Sign Out
Rare serious allergic reactions, including angioneurotic edema and anaphylaxis (rarely fatal), have been reported. Some of these reactions with azithromycin have resulted in recurrent symptoms and required a longer period of observation and treatment.
Observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended.
Pseudomembranous colitis has been reported with the use of macrolide antibiotics. This diagnosis should therefore be considered in patients who get diarrhea after starting the treatment with Azithromycin monohydrate (Zenith). Should pseudomembranous colitis be induced by azithromycin, then anti-peristaltics should be contraindicated.
There is no experience regarding the safety and efficacy of the long-term application of Azithromycin monohydrate (Zenith) for the previously mentioned indications. In case of quickly recurring infections, treatment with another antibacterial agent should be considered.
Due to the theoretical possibility of ergotism, Azithromycin monohydrate (Zenith)and ergot derivatives should not be co-administered (see Interactions).
Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen in treatment with other macrolides. A similar effect with azithromycin cannot be completely ruled out in patients at increased risk for prolonged cardiac repolarization. Therefore, azithromycin should not be used: in patients with congenital or documented acquired QT prolongation; with other active substances that prolong QT interval such as antiarrhythmics of classes IA and III, cisapride and terfenadine; electrolyte disturbance, particularly in cases of hypokalemia and hypomagnesemia; in [patients with clinically relevant bradycardia, cardiac arrhythmia or severe cardiac insufficiency.
Azithromycin monohydrate (Zenith) is not the substance of first choice for the treatment of pharyngitis and tonsillitis caused by Streptococcus pyogenes. For this and for the prophylaxis of acute rheumatic fever, penicillin is the treatment of first choice.
In case of sexually transmitted diseases, a concomitant infection by T. pallidum should be excluded.
Use in renal impairment: No dose adjustment is necessary in patients with mild to moderate renal impairment (GFR 10-80 mL/min). Caution is advised in patients with severe renal impairment (GFR <10 mL/min) as systemic exposure may be increased (see Pharmacokinetics under Actions).
Use in hepatic impairment: Since Azithromycin monohydrate (Zenith) is metabolized in the liver and excreted in the bile, the medicinal product should not be given to patients suffering from severe liver disease. No studies have been conducted regarding the treatment of such patients with Azithromycin monohydrate (Zenith). When severe liver impairment occurs, the treatment with azithromycin should be ceased.
Azithromycin monohydrate (Zenith) should be administered with caution to patients with neurological or psychiatric disorders.
Azithromycin monohydrate (Zenith) is not indicated for the treatment of infected burn wounds.
Azithromycin monohydrate (Zenith) powder for oral solution is not suitable for treatment of severe infections where a high concentration of the antibiotic in the blood is rapidly needed.
Patients with rare congenital abnormalities such as fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase insufficiency should not use this medicinal product.
Effects on the Ability to Drive and Use Machines:
No studies on the effects on the ability to drive and use machines have been performed. However, the possibility of undesirable effects like dizziness and convulsions should be taken into account when performing these activities.
