The efficacy of a 5-day regimen consisting of 500 mg in a single dose on the first day followed by 250 mg once daily for 4 consecutive days was compared with that of a 3-day course of azithromycin given in single daily doses of 500 mg for treatment of atypical pneumonia. In rats, azithromycin doses of 100 and 200 mg/kg bodyweight/day led to mild retardations in foetal ossification and in maternal weight gain. Select one or more newsletters to continue. Cases of fulminant hepatitis potentially leading to life-threatening liver failure have been reported with azithromycin (see section 4.8). In reproduction toxicity studies in animals azithromycin was shown to pass the placenta, but no teratogenic effects were observed (see section 5.3). Follow all directions on your prescription label and read all medication guides or instruction sheets. There is no evidence that this is of relevance to the normal use of azithromycin in humans.Long-term studies in animals have not been performed to evaluate carcinogenic potential. suspensions, may be used.Azithromycin Tablets should be given as a single daily dose. Biliary excretion of azithromycin, predominantly in unchangedform, is a major route of elimination.The identified metabolites (formed by N- and O- demethylising, by hydroxylising of the desosamine and aglycone rings, and by the splitting of the cladinose conjugate) are microbiologically inactive.After a 5 day treatment slightly higher (29%) AUC values were seen in the elderly volunteers (>65 years of age) compared to the younger volunteers (< 45 years of age). Nursing may be resumed thereafter.In fertility studies conducted in rat, reduced pregnancy rates were noted following administration of azithromycin. anaphylactic shock (see section 4.4)Hearing impairment including deafness and/or tinnitus Arrhythmia (see section 4.4) including ventricular tachycardiaDRESS (drug reaction with eosinophilia and systemic symptoms)General disorders and administration site conditionsGeneral disorders and administration site conditionsReporting suspected adverse reactions after authorisation of the medicinal product is important. • - With clinically relevant bradycardia, cardiac arrhythmia or severe cardiac insufficiency. Store in the original packaging to protect from moisture.OPA-PVC-Alu/Alu blisters: This medicinal product does not require any special storage conditions.OPA-PVC-Alu/Alu blister with 2 or 3 tablets of 500 mg.To bookmark a medicine you must sign up and log in.To view the changes to a medicine you must sign up and log in. 4.5 Interaction with other medicinal products and other forms of interaction6.6 Special precautions for disposal and other handling9. Caution should be exercised when azithromycin is administered to patients with severe renal impairment (GFR < 10 ml/min) (see section 4.4 and section 5.2). Nepoužítý liek vráťte do lekárne. Caution is advised in the co-administration of these medicines with azithromycin because of the known enhancing effect of these medicines when used concurrently with the macrolid antibiotic erythromycin. Discontinue azithromycin immediately if signs and symptoms of hepatitis occur.Following the use of azithromycin in neonates (treatment up to 42 days of life), infantile hypertrophic pyloric stenosis (IHPS) has been reported. Azithromycin must be taken at least 1 hour before or 2 hours after the antacids.Co-administration of azithromycin prolonged-release granules for oral suspension with a single 20 ml dose of co-magaldrox (aluminium hydroxide and magnesium hydroxide) did not affect the rate and extent of azithromycin absorption.Co-administration of a 600 mg single dose of azithromycin and 400 mg efavirenz daily for 7 days did not result in any clinically significant pharmacokinetic interactions.Co-administration of a single dose of 1,200 mg azithromycin did not alter the pharmacokinetics of a single dose of 800 mg fluconazole. In patients receiving both azithromycin and antacids, the drugs should not be taken simultaneously.In healthy volunteers, coadministration of a 5-day regimen of azithromycin with 20 mg cetirizine at steady-state resulted in no pharmacokinetic interaction and no significant changes in the QT interval. Because of the long half-life, accumulation in the milk is possible. In these patients, urinary recovery of azithromycin appears to increase perhaps to compensate for reduced hepatic clearance.The pharmacokinetics of azithromycin in elderly men was similar to that of young adults; however, in elderly women, although higher peak concentrations (increased by 30-50%) were observed, no significant accumulation occurred.Pharmacokinetics have been studied in children aged 4 months – 15 years taking capsules, granules or suspension.. 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