Hyzith
Azithromycin USP

Presentation: Hyzith-500 tablet: Each film-coated tablet contains Azithromycin USP 500 mg as Azithromycin dihydrate. Hyzith dry powder for suspension: When reconstituted, each 5 ml suspension contains Azithromycin USP 200 mg as Azithromycin dihydrate.

Properties: Azithromycin is an azalide, derived from the macrolide class of antibiotics. Azithromycin demonstrates activity in vitro, against a wide range of Gram-positive and Gram-negative bacteria including: Staphylococcus aurous, Streptococcus pneumoniae, Streptococcus Pyogenes (Group A) and other Streptococcal species, Haemophilus influenzae, Parainfluenzae; Moraxella catarrhalis; anaerobes pertussis; Bordetella parapertussis, Neisseria gonorrhoeae and Chlamydia trachomatis. Azithromycin also demonstrates in vitro activity against Mycoplasma pneumoniae and hominid; Campylobacter sp. and treponema pallidum.

Pharmacokinetics: Following oral administration, Azithromycin is widely distributed throughout the body; bioavailability is approximately 37%. The time taken to reach peak plasma levels is 2-3 hours. Plasma terminal elimination half-life closely reflects the tissue depletion half-life of 2 to 4 days. Kinetic studies have shown markedly higher Azithromycin levels in tissue than in plasma (up to 50 times the maximum observed concentration in plasma) indicating that the drug is highly tissue bound. Concentrations in target tissues such as lung, tonsil and prostate exceed the MIC 90 for likely pathogens after a single dose of 500 mg.

Indications: Azithromycin is indicated for infections caused by susceptible organism; 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 transmited diseases in men and women, Azithromycin is indicated in the treatment of uncomplicated genital infections due to Chlamydia trachomatis.


DOSAGE AND ADMINISTRATION :
Hyzith-500 tablet and suspension should be administered as a single dose and in common with many other antibiotics should be taken at least 1 hour before or 2 hours after food.

Suspension: Add 7.5 ml of boiled and cooled water to the bottle and shake well to mix uniformly. Adult :
For sexually transmitted diseases caused by Chlamydia trachomatis the dose is 1 g given as a single dose. For all other indications, the total dose is 1.5 g which should be given as 500 mg daily for 3 days or alternatively, initially, 500 mg as a single dose, followed by a 250 mg single daily dose for the next 4 days.

Use in the elderly: :
Normal adult dosage is recommended.

Use in children: :
There is no information on children under six months of age. The dose in children > 6 months is 10 mg / kg as a single daily dose for 3 days, or for body weight 15-25kg, 200mg/day for 3 days; for body weight 26-35 kg, 300mg/day for 3 days; for body weight 36-45 kg, 400 mg/dayfor 3 days. For body weight over 45 kg, normal adult dosage is recommended.

For children, dosage schedule may need to be adjusted.


Contraindications: :
Azithromycin is contraindicated 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 co-administered. As with erythromycin and other macrolides, rare serious allergic reactions, including angioneurotic oedema and anaphylaxis, have resulted in recurrent symptoms and required a long period of observation and treatment.

Precautions and Warnings: As with any antibiotic, observation for signs of superinfections with non-susecptible organism including fungi is recommended.

Use in renal impairment:
-No dose adjustment is needed in Patients with mild renal impairment. But for severe renal impairment caution should be exercised in using Azithromycin.

Use in hepatic impairment:
-Azithromycin should not be used in patients with hepatic disease.

Use During Pregnancy and lactation:
Use in Pregnancy: Azithromycin should be used during pregnancy only if adequate alternatives are not available. Use in lactation: Azithromycin should only be used in lactating women where adequate alternatives are not availabe.

Drug interactions:
The following drugs show interactions with the concomitant use of Azithromycin: Antacids, cyclosporin, Digoxin, Ergot derivatives, Methyl prednisolone, Theophylline, Anti-histamines and warfarin. So Caution should be exercised during use of these drugs with Azithromycin.

Side effects:
The side effects include nausea, vomiting, abdominal discomfort, flatulence, diarrhoea, headache, and skin rashes and are reversible upon discontinuation of therapy.

Over dosage:
Typical symptoms of over dosage with macrolide Anti-biotics include hearing loss, severe nausea, Vomiting and diarrhoea, gastric lavage and general supportive measures are indicated.

How Supplied:
1x3 Film Coated Tablets of Hyzith-500 mg. 200 mg/5 ml of 15 ml Hyzith dry suspension and measuring-instrument.