Azytro

Azytro

azithromycin

Manufacturer:

Aeva

Distributor:

Apex
Full Prescribing Info
Contents
Azithromycin dihydrate.
Description
Each film-coated contains Azithromycin Dihydrate equivalent to Azithromycin 250 mg.
Action
Pharmacology: Pharmacodynamics: Azithromycin is an azalide, derived from the macrolide class of antibiotics. The mode of action of azithromycin is inhibition of protein synthesis in bacteria by binding to the 50s ribosomal subunit and preventing translocation of peptides.
Azithromycin demonstrates activity in vitro against a wide variety of Gram-positive and Gram-negative bacteria including: Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes (Group A) and other Streptococcal species; Haemophilus influenzae and parainfluenzae; Branhamella catarrhalis; anaerobes including Bacteroides fragilis; Escherichia coli; Bordetella pertussis; Bordetella parapertussis; Borrelia burgdorferi; Haemophilus ducreyi; Neisseria gonorrhoeae and Chlamydia trachomatis. Azithromycin also demonstrates in vitro activity against Legionella pneumophila, Mycoplasma pneumoniae and hominis, Campylobacter sp., Toxoplasma gondii and Treponema pallidum.
Pharmacokinetics:
Following oral administration in humans, azithromycin is widely distributed throughout the body; bioavailability is approximately 37%. The time taken to peak plasma levels is 2-3 hours. The plasma terminal elimination half-life closely reflects the tissue depletion half-life of 2 to 4 days.
Indications/Uses
Azytro is indicated for infections caused by susceptible organisms; in lower respiratory tract infections including bronchitis and pneumonia, in skin and soft tissue infections, in otitis media and in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis (Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes pharyngitis, including the prophylaxis of rheumatic fever. Azithromycin is generally effective in the eradication of streptococci from the oropharynx, however, data establishing the efficacy of azithromycin and the subsequent prevention of rheumatic fever are not available at present.)
In sexually transmitted diseases in men and women, Azytro is indicated in the treatment of uncomplicated genital infections due to Chlamydia trachomatis. It is also indicated in the treatment of uncomplicated genital infection due to non-multiresistant Neisseria gonorrhoea, concurrent infection with Treponema pallidum should be excluded.
Azytro is indicated, either alone or in combination with rifabutin, for prophylaxis against Mycobacterium avium - intracellulare complex (MAC) infection, an opportunistic infection prevalent in patients with advanced human immunodeficiency virus (HIV).
Dosage/Direction for Use
To be administered orally.
Azytro should be given as a single daily dose. The period of dosing with regard to infection is given below.
Azytro can be taken with food.
In adults: For the treatment of sexually transmitted diseases caused by Chlamydia trachomatis, or susceptible Neisseria gonorrhea, the dose is 1000 mg as a single oral dose.
For prophylaxis against MAC infections in patients infected with the human immunodeficiency virus (HIV), the dose is 1200 mg once per week.
According to the 1999 USPHS/IDSA Guidelines for the Prevention of Opportunistic infections in Persons infected with Human Immunodeficiency Virus, the optimal criteria for discontinuing MAC prophylaxis remain to be defined. However, a reasonable option would be to consider discontinuing prophylaxis in patients with a CD4+ T-lymphocyte count greater than 100 cells/microlitre for a sustained period (eg. greater than 3-6 months.)
For all other indications, the total dosage of 1500 mg should be given as 500 mg daily for 3 days. As an alternative, the same total dose can be given over 5 days with 500 mg given on day 1, then 250 mg daily on days 2 to 5.
In the elderly: The same dose range as in younger patients may be used in elderly.
In patients with renal impairment: No dose adjustment is necessary in patients with mild to moderate (GFR 10 - 80 ml/min) or severe (GFR < 10 ml/min) renal impairment (see Precautions).
In patients with hepatic impairment: See Precautions.
In children: With the single exception of the treatment of streptococcal pharyngitis, the total dose in children is 30 mg/kg which should be given as a single daily dose of 10 mg/kg daily for 3 days or as an alternative, given 5 days with a single daily dose of 10 mg/kg on day 1, then 5 mg/kg on days 2 -5.
Treatment of acute otitis media in children may be given as either a single dose of 30 mg/kg or as 10 mg/kg daily for 3 days.
Azytro Tablet should only be administered to children weighing more than 45 kg.
Safety and efficacy for the prevention of MAC in children have not been established. Based on pediatric pharmaceutic data, a dose of 20 mg/kg would be similar to the adult dose of 1200 mg but with higher Cmax.
For pediatric streptococcal pharyngitis, azithromycin given as a single dose of 10 mg/kg or 20 mg/kg for 3 days has been shown to be effective; however, do not exceed a daily dose of 500 mg. In clinical trials comparing these two dosage regimens, similar clinical efficacy was observed but greater bacteriologic eradication was evident at the 20 mg/kg/day dose. However, penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes pharyngitis, including prophylaxis of rheumatic fever.
Overdosage
Adverse events experienced in higher than recommended doses were similar to those seen at normal doses. In the event of overdosage, general symptomatic and supportive measures are indicated as required.
