Azithromycin is an antibiotic active against Gram-positive and Gram-negative organisms. Azithromycin interferes with ribosome in susceptible bacteria by inhibiting the translocation of peptides.
Macrozith® 250: Each Capsule contains Azithromycin dihydrate equivalent to 250 mg Azithromycin.
Macrozith® 500: Each film coated Tablet contains Azithromycin dihydrate equivalent to 500 mg Azithromycin.
Macrozith® Granules for Suspension is a dry blend of Azithromycin dihydrate containing the equivalent of 200 mg Azithromycin per 5 ml on reconstitution with water.
Macrozith® is indicated for infections caused by susceptible organisms; in lower respiratory tract infections including bronchitis and pneumonia, skin and soft tissue infections, otitis media and in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis. In sexually transmitted diseases in men and women, Macrozith® is indicated in the treatment of uncomplicated genital infections due to Chlamydia trachomatis.
Dosage & administration:
Macrozith® should be given as a single daily dose. In common with many other antibiotics Macrozith® should be taken at least 1 hour before or 2 hours after food. Macrozith® Suspension can be taken with food.
Adults: For the treatment of sexually transmitted diseases caused by Chlamydia trachomatis, the dose is 1 g given as a single dose. For all other indications, the dose is 1.5g, which should be given as 500mg daily for 3 days.
In the elderly: The same dose range as in younger patients may be used in the elderly.
In children: Macrozith® Suspension should be used for children under 45kg. There is no information on children under 6 months of age. The dose in children is 10mg/kg as a single daily dose for 3 days:
Up to 15kg: (less than 3 years) Measure the dose as closely as possible using the dropper provided. The dropper is graduated in 0.25 ml divisions providing 10mg of Azithromycin in every graduation.
For children weighing more than 15kg, Macrozith® Suspension should be administered using the spoon provided according to the following guidance:
15-25 kg:(3-7 years) 1 teaspoonful (200mg), once daily for 3 days.
26-35 kg:(8-11 years) 1.5 teaspoonful (300mg), once daily for 3 days.
36-45 kg:(12-14 years) 2 teaspoonful (400mg), once daily for 3 days.
Over 45 kg Dose as per adults.
Contraindications, Side effects, and warnings etc:
Macrozith® is contra-indicated in patients with a known hypersensitivity to azithromycin or any of the macrolide antibiotics.
Because of the theoretical possibility of ergotism, Macrozith® and ergot derivatives should not be co-administered.
Macrozith® is well tolerated with a low incidence of side effects.
Gastrointestinal – Anorexia, nausea, vomiting, diarrhoea (rarely resulting in dehydration), loose stools, dyspepsia, abdominal discomfort (pain, cramps), constipation, flatulence, pseudomembranous colitis and rare reports of tongue discoloration.
Skin/Appendages – Allergic reactions such as pruritus, rash, photosensitivity, oedema or urticaria have occurred and there have also been rare reports of serious hypersensitivity reactions – See “Special warnings and special precautions for use”. Rarely, serious skin reactions including erythema multiforme, Stevens Johnson Syndrome and toxic epidermal necrolysis have occurred.
Liver/Biliary – 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.
Central and Peripheral Nervous System – Dizziness/vertigo, convulsions (as seen with other macrolides), headache, somnolence, parasthesia and hyperactivity.
White Blood Cells/RES- Transient mild reduction in neutrophil count has occasionally been observed in clinical trials.
Special Senses – Hearing impairment has been reported with macrolide antibiotics. There have been rare 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 was available the majority of these events were reversible. There have been rare reports of taste perversion. Genitourinary – Interstitial nephritis and acute renal failure have been reported.
Haematopoietic – Thrombocytopenia.
Psychiatric – Aggressive reaction, nervousness, agitation, anxiety.
Reproductive – Vaginitis
Cardiovascuiar -Palpitations and arrythmias including ventricular tachycardia (as seen with macrolides) have been reported.
General – Asthenia and moniliasis have been reported.
Use in Pregnancy and 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, Macrozith® 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 Macrozith® should only be used in lactating women where adequate alternatives are not available.
Antacids: In patients receiving Macrozith® and antacids, Macrozith® should be taken at least 1 hour before or 2 hours after the antacid. Cyclosporin: Some of the related macrolide antibiotics interfere with the metabolism of cyclosporin. In the absence of conclusive data from pharmacokinetic studies or clinical data investigating potential interaction between Macrozith® and cyclosporin, caution should be exercised before co-administration of these two drugs. If co-administration is necessary, cyclosporin levels should be monitored and the dose adjusted accordingly. Ergot derivatives: Because of the theoretical possibility of ergotism, Macrozith® and ergot derivatives should not be co-administered.
Overdose symptoms may include nausea, vomiting, diarrhea, and stomach discomfort.
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 long period of observation and treatment.
As with any antibiotic preparation, observation for signs of superinfection with non-susceptible organisms, including fungi is recommended.
Use in renal impairment: No dose adjustment is needed in patients with mild renal impairment (creatinine clearance> 40ml/min), but there are no data regarding Macrozith® in patients with more severe renal impairment, thus caution should be exercised in using Macrozith® in these patients.
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.
Direction of use:
Macrozith® Granules for Suspension 15 ml: Shake the bottle before adding the water. To prepare 15 ml suspension add 10 ml (2 teaspoonful, use the spoon provided) boiled and cooled water in two portions and shake until all the granules completely mixes with water.
Macrozith® Granules for Suspension 25 ml: Shake the bottle before adding the water. To prepare 25 ml suspension add 17 ml (use the measuring cylinder provided) boiled and cooled water in two portions and shake until all the granules completely mixes with water.
Macrozith® should be stored in a cool and dry place, away from light. Keep out of the reach of children.
Macrozith® 250: 6’s Capsules in Alu-Alu blister pack.
Macrozith® 500: 2 x 3’s Tablets in Alu-Alu blister pack.
Macrozith® Granules for Suspension 15 ml: Amber colour glass bottle containing dry granules to make 15 ml of azithromycin suspension.
Macrozith® Granules for Suspension 25 ml: Amber colour glass bottle containing dry granules to make 25 ml of azithromycin suspension.