ZEDBAC

Posology Azithromycin should be administered as a single daily dose. Dosing recommendations for adult patients are shown in Table 1.

Table 1:

Dosing recommendations for intravenous azithromycin. g. metronidazole) 500 mg once daily for 1 to 2 days, followed by oral dose of 250 mg once daily to complete a 7-day course of treatment. Consideration should be given to the treatment regimens, doses and duration of treatment as recommended in updated treatment guidelines for each indication.

The timing of the switch to oral therapy should be determined at the discretion of the physician and in accordance with clinical response. Special populations Renal impairment No dose adjustment is required in patients with GFR ≥10 ml/min.

2). 2). No data are available in patients with severe hepatic impairment (Child-Pugh Class C). 4). 2). 4). Paediatric population The safety and efficacy of Azithromycin for the intravenous treatment of community acquired pneumonia in the paediatric population have not been established.

There is no relevant use of Azithromycin for the treatment of pelvic inflammatory disease in children under 12 years of age while the safety and efficacy in adolescent girls have not been established. Method of administration For intravenous use after reconstitution and dilution.

The recommended route of administration is by intravenous infusion only. Do not administer as an intravenous bolus or an intramuscular injection. The solution concentration and rate of infusion should be either 1mg/1ml over 3 hours or 2mg/2ml over 1 hour.

A dose of 500mg azithromycin should be infused for a minimum duration of 1 hour. 6.

Summary of the safety profile The most commonly reported adverse reactions during treatment include diarrhoea, headache, vomiting, abdominal pain, nausea and abnormal laboratory test values. 4). 4). Tabulated list of adverse reactions Adverse reactions identified through clinical trial experience and post marketing surveillance are listed below, by system organ class and frequency.

Frequencies of adverse reaction occurrence are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 4) Hepatitis fulminant Hepatic necrosis Blood bilirubin increased Blood alkaline phosphatase increased Skin and subcutaneous tissue disorders Rash Pruritus Urticaria Dermatitis Dry skin Hyperhidrosis Acute generalised exanthemat ous pustulosis (AGEP) Drug reaction with eosinophilia and systemic symptoms (DRESS) Photosensit ivity reaction Toxic epidermal necrolysis Stevens- Johnson syndrome Erythema multiforme Musculoskeletal and connective tissue disorders Osteoarthriti s Myalgia Back pain Neck pain Arthralgi a Renal and urinary disorders Dysuria Renal pain Blood urea increased Blood creatinine increased Acute kidney injury Tubuloin terst itial nephritis Reproductive system and breast disorders Intermenstrual bleeding Testicular disorder General disorders and administration site conditions Injection site pain Injection site inflammation Oedema Asthenia Malaise Fatigue Face oedema Chest pain Pyrexia Pain Peripheral oedema Investigations Blood bicarbonate decreased Blood potassium abnormal Blood chloride increased Blood glucose increased Blood bicarbonate increased Blood sodium abnormal Injury, poisoning and procedural complications Post procedural complication Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

2). Treatment with azithromycin should only be initiated after a careful assessment of the benefit and the risks, considering the local prevalence of resistance, and when preferred treatment regimens are not indicated. 8). At the time of prescription, patients should be advised of the signs and symptoms and monitored closely for skin reactions.

Some of these reactions with azithromycin have resulted in recurrent symptoms and required a longer period of observation and treatment. If an allergic reaction occurs, azithromycin should be discontinued and appropriate therapy should be instituted.

Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued. 8). 5) • With electrolyte disturbance, particularly in cases of hypokalaemia and hypomagnesaemia • With clinically relevant bradycardia, cardiac arrhythmia or severe cardiac insufficiency • Elderly patients: Elderly patients may be more susceptible to drug- associated effects on the QT interval Hepatotoxicity Since liver is the principal route of elimination for azithromycin, the use of azithromycin should be undertaken with caution in patients with significant hepatic disease.

Cases of fulminant hepatitis potentially leading to life-threatening liver failure have been reported with azithromycin. 8). Some patients may have had pre-existing hepatic disease or may have been taking other hepatotoxic medicinal products.

Patients should be advised to stop azithromycin administration and to contact their physician if signs and symptoms of liver dysfunction, such as rapid developing asthenia associated with jaundice, dark urine, bleeding tendency or hepatic encephalopathy develop.

In such cases liver function tests/investigations should be performed immediately. 8). CDAD and pseudomembranous colitis must be considered in patients who present with diarrhoea during or subsequent to the administration of azithromycin.

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