AZROMAX 250 Milligram Coated Tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

AZITHROMYCIN

Tilgjengelig fra:

McDermott Laboratories Ltd t/a Gerard Laboratories

INN (International Name):

AZITHROMYCIN

Dosering :

250 Milligram

Legemiddelform:

Coated Tablets

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2008-02-06

Preparatomtale

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Azromax 250mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg azithromycin (as 263.68
mg azithromycin monohydrate).
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Azromax 250mg Film-Coated Tablets are white, capsule shaped
tablets with ‘AZ’ ‘250’ on one side, and ‘G’ on
the 
reverse.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
Azithromycin is indicated in the following infections caused by
microorganisms that are sensitive to azithromycin: 
-
Lower respiratory tract infections, such as bronchitis and
mild to moderately 
              severe community acquired pneumonia
-
Upper respiratory tract infections, such as sinusitis and
pharyngitis/tonsillitis (see section 4.4)
-
Acute otitis media
-
Skin and soft tissue infections
-
Uncomplicated _Chlamydia trachomatis_ urethritis and cervicitis.
When giving antibiotic treatment consideration must be taken
of bacterial resistance and of the official/local regulations 
relating to the appropriate use of antimicrobial therapy.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
Azithromycin tablets should be given as a single daily dose.
The tablets can be taken with or without food. The 
duration of treatment in each
of the infectious diseases is given below. 
_Children and adolescents over 45 kg body weight, adults and
the elderly: _
The total dosage of azithromycin is 1500 mg which is spread
over three days (500 mg once daily). Alternatively, the 
dosage can be spread over five days (500 mg
as a single dose on the first day and thereafter 250 mg
once daily). 
In uncomplicated _Chlamydia trachomatis_ urethritis and
cervicitis the dosage is 1000 mg as a single oral dose.
_Children and adolescents under 45 kg body weight:_
Tablets are not indicat