Cipronil®, containing Ciprofloxacin is a synthetic quinolones anti-infective agent. Ciprofloxacin has broad spectrum of activity. It is active against most gram-negative aerobic bacteria including Enterobacteriaceae and Pseudomonas aeruginosa. Ciprofloxacin is also active against gram-positive aerobic bacteria including penicillinase producing, non-penicillinase producing, and methicilline-resistant staphylococci, although many strains of streptococci are relatively resistant to the drug. The bactericidal action of Ciprofloxacin results from interference with the enzyme DNA gyrase needed for the synthesis of bacterial DNA.
Following oral administration it is absorbed from the G.I. tract rapidly and well. It is widely distributed into body tissues and fluids. The half-life is about 3.5 hours. About 30% to 50% of an oral dose of ciprofloxacin is excreted in the urine within 24 hours as unchanged drug and biologically active metabolites.
Cipronil® 500: Each film-coated tablet contains Ciprofloxacin 500 mg as Ciprofloxacin Hydrochloride USP.
Cipronil® 750: Each film-coated tablet contains Ciprofloxacin 750 mg as Ciprofloxacin Hydrochloride USP.
Cipronil® PFS : When reconstitute each 5ml contain Ciprofloxacin 250mg.
Cipronil® is used in the treatment of infections caused by sensitive organisms.
Respiratory tract infections: lobar and bronchopneumonia, acute & chronic bronchitis, cystic fibrosis, bronchiectasis.
Ear, nose and throat infections: otitis media, sinusitis, mastoiditis, and tonsilitis.
Skin and soft tissue infection: infection of wound, abscess, cellulitis, furunculosis, impetigo, and infected burn. Acute systemic infections: septicemia peritonitis.
Gastrointestinal tract infections: enteric fever, diarrhoea due to infection, bacillary dysentery, enteritis, peritonitis.
Eye infection: bacterial conjunctivitis. Infections of bone joints: osteomyelitis, septic arthritis. Gonorrhoea: urethral, rectal and pharyngeal gonorrhoea caused by beta lactamase producing organisms.
Dosage and administration
The dose of Cipronil® is determined according to the type of infection, severity of the pathogen and age, weight and effectiveness of the kidney of the patient.
General dosage for adults: 250-750 mg 12 hourly.
For the treatment of gonorrhoea: 500 mg as a single dose.
Depending on the severity of urinary tract infection: 250-500 mg 12 hourly.
Depending on the severity of respiratory tract infection: 250-500 mg 12 hourly according to the direction of the physician.
Serious skin and soft tissue infections and osteomyelitis: Caused by Gram-negative bacteria recommended dose 500-750 mg twice daily. For serious skin and soft tissue infections, the duration of treatment is 5 to 10 days. For osteomyelitis, the usual duration of treatment is 4 to 6 weeks or longer.
Impaired renal function: Dosage adjustments are required with severe renal impairment (serum creatinine > 265 micromole/l or creatinine < 20 ml/minute). Adjustment is achieved by reducing the total daily dose by half, although monitoring of drug serum levels provides the most relieable basis for dose adjustment. Elderly: Although higher Ciprofloxacin serum levels are found in the elderly, no adjustment in dosage is necessary. Children and adolescents (1-17 years): 10 -30 mg /kg/day twice daily. Indication Dose Duration Frequency Complicated Urinary Tract or Pyelonephritis 10mg/kg to 20mg/kg (maximum 750mg per dose; not to be exceeded even in patients weighing > 51 kg) 10 to 21 days Twice daily
Typhoid fever 12mg/kg 10 days Twice daily
Invasive diarrhea 10mg/kg 3 days Twice daily
Shigellosis 10mg/kg 5 days Twice daily
Inhalational anthrax (post exposure) 15mg/kg (maximum 500mg per dose) 60 days Twice daily
Contraindications, Side effects, Warnings etc:
Ciprofloxacin should not be given to patients with a history of hypersensivity to Ciprofloxacin and to other quinolones and to children and in pregnant women.
Nausea, vomiting, abdominal pain, diarrhoea, headache, dizziness, rash, itching, fatigue, joint pain, mild light sensitivity, crystalluria, temporary disturbance of liver enzymes, myalgia, etc.
Pregnancy and lactating mother
Ciprofloxacin cannot be used during pregnancy or for lactating mothers.
Magnesium hydroxide or aluminium hydroxide containing antacids decreases the absorption of Ciprofloxacin. The use of Ciprofloxacin with theophylline may increase the plasma concentration of theophylline.
It should be used with caution in patients with suspected or known CNS disorders such as arteriosclerosis or epilepsy or other factors which predispose to seizures and convulsions. It is excreted in human milk and because of the potential for serious adverse reaction to Ciprofloxacin in infants, it may be used after taking into account the importance of the drug to the mother. Patients taking Ciprofloxacin should drink a large amount of water or other liquids to prevent excessive alkalinity in urine.
Cipronil® should be stored in a cool and dry place, away from light. Keep out of reach of children.
Cipronil® 500 : Each box containing 30 tablets in alu-alu pack.
Cipronil® 750 : Each box containing 12 tablets in alu-alu pack.
Cipronil® PFS :Ciprofloxacin 250mg/5ml Pellets for 60ml suspension.