Contraindications
Azytro is contra-indicated in patients with a known hypersensitivity to azithromycin or any of the macrolide antibiotics.
Because of the theoretical possibility of ergotism, azithromycin and ergot derivatives should not be coadministered.
Special Precautions
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.
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 (see Side Effects).
As with any antibiotic preparation, observation for signs of superinfection with nonsusceptible organisms, including fungi is recommended.
Use in renal impairment: In patients with severe renal impairment (GFR <10 ml/min a 33% increase in systemic exposure to azithromycin was observed (see Pharmacology: Pharmacokinetics under Actions).
Use in hepatic impairment: As the liver is the principal route of excretion of azithromycin, it should not be used in patients with hepatic disease.
Use In Pregnancy & Lactation
Use in pregnancy: Animal reproduction studies have demonstrated that azithromycin crosses the placenta, but have revealed no evidence of harm to the foetus. There are no adequate and well controlled studies in pregnant women. Since animal studies are not always predictive of human response, azithromycin should be used during pregnancy only if adequate alternatives are not available.
Use in lactation: No data on secretion of azithromycin in breast milk are available, so that azithromycin should only be used in lactating women where adequate alternatives are not available.
Side Effects
Azithromycin is well tolerated with a low incidence of side effects.
Infections and infestations: Moniliasis and vaginitis.
Blood and Lymphatic System Disorders: Thrombocytopenia. Transient mild reductions in neutrophil counts have occasionally been observed in clinical trials.
Immune system disorders: Anaphylaxis (rarely fatal) (see Precautions).
Metabolism and nutrition disorders: Anorexia.
Psychiatric disorders: Aggressive reaction, nervousness, agitation and anxiety.
Nervous System Disorders: Dizziness, convulsions (as seen with other macrolides), headache, somnolence, parasthesia, hyperactivity and syncope. There have been rare reports of taste perversion.
Ear and Labyrinth Disorders: Vertigo, hearing impairment has been reported with macrolide antibiotics. There have been reports of hearing impairment, including hearing loss, deafness and/or tinnitus in some patients receiving azithromycin. Many of these have been associated with prolonged use of high doses in investigational studies. In those cases where follow-up information were available the majority of these events was reversible.
Cardiac Disorders: Palpitations and arrythmias including ventricular tachycardia (as seen with macrolides) have been reported. There have been rare reports of QT prolongation and torsades de pointes (see Precautions).
Vascular Disorders: Hypotension.
Gastrointestinal Disorders: Nausea, vomiting/diarrhoea (rarely resulting in dehydration), loose stools, dyspepsia, abdominal discomfort (pain/cramps), constipation, flatulence, pseudomembranous colitis, pancreatitis and rare reports of tongue discoloration.
Hepatobiliary Disorders: Abnormal liver function including hepatitis and cholestatic jaundice have been reported, as well as rare cases of hepatic necrosis and hepatic failure, which have rarely resulted in death.
Skin and Subcutaneous Tissue Disorders: Allergic reactions including, pruritus, rash, photosensitivity, oedema, urticaria and angioedema (see Precautions).
Rarely, serious skin reactions including erythema multiforme, Stevens Johnson Syndrome and toxic epidermal necrolysis have occurred.
Musculoskeletal and Connective Tissue Disorders: Arthralgia.
Renal and urinary disorders: Interstitial nephritis and acute renal failure.
General Disorders and Administration Site Conditions: Asthenia, fatigue and malaise have been reported.
Drug Interactions
Antacids: In patients receiving azithromycin and antacids, azithromycin should be taken at least 1 hour before or 2 hours after the antacid.
Cyclosporin: Caution should be exercised before considering coadministration of azithromycin and cyclosporin. If coadministration is necessary, cyclosporin levels should be monitored and the dose adjusted accordingly.
Digoxin: 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 and digoxin the possibility of raised digoxin levels shoud be borne in mind, and digoxin levels monitored.
Ergot derivatives: Because of the theoretical possibility of ergotism, azithromycin and ergot derivatives should not be coadministered.
Terfenadine: As with other macrolides, azithromycin should be administered with caution in combination with terfenadine.
Theophylline: Theophylline levels may be increased in patients taking azithromycin.
Coumarin-Type Oral Anticoagulants: Consideration should be given to the frequency of monitoring prothrombin time when azithromycin is used in patients receiving coumarin-type oral anticoagulants.
Zidovudine: To be used with caution as administration of azithromycin increased the concentrations of phosphorylated zidovudine, the clinically active metabolite, in peripheral blood mononuclear cells. The clinical significance of this finding is unclear, but it may be of benefit to patients.
Storage
Store below 30°C.
MIMS Class
ATC Classification
J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Presentation/Packing
FC tab 250 mg (white, oval shaped, engraved with "AV" on one side and plain on the other side) x 5 x 6's.
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