OCIMIX (FDC of Ciprofloxacin and Ornidazole Tablets)New delhi
A Quality Product from
Panacea Biotec Ltd. [View Profile]
New Delhi - India
Ocimix [Fixed Dose Combination of ciprofloxacin and ornidazole] contains ciprofloxacin which is 1 ?cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid and ornidazole which is 1-Chloro-3- (2-methyl-5-nitroimidazol-1-yl) propan-2-ol.
Ocimix is a white, oblong, biconvex, film coated tablet having score line on one side and plain on the other side.
Each film-coated tablet contains
Ciprofloxacin Hydrochloride IP
equivalent to Ciprofloxacin .............. 500 mg
Ornidazole ..................................... 500 mg
Colour: Titanium di oxide
Pharmacology and mechanism of action :
Ciprofloxacin exerts its antimicrobial action by binding to bacterial enzymes Gyrase and Topoisomerase IV, which are responsible for DNA replication in bacteria.
The drug is highly active against aerobic gram negative bacteria viz. E. coli, K. pneumoniae, Enterobactor, Citrobactor, Salmonella, Shigella, Yersinia, Proteus, Serratia, H. influenzae, H. ducreyi, B. catarrhalis, Vibrio, C. jejuni, M. catarrhalis, Neisseria, Pseudomonas, Brucella, Legionella, Providentia etc. The aerobic gram-positive bacteria (viz. S. epidermidis, Methicillin sensitive S. aureus, S. pneumoniae, Enterococcus faecalis, S. pyogens) and some anaerobic bacteria (viz. B. fragilis, fusobacterium, Peptostreptococcus, Clostridium) are moderately or mildly susceptible.
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.
Rationale for combination of ciprofloxacin and ornidazole
Few studies have shown the combination of Nitroimidazoles and Quinolones to be effective clinically. This gives an indication for combining ornidazole and ciprofloxacin specially in mixed infections. Ornidazole which is a new derivative of nitroimidazole series has a longer half-life. It is recommended to be given twice a day. Ciprofloxacin is also recommended twice daily. Therefore, it appears appropriate to combine ornidazole and ciprofloxacin as fixed dose combinations. Moreover, FDC will provide broad spectrum of activity as individual drugs are active against different pathogens
Maximum plasma concentrations (C max) between 0.8 and 3.9 mg/L are achieved 1 to 2 hours after oral administration of single 250 to 750 mg doses. Ciprofloxacin has bioavailability of approximately 70% after oral administration. The volume of distribution (Vd) is 2.1 to 5 l/kg and it is mainly distributed in bile, kidney, liver, gall bladder, prostate and lungs. It is approx. 30 % bound to plasma proteins. The elimination half-life of ciprofloxacin is 3-5 hours. It is largely excreted unmetabolized in urine and faeces1.
Ornidazole is readily absorbed from the GIT and peak plasma concentrations of about 30 mcg/ml are achieved within 2 hours of a single dose of 1.5 g. Food does not affect extent but rate of absorption of ornidazole. Ornidazole is less than 15% bound to plasma proteins. It is widely distributed in body tissues and fluids, including cerebrospinal fluid. Antibacterial concentrations are achieved in vaginal secretions, amniotic fluid, appendix and intestinal tissues. More than 90% of ornidazole dose is metabolized in liver. The metabolites are active and have same activity against anaerobic bacteria as the ornidazole. The elimination half-life (t1/2) of Ornidazole is 12 ? 14 hours. It is excreted in the urine, mainly as conjugates and metabolites and to a lesser extent in the feces. Biliary excretion may be important in the elimination of ornidazole and its metabolites2.
Pharmacokinetics in special populations :
Renal: Renal clearance of ciprofloxacin is decreased, and thus Cmax, t ? and AUC values are increased in elderly versus younger patients. Similar variations in these parameters with ciprofloxacin have also been noted in patients with renal impairment.
The kinetics of ornidazole is not altered in patients with renal insufficiency. However, elimination of ornidazole is increased in patients undergoing hemodialysis.
Hepatic: The elimination half-life of ornidazole was longer (22 hrs) in patients suffering from hepatic cirrhosis, as compared to normal subjects (14 hours). The clearance was weaker (35 ml / min) in hepatic insufficiency as compared to normal individuals. (51 ml / min). The dosage interval should be doubled in patients with severely diminished liver function.
No significant changes have been observed with ornidazole in hepatic impairment.
Pediatric Use: Safety and effectiveness in pediatric patients and adolescents less than 18 years of age have not been established, except for use in inhalational anthrax (post-exposure).
Ocimix is indicated for treatment of diarrhoea, gynaecological and pelvic infections with protozoa, anaerobic and aerobic gram negative organisms. It is also indicated for mixed infections related to oral cavity and teeth.
