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Azithromycin Dihydrate Syrup

Azithromycin Dihydrate

Short Description

Azithromycin Dihydrate containing Azithromycin dihydrate (equivalent with Azithromycin) as active ingredient is available in dry syrup 200 mg/5 ml.

Indications

Azithromycin Dihydrate is indicated for the treatment of patients with mild to moderate infections (i.e. pneumonia,) caused by susceptible strains of the designated microorganisms in the specific conditions listed as follow :

  • Lower respiratory tract : Acute bacterial exacerbations of chronic obstructive pulmonary disease due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae. Community-acquired pneumonia of mild severity due to Streptococcus pneumoniae or Haemophilus influenzae in patients appropriate for outpatient oral therapy.

  • Upper respiratory tract : Streptococcal pharyngitis/tonsillitis : As an alternative to first-line therapy of acute pharyngitis/tonsillitis due to Streptococcus pyogenes occuring in individuals who cannot use the 1st-line therapy.

  • Skin and skin structure : Uncomplicated skin and skin structure infections due to Staphylococcus aureus, Streptococcus pyogenes or Streptococcus agalactiae. Abscesses usually required surgical drainage.

  • Sexually transmitted diseases : Non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.

Azithromycin, at the recommended dose, should not be relied upon to treat gonorrhea or syphilis. Antimicrobial agents used in high doses for short periods of time to treat non-gonococcal urethritis may mask or delay the symptoms of incubating gonorrhea or syphilis. All patients with sexually-transmitted urethritis or cervicitis should have a serologic test for syphilis and appropriate cultures for gonorrhea performed at the time of diagnosis. Appropriate antimicrobial therapy and follow-up tests for these disease should be initiated if infection is confirmed. Appropriate culture and susceptibility tests should be performed before treatment to determine the causative organism and its susceptibility to Azithromycin. Therapy with Azithromycin may be initiated before results of these tests are known; the results become available, antimicrobial therapy should be adjusted accordingly.

Specification

Azithromycin Dihydrate should be administered as a single dailyd ose. The period of dosing with regard to infection is given below :


Adults (including elderly) :

  • For the treatment of sexually transmitted diseases caused by Chlamydia trachomatis, Haemophilus ducreyi, or susceptible Neisseria gonorrhoeae the dose is 1000 mg as a single oral dose.

  • For all other indications in which the oral formulation is administered, the total dosage of 1500 mg should be given as 500 mg daily for 3 days. As an alternative, the same total dose can be given over 5 days with 500 mg given on day 1, then 250 mg daily on days 2 – 5.

  • Elderly patients may be more susceptible to development of torsades de pointes arrhythmia than younger patients (see WARNINGS AND PRECAUTIONS).

Children :

There is no information on children less than 6 months.

The total dose of 30 mg/kg should be given as a single daily dose of 10 mg/kg or as an alternative, given over 5 days with single daily dose of 10 mg/kg dose on day 1, then 5 mg/kg on days 2 - 5.


15 - 25 kg :

  • 3-DAY REGIMEN : 200 mg (5 ml) once daily on days 1 - 3

  • 5-DAY REGIMEN : 200 mg (5 ml) once a day on day 1, then 100 mg (2.5 ml) once daily on days 2 - 5

26-35 kg :

  • 3-DAY REGIMEN : 300 mg (7.5 ml) once daily on days 1 -3

  • 5-DAY REGIMEN : 300 mg (7.5 ml) once a day on day 1, then 150 mg (3.75 ml) once daily on days 2 - 5

36-45 kg :

  • 3-DAY REGIMEN : 400 mg (10 ml) once daily on days 1 - 3

  • 5-DAY REGIMEN : 400 mg (10 ml) once a day on day 1, then 200 mg (5 ml) once daily on days 2 - 5

> 45 kg :

  • Dose as per adults

Azithromycin can be taken with or without food.


Patients with renal impairment :

No dose adjustment is necessary in patients with mild to moderate renal impairment (GFR 10 - 80 ml/minute). Caution should be exercised

when Azithromycin is administered to patients with severe renal impairment (GFR < 10 ml/minute).

Patients with hepatic impairment :

The same dosage as in patients with normal hepatic function may be used in patients with mild to moderate hepatic impairment.

Preparation of Azithromycin Dihydrate Dry syrup :

Add 8 ml drinking water then shake till evenly suspended. Keep tightly closed. Shake immediately prior to use.

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