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Azithromycin: Organs and Systems

Cardiovascular

Torsade de pointes and cardiorespiratory arrest have been reported in a patient with congenital long QT syndrome who took azithromycin. In a prospective study of 47 previously healthy people, there was a modest statistically insignificant prolongation of the QTC interval without clinical consequences after the end of a course of azithromycin 3 g/day for 5 days.

Sensory systems

Ears

Azithromycin can cause ototoxicity. In one study, 8 (17%) of 46 HIV-positive patients had probable (n = 6) or possible (n = 2) ototoxicity with azithromycin. The effects were hearing loss (88%), tinnitus (37%), plugged ears (37%), and vertigo (25%), developing at a mean of 7.6 weeks (1.5-20 weeks) after the start of long-term azithromycin therapy for Mycobacterium avium infection. The symptoms resolved in a mean of 4.9 weeks (2-11 weeks) after withdrawal.

Sensorineural hearing loss has been attributed to azithromycin.

• A 35-year old Caucasian man with AIDS and multiple opportunistic infections, including Mycobacterium kansasii and Mycobacterium avium complex (MAC) disease developed moderate to severe primary sensorineural hearing loss after 4-5 months of therapy with oral azithromycin 500 mg/day. Other medications included ethambutol, isoniazid, rifabutin, ciprofloxacin, co-trimoxazole, fluconazole, zidovudine (later switched to stavudine), lamivudine, indinavir, methadone, modified-release oral morphine, pseudoephedrine, diphenhydramine, megestrol acetate, trazodone, sorbitol, salbutamol by metered-dose inhaler and nebulizer, ipratropium, and oral morphine solution as needed. Significant improvement of the hearing impairment was documented 3 weeks after drug withdrawal.

A literature review identified several cases of ototoxicity in HIV-positive patients treated with azithromycin for Mycobacterium avium complex infection. In four series, 14-41% of such patients had some degree of hearing loss. However, some patients were also taking other potentially ototoxic drugs, which may have contributed to the high frequency of hearing loss reported. Hearing loss improved markedly after withdrawal of azithromycin. Hearing loss may be more common and probably more severe with high-dose azithromycin than with high-dose clarithromycin.

• A 47-year-old woman who had a left lung transplantation 3 months earlier and who was taking ticarcillin + -clavulanate and aztreonam for sinusitis, was given co-trimoxazole, ticarcillin + clavulanate, azithromycin (500 mg/day intravenously), and ganciclovir for presumed pneumonia. Other drugs included tacrolimus, mycophenolate, prednisone, lansoprazole, diltiazem, itraconazole, warfarin, alendronate, ipratropium bromide, folic acid, and nystatin. The next day, rimantadine and vancomycin were added, and co-trimoxazole was reduced. A neurological examination to assess symptoms of peripheral neuropathy noted no hearing deficit. On day 3, vancomycin, ticarcillin + – clavulanate, and ganciclovir were withdrawn. On the fifth day, mild tinnitus and reduced hearing developed and gradually progressed to complete deafness. After eight doses, azithromycin was withdrawn, and 20 days later her hearing was back to baseline.

Low-dose exposure to azithromycin has been associated with irreversible sensorineural hearing loss in otherwise healthy subjects. Even a single oral dose of azithromycin altered the conjunctival bacterial flora of children from a trachoma endemic area. However, the clinical significance is not yet clear.

Psychological, psychiatric

Azithromycin can cause delirium.

Hematologic

The effects of combining azithromycin and rifabutin have been studied in 50 subjects with or without HIV infection, of whom 19 took azithromycin 1200 mg/day and rifabutin 600 mg/day, and 31 took azithromycin 600 mg/day and rifabutin 300 mg/day. Neutropenia was the most common adverse event, in 33 of 50 subjects. Low-grade nausea, diarrhea, fatigue, and headache were also common, and most subjects had more than one type of event. There was no significant pharmacokinetic interaction between the two drugs.

Gastrointestinal

In a review of 12 clinical studies most of the adverse events in those taking azithromycin affected the gastrointestinal system, and were reported in 138 (8.5%) azithromycin-treated patients. Abdominal pain, diarrhea, nausea, and vomiting were the most frequently reported gastrointestinal adverse events.

Gastrointestinal symptoms were the most common adverse effects reported in a trial of azithromycin in disseminated Mycobacterium avium complex in 62 patients with AIDS. Erythromycin is a motilin receptor agonist. This mechanism may be at least partly responsible for the gastrointestinal adverse effects of macrolides. Azithromycin may act on gastrointestinal motility in a similar way to erythromycin, as it produces a significant increase in postprandial antral motility.

Liver

Azithromycin can cause intrahepatic cholestasis.

• A 33-year-old woman and a 72-year-old man developed cholestasis after they had taken a 5-day course of azithromycin. The woman was given colestyramine and underwent six courses of plasmapheresis; 2 months later, her total bilirubin and serum transaminases were back to normal. After withdrawal of azithromycin, the man’s symptoms resolved within 1 month and his liver enzymes returned to normal.

Skin

• A 19-year-old man with infectious mononucleosis developed a maculopapular, non-pruritic rash after one dose of azithromycin 500 mg.

Immunologic

Occupational allergic contact dermatitis has been attributed to azithromycin.

• A 32-year-old pharmaceutical worker had been loading reactors at three different stages of azithromycin synthesis for the past 3 years and had been exposed to airborne powders. He wore overalls and latex gloves. His symptoms had persisted for 1 year in the form of pruritus, erythema, vesicles, and scaling of the face and forearms. A positive patch test and a positive workplace challenge were considered reliable in the diagnosis of occupational allergic contact dermatitis induced by azithromycin. After transfer to another work station that excluded exposure to azithromycin, he had no further work-related symptoms.

Hypersensitivity to azithromycin has been reported.

• A 79-year-old man developed fever, mental changes, a rash, acute renal insufficiency, and hepatitis after he had completed a 5-day course of oral azithromycin (500 mg initially then 250 mg/day). With intravenous hydration only, his fever abated and his urinary output and renal and hepatic function returned to normal over the next 4 days. His mental status improved significantly. The skin rash was followed by extensive desquamation.

Azithromycin has been associated with Churg-Strauss syndrome in a patient with atopy.

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Spanish And French Translations Of Common Medication Words:

English Spanish French
Medications Medicamentos Médicaments
Tablets Comprimidos Comprimés
Capsules Cápsulas Gélules
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Synonyms of Azithromycin *:

Aritromicina [Spanish], Azithramycine, Azithromycin Dihydrate, Azithromycine [French], Azithromycinum [Latin]

* Official titles and synonyms used in the British, European, and US Pharmacopoeias. INNs in the other main official languages (French, Latin, and Spanish) have also been included in the list of synonyms where these differ from the English INN.

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Dosage forms of Azithromycin:

Name, Strength, Form, Route
Azithromycin Powder, for solution Intravenous
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Azithromycin Powder, for suspension Oral
Azithromycin 250 mg Tablet Oral
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Trimox 125 mg/5ml Suspension 150ml Bottle Trimox 250 mg/5ml Suspension 80ml Bottle Azithromycin 500 mg tablet Azithromycin 600 mg tablet
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Therapeutic classes of Azithromycin:

Anti-Bacterial Agents, Macrolides, Other Macrolides

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