COMPOSITION: Each Tablet contains:-
OFLOXACIN 200 mg
ORNIDAZOLE 500 mg
- Ofloxacin belongs to the group of medicines called 4-fluoroquinolone antibiotics. It acts by killing the bacteria that cause infection.
- Ornidazole is an antibiotic (anti-bacteria and anti-protozoal) drug belonging to the class of imidazole derivatives. It interacts with DNA inside the microorganism to cause protein synthesis inhibition and cell death.
Ornidazole is a synthetic antibacterial compound. It possesses direct trichomonacidal and amoebicidal activity against Balantidium coli, Blastocystis Hominis, Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia, and obligate anaerobic bacteria. Gram-negative anaerobic bacilli and clostridia are also susceptible.
Organisms susceptible to Ofloxacin include Chlamydia trachomatis, Citobacter diversus, Enterobacter aerogenes, E. coli, Haemophilus influenza, Klebsiella pneumoniae, Neisseria gonorrhoeae, Proteus mirabillis, Pseudomonas aeruginosa, Staphylococcus aureus, Streptococcus pneumoniae and Streptococcus pyogenes. Penicillinase-producing organisms are equally sensitive to Ofloxacin.
Other organisms susceptible in vitro to Ofloxacin include the following:
Gram-Positives: Enterococcus faecalis, Staphylococcus epidermidis including methicillin-resistant strains, Staphylococcus saprophyticus, Streptococcus agalactiae.
Gram Negatives: Acinetobacter spp., Aeromonas hydrophila, Campylobacter jejuni, Citrobacter freundii, Enterobacter cloacae, Haemophilus parainfluenzae, Klebsiella oxytoca, Branhamella catarrhalis, Morganella morganii, Neisseria meningitidis, Proteus vulgaris, Providencia rettgeri, Salmonella spp., Serratia marcescens, Shigella spp., Vibrio cholerae, Yersinia enterocolitica.
Anaerobes: Bacteroides fragilis, Clostridium spp., Gardnerella vaginalis, Peptostreptococci.
Other Organisms: Legionella pneumophila, Mycoplasma pneumoniae, M. tuberculosis, M. leprae and Urea-plasma urealyticum.
Ornidazole is readily absorbed from the gastro-intestinal tract and peak plasma concentrations of about 30 mcg/mL have been reached within 2 hrs of a single dose of 1.5 g. After repeated oral doses of 500 mg every 12 hours, steady state peak and trough concentrations are 14 and 6 mcg/mL respectively. Ofloxacin is rapidly and completely absorbed after oral administration. Time to reach Cmax (Tmax) was not altered significantly and remained between 1 to 2 hours. The Cmax ranged from 2.6 mcg/mL after a 200 mg dose. Food does not affect absorption.
The plasma elimination half-life of Ornidazole is 12 to 14 hours longer than that of Metronidazole, which effectively decreases the frequency of dosing. Less than 15% is bound to plasma proteins. It is widely distributed in body tissues and fluids including the Cerebro-Spinal Fluid. Ofloxacin penetrates well into body tissues and fluids with concentrations ranging from 0.8 to 1.5 times the concurrent serum levels.
Very high levels are reached in sputum, saliva, nasal and bronchial secretions, tears and blister fluid. Concentrations in lung tissue could almost double the serum levels. Ofloxacin penetrates into polymorphs in very high concentrations. Ofloxacin crosses the placenta into the foetal blood and is excreted into breast milk.
Ornidazole is metabolised in the liver and is excreted in the urine, mainly as conjugates and metabolites, and to a lesser extent in the faeces. Ofloxacin is metabolized in the body only to a very limited extent.
Biliary excretion may be important in the elimination of Ornidazole and its metabolites. Kidney is the major elimination route for Ofloxacin. Between 72 and 98.5% of unchanged drug is eliminated within 48 hours.
INDICATION : : Mixed diarrhea, Postoperative infections, Upper and Lower respiratory tract infections, Peritonsillar abscess, Appendicitis, Biliary infections, Osteomyelitis, Wound infections, Infections in cancer patients, Gynecological infections, Dental infections, Diabetic foot infections.
DOSAGE : As directed by the physician
SIDE EFFECTS : Headache, Vertigo, Nausea and vomiting, Tremor, Drowsiness/ sleepiness, Fits, Allergic reaction e.g. itching, Taste disturbances, Dizziness and tiredness, Feeling of numbness or tingling in hands or feet, Allergic reactions of skin like redness, Diarrhea