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The chemistry, mechanism of action, antimicrobial spectrum, pharmacokinetics, clinical efficacy, adverse effects, drug interactions, and dosage and administration of clarithromycin and azithromycin are described. Clarithromycin and azithromycin are new macrolide antibiotics that are similar in structure to erythromycin. Compared with erythromycin, clarithromycin demonstrates increased activity against Staphylococcus aureus, streptococci, Legionella pneumophila, Moraxella catarrhalis, and Chlamydia trachomatis. Clarithromycin also has in vitro activity against Mycobacterium avium complex (MAC) and Toxoplasma gondii. Azithromycin has increased gram-negative activity compared with erythromycin, including activity against Haemophilus influenzae, while maintaining activity against gram-positive organisms. Azithromycin also has activity against sexually transmitted organisms including Chlamydia trachomatis. The pharmacokinetic profiles of clarithromycin and azithromycin are characterized by good oral bioavailability, excellent tissue penetration and persistence, and long elimination half-lives, which allow for once-daily or twice-daily dosing. Initial data show that clarithromycin and azithromycin are effective for the treatment of upper-respiratory-tract and lower-respiratory-tract infections and infections of the skin and skin structures. Azithromycin has been shown to be effective for the treatment of sexually transmitted diseases caused by Chlamydia trachomatis. Clarithromycin and azithromycin have been used to treat MAC and Toxoplasma infections in patients with the acquired immunodeficiency syndrome. The most frequently reported adverse effects for both agents have been nausea, diarrhea, and abdominal pain. Oral formulations of clarithromycin and azithromycin have recently been approved by the FDA. Clarithromycin and azithromycin are new macrolide antibiotics that have potential advantages over erythromycin; however, the role of these agents will be better defined as results of more ongoing trials become available for evaluation.
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PMID:Clarithromycin and azithromycin: new macrolide antibiotics. 151 40

Azithromycin is an azalide antimicrobial agent. Structurally related to the macrolide antibiotic erythromycin, its mechanism of activity (similar to erythromycin) is interference with bacterial protein synthesis by binding to the 50S component of the 70S ribosomal subunit. Although slightly less potent than erythromycin against gram-positive organisms, azithromycin demonstrates superior activity in vitro against a wide variety of gram-negative bacilli, including Haemophilus influenzae. Absorption is approximately 37% after a 500-mg oral dose. The large volume of distribution (23 L/kg) and low peak serum level (0.4 micrograms/ml) are consistent with data demonstrating extensive tissue distribution and intracellular accumulation. Metabolism is predominantly hepatic (to inactive metabolites), with biliary excretion a major pathway of elimination. Drug elimination is biphasic, with a terminal half-life of up to 5 days. Published trials have examined the efficacy and safety of azithromycin in the treatment of adults with upper and lower respiratory tract infections, skin and skin structure infections, streptococcal pharyngitis, and sexually transmitted diseases. Many used a 5-day course of 250 mg once daily, supplemented with a 250-mg dose on the first day of therapy. Selected trials in sexually transmitted diseases examined single 1-g doses. Promising results also were obtained with oral daily doses of 500 mg in patients with human immunoviral infection who also had Mycobacterium avium complex infection and in animals with toxoplasmosis. Adverse reactions are primarily gastrointestinal (nausea, diarrhea, abdominal pain), with minimal laboratory abnormalities reported. Gastrointestinal tolerance is better than that of erythromycin. Drug interactions have not been observed to date, although coadministration of azithromycin with a large meal may reduce absorption by up to 50%.
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PMID:Azithromycin--spectrum of activity, pharmacokinetics, and clinical applications. 131 48

