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Each tablet contains:
Composition:
Ofloxacin U.S.P.....................................................................200
mg
Ornidazole............................................................................
500 mg
Indications:
To treat diarrhea and dysentery of
Protozoal, Bacterial & Mixed origin.
Description:
The primary mechanism of action of ofloxacin appears to be
the specific inhibition of DNA gyrase (topoisomerase
II). This enzyme is responsible for the
negative supercoiling of bacterial DNA
and consequently for its topological
configuration, governing functions such
as RNA transcription, protein synthesis,
DNA replication and repair functions.
The antimicrobial activity of ornidazole is due
to the reduction of the nitro group to a
more reactive amine that attacks
microbial DNA, brings about loss of
helical structure of DNA and subsequent
DNA breakage thus inhibiting further
synthesis and causing degradation of
existing DNA.
After passive absorption into bacterium
cell, the nitro group of ornidazole is
reduced to amine group by ferrodoxin
type redox system. The formation of
redox intermediate intracellular
metabolites is believed to be the key
component of microorganism killing for
Ornidazole.
The drug is active against anaerobic
bacteria viz. Peptostreptococcus,
Clostridium, B. fragilis, Prevotella,
Porphyronomas, Fusobacterium and
protozoa viz. E. histolytica,
T. vaginalis, G. intestinalis etc.
The mechanism of action is similar in
protozoa.
ContraIndications:
In patients with a history of hypersensitivity to ofloxacin
or to any of the components of this
medication. A history of
hypersensitivity to other quinolones
also contraindicates use of ofloxacin.
Patients with known hypersensitivity to
ornidazole or any component of this
formulation or active renal disease or
hepatic cirrhosis.
Precautions:
General: Prolonged use of ofloxacin ophthalmic solution may
result in overgrowth of nonsusceptible
organisms, including fungi.
Drug Interactions:
Specific drug interaction studies
have not been conducted with ofloxacin
ophthalmic solution. Interactions
between ofloxacin and caffeine have not
been detected. Systemic use of ofloxacin
with nonsteroidal anti-inflammatory
drugs has shown that the risk of CNS
stimulation and convulsive seizures may
increase. A pharmacokinetic study in 15
healthy males has shown that the
steady-state peak theophylline
concentration
increased by an average of approximately
9% and the AUC increased by an average
of approximately 13% when oral ofloxacin
and theophylline were administered
concurrently.
Adverse Reactions:
Ophthalmic Use of Ofloxacin: The
most frequently reported drug-related
adverse reaction was transient ocular
burning or discomfort. Other reported
reactions were ocular redness, stinging,
itching, photophobia, tearing and
dryness. One report of dizziness, one
report of headache and one spontaneous
report of toxic epidermal necrolyis have
also been received.
Gastrointestinal effects like nausea,
vomiting, anorexia and metallic or
bitter taste.
CNS effects like dizziness, vertigo and
somnolence, rigidity, tremor,
coordination problems, convulsions
(rare), impairment of consciousness and
signs of sensitive or mixed peripheral
neuropathy have been observed.
Blood dyscrasias like medullar aplasia
and neutropenia may be encountered
occasionally.
Other adverse events such as fatigue,
loose stools, and headache have also
been reported.
Dosage :
As per the physician’s advice.
Presentations:
10 tablets
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