Beuflox 500 & 750
Ciprofloxacin tablet

Presentation
Beuflox 500: Each film-coated tablet contains Ciprofloxacin Hydrochloride USP equivalent to Ciprofloxacin 500 mg.
Beuflox 750: Each film-coated tablet contains Ciprofloxacin Hydrochloride USP equivalent to Ciprofloxacin 750 mg.

Description
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 tablet 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 tablet 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 tablet 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 diarrhoea. 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 and Administration
InfectionType or SeverityUnit DoseFrequencyUsual Durations

Acute Sinusitis Mild/Moderate 500 mg b.i.d. 10 Days

Lower Mild/Moderate 500 mg b.i.d. 7 to 14 Days
Respiratory Tract Severe/Complicated 750 mg b.i.d. 7 to 14 Days

Urinary Tract Acute Uncomplicated 250 mg (1/2 tablet) b.i.d. 3 Days
Mild/Moderate 250 mg (1/2 tablet) b.i.d. 7 to 14 Days
Severe/Complicated 500 mg b.i.d. 7 to 14 Days

Chronic Bacterial Mild/Moderate 500 mg b.i.d. 28 Days
Prostatitis

Intra-Abdominal Complicated 500 mg b.i.d. 7 to 14 Days

Skin andMild/Moderate 500 mg b.i.d. 7 to 14 Days
Skin Structure Severe/Complicated 750 mg b.i.d. 7 to 14 Days

Bone and Joint Mild/Moderate 500 mg b.i.d. ³ 4 to 6 weeks
Severe/Complicated 750 mg b.i.d. ³ 4 to 6 weeks

Infectious Diarrhea Mild/Moderate/Severe 500 mg b.i.d. 5 to 7 Days

Typhoid FeverMild/Moderate 500 mg b.i.d. 10 Days

Urethral and Cervical Uncomplicated 250 mg (1/2 tablet) single dose single dose
Gonococcal Infections


Use in 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.

Side effects
Ciprofloxacin is generally well tolerated. Frequent adverse reactions are-Gastrointestinal disturbance: e.g. nausea diarrhoea, 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 sensitinits, 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.

Contraindications
Ciprofloxacin is contraindicated in patients who have hypersensitivity to Ciprofloxacin or other quinolones. Ciprofloxacin is also contraindicated in children and growing adolescents except where the benefits of treatment outweigh the risk.

Precautions
Ciprofloxacin should be used with caution in patients with a history of convulsive disorders. Crystaluria 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.

Drug interactions
Concurrent administration of Ciprofloxacin with theophylline may lead to elevated plasma concentrations of theophylline and prolongation of its elimination half-life. This may result in increased risk of theophylline related adverse reactions. If concomitant use cannot be avoided 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 resulting in serum and urine levels lower than desired, 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. This should be considered if patients are receiving both drugs concomitantly. 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.

Information for patients
Beuflox tablet should be swallowed whole with an adequate amount of liquid, it may be taken with or without meals. The preferred time of dosing is two hours after a meal and patients should not take antacid within two hours of dosing.

Commercial pack
Beuflox 500 : Box containing 2 blister strips of 10 film coated tablet.
Beuflox 750 : Box containing 2 blister strips of 10 film coated tablet.