Patients with known hypersensitivity to ciprofloxacin or ornidazole or any component of this formulation or active renal disease or hepatic cirrhosis.
Warnings and Precautions
Pregnancy and lactation: There are no adequate and well-controlled studies in pregnant women and ciprofloxacin is excreted in human milk . Therefore the drug should be prescribed to pregnant or nursing mother only if the potential benefit justifies the potential risk to the feotus/neonate.
Multivalent cations: Multivalent cations decrease absorption of ciprofloxacin, therefore it should be administered at least 2 hours before or 6 hours after these preparations.
Colitis: Pseudomembranous colitis has been reported with nearly all antibacterial agents, including ciprofloxacin.
Regular laboratory tests and clinical control are indicated in case of use of high ornidazole doses or if duration of therapy exceeds 10 days.
Blood disorders: Leukocyte counts should be checked before and after start of therapy (especially in repeat therapy), in patients with history of blood disorders.
CNS: Severe diseases of central and peripheral nervous system may get aggravated on Ornidazole therapy. Treatment should be discontinued in case of onset of peripheral neuropathy, ataxia, vertigo or confusion.
Candidiasis: Ornidazole therapy may aggravate existing candidiasis. Necessary precautions should be taken.
Pregnancy and lactation: No controlled studies of effect of the drug on pregnant women are available. Ornidazole should be prescribed to pregnant and nursing women only if the potential benefit to the mother outweighs potential risk to the feotus / neonate.
Lithium therapy: 5 ? nitroimidazoles (mainly metronidazole) have been found to decrease renal elimination of lithium. So, in patients undergoing concurrent lithium therapy, plasma lithium concentrations as well as Creatinine and electrolyte concentrations should be monitored.
Ocimix should be used with caution in conditions where the individual drugs have been used with precautionary approach.
Adverse Events :
Gastrointestinal disturbances such as nausea, diarrhoea, vomiting, dyspepsia, anorexia or abdominal pain.
CNS related adverse events include dizziness, headache, restlessness or tremors.
Dermatological reactions like rashes or pruritis.
Ciprofloxacin is rarely associated with phototoxicity.
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.
Drug Interactions :
Multivalent cations: Concomitant administration of ciprofloxacin with multivalent cation ? containing products (e.g. Magnesium / Aluminium antacids, calcium / iron / zinc preparations, buffered or chewable tablets etc.) may decrease it?s absorption substantially. This results in lower serum and urine levels.
Probenecid: Probenecid interferes with renal tubular secretion of ciprofloxacin. Co-administration of probenecid with ciprofloxacin results in about a 50% reduction in the ciprofloxacin renal clearance and a 50% increase in its concentration in the systemic circulation.
Theophylline: Concomitant administration of ciprofloxacin with theophylline decreases the clearance of theophylline resulting in elevated serum theophylline levels and increases risk of a patient developing CNS or other adverse reactions. If concomitant use cannot be avoided, serum levels of theophylline should be monitored and dosage adjustments made as appropriate.
Alcohol intolerance: Unlike other nitro-imidazoles, ornidazole does not inhibit enzyme aldehyde dehydrogenase. No disulfiram like reaction has been reported on consumption of alcohol. However, as is the case with all imidazoles, this drug should be avoided in concomittance with alcohol usage.
In case of overdosage, the patient should be observed carefully and symptomatic treatment should be given. The stomach should be emptied by gastric lavage or vomiting. All the supportive measures and hydration should be maintained. In case of convulsions, intravenous diazepam is recommended.
Dosage and Administration :
One tablet of Ocimix is recommended as twice daily therapy.
Store at a temperature below 30o C, protect from light and moisture
Blister pack of 10x10 tablets.
1. Davis R, Markhan A and Balfour JA. Ciprofloxacin ? An update review of its pharmacology, therapeutic efficacy and tolerability. Drugs, 1996 Jun; S1(6):1019-1074.
2. Boeckh M, Code H, Deppermann KM et al. Pharmacokinetics and serum bactericidal activities of quinolones in combination with clindamycin, metronidazole and ornidazole. Antimicrobial agents and chemotherapy, 1990, Dec; 34(12):240-14.
3. Mc Clain RM and Downing JC. Reproduction studies in rats treated with ornidazole. Toxicology and Applied Pharmacology, 1988; 92:480
4. Yoshioka K, Youngs DJ, Keighley MR. A randomised prospective controlled study of Ciprofloxacin with metronidazole versus amoxicillin / clavulinic acid with metronidazole in the treatment of intra abdominal infection. Infection, 1991, Jan-Feb.; 19(1):25-9
5. Prantera C, Zannoni F, Scribano ML et al. An antibiotic regimen for the treatment of active Crohn?s disease: a randomised controlled clinical trial of metronidazole plus Ciprofloxacin. Am J of Gastroenterology, 1996, Feb; 91(2): 328-32.
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