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CIPROFLOXACIN TABLETS 500MG
Composition
Each tablet contains ciprofloxacin 500mg.
Pharmacology
Ciprofloxacin inhibits DNA-gyrase in susceptible organisms, inhibits relaxation of supercoiled DNA
and promotes breakage of double-stranded DNA
Maximum serum concentrations (Cmax) of 1.21μg/mL and 2.5μg/mL are attained 1 to 2 hours after oral dosing with 250mg and 500 mg in health volunteers, respectively. After oral administration, ciprofloxacin is widely distributed throughout the tissues and fluids (including cerebrospinal fluid). Tissue concentrations often exceed serum concentrations. The binding of ciprofloxacin to serum proteins is 20 to 40%,and the serum elimination half-life in subjects with normal renal function is approximately 4 hours. Ciprofloxacin is partly metabolized in the liver. The metabolites have antimicrobial activity, but are less active than unchanged ciprofloxacin. Approximately 40 to 50% of an orally administered dose is excreted in the urine as unchanged drug and 15% as metabolites within 24 hours, partly excreted in feces and biliary.
Indications
Treatment of susceptible bacteria infections:
1. Urinary tract infections: complicated or uncomplicated urinary tractinfections, bacterial
prostatitis, neisseria gonorrheal urethritis and cervicitis (including caused by penicillinase-
producing strains).
2. Respiratory tract infections: including bronchiectasis. bronchitis. and pneumonia caused by
susceptible gram-negative bacilli.
3. Gl infections: caused by susceptible strains of Shigella, Salmonella, enterotoxigenic E. coli,
Aeromonas hydrophila, Vibrio parahaemolyticus.
4. Typhoid fever.
5. Bone and joint infections.
6. Skin and soft structure infections.
7. Systemic infection such as septicemia.
Dosage and Administration
For oral administration.
1.Adults:0.5g-1.5g/day divided into 2-3times.
2. Bone and joint infections: 1g-1.5g/day divided into 2-3 times for4-6 weeks.
3. Pneumonia and skin and soft tissues infections: 1g-1.5g/day divided into 2-3times for 7-14days
4. GI Infections: 1g/day divided into 2times for 5-7days
5. Typhoid fever: 1.5giday divided into 2-3times for10-14 days.
6. Urinary tract infections: acute, uncomplicated low urinary tract infections: 0.5g/day divided into 2 times for 5-7 days. Complicated urinary tract infections: 1g/day divided into 2 times for 7-14days.
7. Simple gonorrhea: 0.5g daily for 1 day.
Contraindications
Hypersensitivity to ciprofloxacin, any component or other quinolones.
Adverse Reactions
Nausea, vomiting. Diarrhea, epigastric distress, headache, restlessness, abdominal pain, skin rash
and arthralgia.
Warnings/Precautions
1. Ciprofloxacin should be used in pediatric patients (less than 18years of age)only for infections
of Complicated Urinary Tract or Pyelonephritis and Inhalational Anthrax.
3. Convulsions, increased intracranial pressure and toxic psychosis have been reported in patients
receiving quinolones, including ciprofloxacin. Ciprofloxacin may also cause central nervous system (CNS)events including: dizziness. confusion, tremors, hallucinations, depression, and, rarely, suicidal thoughts or acts.
4. Pseudomembranous colitis has been reported with nearly all antibacterial agents, including
ciprofloxacin, and may range in severity from mild to life-threatening.
5. Ruptures of the shoulder, hand, Achilles tendon or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including ciprofloxacin.
Pregnancy and Lactation
There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin is excreted in human milk. The amount of ciprofloxacin absorbed by the nursing infant is unknown. Because of the potential for serious adverse reactions in infants nursing from mothers taking ciprofloxacin, a decision should be made whether to discontinue nursing or to discontinue the drug. taking into
account the importance of the drug to the mother.
Pediatric Use
Ciprofloxacin, like other quinolones, causes arthropathy and histological changes in weight-bearing joints of juvenile animals resulting in lameness. Therefore, the use of the drug should be cautious.
Geriatric use
Drug dosage reduction may be necessary in geriatric patients due to the renal function impairment.
Drug Interactions
1. Concomitant administration of tizanidine and ciprofloxacin is contraindicated
2. Concurrent administration of ciprofloxacin with theophylline may lead to elevated serum concentrations of theophylline and prolongation of its elimination half-life. This may result in increased risk of theophylline-related adverse reactions.
3. Some quinolones, including ciprofloxacin, have been associated with transient elevations in
serum creatinine in patients receiving cyclosporine concomitantly.
4. Altered serum levels of phenytoin (increased and decreased) have been reported in patients
receiving concomitant ciprofloxacin.
5. The concomitant administration of ciprofloxacin with the sulfonylure a glyburide has, in some
patients, resulted in severe hypoglycemia. Fatalities have been reported.
6. Quinolones, including ciprofloxacin, have been reported to enhance the effects of the oral
anticoagulant warfarin or its derivatives.
7. Probenecid interferes with renal tubular secretion of ciprofloxacin and produces an increase in
the level of ciprofloxacin in the serum.
8. Renal tubular transport of methotrexate may be inhibited by concomitant administration of
ciprofloxacin potentially leading to increased plasma levels of methotrexate.
9. Non-steroidal anti-inflammatory drugs (but not acetyl salicylic acid) in combination of very high doses of quinolones have been shown to provoke convulsions in pre-clinical studies.
Overdosage
In the event of an acute overdosage, the stomach should be emptied by inducing vomiting or by gastric lavage. The patient should be carefully observed and given supportive treatment. Adequate hydration must be maintained. Only a small amount of ciprofloxacin (<10%) is removed from the body after hemodialysis or peritoneal dialysis. Serious adverse effects were not observed in rats receiving single oral doses of ciprofloxacin as high as 2,000mg/kg.
Presentation
500mg/tablet, 1x10 tablets/box
Storage
Store in a cool place, protected from light and humidity.
Validity
3years.
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