The toleration and safety profile of the azalide antibiotic, azithromycin, has been assessed in 3,995 patients aged 2-94 (mean, 36) years, comprising 1,644 females and 2,351 males. Patients with infections of the respiratory tract or skin/skin structure received 1.5 g azithromycin over 5 days; patients with urethritis/cervicitis caused by Chlamydia were treated with 1 g as a single dose. Assessments of side effects and laboratory safety test abnormalities were made pretreatment and approximately 7-14 and 30 days after the start of therapy. Twelve standard antibiotics have been used for comparison. Overall, side effects were recorded in 12.0% of patients, significantly less (p less than 0.05) than with comparative drugs (14.2%). The most common side effects were diarrhea (3.6%), abdominal pain (2.5%), and other gastrointestinal symptoms. Ninety-three percent of side effects were classed as mild or moderate, and only 0.7% of patients withdrew from treatment, significantly less (p less than 0.001) than with comparative agents (2.6%). The frequency of side effects was not affected by patient age. Azithromycin had no marked or consistent effect on laboratory safety parameters. Treatment-related laboratory abnormalities were rare, the most common being transient increases of ALT and AST in 1.7% and 1.5% of patients, respectively. Specific tests revealed no neurologic, audiometric, or ophthalmologic abnormalities, or evidence of phospholipidosis. There were no pharmacokinetic interactions observed with theophylline, warfarin, cimetidine, carbamazepine, or methylprednisolone, but coadministration with food altered the absorption of the drug. Coadministration with antacids decreased the peak serum concentration of azithromycin, but did not affect its overall absorption. Azithromycin was well tolerated in the presence of a wide variety of concurrent illnesses and medications.
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PMID:Clinical toleration and safety of azithromycin. 165 42

One hundred and eighty-two patients were enrolled in a randomized third-party blinded study to assess the efficacy and safety of azithromycin in the treatment of sexually transmitted diseases. Three regimens of azithromycin, including a single oral dose, were compared with a standard treatment with doxycycline. The patients were followed for four weeks. Efficacy was evaluated in 168 patients (113 azithromycin, 55 doxycycline). Fourteen patients had negative cultures or did not come for all follow-up visits. Of the 168, 138 were infected with Chlamydia trachomatis, 43 with Neisseria gonorrhoeae, and 45 with Ureaplasma urealyticum. Ninety-six per cent of patients with chlamydial infections and 92% of those with gonorrhoea were cured with azithromycin. Two patients infected with N. gonorrhoeae, four with C. trachomatis and six with U. urealyticum had positive cultures on follow-up visits after receiving azithromycin. Of these 11 patients with positive cultures on follow-up visits, seven (five with U. urealyticum and two with C. trachomatis) violated the protocol by having intercourse with infected individuals during the study. Azithromycin was very well tolerated; one patient complained of mild abdominal pain shortly after receiving the drug, seven patients complained of mild nausea and two patients had mild diarrhoea.
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PMID:Azithromycin in the treatment of sexually transmitted disease. 215 28

Azithromycin is effective against Chlamydia trachomatis in vitro and as a single dose for the treatment of chlamydia infection of the genital tract. A randomized single-blind study was conducted in 2 Gambian villages (Jali with a population of 900 and Berending with 500) in order to assess the effectiveness and safety of a single oral dose of 20 mg/kg azithromycin compared with conventional treatment in ocular C. trachomatis infection. In May 1992 an ocular survey was done in both villages, and 199 subjects with active trachoma were identified (128 in Jali and 71 in Berending). Of these, 194 patients were randomly assigned to conventional or azithromycin treatment. Azithromycin was administered in a single dose of 20 mg/kg. Subjects receiving conventional treatment were given 1% tetracycline eye ointment to each eye twice daily for 6 weeks. Severe cases were given oral erythromycin stearate based on an adult dose of 250 mg 4 times daily for 2 weeks. Subjects were examined 4, 8, 16, and 26 weeks after treatment. In 20% of the subjects diarrhea, vomiting, and abdominal pain occurred. Clinical signs had resolved by 6 months' follow-up in 146 patients: 70 (72%) in the conventional treatment group, and 76 (78%) in the azithromycin group. At 6 months the symptoms of 9 subjects with severe disease, and 21 with moderate disease had resolved. However, during follow-up, 11 of those with severe disease, 30 of those with moderate disease, and 129 of those with mild disease had resolution at some point, which reflects the scale of re-emergent disease. To allow for the effect of recrudescent disease on point prevalences at follow-up, a survival analysis of time to loss of clinical signs as outcome was done. There was no difference between treatments (p 0.9). 21 of the 194 subjects were antigen positive in their nasal secretions at baseline. Of these, 18 still had clinical signs at 4 weeks compared with 87 of the 173 with antigen-negative nasal secretions ( p = 0.004; odds ratio 5.93).
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PMID:Randomised controlled trial of single-dose azithromycin in treatment of trachoma. 810 27

