AZITHROMYCIN

Posology The duration of treatment in each of the infectious diseases is given below. Paediatric population over 45 kg body weight, adults The total dosage of azithromycin is 1500 mg which is spread over three days (500 mg once daily).

Alternatively, the dosage can be spread over five days (500 mg as a single dose on the first day and thereafter 250 mg once daily). In uncomplicated Chlamydia trachomatis urethritis and cervicitis the dosage is 1000 mg as a single oral dose.

For sinusitis, treatment is aimed at adults and adolescents over 16 years of age. Other pharmaceutical forms are available to treat patients weighing more than 45 kg. Paediatric population under 45 kg body weight Azithromycin suspension should be used for children under 45 kg.

The following recommendations refer to the reconstituted 40 mg/ ml (200 mg/5 ml) suspension. With as only exception the treatment of Streptococci pharyngitis, the total dose in children 1 year and older is 30 mg/kg, to be administered as one single daily dose of 10 mg/kg for three days.

As an alternative azithromycin can also be administered over a period of 5 days with one single dose of 10 mg/kg on day 1, followed by one single daily dose of 5 mg/kg on days 2 through 5. 25 ml divisions. 25 ml of the azithromycin suspension providing 10 mg of azithromycin.

5 ml * Separate dosage recommendations apply for streptococcal pharyngitis and are described below.

For the treatment of Streptococci pharyngitis in children aged 2 years or more:

Azithromycin in a single dose of 10 mg/kg or 20 mg/kg for three days, in which the maximum daily dose of 500 mg should not be exceeded. 1). The maximum dosage in children correlates with the common dosage in adults with 1500 mg azithromycin.

Sinusitis For the treatment of sinusitis, limited data is available for the treament of children under 16 years of age. Elderly The same dosage as recommended for adult patients is used in the elderly. 4). 4). 4). Method of administration Azithromycin should be given as a single daily dose.

The suspension can be taken with or without food.

The table below lists the adverse reactions identified through clinical trial experience and post-marketing surveillance by system organ class and frequency. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

About 13% of patients included in clinical trials reported adverse events, most commonly gastro-intestinal disorders. 4) Hepatitis fulminant Hepatic necrosis Skin and subcutaneou s tissue disorders Rash Pruritus Urticaria Dermatitis Dry skin Hyperhidrosi s Photosensitiv ity reaction, acute generalised exanthemato us pustulosis (AGEP) Drug reaction with eosinophilia and systemic symptoms (DRESS) Stevens- Johnson syndrome Toxic epidermal necrolysis Erythema multiforme Maculopapul ar rash Musculoskel etal and connective tissue disorders Osteoarthritis Myalgia Back pain Neck pain Arthralgia Renal and urinary disorders Dysuria Renal pain Acute renal failure Interstitial nephritis Reproductiv e system and breast disorders Metrorrhagia Testicular disorder Vaginitis General disorders and administrati on site conditions Oedema Asthenia Malaise Fatigue Face oedema Chest pain Pyrexia Pain Peripheral oedema Investigatio ns Lymphocyte count decreased Eosinophil count increased Blood bicarbonate decreased Basophils increased Monocytes increased Neutrophils increased Aspartate aminotransfe rase increased Alanine aminotransfe rase 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, poisoning and procedural complicatio ns Post procedural complication Adverse reactions possibly or probably related to Mycobacterium Avium Complex prophylaxis and treatment based on clinical trial experience and post-marketing surveillance.

These adverse reactions differ from those reported with immediate release or the prolonged release formulations, either in kind or in frequency: Very Common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1000 to <1/100) Metabolism and nutrition disorders Anorexia Nervous system disorders Dizziness Headache Paraesthesia Dysgeusia Hypoaesthesia Eye disorders Visual impairment Ear and labyrinth disorders Deafness Hearing impaired Tinnitus Cardiac disorders Palpitations Gastrointestinal disorders Diarrhoea Abdominal pain Nausea Flatulence Abdominal discomfort Loose stools Hepatobiliary disorders Hepatitis Skin and subcutaneous tissue disorders Rash Pruritus Stevens- Johnson syndrome Photosensitivity reaction Musculoskeletal and connective tissue disorders Arthralgia General disorders and administration site conditions Fatigue Asthenia Malaise Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Allergic reactions As with erythromycin and other macrolides, serious allergic reactions, including angioedema and anaphylaxis (rarely fatal), drug reaction with eosinophilia and systemic symptoms (DRESS) and severe dermatologic reactions such as acute generalised exanthematous pustulosis (AGEP), Stevens-Johnson-syndrome and toxic epidermal necrolysis (TEN) 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 drug 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. Renal impairment No dose adjustment is necessary in patients with a GFR between 10 and 80 mL/min. 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. 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. 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. Ergot alkaloids and azithromycin In patients receiving ergot derivatives, ergotism has been precipitated by coadministration of some macrolide antibiotics.

There are no data concerning the possibility of an interaction between ergot and azithromycin. However, because of the theoretical possibility of ergotism, azithromycin and ergot derivatives should not be coadministered. 8). Therefore as the following situations may lead to an increased risk for ventricular arrhythmias (including torsades 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: - With congenital or documented QT prolongation - Currently receiving treatment with other active substances known to prolong QT interval such as antiarrhythmics of class IA (quinidine and procainamide) and class III (dofetilide, amiodarone and sotalol), hydroxychloroquine, cisapride and terfenadine; antipsychotic agents such as pimozide; antidepressants such as citalopram; and fluoroquinolones such as moxifloxacin and levofloxacin - With electrolyte disturbance, particularly in cases of hypokalaemia and hypomagnesemia - With clinically relevant bradycardia, cardiac arrhythmia or severe cardiac insufficiency.

The following should be considered before prescribing azithromycin:

Azithromycin is not suitable for treatment of severe infections where a high concentration of the antibiotic in the blood is rapidly needed. In areas with a high incidence of erythromycin A resistance, it is especially important to take into consideration the evolution of the pattern of susceptibility to azithromycin and other antibiotics.

1). This should be taken into account when treating infections caused by Streptococcus pneumoniae. Soft tissue infection The main causative agent of soft tissue infections, Staphylococcus aureus, is frequently resistant to azithromycin.

Therefore, susceptibility testing is considered a precondition for treatment of soft tissue infections with azithromycin. Pharyngitis/tonsillitis Azithromycin 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. Sinusitis Often, azithromycin is not the substance of first choice for the treatment of sinusitis. Acute otitis media Often, azithromycin is not the substance of first choice for the treatment of acute otitis media.

Infected burn wounds Azithromycin is not indicated for the treatment of infected burn wounds. Sexually transmitted disease In case of sexually transmitted diseases a concomitant infection by T. pallidum should be excluded. Superinfections As with any antibiotic preparation, observation for signs of superinfection with non- susceptible organisms, including fungi is recommended.

Neurological or psychiatric diseases Azithromycin should be administered with caution to patients suffering from neurological or psychiatric diseases. 8). Clostridioides difficile-associated diarrhoea Clostridiioides difficile-associated diarrhoea (CDAD) has been reported with the use of nearly all antibacterial agents, including azithromycin, and may range in severity from mild diarrhoea to fatal colitis.

Treatment with antibacterial agents alters the normal flora of the colon […]

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