b>Numerous clinical trials have confirmed Sumamed's efficacy in the treatment |
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of:</p> |
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<ol> |
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<li><b>upper respiratory tract infections</b>: |
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<ul> |
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<li>bacterial pharyngitis/tonsillitis,</li> |
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<li>bacterial sinusitis,</li> |
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<li>bacterial otitis media.</li> |
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</ul> |
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</li> |
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<li><b>lower respiratory tract infections</b>: |
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<ul> |
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<li>bacterial bronchitis,</li> |
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<li>acute exacerbation of chronic bronchitis,</li> |
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<li>interstitial pneumoniae,</li> |
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<li>alveolar pneumoniae.</li> |
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</ul> |
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</li> |
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<li><b>sexually transmitted diseases</b>: |
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<ul> |
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<li>uncomplicated urethritis,</li> |
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<li>uncomplicated cervicitis.</li> |
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</ul> |
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</li> |
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<li><b>gastric and duodenal infections</b> caused by <i>Helicobacter pylori</i>.</li> |
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<li><b>skin and soft tissue infections</b>: |
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<ul> |
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<li>erysipelas,</li> |
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<li>impetigo secondary pyoderma,</li> |
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<li>erythema migrans.</li> |
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</ul> |
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</li> |
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</ol> |
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<p><b>Drug interactions</b><br> |
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Azithromycin, unlike majority of macrolides, does not bind to cytochrom P-450 |
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in the liver, resulting in low potential for drug to drug interaction.</p> |
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<p><b>Safety</b><br> |
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Azithromycin is either better or equally well tolerated, compared to other antibiotics. |
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The toleration and safety profile of azithromycin have been assessed in 4,727 |
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patients enrolled in clinical trials carried out in Croatia, the Czech Republic, |
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Hungary, Macedonia, Poland, the Slovak Republic, Slovenia, Russia and the former |
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Yugoslavia.</p> |
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<p><b>Side effects</b> were recorded in 5.65% of the adult patients treated with |
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azithromycin. A statistically higher incidence of side effects (13.89%) was |
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noticed in adult patients treated with comparative antibiotics. In children |
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treated with azithromycin, side effects were recorded in 6.52% of the patients. |
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The incidence of side effects (17.65%) was statistically higher in children |
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treated with other antibiotics. </p> |
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