Each film-coated tablet contains:
Active ingredients :
hydrochloride ..................... 436.33 mg (Eq.
to Moxifloxacin 400 mg)
croscarmellose sodium, magnesium stearate,
Treatment of the bacterial infections in
patients of 18 years and older caused by
bacteria susceptible to Moxifloxacin.
Oral Moxifloxacin should be restricted
for use only when treatment with other
antibiotics cannot be used, or have failed
for treatment of the following indications :
exacerbations of chronic bronchitis.
Community acquired pneumonia, except severe
Moxifl therapy is not recommended for
use in monotherapy of mild to moderate
pelvic inflammatory disease but should be
given in combination with another
appropriate antibacterial agent (e.g. A
cephalosporin) due to increasing
Moxifloxacin resistance of Neisseria
gonorrhea unless Moxifloxacin-resistant
Neisseria gonorrhea can be excluded.
Moxifl should not be used to initiate
therapy for any type of skin and skin
structure infection or in severe
Moxifl may also be used to complete a
course of therapy in patients who have shown
improvement during Initial treatment with
intravenous Moxifloxacin for the treatment
of the following indications:
Complicated skin and skin structure
Consideration should be given to official
guidance on the appropriate use of
antibacterial agents and prevalence of
Remarkable Recovery Rates:
Hypersensitivity to Moxifloxacin, other
quinolones or to any of the excipients.
Patients below 18 years of age.
Patients with a history of tendon
disease/disorder related to quinolone
in preclinical investigations and in humans,
changes in cardiac electrophysiology have
been observed following exposure to
Moxifloxacin, in the form of QT
Effects on ability to
drive and use machines:
No studies on the effects
of Moxifloxacin on the ability to drive and
use machines have been performed. However,
fluoroquinolones including Moxifloxacin may
result in an impairment of the patient's
ability to drive or operate machinery due to
CNS reactions (e.g. Dizziness; acute,
transient loss of vision) or acute and short
lasting loss of consciousness (syncope).
Patients should be advised to see how they
react to Moxifloxacin before driving or
Drugs & Food
Ranitidine, probenecid, oral contraceptives,
calcium supplements, morphine administered
parenterally, theophylline, cyclosporine or
itraconazole : Clinical studies have shown
that there are no interactions following
concomitant administration of moxifloxacin
with these drugs.
Cytochrome P450 enzymes: In vitro studies
with human cytochrome P450 enzymes support
this data. Considering these results a
metabolic interaction via cytochrome P450
enzymes is unlikely.
Interaction with food: Moxifloxacin has no
clinically relevant interaction with food
including dairy products.
Use during pregnancy
Pregnancy and lactation:
Pregnancy The use of Moxifloxacin during
pregnancy must not be used. The safety of
Moxifloxacin in human pregnancy has not been
evaluated. Reversible joint injuries are
described in children receiving some
quinolones; however this effect has not been
reported as occurring on exposed fetuses.
Animal studies have shown reproductive
toxicity. The potential risk for humans is
The use of
Moxifloxacin during breast feeding is
contraindicated. As with other quinolones,
Moxifloxacin has been shown to cause lesions
in the cartilage of the weight bearing
joints of immature animals. Preclinical data
indicate that Moxifloxacin passes into milk.
One 400 mg
film-coated tablet once daily.
No adjustment of dosage is required
in patients with mild to severely impaired renal
function or in patients on chronic dialysis i.e.
Hemodialysis and continuous ambulatory peritoneal
There is insufficient data in patients
with impaired liver function.
No adjustment of
dosage is required in the elderly and in patients
with low body weight.
Children and adolescents:
is contraindicated in children and adolescents (< 18
safety of Moxifloxacin in children and adolescents
have not been established.
Method of administration:
Moxifl film-coated tablet should be
swallowed whole with sufficient liquid and may be
taken independent of meals.
Duration of administration:
Moxifl should be used for the following
exacerbation of chronic bronchitis 5 -10 days
Community acquired pneumonia 10 days
bacterial sinusitis 7 days
to moderate pelvic inflammatory disease 14 days
Moxifl have been studied in clinical trials for up
to 14 days treatment.
recommended dose (400 mg once daily) and duration of
therapy for the indication being treated should not
at temperature not exceeding 30°C.
in dry place.
out of reach and sight of children.
Carton box containing one Al / transparent
PVC blister, of 5 film-coated-tablets and