AVELOX TABLET 400 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

MOXIFLOXACIN HCl EQV MOXIFLOXACIN

Available from:

BAYER (SOUTH EAST ASIA) PTE LTD

ATC code:

J01MA14

Dosage:

400 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

MOXIFLOXACIN HCl EQV MOXIFLOXACIN 400 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Bayer AG

Authorization status:

ACTIVE

Authorization date:

2000-07-13

Patient Information leaflet

PRESCRIPTION USE ONLY     

1. NAME OF THE MEDICINAL PRODUCT 

Avelox 400 mg film-coated tablets 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

1 film-coated tablet contains 400 mg
moxifloxacin (as hydrochloride).  

3. PHARMACEUTICAL FORM 

Film-coated tablet 

Dull red film-coated tablet with an oblong, convex shape
with facet, a dimension of 17 x 7 mm 
with 10 mm radius of curvature and a
weight of 693.8-699.8 mg. “Bayer” on one side and “M 
400” on the other side. 

4. CLINICAL PARTICULARS   
4.1 INDICATIONS  

Avelox 400 mg film-coated tablets are indicated for the
treatment of the following bacterial infections 
caused by susceptible strains: 

• 
Respiratory tract infections: 

Acute Bacterial Sinusitis caused
by _Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella _
_catarrhalis. _

Acute Bacterial Exacerbation of Chronic Bronchitis caused
by _Streptococcus pneumoniae, Haemophilus _
_influenzae, Haemophilus parainfluenzae, Klebsiella
pneumoniae, Staphylococcus aureus, or Moraxella _
_catarrhalis. _

Community Acquired Pneumonia (of mild to moderate severity) caused
by _Streptococcus pneumoniae, _
_Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydia
pneumoniae, or Moraxella catarrhalis._ 

• 
Uncomplicated skin and skin structure
infections caused by _Staphylococcus aureus _or_ Streptococcus _
_pyogenes _

• 
Complicated skin and skin structure infections caused
by methicillin-susceptible _Staphylococcus _
_aureus_, _Escherichia coli_, _Klebsiella
pneumoniae_ or _Enterobactercioacae_. 

AVELOX

® 
Avelox Tablet _CCDS 19_SG_4 June 2014

• 
Mild to moderate pelvic inflammatory disease
(i.e. infections of female upper genital tract, including 
salpingitis and endometritis), without an associated tubo-ovarian
or pelvic abscess. 
Avelox 400 mg film-coated tabl

Summary of Product characteristics

Avelox Tablet _CCDS 23_December 2020
PRESCRIPTION USE ONLY
1. NAME OF THE MEDICINAL PRODUCT
Avelox 400 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 film-coated tablet contains 400 mg moxifloxacin (as hydrochloride).
3. PHARMACEUTICAL FORM
Film-coated tablet
Dull red film-coated tablet with an oblong, convex shape with facet, a
dimension of 17 x 7 mm
with 10 mm radius of curvature and a weight of 693.8-699.8 mg.
“Bayer” on one side and “M
400” on the other side.
4. CLINICAL PARTICULARS
4.1 INDICATIONS
Avelox 400 mg film-coated tablets are indicated for the treatment of
the following bacterial infections
caused by susceptible strains:
•
Respiratory tract infections:
Acute Bacterial Sinusitis caused by _Streptococcus pneumoniae,
Haemophilus influenzae, or Moraxella _
_catarrhalis. _
Acute Bacterial Exacerbation of Chronic Bronchitis caused by
_Streptococcus pneumoniae, Haemophilus _
_influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae,
Staphylococcus aureus, or Moraxella _
_catarrhalis. _
Community Acquired Pneumonia (of mild to moderate severity) caused by
_Streptococcus pneumoniae, _
_Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydia pneumoniae,
or Moraxella catarrhalis._
•
Uncomplicated skin and skin structure infections caused by
_Staphylococcus aureus _or_ Streptococcus _
_pyogenes _
•
Complicated skin and skin structure infections caused by
methicillin-susceptible _Staphylococcus _
_aureus_, _Escherichia coli_, _Klebsiella pneumoniae_ or
_Enterobactercioacae_.
AVELOX
®
TABLET
Avelox Tablet _CCDS 23_December 2020
•
Mild to moderate pelvic inflammatory disease (i.e. infections of
female upper genital tract, including
salpingitis and endometritis), without an associated tubo-ovarian or
pelvic abscess.
Avelox 400 mg film-coated tablets are not recommended for use in
monotherapy of mild to moderate
pelvic inflammatory disease but should be given in combination with
another appropriate antibacterial
agent (eg. a cephalosporin) due to increasing moxifloxacin r