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Author: Admin | 2025-04-28
Occurring witha frequency > 1% were: rash (5%), anorexia (2%), fever (2%), and dermatitis (2%).In a second trial of 337 pediatric subjects, ages 2 yearsto 12 years, the most frequently reported treatment-related adverse reactionsalso included vomiting (14%), diarrhea (7%), loose stools (2%), nausea (4%) andabdominal pain (4%).A third trial investigated the tolerability of twodifferent concentrations of azithromycin oral suspension in 120 pediatricsubjects (ages 3 months to 48 months), all of whom were treated withazithromycin. The study evaluated the hypothesis that a more dilute, lessviscous formulation (the recommended 27 mg/mL concentration of Zmax) is lesslikely to induce vomiting in young children than a more concentrated suspensionused in other pediatric studies. The vomiting rate for subjects taking thedilute concentration azithromycin was 3% (2/61). The rate was numerically lowerbut not statistically different from the vomiting for the more concentratedsuspension Across both treatment arms, the only treatment-related adverseevents with a frequency of > 1% were vomiting (6%, 7/120) and diarrhea (2%,2/120).Treatment-related adverse reactions with a frequency of Body as a whole: Chills, fever, flu syndrome,headache;Digestive: Abnormal stools, constipation,dyspepsia, flatulence, gastritis, gastrointestinal disorder, hepatitis;Hematologic and lymphatic: Leukopenia;Nervous system: Agitation, emotional liability,hostility, hyperkinesia, insomnia, irritability, paresthesia, Somnolence;Respiratory: Asthma, bronchitis, cough, dyspnea, pharyngitis, rhinitis;Skin and appendages: Dermatitis, fungaldermatitis, maculopapular rash, pruritus, urticaria;Special senses: Otitis media, taste perversion;Urogenital: Dysuria.Postmarketing Experience With Other Azithromycin ProductsBecause these reactions are reported voluntarily from apopulation of uncertain size, reliably estimating their frequency orestablishing a causal relationship to drug exposure is not always possible.Adverse events reported with azithromycin immediaterelease formulations during the postmarketing period for which a causalrelationship may not be established include:Allergic: Arthralgia, edema, urticaria and angioedemaCardiovascular: Palpitations and arrhythmiasincluding ventricular tachycardia and hypotensionThere have been reports of QT prolongation and torsadesde pointes.Gastrointestinal: Anorexia, constipation,dyspepsia, flatulence, vomiting/diarrhea, pseudomembranous colitis, pancreatitis, oral candidiasis, pyloric stenosis, and rare reports of tongue discolorationGeneral: Asthenia, paresthesia,
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