During the past decade, there has been a resurgence of interest in the development of oral macrolide and fluoroquinolone antimicrobial agents. Azithromycin and clarithromycin are two new oral macrolides whose pharmacokinetics (compared with those of erythromycin) are characterized by improved oral bioavailability, increased tissue penetration and persistence, and longer elimination half-lives. A limited number of interactions with other drugs have been reported for azithromycin and clarithromycin. The most common adverse reactions to the new macrolide agents include nausea, diarrhea, and abdominal pain. Norfloxacin, ciprofloxacin, ofloxacin, temafloxacin, and lomefloxacin are the oral fluoroquinolones that have been marketed in the United States thus far. In comparison to nalidixic acid, the newer fluoroquinolones have improved pharmacokinetic properties, including greater oral absorption, increased peak serum concentrations and areas under the curve, higher tissue concentrations, and longer elimination half-lives. Divalent or trivalent cations can alter the absorption of all fluoroquinolones. Some of the fluoroquinolones (norfloxacin, ciprofloxacin, and ofloxacin) can inhibit the cytochrome P-450 enzyme system and thereby cause increased serum concentrations of drugs like theophylline and caffeine. Adverse reactions to the fluoroquinolones primarily involve the gastrointestinal system, skin, and central nervous system.
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PMID:New oral macrolide and fluoroquinolone antibiotics: an overview of pharmacokinetics, interactions, and safety. 839 14

In women, Chlamydia trachomatis infection often occurs in the urethra or cervix, with up to 70% of infections associated with few or no symptoms. Inadequate treatment may lead to infection of the upper genital tract and subsequent pelvic inflammatory disease (PID) in 10 to 40% of patients. PID causes an increased relative risk of ectopic pregnancy of 2.5 to 7.9 and PID may also lead to tubal infertility in about 17% of patients. 60% of infants born of mothers with C. trachomatis infection may become infected, leading to conjunctivitis in 23% and pneumonia in 21%. All of these sequelae of C. trachomatis infection may require in- or outpatient treatment. With > 4 million infections estimated to occur each year in the US, C. trachomatis is one of the most common and costly of the sexually transmitted pathogens. Treatment options for uncomplicated C. trachomatis infections in nonpregnant women include single-dose azithromycin 1000 mg or doxycycline 100 mg twice daily for 7 days orally. In clinical trials, the bacteriological cure rate of single dose azithromycin 1000 mg (95 to 100%) was similar to that of oral doxycycline 200 mg/day for 7 days (88 to 100%) in nonpregnant women. Azithromycin was at least as well tolerated as doxycycline and was associated with mainly mild gastrointestinal adverse effects including diarrhoea, nausea and abdominal pain. Pharmacoeconomic analyses have sought to determine if the 2.7- to 12-fold higher acquisition costs of azithromycin in comparison with doxycycline are offset by its simple single-dose regimen which is likely to aid patient compliance and so optimise drug efficacy. All analyses were retrospective cost-effectiveness decision-tree models and mainly considered direct costs. All models incorporated an estimate of noncompliance with doxycycline and its influence on efficacy. For the treatment of confirmed C. trachomatis infection, azithromycin saved around $US1200 per major outcome avoided (1993 values; third-party payer perspective in the US) or US$3502 per case of PID avoided (1993 values; US healthcare system perspective) compared with doxycycline. If infection was treated empirically, azithromycin was more costly than doxycycline by $US792 (1993 values), but the result was sensitive to changes of some parameters of the model. Azithromycin was more costly than doxycycline from the perspective of a public health clinic which paid for the treatment of initial infection and acute sequelae only. Thus, pharmacoeconomic data from the US support the use of azithromycin in the treatment of nonpregnant women with confirmed C. trachomatis urogenital infections from the perspective of the healthcare system or third-party payer; however, from the perspective of a public clinic, doxycycline is the less costly option. Decreases in doxycycline compliance or azithromycin acquisition cost are factors that favour azithromycin.
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PMID:Azithromycin. A pharmacoeconomic review of its use as a single-dose regimen in the treatment of uncomplicated urogenital Chlamydia trachomatis infections in women. 1017 26

