COMPOSITION :
Each capsule contains : Azithromycin dihydrate USP equivalent to Azithromycin 250 mg. Each f/c tablet contains : Azithromycin dihydrate USP equivalent to Azithromycin 500 mg. Each 5ml suspension (teaspoonful) contains : Azithromycin dihydrate USP equivalent to Azithromycin 200 mg.
DESCRIPTION :
Azithromycin is a semisynthetic azalide antibiotic, a subclass of the macrolides. It acts by binding to the 50S ribosomal subunit of susceptible organisms and thus inhibiting microbial protein synthesis. Azithromycin has a broad spectrum antibacterial activity and following oral administration, peak plasma levels are reached approximately in 2-3 hours. Azithromycin demonstrates activity in vitro against a wide range of Gram positive and Gram negative bacteria including : Staphylococcus aureus, streptococcus pneumoniae, streptoccocus bacteria pyogenes (Group A) and other streptococcal species, haemophilus influenzae, and parainfluenzae. Moraxella catarrhalis, anaerobes including Bacteroides fragilis, Escherischia coli Bordetella pertussis, Bordetella parapertussis Borrelia burgdorferi, Haemophilus ducreyi also it is active against Neisseria gonorrhoeae, Chlamydia trachomatis, Legionella pneumophila, mycoplasma pneumoniae and hominis, Campylobacter SP. Toxoplasma gondii and Treponema pallidum. Biliary excretion of Azithromycin, predominantly as unchanged drug, is a major route of elimination, approximately 6% of the administered dose appears in urine. Plasma terminal elimination half life is 2 to 4 days.
INDICATIONS :
Zithrox is indicated for infections caused by susceptible organisms in:
- Lower respiratory tract infections.
- Upper respiratory tract infections.
- Skin and soft tissue infections.
- Uncomplicated genital infections due to Chlamydia trachomatis.
DOSAGE & ADMINISTRATION :
Zithrox like other many antibiotics should be taken at least one hour before or 2 hours after food as food decreases the absorption of Azithromycin.
- Adults and elderly:
For sexually transmitted diseases caused by Chlamydia trachomatis the dose is 1g given as a single dose. For all other indications, the total dose is 1.5 g which should be given 500 mg daily for 3 days.
- Children :
Zithrox powder for oral suspension should be used for children under 45 kg. There is no information for children under six months of age. The dose in children is 10 mg / kg as a single daily dose for 3 days. Children over 45 kg : Dose as per adults.
* Preparation of suspension : Add 7.5 ml of purified water using measuring cup with shaking.
RESTRICTIONS ON USE : Contraindications
- Azithromycin is contraindicated in patients with hypersensitivity to Azithromycin or to any of the macrolides antibiotics.
- Azithromycin should not be used in patients with hepatic disease. Use in pregnancy and lactation
It should not be used during pregnancy and lactation unless absolutely needed.
DRUG INTERACTIONS :
- Azithromycin should be taken at least 1 hour before or 2 hours after the antacid.
- In patients receiving concomitant Azithromycin and digoxin the possibility of raised digoxin levels should be borne in mind.
- Ergot derivatives should not be coadministered with Azithromycin because of the possibility of ergotism.
- Azithromycin interferes with metabolism of cyclosporin so caution should be exercised before coadministration of these two drugs.
SIDE EFFECTS : Azithromycin is well tolerated.
- The most common side effects are: nausea, abdominal discomfort, vomiting, flatulence and diarrhoea.
- Occasionally reversible elevations in liver transaminases can be seen similar to other macrolides and penicillins.
- Transient reductions in neutrophil counts have occasionally been observed in clinical trials.
OVERDOSAGE :
Symptoms of Azithromycin overdosage may include hearing loss, nausea, vomiting and diarrhea. If overdosage was happened seek the medical attention immediatly for gastric lavage and general supportive measures.
STORAGE INSTRUCTIONS :
Zithrox capsules and tablets : store below 30°C, in a dry place.
Zithrox Powder for oral suspension
Dry Powder : store below 30°C, in a dry place. Protect from sunlight.
After reconstitution : store at room temperature for 5 days. PRESENTATIONS :
Zithrox Capsules : Pack of 6 capsules and hospital packs of different sizes. Zithrox Tablets : Pack of 3 tablets and hospital packs of different sizes. Zithrox Powder for oral suspension : Bottle of 15 ml, 22.5 ml and 30 ml.