400 mg
Trade Name
Eliflox
Film-coated tablet
Request Type
New Registration
Drug Type
Generic(Multisource) Drug
Approval Date
SFDA Approved Use
Moxifloxacin 400mg tablets are indicated for the treatment of the following bacterial infections in patients of 18 years and older caused by bacteria susceptible to moxifloxacin. Moxifloxacin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections or when these have failed:
- Acute bacterial sinusitis (adequately diagnosed)
- Acute exacerbations of chronic bronchitis (adequately diagnosed)
- Community-acquired pneumonia, except severe cases
- Mild to moderate pelvic inflammatory disease (i.e. infections of the female upper genital tract, including salpingitis and endometritis), without an associated tube-ovarian or pelvic abscess
Moxifloxacin 400mg tablets are not recommended for use in monotherapy of mild to moderate pelvic inflammatory disease but should be given in combination with another appropriate anti-bacterial agent (e.g. a cephalosporin) due to increasing moxifloxacin resistant Neisseria gonorrhoeae unless moxifloxacin- resistant Neisseria gonorrhoeae can be excluded
Moxifloxacin 400mg tablets may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous moxifloxacin for the following indications:
- Community-acquired pneumonia
- Complicated skin and skin structure infections
Moxifloxacin 400mg film-coated tablets should not be used to initiate therapy for any type of skin structure infection or severe community-acquired pneumonia
- Acute bacterial sinusitis (adequately diagnosed)
- Acute exacerbations of chronic bronchitis (adequately diagnosed)
- Community-acquired pneumonia, except severe cases
- Mild to moderate pelvic inflammatory disease (i.e. infections of the female upper genital tract, including salpingitis and endometritis), without an associated tube-ovarian or pelvic abscess
Moxifloxacin 400mg tablets are not recommended for use in monotherapy of mild to moderate pelvic inflammatory disease but should be given in combination with another appropriate anti-bacterial agent (e.g. a cephalosporin) due to increasing moxifloxacin resistant Neisseria gonorrhoeae unless moxifloxacin- resistant Neisseria gonorrhoeae can be excluded
Moxifloxacin 400mg tablets may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous moxifloxacin for the following indications:
- Community-acquired pneumonia
- Complicated skin and skin structure infections
Moxifloxacin 400mg film-coated tablets should not be used to initiate therapy for any type of skin structure infection or severe community-acquired pneumonia