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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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Quality
