Description

Composition
Azikil 500 Tablet: Each film coated tablet contains Azithromycin Dihydrate
USP equivalent to Azithromycin 500 mg.
Azikil 20 ml Powder for Suspension: After reconstitution, each 5 ml
suspension contains Azithromycin Dihydrate USP equivalent to Azithromycin
200 mg.
Azikil 35 ml Powder for Suspension: After reconstitution, each 5 ml
suspension contains Azithromycin Dihydrate USP equivalent to Azithromycin
200 mg.
Azikil 50 ml Powder for Suspension: After reconstitution, each 5 ml
suspension contains Azithromycin Dihydrate USP equivalent to Azithromycin
200 mg.
Pharmacology
Azithromycin is an azalide antibiotic, a subclass of macrolide antibiotic. It acts
by binding to the 50s ribosomal subunit of susceptible microorganisms and
thus interfering with microbial protein synthesis. Azithromycin has been shown
to be active against most strains in the following microorganisms, both In vitro
and in clinical infections:
Gram-positive microorganisms: Staphylococcus aureus, Streptococcus
agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes.
Gram-negative microorganisms: Haemophilus ducreyi, Haemophilus
influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae, Escherichia coli.
Indication
Azithromycin is indicated for infections caused by susceptible organisms in-
● Upper respiratory tract infections including sinusitis, pharyngitis and tonsillitis
● Lower respiratory tract infections including bronchitis, acute bacterial
exacerbations of chronic obstructive pulmonary disease (COPD)
● Otitis media
● Skin and soft tissue infections including cellulitis, pyoderma, erysipelas,
wound infections
● Diarrhea, Shigellosis
● Sexually transmitted diseases, especially in the treatment of
non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis
● Genital ulcer disease in men due to Haemophilus ducreyi (chancroid)
● Mild or moderate typhoid due to multiple-antibacterial resistant organisms
● Prophylaxis against a-hemolytic (viridans group) streptococcal bacterial
endocarditis
● Other infections including odontogenic infections, bartonella infections,
toxoplasmosis, babesiosis
Dose and Administration
a) Route of administration: Oral
Azithromycin Tablet & Powder for Suspension can be taken with or without food.
● Adult: For respiratory tract infections, otitis media and skin & soft tissue
infections: 500 mg once daily for 3 days or an alternative to this as 500 mg
once on day 1, followed by 250 mg once daily for next 4 days.
● For sexually transmitted diseases like genital ulcer, non-gonococcal
urethritis and cervicitis due to Chlamydia trachomatis : a single 1 gm (1000
mg) dose.
● For the treatment of urethritis and cervicitis due to Neisseria gonorrhoeae : a
single 2 gm (2000 mg) dose. In typhoid, 500 mg once daily for 7 days.
● In Cholera, a single 1 gm (1000 mg) dose.
● In Shigellosis, 500 mg once on day 1, followed by 250 mg once daily for next
4 days.
Children:

● Elderly: same as for adults.
Contra-indications
Azithromycin is contraindicated in patients hypersensitive to Azithromycin or
any other macrolide antibiotic. Co-administration of ergot derivative and
Azithromycin is contraindicated. Azithromycin is contraindicated in patients
with hepatic diseases.
Warning & Precautions
As with any antibiotic, observation for signs of super infection with
non-susceptable organisms, including fungi, is recommended. Precaution
should be taken in patients with more severe renal impairment.
Side effects
a) Common: Azithromycin is well tolerated with a low incidence of side effects.
The side effects include nausea, vomiting, abdominal discomfort
(pain/cramps), flatulence, diarrhea, headache, dizziness, and skin rashes and
are reversible upon discontinuation of therapy.
b) Rare: Reversible elevations in liver transaminases have been observed
occasionally. Transient mild reductions in neutrophil counts have occasionally
been observed in clinical trials, although causal relationship to Azithromycin
has not been established.
Use in Pregnancy & Lactation
Pregnancy: US FDA pregnancy category B. In the animal studies, no
evidence of harm to the fetus due to Azithromycin was found.
Lactation: It is not known whether Azithromycin is excreted in human milk.
Caution should be exercised when administered to nursing mother.
Use in Children & Adolescents
Should be used as per direction of physician.
Drug interactions
a) With medicine: Peak serum levels but not the total extent of absorption
were reduced by the presence of magnesium and aluminum-containing
antacids. Azithromycin should be taken at least 1 hr before or 2 hrs after these
antacids. In patients receiving ergot alkaloids, Azithromycin should be avoided
concurrently because of the possibilty of ergotism result in from interaction of
Azithromycin with the cytochrome P-450 system However, no cases of such
interaction have been reported. Macrolides have been known to increase the
plasma concentration of digoxin and cyclosporine. Therefore, if
co-administration is necessary caution should be exercised and serum levels
of digoxin and cyclosporine should be checked.
b) With food & others: No adequate data are available.
Direction for reconstitution of suspension
Shake the bottle to loosen powder.
● 20 ml: Add 15 ml (3 tea spoonful) with the help of supplied measuring cup of
boiled and cooled water to the dry powder of the bottle.
● 35 ml: Add 25 ml (5 tea spoonful) with the help of supplied measuring cup of
boiled and cooled water to the dry powder of the bottle.
● 50 ml: Add 35 ml (7 tea spoonful) with the help of supplied measuring cup of
boiled and cooled water to the dry powder of the bottle.
For ease of preparation, add boiled and cooled water in two proportions.
Shake well after each addition until all the powder is in suspension.
● Note: Shake the suspension well before each use. Keep the bottle tightly
closed. The reconstituted suspension should be stored in a cool and dry
place, preferably in refrigerator.
Overdose
There are no data available on overdose with Azithromycin. Typical symptoms
of overdosage with macrolide antibiotics include hearing loss, severe nausea,
vomiting and diarrhea. Gastric lavage and general supportive measures are indicated.
Storage
Store below 30°C. Protected from light. Keep all medicines out of reach of
children.
Packing
Azikil 500 Tablet: Each box contains 12 (3×4) tablets in blister pack.
Azikil 20 ml Powder for Suspension: Each box contains one bottle of
Azithromycin powder. After reconstitution as per direction bottle contains 20
ml suspension.
Azikil 35 ml Powder for Suspension: Each box contains one bottle of
Azithromycin powder. After reconstitution as per direction bottle contains 35
ml suspension.
Azikil 50 ml Powder for Suspension: Each box contains one bottle of
Azithromycin powder. After reconstitution as per direction bottle contains 50
ml suspension