Azithromycin (Zithromax) has been used to treat a number of infections, including mycobacterium avium complex (MAC). A study using Azithromycin to prevent MAC shows the drug's effectiveness in reducing the outbreak of MAC and also protecting from other infections, including PCP. This study involved 180 HIV-positive subjects, of which 89 received 1200 mg of Azithromycin once a week, and 91 received a placebo once a week. Fifteen percent of the treated subjects developed MAC infections compared to 30 percent of the placebo group. In addition, more subjects taking the placebo developed PCP than subjects taking the Azithromycin. Diarrhea, nausea, and abdominal pain were the most common side effects from Azithromycin.
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PMID:Azithro once a week for MAC. 1136 25

The aim of the study was to investigate the efficacy, safety and compliance of 500 mg azithromycin thrice weekly for 12 weeks in moderate inflammatory acne vulgaris. An open-label, noncomparative study was carried out for 12 weeks at Department of Dermatology and Plastic Surgery, La Sapienza University in Rome. Fifty-seven patients (20 male and 37 female) between 13 and 41 years of age, affected by moderate papulopustular and nodular acne vulgaris, were enrolled in the study. Azithromycin 500 mg was administered orally thrice weekly for 12 weeks. Patients were examined at baseline, 4 weeks, 8 weeks and 12 weeks (completion of treatment), evaluating both clinical (Global Acne Grading System, GAGS) and quality of life (Acne Quality of Life Questionnaire, AQoL) improvements. Forty-six patients completed the study and showed significant improvement. Six patients interrupted their treatment, while five patients did not complete the study for unknown reasons. Side effects (diarrhea and abdominal pain) were recorded in eight patients. Azithromycin, 500 mg thrice weekly for 12 weeks, is a safe and effective treatment for moderate acne vulgaris with excellent patient compliance.
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PMID:Moderate acne vulgaris: efficacy, tolerance and compliance of oral azithromycin thrice weekly for. 1835 3

Epstein-Barr virus (EBV), cytomegalovirus (CMV), and Mycoplasma pneumoniae are common pathogens of respiratory infection among children and young adults. Although single infection of 1 of these pathogens is common enough, their coinfection has been rarely reported. A 19-year-old woman presented with severe upper abdominal pain for 5 hours as well as flu-like symptoms and jaundice for 2 to 3 weeks. Initial tests found pancytopenia, abnormal liver functions, and presence of atypical lymphocytes in blood smear; the computed tomography of the abdomen revealed para-aortic lymphadenopathy, splenomegaly, and a wedge-shaped focal hypodensity lesion at the periphery of the spleen that was later diagnosed as splenic infarction. Her presentation raised suspicion of infectious mononucleosis. Nevertheless, monospot test, human immunodeficiency virus screening, and hepatitis viral serology were all negative, except that her M pneumoniae immunoglobulin M was found positive. Azithromycin was promptly given, but her fever and abdominal pain persisted. A strong suspicion of mononucleosis led to serological tests for EBV and CMV, which confirmed coinfection of EBV and CMV. By hospital day 7, her fever and abdominal pain had subsided and her liver function became normal. This case exemplifies the challenges in the diagnosis of coinfection of multiple respiratory pathogens and its associated complications. Greater awareness among clinicians would ensure an earlier and more accurate diagnosis of coinfection of EBV/CMV with other respiratory pathogen(s).
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PMID:Splenic infarction caused by a rare coinfection of Epstein-Barr virus, cytomegalovirus, and Mycoplasma pneumoniae. 2518 5


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