ZITHROMAX TABLET 600 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

AZITHROMYCIN DIHYDRATE EQV AZITHROMYCIN

Available from:

PFIZER PRIVATE LIMITED

ATC code:

J01FA10

Dosage:

600 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

AZITHROMYCIN DIHYDRATE EQV AZITHROMYCIN 600 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

HAUPT PHARMA LATINA SRL

Authorization status:

ACTIVE

Authorization date:

1999-01-29

Patient Information leaflet

Page 1 of 22 

ZITHROMAX 
(TABLETS, POWDER FOR ORAL SUSPENSION, POWDER FOR
INTRAVENOUS SOLUTION (IV)) 

1. 

NAME

OF

THE

MEDICINAL

PRODUCT 

ZITHROMAX
*
, ZITHROMAX

 IV. 

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 

POWDER  FOR  ORAL  SUSPENSION:  Azithromycin  dihydrate  209.64 mg/5 ml 
equivalent to 200 mg/5 ml of azithromycin base. 

FILM-COATED TABLET 250 MG: Azithromycin dihydrate 262.05 mg equivalent to 
250 mg azithromycin base. 

FILM-COATED TABLET 500 MG: Azithromycin dihydrate 524.10 mg equivalent to 
500 mg azithromycin base. 

FILM-COATED TABLET 600 MG: Azithromycin dihydrate 628.93 mg equivalent to 
600 mg azithromycin base. 

POWDER  FOR  INTRAVENOUS  SOLUTION  (IV):  Azithromycin  dihydrate  524.1  mg 
equivalent to 500 mg azithromycin base. 

3.  PHARMACEUTICAL FORM 

POWDER  FOR  ORAL  SUSPENSION:  Azithromycin  powder  for  oral  suspension  is 
presented  as  a  dry  powder  which  yields,  on  reconstitution  with  water,  an 
off-white to orange to brown suspension containing the equivalent of 200 mg 
azithromycin per 5 ml. 

FILM-COATED  TABLETS:  Azithromycin  film-coated  tablets  are  capsular  shaped 
and contain azithromycin dihydrate equivalent to 250 mg, 500 mg, or 600 mg 
of  azithromycin  and  engraved  with  either  “ZTM 250,”  “ZTM 500,”  or 
“ZTM 600”. 

INTRAVENOUS: Azithromycin is supplied in lyophilized form under a vacuum in a 
10  ml  vial  equivalent  to  500  mg  azithromycin  for  intravenous  administration. 
Upon  reconstitution,  azithromycin  powder  yields  a  solution  containing  the 
equivalent of 100 mg azithromycin per 1 ml. 

Page 2 of 22 

4.

CLINICAL

PARTICULARS 

Summary of Product characteristics

ZITHROMAX
TABLETS, POWDER FOR ORAL SUSPENSION, POWDER FOR INTRAVENOUS (IV)
SOLUTION
1.
NAME
OF
THE
MEDICINAL
PRODUCT
ZITHROMAX
*
, ZITHROMAX

IV.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
POWDER
FOR
ORAL
SUSPENSION:
Azithromycin
dihydrate
209.64 mg/5 ml
equivalent to 200 mg/5 ml of azithromycin base.
FILM-COATED TABLET 250 MG: Azithromycin dihydrate 262.05 mg equivalent
to 250 mg azithromycin base.
FILM-COATED TABLET 500 MG: Azithromycin dihydrate 524.10 mg equivalent
to 500 mg azithromycin base.
FILM-COATED TABLET 600 MG: Azithromycin dihydrate 628.93 mg equivalent
to 600 mg azithromycin base.
POWDER FOR INTRAVENOUS (IV) SOLUTION: Azithromycin dihydrate 524.1 mg
equivalent to 500 mg azithromycin base.
3. PHARMACEUTICAL FORM
POWDER FOR ORAL SUSPENSION: Azithromycin powder for oral suspension is
presented as a dry powder, which yields, on reconstitution with water,
an
off-white to orange to brown suspension containing the equivalent of
200 mg
azithromycin per 5 ml.
FILM-COATED TABLETS: Azithromycin film-coated tablets are capsular
shaped
and contain azithromycin dihydrate equivalent to 250 mg, 500 mg, or
600 mg
azithromycin.
POWDER FOR INTRAVENOUS SOLUTION: Azithromycin is supplied in a
lyophilized
form under a vacuum in a 10 ml vial equivalent to 500 mg azithromycin
for IV
administration. Upon reconstitution, azithromycin powder yields a
solution
containing the equivalent of 100 mg azithromycin per 1 ml.
4.
CLINICAL
PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Azithromycin is indicated for infections caused by susceptible
organisms; in
lower respiratory tract infections including bronchitis and pneumonia,
in
odontostomatological infections, in skin and soft tissue infections,
in acute
otitis media and in upper respiratory tract infections including
sinusitis and
pharyngitis/tonsillitis. (Penicillin is the usual drug of choice in
the treatment of
_Streptococcus pyogenes_ pharyngitis, including the prophylaxis of
rheumatic
fever. Azithromycin is generally effective in the eradication of
streptococci
from the oropha