AZITHROMYCIN

Adults In uncomplicated Chlamydia trachomatis urethritis and cervicitis, the dose is 1,000 mg in one 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. Alternatively the same total dose (1,500 mg) can also be given over a period of 5 days with 500 mg on the first day and then 250 mg on days 2 to 5.

To treat these patients other pharmaceutical forms are also available. Elderly people The same dose as in adult patients is used in the older people. 4). Children and adolescents (< 18 years) The total dose in children aged 1 year and older is 30 mg/kg administered as 10 mg/kg once daily for three days, or over a period of five days starting with a single dose of 10 mg/kg on the first day, followed by doses of 5 mg/kg per day for the following 4 days, according to the tables shown below.

There are limited data on use in children younger than 1 year. 5 ml + 15 ml The dose for the treatment of pharyngitis caused by Streptococcus pyogenes is an exception: in the treatment of pharyngitis caused by Streptococcus pyogenes Azithromycin has proved to be effective when it is administered to children as a single dose of 10 mg/kg or 20 mg/kg for 3 days with a maximum daily dose of 500 mg.

At these two doses a comparable clinical effect was observed, even if the eradication of the bacteria was more significant at a daily dose of 20 mg/kg. Penicillin is however the drug of first choice in the treatment of pharyngitis caused by Streptococcus pyogenes and the prevention of subsequent rheumatic fever.

4). 4). 6. After reconstitution the drug can be administered using a PE/PP syringe for oral use. After taking the suspension a bitter after-taste can be avoided by drinking fruit juice directly after swallowing. Azithromycin powder for oral suspension should be given in a single daily dose.

The suspension may be taken together 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.

g. 4) Hepatitis fulminant Hepatic necrosis Very Commo n (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1000 to < 1/100) Rare (≥ 1/10,000 to <1/1,000) Frequency Not Known Skin and Subcutaneous Tissue Disorders Skin rash Pruritus Urticaria, Dermatitis Dry skin Hyperhidrosis Stevens-Johnson syndrome Photosensitivity reaction Acute generalised exanthemato us pustulosis (AGEP) DRESS syndrome( drug reaction with eosinophili a and systemic symptoms) Toxic epidermal necrolysis Erythema multiforme Musculoskeletal and Connective Tissue Disorders Arthralgi a 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 Oedema Asthenia Malaise Face edema Chest pain Pyrexia Pain Peripheral edema Very Commo n (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1000 to < 1/100) Rare (≥ 1/10,000 to <1/1,000) Frequency Not Known Investigations Lymphocyt e count decreased Eosinophil count increased Blood bicarbonat e decreased Basophils increased Monocytes increased Neutrophil s 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, Poisoning, and procedural complications 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 Hypoesthesia Eye Disorders Visual impairment Ear and Labyrinth Disorders Deafness Hearing impaired Tinnitus Cardiac Disorders Palpitations Gastrointestinal Disorders Diarrhea 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 Google play or Apple App store.

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. 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.

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. Pseudomembranous colitis Pseudomembranous colitis has been reported with the use of macrolide antibiotics. This diagnosis should therefore be considered in patients who get diarrhoea after starting treatment with azithromycin.

Ergot derivatives 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.

5). Superinfection As with any antibiotic preparation, observation for signs of superinfection with non-susceptible organisms, including fungi is recommended. Cross resistance Cross-resistance exists between azithromycin and other macrolides (erythromycin, clarithromycin, roxithromycin), lincosamides and streptogramin B (MLSB phenotype).

Concomitant use of several medicinal products from the same or related group of antibacterial agents is not recommended. Clostridoides difficile associated diarrhea Clostridoides difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including azithromycin, and may range in severity from mild diarrhea to fatal colitis.

Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.

CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

2). 8). 5); 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 Epidemiological studies investigating the risk of adverse cardiovascular outcomes with macrolides have shown variable results.

Some observational studies have identified a rare short term risk of arrhythmia, myocardial infarction and cardiovascular mortality associated with macrolides including azithromycin. Consideration of these findings should be balanced with treatment benefits when prescribing azithromycin.

8). Pediatric population Safety and efficacy for the […]

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