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Store in airtight containers. The United States Pharmacopeia 31, Azithromycin. It is anhydrous or contains one or two molecules of water of hydration. Gastrointestinal disturbances are the most frequent adverse effect of azithromycin but are usually mild and less frequent than with erythromycin.
Headache, somnolence, and taste disturbances may occur. Severe hypersensitivity reactions occur rarely but may be prolonged. Thrombocytopenia and mild transient neutropenia have been rarely reported in patients receiving azithromycin. Pain and inflammation may occur at the site of intravenous infusions particularly at high concentrations. Licensed product information states that azithromycin should be used with caution in patients with hepatic or renal impairment.
It should not be given to those with severe hepatic impairment as safety has not been established. Although plasma concentrations may be increased in renal impairment dosage adjustment is not usually required. In general, adverse effects were associated with higher serum-azithromycin concentrations. Reversible sensorineural hearing loss was reported in 3 patients given oral azithromycin mg daily with clofazimine and ethambutol for the treatment of disseminated Mycobacterium avium complex infection.
Irreversible hearing loss has also been reported after low-dose exposure to oral azithromycin. A patient who had had 8 days of treatment with intravenous azithromycin mg daily for pneumonia reported complete deafness, which had resolved 20 days after stopping the drug. See also Incidence of Adverse Effects, above. The syndrome of inappropriate antidiuretic hormone secretion was associated with azithromycin treatment in a patient. Acute interstitial nephritis leading to irreversible renal failure has been reported in a patient who received azithromycin for 9 days. A later report described a patient who developed recurrent acute interstitial nephritis after courses of azithromycin.
Repeated exposure resulted in persistent renal damage; leucocytosis and eosinophilia were still present 1 year later. A syndrome characterised by eosinophilia, arthralgia, fever, and rash was associated with azithromycin or roxifhromycin treatment in a patient on separate occasions.
The original authors believed the condition represented the Churg-Strauss syndrome, although this was disputed in correspondence and attributed to the eosinophilia-myalgia syndrome.
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For a discussion of drug interactions of macrolide antibacterials, see Erythromycin. Giving azithromycin with antacids containing aluminium or magnesium salts can reduce the rate, but not the extent, of its absorption; azithromycin should be given at least 1 hour before or 2 hours after the antacid. Azithromycin serum concentrations are markedly increased when it is given with nelfinavir, but the clinical significance of this is uncertain. US licensed product information for azithromycin states that dosage adjustment is not required although the patient should be closely monitored for adverse effects.
As for Erythromycin. Azithromycin is less active than erythromycin against streptococci and staphylococci, but has greater activity than erythromycin in vitro against some Gram-negative organisms such as Haemophilus influenzae and Moraxella catarrhalis Branhamella catarrhalis , as well as having activity against some of the Enterobacteriaceae such as Escherichia coli and Salmonella and Shigella spp.
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