Azithromycin Unicorn 500mg Tablets

AZITHROMYCIN UNICORN 500 is macrolide antibacterial medicine indicated in the treatment of mild to moderate infections caused by susceptible organisms; in lower respiratory tract infections including bronchitis (due to Haemophilus influenzae, Moraxella catarrhalis, Streptococcus pneumoniae or Staphylococcus aureus) and pneumonia (due to, Streptococcus pneumoniae or Haemophilus influenzae), uncomplicated skin and soft tissue infections; sinusitis (due to Haemophilus influenzae, Streptococcus pneumoniae or Staphylococcus aureus) and as an alternative to first line therapy of pharyngitis/tonsillitis. AZITHROMYCIN UNICORN 500 is indicated in the treatment of uncomplicated genital infections due to Chlamydia trachomatis and/or non-multiresistance Neisseria gonorrhoea in sexually transmitted diseases. It is also indicated in the treatment of chancroid due to Haemophilus ducreyi.

Children 1 year and over: AZITHROMYCIN UNICORN 500 is indicated in the treatment of bacterial exacerbations of pharyngitis/tonsillitis and otitis media caused by susceptible organisms in children over 45 kg.

AZITHROMYCIN UNICORN 500 tablets should be taken whole as a single dose. Adults: For all indications other than sexually transmitted diseases, the total dose is 1,5 g which should be given as 500 mg daily for 3 days. For sexually transmitted diseases caused by Chlamydia trachomatis or Haemophilus ducreyi, the dose is 1 g (2 x 500 mg) given as a single dose. For uncomplicated genital infections caused by non-multiresistant N. gonorrhoea, the dose is 1 g given as a single oral dose. For children over 45 kg body weight, the dose is as for adults. Note that this formulation is not suitable for children with a body weight of under 45 kg.

Method of Administration: These tablets can be taken orally, with or without food and in a single daily dose.

• Hypersensitivity to azithromycin, erythromycin, any of the macrolide or ketolide antibiotics, or any of the excipients (see section 2).
• AZITHROMYCIN UNICORN 500 should not be co-administered with ergot derivatives due to the risk of ergotism.
• AZITHROMYCIN UNICORN 500 is contraindicated in patients with liver disease.

Use in elderly: No dosage adjustments are necessary for elderly patients.

Use in children: Hypersensitivity: Rare serious allergic reactions, such as anaphylaxis and angioedema, and dermatologic reactions including Acute Generalized Exanthematous Pustulosis (AGEP), Stevens-Johnson Syndrome and toxic epidermal necrolysis have been reported in patients taking azithromycin. Fatalities have been reported. Cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have also been reported. These patients required prolonged periods of observation and symptomatic treatment. Allergic symptoms may recur after symptomatic therapy has been discontinued. These patients require prolonged periods of observation and symptomatic treatment.

Hepatotoxicity: Cases of fulminant hepatitis potentially leading to life-threatening liver failure, have been reported (see section 4.8). In case of signs and symptoms of liver dysfunction, such as rapidly developing asthenia associated with jaundice, dark urine, bleeding tendency or hepatic encephalopathy, liver function tests/investigations should be performed immediately. AZITHROMYCIN UNICORN 500 should be stopped if liver dysfunction has emerged.

Prolongation of the QT interval: Prolonged cardiac repolarisation and QT interval, imparting a risk of developing cardiac dysrhythmia and torsade de pointes, have been reported with macrolides. Caution is required when treating patients:

• with congenital or documented QT prolongation;
• currently receiving treatment with another active substance known to prolong QT interval, such as dysrhythmic medicines classes IA (quinidine, procainamide) and III (dofetilide, amiodarone, sotalol), and cisapride;
• with electrolyte disturbance, particularly in case of hypokalaemia and hypomagnesaemia;
• with clinically relevant bradycardia, cardiac dysrhythmia or severe cardiac insufficiency.

Elderly patients: elderly patients may be more susceptible to medicine-associated effects on the QT interval.

Superinfection: Patients treated with AZITHROMYCIN UNICORN 500 should be closely monitored for signs or symptoms of superinfections (including fungi).

