The active ingredients in CT-JIL are: • Ciprofloxacin; 1- Cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-piperazin-1-ylquinoline-3-carboxylic acid. • Tinidazole; 1-[2-(Ethylsulphonyl)ethyl]-2-methyl-5-nitroimidazole.
CT-JIL comes as a white, oval, film- coated caplet embossed CT- JIL on one side and plain on the other side and contains 500mg Ciprofloxacin and 600mg Tinidazole.
CT-JIL is a fixed dose combination of Ciprofloxacin and Tinidazole and is indicated for the treatment of a wide range of infections caused by susceptible Gram-positive and Gram-negative organisms along with anaerobes and protozoa:
E. Coli and Citrobacter, Enterobacter, Klebsiella, Proteus, Providencia, Salmonella, Serratia, Shigella and Yersinia spp., Pseudomonas aeruginosa, Haemophillus ducreyi, H. Influenza, Moraxella catarrhais(Branhamella catarrhais) and Neiserria gonorrhoea. It is also active against beta-lactamase producing strains, N.meningitidis, Ancinetobacter spp., Campylobacter spp., Gardnerrella vaginitis,Helicobacter pylori, Legionella spp., Pasteurella multocida, Vibrio spp., and Brucella melitensis.
Staphylococci, including penicillnase-producing and penicillinase-nonproducing strains, some meticillin-resistant strains, Streptococci and enterococci, Bacillus anthracis and Corynebacterium spp. Anaerobes: Clostridium and Bacteroides spp., Gardnerella vaginalis, and Campylobacter spp. Other Organisms: Mycobacteria,mycoplasmas, rickettsias, Chlamydia trachomonas and the protozoan Plasmodium falciparum.
Ciprofloxacin is rapidly and well absorbed from the gut. Oral bioavailability is approximately, 70%. Peak plasma concentration is achieved 1-2 hours after dose. Absorption may be delayed by presence of food, but is not substantially affected overall. Plasma half-life is about 3.5 – 4.5 hours and may be prolonged in renal impairments.Plasma protein binding is 20 – 40%. It is mainly eliminated by urinary excretion.
Tinidazole is rapidly and completely absorbed after oral administration and is widely distributed in the body. Peak serum levels usually occur within 2 hours after administration and decline slowly with an elimination half-life of 12- 14 hours. Protein binding is 12%. It is excreted in the urine and to a lesser extent faeces.
CT-JIL is used in the treatment of a wide range of infections including, Amoebiasis, trichomoniasis, giardiasis, acute ulcerative gingivitis, non- specific vaginitis, anthrax, biliary-tract infections, infected bites and stings, cat scratch disease, chanchroid, exacerbations of cystic fibrosis, gastro-enteritis, (including traveller’s diarrhoea and campylobacter enteritis,cholera, salmonella enteritis, and shigellosis), gonorrhoea, infections in immuno compromised patients (neutropenia), legionnaire’s disease, otitis externia, otitis media, peritonitis, Q fever, lower respiratory tract infections(including pseudomonas infections in cystic fibrosis but excluding infections due to streptococci pneumonia such as pneumococcus pneumonia),septicaemia, skin and soft-tissue infections, ulcers and pressure sores infected with anaerobic bacteria, spotted fever, typhoid and paratyphoid fever, typhus and urinary tract infections. It is also useful in surgical prophylaxis, prophylaxis of meningococcal meningitis and in the treatment of anaerobic bacterial infections.
MODE OF ACTION:
Ciprofloxacin acts by inhibiting the A subunit of DNA gyrase (topoisomerase) which is essential in the reproduction of bacterial DNA.
DOSAGE AND ADMINISTRATION:
CT-JIL should be taken with food. Patients should be advised to drink plenty of fluid.
Adults: 1 caplet twice daily depending on the severity of the infection.
Children less than 18 years:
CT-JIL should be used with caution.
Duration of therapy is usually 5 – 14 days depending on the infection. Take at regular intervals. Complete course of treatment unless otherwise directed. Swallow the caplet whole, not chewed.
Special Dosage Recommendations
• Gonorrhoea/urethral infections: 1 caplet daily, for 3 days depending on pattern of resistance
• Prophylaxis of meningococcal meningitis: Single dose of 1 caplet 60 – 90 minutes before the procedure.
• Urinary tract infections: 1 caplet twice daily for 7 – 10 days depending on the severity of infection and susceptibility.
• Uncomplicated acute cystitis in women: 1 caplet daily for 5 days.
• Lower respiratory tract infections: 1 caplet twice daily for 7 – 14 days.
• Bones and joint infections: 1 caplet twice daily for 4 – 6 weeks
• Thyphoid fever: 1 caplet twice daily for 10 days
• Chancroid: 1 caplet twice daily for 5 days
• Infectious diarrhoea: 1 caplet twice daily for 5 – 7 days.
• Treatment of Anaerobic infections: 1 caplet twice daily for 5 – 10 days depending on the severity of infection.
• Nonspecific vaginitis: 2 caplets as a single dose for two consecutive days (total dosage of 4 caplets).
• Acute ulcerative gingivitis: Single daily dose of 2 caplets, then 1 caplet daily for 5 – 7 days.
• Urogenital Trichomoniasis: Single dose of 2 caplets.
• Intestinal Amoebiasis: Single dose of 2 caplets for 2 – 3 days (continued for up to 6 days if ineffective).
CT-JIL is usually well tolerated. Common side effects include gastrointestinal disturbances like nausea, vomiting, diarrhoea, abdominal pain, an unpleasant metallic taste, furry tongue, glossitis, darkening of the urine and dyspepsia.
Other effects are CNS disturbances like headache, dizziness, restlessness, tremor, insomnia, drowsiness, visual and other sensory disturbances.Hypersensitivity reactions like rash, pruritus, and fever have also been reported. Rarely cardiovascular effects like tachycardia, hot flushes, syncope, oedema, and sweating have been reported. Haematological disturbances like eosinophilia, leucopenia and thrombocytopenia may also occur.
PRECAUTIONS AND WARNING:
It should be used with caution in patients with epilepsy or history of CNS disorders and in patients with G6PD deficiency or myasthenia gravis.
Doses should be reduced in renal and hepatic impairments.
Adequate fluid intake should be maintained during treatment and excessive alkalinity of the urine avoided because of the risk of crystalluria. Avoid antacids or products containing zinc or iron within 4 hours before or 2 hours after dosing. The ability to drive or operate machinery may be impaired especially when alcohol is taken.
CT-JIL should not be used by patients with known history of hypersensitivity to Ciprofloxacin or any fluoroquinolone antimicrobial agent. It is contra indicated in pregnant women and breast feeding mothers.
Antacids containing Aluminium, calcium, magnesium and zinc salts reduce absorption of Ciprofloxacin so also does iron. Sucralfate releases aluminium ions in the stomach and thereby reduces the absorption of Ciprofloxacin.
Dairy products with high calcium contents might also interfere with Ciprofloxacin absorption.The urinary excretion of Ciprofloxacin is reduced by probenecid.
Ciprofloxacin interferes with the clearance of drugs like theophylline and caffeine.Concomitant use with cyclosporine may result in increase of serum creatinine concentration.
Ciprofloxacin and Tinidazole enhance the effect of oral anticoagulants.Tinidazole impairs the clearance of phenytoin. Plasma concentration of Tinidazole are decreased in the presence of phenobarbitone.
CT-JIL comes in packs of 2 x 10
Tell your Doctor or Pharmacist if you notice any undesirable symptoms, even those not mentioned in this writeup.