Aphamea Brochure
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Each capsule contains:‎
Azithromycin dihydrate 262.05 mg equivalent to 250 mg azithromycin base.

Azithromycin is indicated for the treatment of the following infections ‎when known or likely to be due to one or more susceptible ‎microorganisms :‎
‎- bronchitis ‎
‎- community-acquired pneumonia ‎
‎- sinusitis ‎
‎- pharyngitis/tonsillitis ‎
‎- otitis media ‎
‎- skin and soft tissue infections ‎
‎- uncomplicated genital infections due to Chlamydia trachomatis and ‎Neisseria gonorrhoeae.‎

Azithromycin should be given as a single daily dose. Azithromycin ‎Capsules should be taken at least 1 hour before or 2 hours after food. ‎
Children over 45 kg body weight and adults, including elderly ‎patients: ‎
The total dose of azithromycin is 1500 mg which should be given over ‎three days (500 mg once daily). ‎
In uncomplicated genital infections due to Chlamydia trachomatis, the ‎dose 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. ‎
In children under 45 kg body weight: Azithromycin Capsules are not ‎suitable for children under 45 kg. ‎
Renal failure: ‎
No dose adjustment is necessary in patients with mild to moderate renal ‎impairment (GFR 10 - 80 ml/min). Caution should be exercised when ‎azithromycin is administered to patients with severe renal impairment ‎‎(GFR < 10 ml/min) .‎
Hepatic failure:‎
Since azithromycin is metabolised in the liver and excreted in the bile, ‎the drug should not be given to patients suffering from severe liver ‎disease. No studies have been conducted regarding treatment of such ‎patients with azithromycin .‎
Azithromycin Capsules are for oral administration only. ‎
As with erythromycin and other macrolides, rare serious allergic ‎reactions including angioneurotic oedema and anaphylaxis (rarely fatal), ‎have been reported. Some of these reactions with azithromycin have ‎resulted in recurrent symptoms and required a longer period of ‎observation and treatment. ‎
Since the 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 . 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.‎
Ergot derivatives:
In patients receiving ergot derivatives, ergotism has been precipitated by ‎co-administration 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 co-‎administrated.‎
Prolongation of the QT interval:
Prolonged cardiac repolarisation and QT interval, imparting a risk of ‎developing cardiac arrhythmia and torsades de pointes, have been seen ‎in treatment with other macrolides. A similar effect with azithromycin ‎cannot be completely ruled out in patients at increased risk for ‎prolonged cardiac repolarisation ; therefore caution is required when ‎treating patients:‎
‎• With congenital or documented QT prolongation‎
‎• Currently receiving treatment with other active substance known to ‎prolong QT interval such as antiarrhytmics of classes Ia and III, cisapride ‎and terfenadine.
‎• With electrolyte disturbance, particularly in case of hypokalaemia and ‎hypomagnesemia.
‎• With clinically relevant bradycardia, cardiac arrhythmia or severe ‎cardiac insufficiency. ‎
As with any antibiotic preparation, observation for signs of ‎superinfection with non-susceptible organisms including fungi is ‎recommended. ‎
Clostridium difficile associated diarrhoea:
Clostridium difficile associated diarrhoea (CDAD) has been reported with ‎use of nearly all antibacterial agents, including azithromycin, and may ‎range in severity from mild diarrhoea to fatal colitis. Strains of C. difficile ‎producing hypertoxin A and B 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. Therefore, CDAD must be ‎considered in patients who present with diarrhoea during or subsequent ‎to the administration of any antibiotics. Careful medical history is ‎necessary since CDAD has been reported to occur over two months after ‎the administration of antibacterial agents. Discontinuation of therapy ‎with azithromycin and the administration of specific treatment for C. ‎difficile should be considered. ‎
Streptococcal infections:
Penicillin is usually the first choice for treatment of pharyngitis/tonsillitis ‎due to Streptococcus pyogenes and also for prophylaxis of acute ‎rheumatic fever. Azithromycin is in general effective against ‎streptococcus in the oropharynx, but no data are available that ‎demonstrate the efficacy of azithromycin in preventing acute rheumatic ‎fever. ‎
Renal impairment: ‎
In patients with severe renal impairment (GFR <10 ml/min) a 33% ‎increase in systemic exposure to azithromycin was observed. ‎
Myasthenia gravis:
Exacerbations of the symptoms of myasthenia gravis and new onset of ‎myasthenia syndrome have been reported in patients receiving ‎azithromycin therapy. ‎
Drug Interactions : ‎
In a pharmacokinetic study investigating the effects of ‎simultaneous administration of antacid with azithromycin, no effect on ‎overall bioavailability was seen, although peak serum concentrations ‎were reduced by approximately 24%. In patients receiving both ‎azithromycin and antacids, the drugs should not be taken ‎simultaneously. ‎
Some of the macrolide antibiotics have been reported to impair ‎the microbial metabolism of digoxin in the gut in some patients. In ‎patients receiving concomitant azithromycin, a related azalide antibiotic, ‎and digoxin the possibility of raised digoxin levels should be borne in ‎mind.‎
Ergot derivatives:
Due to the theoretical possibility of ergotism, the ‎concurrent use of azithromycin with ergot derivatives is not ‎recommended. ‎
Coumarin-Type Oral Anticoagulants:
Although a causal relationship has ‎not been established, consideration should be given to the frequency of ‎monitoring prothrombin time when azithromycin is used in patients ‎receiving coumarin-type oral anticoagulants. ‎
if co-administration of these drugs is necessary, ciclosporin ‎levels should be monitored and the dose adjusted accordingly. ‎