AZITHROMYCIN

Posology Children and adolescents over 45 kg body weight and adults In uncomplicated Chlamydia trachomatis urethritis and cervicitis the dosage is 1,000 mg as a single oral dose. For all other indications the dose is 1,500 mg, to be administered as 500 mg per day for three consecutive days.

Elderly people The same dose range as in adult patients may be used in the elderly. 4). Paediatric population Azithromycin film-coated tablets should only be administered to children weighing more than 45 kg when normal adult dose should be used.

g. suspensions, may be used. 4). 2). 4). Method of administration Azithromycin 250 mg film-coated tablet should be administered as a daily single dose. Azithromycin 250mg film-coated tablet may be taken with food.

The table below lists the adverse reactions identified through clinical trial experience and postmarketing surveillance by system organ class and frequency.

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.

Approximately 13% of patients in clinical trials reported adverse events, wherein gastrointestinal disorders were the most. 4) Uncommon Leukopenia Neutropenia Eosinophilia Blood and lymphatic system disorders Not known Thrombocytopenia Haemolytic anaemia Uncommon Angioedema Hypersensitivity Immune system disorders Not known Severe (partly fatal) Anaphylactic reaction eg.

4). 4)* Hepatitis fulminant Hepatic necrosis Uncommon Rash Pruritus Urticaria Dermatitis Dry skin Hyperhidrosis Rare Photosensitivity reaction Acute generalised exanthematous pustulosis (AGEP) DRESS (drug reaction with eosinophilia and systemic symptoms) Skin and subcutaneous tissue disorders Not known Steven-Johnson syndrome Toxic epidermal necrolysis Erythema multiforme Uncommon Osteoarthritis Myalgia Back pain Neck pain Musculoskeletal and connective tissue disorders Not known Arthralgia Uncommon Dysuria Renal pain Renal and urinary disorders Not known Renal failure acute Nephritis interstitial Reproductive system and breast disorders Uncommon Metrorrhagia Testicular disorder General disorders and administration site conditions Uncommon Oedema Asthenia Malaise Fatigue Face oedema Chest pain Pyrexia System Organ Class Frequency Adverse reaction Pain Peripheral oedema Common Lymphocyte count decreased Eosinophil count increased Blood bicarbonate decreased Basophils increased Monocytes increased Neutrophils increased Investigations Uncommon Aspartate aminotransferase increased Alanine aminotransferase increased Blood bilirubine 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 Uncommon Post procedural complication Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Hypersensitivity As with erythromycin and other macrolides, rare serious allergic reactions, including angioneurotic oedema and anaphylaxis (rarely fatal), dermatologic reactions including acute generalised exanthematous pustulosis (AGEP), Stevens Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (rarely fatal) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported.

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, the medicinal product 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. Hepatoxicity 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 asthenia 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. Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure have been reported, some of which have resulted in death.

Discontinue azithromycin immediately if signs and symptoms of hepatitis occur. Infantile hypertrophic pyloric stenosis (IHPS) Following the use of azithromycin in neonates (treatment up to 42 days of life), infantile hypertrophic pyloric stenosis (IHPS) has been reported.

Parents and caregivers should be informed to contact their physician if vomiting or irritability with feeding occurs. Ergot derivatives In patients receiving ergotamine derivatives, ergotism has been precipitated by coadministration of some macrolide antibiotics.

1.