Description
Composition:
Efloxin 250 Tablet: Each film-coated tablet contains Ciprofloxacin Hydrochloride USP equivalent to Ciprofloxacin 250 mg.
Efloxin 500 Tablet: Each film-coated tablet contains Ciprofloxacin Hydrochloride USP equivalent to Ciprofloxacin 500 mg.
EfloxinPowder for Suspension: After reconstitutioneach 5 ml of suspension contains Ciprofloxacin USP 250 mg.
Pharmacology:
Ciprofloxacin is a synthetic 4-quinolone derivative with bactericidal activity against a wide range of gram-positive and gram-negative organism. 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 methicillin resistant Staphylococci. However many strains of Streptococci are relatively resistant to the drug. The bactericidal activity of Ciprofloxacin results from interference with the enzyme DNA gyrase needed for the synthesis of bacterial DNA. The mode of action of Ciprofloxacin is different from other antibiotics like penicillins, cephalosporins, aminoglycosides, tetracyclines and for this reason it is observed that organisms resistant to these antibiotics are susceptible to Ciprofloxacin. Ciprofloxacin is well absorbed from the GIT after oral administration and it is widely distributed into the body tissues and fluid. The half-life of Ciprofloxacin is 3.5 – 4.5 hours. About 30-50% of an oral dose of Ciprofloxacin is excreted in the urine within 24 hours as unchanged drug and active metabolites.
Indications:
Ciprofloxacin is indicated for the treatment of the following infections caused by sensitive bacteria:
Severe systemic infections: e.g; septicemia, bacteremia, peritonitis, infections in immunosuppressed patients with haematological or solid tumors and in patients in intensive care unit with specific problems such as infected burns.
Respiratory tract infections: Lobar and broncho pneumonia, acute and chronic bronchitis and empyema.
Urinary tract infections: Uncomplicated and complicated urethritis, cystitis, pyelonephritis, prostatitis and epididymitis.
Skin and soft tissue infections: Infected ulcers, wound infections, abscesses, cellulitis, otitis externa, erysipelas and infected burns.
Gastrointestinal infections: Enteric fever, infective diarrhea.
Infections of the biliary tract: Cholangitis, cholecystitis, empyema of the gall bladder.
Intra-abdominal infections: Peritonitis, intra abdominal abscesses.
Bone and joint infections: Osteomyelitis, septic arthritis.
Pelvic infections: Salpingitis, endometritis, pelvic inflammatory diseases.
Eye, ear, nose and throat infections: Otitis media, sinusitis, mastoiditis, tonsillitis.
Gonorrhoea: Urethral, rectal and pharyngeal gonorrhoea caused by beta-lactamase producing organism or organisms moderately sensitive to penicillin.
Dosage & Administration:
Urinary Tract infection: Acute uncomplicated: 250 mg twice daily for 3 days; Mild/Moderate: 250 mg twice daily for 7 to 14 days; Severe/Complicated: 500 mg twice daily for 7 to 14 days; Chronic Bacterial Prostitis : 500 mg twice daily for 28 days; Lower Respiratory Tract infection: Mild/Moderate: 500 mg twice daily for 7 to 14 days, Severe/Complicated : 750 mg twice daily for 7 to 14 days; Acute Sinusitis : 500 mg twice daily for 10 days; Skin and Skin Structure infection: Mild/Moderate : 500 mg twice daily for 7 to 14 days, Severe/Complicated : 750 mg twice daily for 7 to 14 days, Bone and joint infection: Mild/Moderate 500 mg twice daily for 4 to 6 weeks, Severe/Complicated : 750 mg twice daily for 4 to 6 weeks, Intra Abdominal Infection: 500 mg twice daily for 7 to 14 days, Infectious Diarrhea: Mild/Moderate/Severe: 500 mg twice daily for 5 to 7 days, Typhoid Fever : 500 mg twice daily for 10 days, Urethral & Cervical Gonococcal Infections: Uncomplicated: 250 mg Single dose.
Contraindication:
Ciprofloxacin is contraindicated in patients who have hypersensitivity to Ciprofloxacin or other quinolones.
Warning & Precaution:
Ciprofloxacin should be used with caution in patients with a history of convulsive disorders. Crystalluria related to the use of Ciprofloxacin has been observed only rarely. Patients receiving Ciprofloxacin should be well hydrated to avoid excessive alkalinity of the urine.
Efloxin Injection should only be administered by slow intravenous infusion over a period of 60 minutes. Local IV site reactions have been reported with the intravenous administration of Ciprofloxacin. These reactions are more frequent if infusion time is 30 minutes or less or if small vein of the hand are used.
Side Effects:
Ciprofloxacin is generally well tolerated. Frequent adverse reactions are- Gastrointestinal disturbance: e.g. nausea diarrhea, vomiting, dyspepsia, abdominal pain. Disturbance of the CNS: e.g. dizziness, headache, tiredness, confusion, convulsions. Hypersensitivity reactions: e.g. skin rashes, pruritus, and possible systemic reactions. Other possible side effects are – joint pain, light sensitivity, transient increase in liver enzyme (especially in patients with history of liver damage), serum bilirubin, urea or serum creatinine. Arthralgia and myalgia may also occur.
Pregnancy and Lactation:
Reproduction studies performed in rats and rabbits using parenteral and oral administration did not reveal any evidence of teratogenicity, impairment of fertility or impairment of pre or postnatal development. However, as with other quinolones, Ciprofloxacin has been shown to cause arthropathy in immature animals and therefore, its use during pregnancy is not recommended. Studies in rats have indicated that Ciprofloxacin is secreted in milk, administration to nursing mothers is thus not recommended.
Drug interaction:
Concurrent administration of Ciprofloxacin with theophylline may lead to elevated plasma concentrations of theophylline. Plasma level of theophylline should be monitored and dosage adjustments made as appropriate. Antacid containing magnesium hydroxide or aluminium hydroxide may interfere with the absorption of Ciprofloxacin & concurrent administration of these agents with Ciprofloxacin should be avoided. Probenecid interferes with renal tubular secretion of Ciprofloxacin and produces an increase in the level of Ciprofloxacin in the serum. As with other broad spectrum antibiotics prolonged use of Ciprofloxacin may result in over growth of non-susceptible organisms. Repeated evaluation of patient’s conditions and microbial susceptibility testing is essential. If superinfections occur during therapy, appropriate measure should be taken.
Packing:
Efloxin 250 Tablet: Box containing 30 film coated tablet.
Efloxin 500Tablet: Box containing 30 film coated tablet.
Efloxin Powder for Suspension:Each glass bottle contains powder for preparing 60 ml suspension.