Clostridium difficile associated diarrhoea: Clostridium difficile associated diarrhoea (CDAD) has been reported and may range in severity from mild diarrhoea to fatal pseudomembranous colitis (see section 4.8). Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C. difficile. 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. It is therefore important to consider the diagnosis of CDAD in patients who present with diarrhoea during or subsequent to treatment with AZITHROMYCIN UNICORN 500. Careful medical history is necessary, since CDAD has been reported to occur over two months after the administration of antibiotics. Discontinuation of therapy with AZITHROMYCIN UNICORN 500 and appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of Clostridium difficile, and surgical evaluation should be instituted as clinically indicated.

Myasthenia gravis: Exacerbation of the symptoms of myasthenia gravis and new onset of myasthenia syndrome have been reported (see section 4.8).

Renal impairment: Caution should be taken when prescribing AZITHROMYCIN UNICORN 500 to patients with renal impairment. Increased systemic exposure to AZITHROMYCIN UNICORN 500 has been reported in patients with severe renal impairment (glomerular filtration rate (GFR) < 10 ml/min).

Sexually Transmitted Infections: AZITHROMYCIN UNICORN 500, at the recommended dose, should not be relied upon to treat syphilis. Antibacterial agents used to treat non-gonococcal urethritis may mask or delay the symptoms of incubating syphilis. All patients with sexually transmitted urethritis or cervicitis should have a serologic test for syphilis and appropriate testing for gonorrhoea performed at the time of diagnosis. Appropriate antibacterial therapy and follow-up tests for these diseases should be initiated if infection is confirmed.

The safety of AZITHROMYCIN UNICORN 500 in children under the age of 1 year has not been established. AZITHROMYCIN UNICORN 500 is not indicated for children weighing less than 45 kg (see section 4.1).

AZITHROMYCIN UNICORN 500 contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take AZITHROMYCIN UNICORN 500.

Co-administration of nelfinavir at steady-state with a single oral dose of azithromycin resulted in increased azithromycin serum concentrations. Although a dose adjustment of azithromycin is not recommended when administered in combination with nelfinavir, close monitoring for known adverse reactions of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted.

Macrolides, including azithromycin, have the potential to interact with a large number of medicines through their action on hepatic cytochrome P450 isoenzymes. Macrolides inhibit metabolism by microsomal cytochromes by competitive inhibition and by the formation of inactive complexes. Such interactions can occur with non-sedative antihistamines and cisapride.

An increase in the serum concentrations of ciclosporin, digoxin, hexobarbital or phenytoin has been reported with the concurrent use of azithromycin. Caution should be exercised before co-administration of ciclosporin and azithromycin. If co-administration is necessary, ciclosporin levels should be monitored and the dose adjusted accordingly.

Some of the macrolide antibiotics have been reported to impair the metabolism of digoxin (in the gut) in some patients. Therefore, in patients receiving concomitant AZITHROMYCIN UNICORN 500, a related azalide antibiotic, and digoxin the possibility of raised digoxin levels should be borne in mind.

There have been less frequent reports of an interaction in patients receiving AZITHROMYCIN UNICORN 500 and terfenadine where the possibility of such an interaction could not entirely be excluded.

Co-administration of AZITHROMYCIN UNICORN 500 with ergotamine or dihydroergotamine has been associated with acute ergot toxicity.

Concurrent use with aluminium and magnesium containing antacids has decreased the peak serum concentration by approximately 24%. AZITHROMYCIN UNICORN 500 tablets should be taken at least 1 hour before or 2 hours after the antacid.

A single dose of cimetidine administered 2 hours before AZITHROMYCIN UNICORN 500 had no effect on the pharmacokinetics of azithromycin.

Concurrent use of warfarin and azithromycin has been associated with increased anticoagulant effects. The prothrombin time of these patients should be monitored.

A variety of broad-spectrum antibiotics, including azithromycin have been reported to decrease oral contraceptive efficacy. It is recommended that additional contraceptive precautions should be used while taking, and for 7 days after stopping AZITHROMYCIN UNICORN 500. If these 7 days run into the last 7 days of the cycle, then the tablet free interval (or the 7 inert tablets) should be omitted and the next cycle of tablets started immediately.

