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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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