Composition
Ciprodyl 500 tablet: Each film coated tablet contains Ciprofloxacin hydrochloride USP equivalent to Ciprofloxacin 500 mg.
Pharmacology
Ciprofloxacin is a synthetic broad spectrum antimicrobial agent for oral administration. 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, 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 rapidly and well absorbed from the G.I. tract. 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.
Indication
Ciprofloxacin is used in adults for the treatment of urinary tract infections, lower respiratory tract infections, skin and soft tissue infections, acute sinusitis, chronic bacterial prostatitis, bone and joint infections and G.I. infections, caused by susceptible gram-negative and gram-positive aerobic bacteria. It is also used for the treatment of uncomplicated gonorrhoea caused by penicillinase producing Neisseria gonorrhoeae.
Dosage & administration
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required.
Adult Dose (Oral):
Urinary Tract infection: 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
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
Bone and joint infection:
Mild/Moderate: 500 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
Elderly: Although higher Ciprofloxacin serum levels are found in the elderly, no adjustment of dosage is necessary.
Contra-indication
Patients with a history of hypersensitivity to ciprofloxacin or other quinolones. Concomitant administration with tizanidine is contraindicated.
Warning & precaution
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 convulsion.
Side effects
Adverse effects include nausea and other gastrointestinal disturbances, headache, dizziness and skin rashes. Crystalluria has occurred with high doses of ciprofloxacin.
Use in pregnancy & lactation
There are no adequate and well-controlled studies in pregnant & lactating women.
Use in children & adolescents
Though not recommended for the children where benefit out - weighs risk, a dosage of 7.5 - 15 mg/kg/day in two divided doses can be given.
Drug interaction
Increased plasma levels of theophylline have been observed following concurrent administration with Ciprofloxacin.
Overdose
In the event of acute, excessive oral overdosage, reversible renal toxicity has been reported in some cases. Therefore, apart from routine emergency measures, it is recommended to monitor renal function and to administer Mg- or Ca-containing antacids which reduce the absorption of ciprofloxacin. Only a small amount of ciprofloxacin (< 10 %) is removed from the body after haemodialysis or peritoneal dialysis.
Storage
Keep out of the reach of children. Keep below 30°C, protect from light.
Packing
Ciprodyl 500 tablet: Each box contains 3x10's tablet in blister pack.
