Azomax

Indonesia • Dexa Medica

Indication

Azomax film-coated caplet are indicated for the treatment of mild and moderate infection, caused by susceptible strain of the designed microorganisms in the specific conditions listed below:

Lower respiratory tract infection
Acute bacterial exacerbations of chronic obstructive pulmonary disease due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumonia. Mild to severe community-acquired pneumonia caused by Streptococcus pneumonia or Haemophilus influenza, in outpatients appropriate for oral therapy.

Upper respiratory tract infection
As an alternative to first-line therapy of acute pharyngitis/tonsillitis caused by Streptococcus pyogenes occurring in individuals who cannot use first-line therapy.

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

Sexually-transmitted disease
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 diseases 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; once the results become available, antimicrobial therapy should be adjusted accordingly.

Composition

Azithromycin 500 mg

Package

1 blister of 10 caplets

Dosage Forms

Caplet

ATC Classification

J01F

Warning

Alcohol
Consult Your Doctor
Safety of this item for use with alcohol has not been established. Please consult your doctor.
Machinery
Consult Your Doctor
Safety of this item for use while operating heavy machinery has not been established. Please consult your doctor.
Pregnancy
Consult Your Doctor
Safety of this item for use during pregnancy has not been established. Please consult your doctor.
Lactation
Consult Your Doctor
Safety of this item for use during lactation has not been established. Please consult your doctor.

Dosage

18 to 65 Years Old

Azomax should be administered as a single daily dose. The period of dosing with regard to infection is given below. Azomax can be taken with or without food. Consult your physician every 2 weeks.

For the treatment of sexually transmitted diseases caused by Chlamydia trachomatis, Haemophilus ducreyi, or susceptible Neisseria gonorrhoeae:
The dose is 1.000 mg as a single oral dose.

For all indications in which the oral formulation is administered:
The total dosage of 1.500 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.

65 Years Old and Above

The same dosage as in adult patients used in the elderly.

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 patient with normal hepatic function may be used in patients with mild to moderate hepatic impairment.