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.
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.
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
Suspension: Add 7.5 ml of boiled
and cooled water to the bottle and shake well to mix uniformly.
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
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
dosage schedule may need to be adjusted.
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
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.
The side effects include nausea, vomiting,
abdominal discomfort, flatulence, diarrhoea, headache, and
skin rashes and are reversible upon discontinuation of therapy.
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.
1x3 Film Coated Tablets of Hyzith-500
mg. 200 mg/5 ml of 15 ml Hyzith dry suspension and measuring-instrument.