Safety in pregnancy and lactation has not been established.

Breast feeding: The safety and efficacy of AZITHROMYCIN UNICORN 500 in breastfeeding has not been established.

Fertility: No fertility data available.

AZITHROMYCIN UNICORN 500 may cause dizziness, and vision impairment (see section 4.8). Patients should be advised not to drive or handle machines or tools if this happens.

System Organ Class Frequency Side effects Blood and the lymphatic system disorders Less frequent Leukopenia, neutropenia, eosinophilia Frequency unknown Thrombocytopenia, haemolytic anaemia Infections and infestations Less frequent Candidiasis, oral candidiasis, vaginal infection, pneumonia, fungal infection, bacterial infection, pharyngitis, gastroenteritis, respiratory disorder, rhinitis Frequency unknown Pseudomembranous colitis Immune system disorders Less frequent Angioedema, hypersensitivity Frequency unknown Anaphylactic reaction Metabolism and nutrition disorders Frequent Anorexia Psychiatric disorders Less frequent Nervousness, agitation, restlessness Frequency unknown Aggression, anxiety, somnolence, insomnia, delirium, hallucination Nervous system disorders Frequent Dizziness, headache, paraesthesia, disgeusia Less frequent Hypaesthesia, hyperkinesia Frequency unknown Myasthenia gravis, syncope, convulsion, psychomotor hyperactivity, anosmia Eye disorders Frequent Visual impairment Ear and labyrinth disorders Frequent Deafness Less frequent Hearing impairment (including tinnitus), ear disorder, vertigo, hearing loss Cardiac disorders Less frequent Palpitations Frequency unknown Torsade de pointes, dysrhythmia (including ventricular tachycardia, prolonged electrocardiogram QT) Vascular disorders Less frequent Hot flushes Frequency unknown Hypotension Respiratory, thoracic and mediastinal disorders Less frequent Dyspnoea, epistaxis, cough, pleural effusion Gastrointestinal disorders Frequent Abdominal discomfort (pain/cramps), diarrhoea (rarely resulting in dehydration), nausea, vomiting, flatulence, dyspepsia, constipation, loose stools Less frequent Gastritis, dysphagia, abdominal distension, dry mouth, eructation, mouth ulceration, salivary hypersecretion, pyloric stenosis Frequency unknown Pseudomembranous colitis, taste disturbances, pancreatitis, tongue discolouration, melaena Hepatobiliary disorders Less frequent Hepatitis Frequency unknown Abnormal hepatic function, cholestatic jaundice, hepatic necrosis and hepatic failure, which have rarely resulted in death Skin and subcutaneous tissue disorders Frequent Rash, pruritus Less frequent Stevens-Johnson syndrome, photosensitivity reaction, urticaria, fungal dermatitis, dry skin, hyperhidrosis, eczema, sweating, vesiculobullous rash, AGEP, and DRESS Frequency unknown Toxic epidermal necrolysis, erythema multiforme Musculoskeletal, connective tissue and bone disorders Frequent Arthralgia Less frequent Osteoarthritis, myalgia, back pain, neck pain Renal and urinary disorders Less frequent Dysuria, renal pain Frequency unknown Acute interstitial nephritis, renal failure Reproductive system and breast disorders Less frequent Metrorrhagia, testicular disorder General disorders and administrative site conditions Frequent Fatigue Less frequent Face oedema, chest pain, pyrexia, peripheral pain, oedema, malaise, asthenia, fever Frequency unknown Allergic reactions (including difficulty in breathing, swelling of the face, mouth, neck, hands or feet, skin rash) Investigations Frequent Decreased: lymphocyte count, blood bicarbonate; increased: eosinophil count, basophils, monocytes, neutrophils Less frequent Abnormal: blood potassium, sodium; decreased: haematocrit, bicarbonate; increased: aspartate aminotransferase, alanine aminotransferase, blood bilirubin, blood urea, blood creatinine, blood alkaline phosphatase, chloride, glucose, platelets, bicarbonate.

There are no known symptoms of overdosage. Typical symptoms of overdosage include hearing loss, severe nausea, vomiting and diarrhoea. Treatment is symptomatic and supportive.