AZITHROMYCIN

Posology Azithromycin tablets should be given as a single daily dose. The duration of treatment in each of the infectious diseases is given below. The tablets can be taken with or without food. The tablets should be taken with ½ glass of water.

Adults, elderly, children and adolescents over 45 kg body weight:

The total dose is 1500 mg, administered as 500 mg once daily for 3 days. Alternatively, the same total dose (1500 mg) can be administered in a period of 5 days, 500 mg on the first day and 250 mg on day 2 to 5. In the case of uncomplicated Chlamydia trachomatis urethritis and cervicitis, the dosage is 1000 mg as a single oral dose.

For susceptible Neisseria gonorrhoeae the recommended dose is 1000 mg or 2000 mg of azithromycin in combination with 250 or 500 mg of ceftriaxone according to local clinical treatment guidelines. For patients who are allergic to penicillin and/or cephalosporins, prescribers should consult local treatment guidelines.

For sinusitis, treatment is indicated for adults and adolescents 16 years of age and over.

Children and adolescents 45 kg and under body weight:

Azithromycin tablets are not suitable for these patients. Other dosage forms are available for this group of patients. g. suspensions may be used.

Elderly patients:

No dose adjustments are required for elderly patients. 4). 4). 4). Method of administration For oral use.

The table below lists the adverse reactions identified through clinical trial experience and post-marketing surveillance by system organ class and frequency. Adverse reactions identified from post-marketing experience are included in italics.

The frequency grouping is defined using the following convention:

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); and Not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Adverse reactions possibly or probably related to azithromycin based on clinical trial experience and post-marketing surveillance: 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 frequency cannot be estimated from the available data Infections and infestations Candidiasis, oral, candidiasis, vaginal infection, pneumonia, fungal infection, bacterial infection, pharyngitis, gastroenteritis, respiratory disorder, rhinitis.

4) including ventricular tachycardia. 4)*, hepatitis fulminant, hepatic necrosis, Skin and subcutaneous tissue disorders Rash, pruritus Stevens-Johnson syndrome, photosensitivity reaction, urticaria, Dermatitis, dry skin, hyperhidrosis Allergic reactions including angioneurotic oedema Toxic epidermal necrolysis, erythema multiforme, Musculoskeletal and connective tissue disorders Arthralgia Osteoarthritis, Myalgia, back pain, neck pain Renal and urinary disorders Dysuria, renal pain Renal failure acute, nephritis interstitial Reproductive system and breast disorders Metrorrhagia, testicular disorder General disorders and administration site conditions Fatigue Chest pain, face oedema, pyrexia, peripharal pain, oedema malaise asthenia Investigations Lymphocyte count decreased, eosinophil count increased, blood bicarbonate decreased, basophils increased, monocytes increased, neutrophils increased Aspartate aminotransferase increased, alanine aminotransferase increased, blood bilirubin increased, blood urea increased, blood creatinine increased, blood potassium abnormal, blood alkaline phosphatase increased, chloride increased, glucose increased, platelets increased, hematocrit decreased, bicarbonate increased, abnormal sodium Injury and poisoning Post procedural complications Adverse reactions possibly or probably related to Mycobacterium Avium Complex prophylaxis and treatment based on clinical trial experience and post-marketing surveillance.

Allergic reactions:

As with erythromycin and other macrolides, rare serious allergic reactions (rarely fatal) including angioneurotic oedema and anaphylaxis (rarely fatal) have been reported. Some of these reactions with azithromycin have caused recurrent symptoms and have required longer observation and treatment.

73m2). 2).

Hepatic impairment:

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. 8). Some patients may have had pre-existing hepatic disease or may have been taking other hepatotoxic medicinal products.

In case of signs and symptoms of liver dysfunction, such as rapid developing astheni associated with jaundice, dark urine, bleeding tendency or hepatic encephalopathy, liver function tests/ investigations should be performed immediately.

Azithromycin administration should be stopped if liver dysfunction has emerged.

Ergot alkaloids and azithromycin:

The concurrent use of ergot alkaloids and macrolide antibiotics has been found to accelerate the development of ergotism. The interactions between ergot alkaloids and azithromycin have not been studied. The development of ergotism is however possible, so that azithromycin and ergot alkaloid derivatives should not be administered simultaneously.

8). Therefore as the following situations may lead to an increased risk : - for ventricular arrhythmias (including torsade de pointes) which can lead to cardiac arrest, azithromycin should be used with caution in patients with ongoing proarrhythmic conditions (especially women and elderly patients) such as patients.

1.