| a) Generic Name |
Azithromycin Dihydrate USP
|
| b) Trade/Brand Name |
To be submitted at the time of inclusion.
|
| 04. Product Data Sheet |
| a) Presentation |
Powder for Suspension
When reconstituted each 5 ml suspension contains Azithromycin Dihydrate USP equivalent to Azithromycin 200 mg.
|
| b) Indications |
This product is used as an azalide antibiotic. It covers the spectrum of Erythromycin but is slightly more active against Haemophilus influenzae. It is also active against Chlamydia trachomatis and Haemophilus ducreyi. It acts by interfering with microbial protein synthesis by binding to the 50 S ribosomal subunit of susceptible microorganisms.
This product is indicated for the treatment of the following infections caused by susceptible microorganisms :
i) Lower respiratory tract infections e.g. bronchitis, pneumonia etc.
ii) Upper respiratory tract infections e.g. sinusitis, pharyngitis, tonsillitis etc.
iii) Skin and soft tissue infections.
iv) Uncomplicated genital infections due to Chlamydia trachomatis in both men and women.
v) Otitis media.
vi) Typhoid fever.
|
| c) Dosage & administration |
i) Upper and lower respiratory tract, skin and soft tissue infections :
Children : 10 mg per Kg body weight once on first day, then followed by 5 mg per Kg body weight daily for the next 4 days.
ii) Uncomplicated genital infections due to Chlamydia trachomatis : 1 g as a single dose.
iii) Typhoid fever :
Children : 10 mg per Kg body weight once daily for 7 days or 20 mg per Kg body weight once daily for 5 days.
Azithromycin 250 mg tablet can be taken without regard to meal.
|
| d) Side effects |
The most common side effects nausea, vomiting, flatulence, abdominal discomfort, loose motion, rash, reversible elevations in liver transaminases, transient mild reductions in neutrophil counts etc.
|
| e) Precautions and
Warnings
|
Superinfection, moderate or severe renal impairment, hepatic impairment, Pregnancy and Lactation.
|
| f) Contraindications
|
It is contraindicated in patients with known hypersensitivity to Azithromycin or other macrolide antibiotics, hepatic impairment, children below the age of 6 months.
|
| i) Drug Interactions : |
Absorption reduced in presence of food, antacid and ergot alkaloids. Increase plasma concentration of digoxin and cyclosporine.
|
| k) Storage Conditions |
• Store in a cool and dry place, protect from light.
• Keep out of the reach of children.
|
| l) Package Quantity |
To be submitted at the time of inclusion.
|
