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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

   


Note : This product information is intended only for residents of the India. Taj Pharmaceuticals Limited,  medicines help to treat and prevent a range of conditions—from the most common to the most challenging—for people around the world.

Information for Health Care Professionals

*** Please consult local Prescribing Information for any product before use. This website is an international information resource for healthcare professionals with an interest in disease management. This website is not intended to replace the advice of a qualified healthcare professional. Above brand is a trademark of the Taj group of companies (Taj Pharmaceuticals Limited).


 



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