CIPROKANT-500 (Ciprofloxacin)

CIPROKANT-500 (Ciprofloxacin)

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CIPROKANT-500 (Ciprofloxacin)

Ciprofloxacin tablets 500mg is indicated for the treatment of a wide variety of infections caused by susceptible gram-positive and gram-negative organisms including mixed infections caused by two or more organisms. It may also be used for infections caused by multi-drug resistant bacteria. Ciprofloxacin tablets 500mg is indicated for the treatment of the following infections caused by susceptible bacteria:

Respiratory tract infections: Acute and chronic bronchitis, obstructive airways disease (COPD), emphysema, lung abscess, bronchiectasis, lobar and bronchopneumonia, acute exacerbation of cystic fibrosis, otitis media, sinusitis and mastoiditis especially due to gram-positive bacteria (including Pseudomonas sp.)

Urinary tract infections: Acute and chronic pyelonephritis, cystitis, urethritis, prostatitis, epididymitis and chronic complicated or recurrent UTI caused by multi-drug resistant organisms and/or Pseudomonas aeruginosa.

Skin and soft tissue infections: In surgical and post-operative wound infections due to gram-negative organisms such as Pseudomonas aeruginosa. Also useful in infections caused by resistant Staphylococci including infected ulcer, wound infections, abscesses, cellulitis, erysipelas, infected burns.

Surgical infections: Peritonitis, intra-abdominal abscess, cholecystitis, emphysema of gall bladder, cholangitis.

Bone and joint infections: Acute and chronic osteomyelitis, septic arthritis.

Pelvic infections: Salpingitis, endometritis, pelvic inflammatory disease

Sexually transmitted diseases: Gonorrhea including that caused by beta-lactamase producing strains and chancroid caused by H.ducreyi.

Gastrointestinal infections: Enteric fever, infective diarrhoea

Severe systemic infections: Septicaemia, bacteraemia, infections in immunocompromised patients

Dosage and administration

Ciprofloxacin tablets 500mg should be swallowed whole with adequate amount of liquid. Ciprofloxacin can be taken without regard to meals. Fluids should be taken liberally. Antacids should not be taken concomitantly or within two hours of dosing

Adult

Respiratory tract, bone and joint infections: Mild/moderate 500mg twice daily. Severe/complicated 750mg twice daily

Urinary tract infections: Mild/moderate 250mg twice daily. Severe/complicated 500mg twice daily

Infectious diarrhoea: Mild/moderate/severe 500mg twice daily

Gonorrhoea: 500mg single dose. Non-gonococcal urethritis: 750mg twice daily

Chancroid: 500mg twice daily

Other infections: 500mg-750mg twice daily

Mechanism of action

As a fluoroquinolones antibacterial agent, the bactericidal action of ciprofloxacin results from the inhibition of both type ii topoisomerase (DNA-gyrase) and topoisomerase iv, required for bacterial DNA replication, transcription, repair and recombination.

Contraindications

  • Hypersensitivity to the active substance, to other quinolones or to any of the excipients .
  • Concomitant administration of ciprofloxacin and tizanidine

Warning and precautions

Pediatric use: As with other drugs of this class, ciprofloxacin has been shown to cause arthropathy in weigh-bearing joints of immature animals. Hence ciprofloxacin is usually not recommended for use in children. However, if benefits are considered to outweigh the potential risk, it may be administered

In impaired renal damage: Dosage adjustments will be required in patients with moderate to severe impairment of renal function. Monitoring of serum drug levels is the most reliable basis for dosage adjustment.

If creatinine clearance is less than 20ml/min, half the recommended dosage may be administered.

CNS stimulation: As ciprofloxacin may cause CNS stimulation, it should be used with caution in patients with CNS disorders such as severe cerebral arteriosclerosis or epilepsy.

Crystalluria: Inadequate intake of water, when on ciprofloxacin, can cause crystalluria.

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Phototoxicity: Moderate to severe phototoxicity manifested by an exaggerated sunburn reaction has been observed in patients who are exposed to direct sunlight with some members of the quinolone class of drugs. Therapy should be discontinued if phototoxicity occurs.

Interactions

Theophylline: Serum concentrations and elimination half-life of theophylline may be increased when it is used concurrently with ciprofloxacin. Theophylline doses should be reduced and plasma levels monitored.

Antacids: Antacids containing magnesium hydroxide and/or aluminium hydroxide may interfere with the absorption of ciprofloxacin, resulting in lower serum and urine levels; concurrent administration of antacids with ciprofloxacin should be avoided.

Anticoagulants: Prolongation of bleeding time has been reported during concomitant administration of ciprofloxacin and anticoagulants.

Cyclosporin: Transient increases in serum creatinine have been seen following concomitant administration of cyclosporin and ciprofloxacin

Caffeine: Ciprofloxacin may interfere with the metabolism of caffeine, resulting in reduced clearance of caffeine.

Side effects

Ciprofloxacin is generally well tolerated. Diarrhoea, vomiting, abdominal pain, headache, restlessness and rash, have been reported. Other side effects which have been reported very rarely include myalgia, tendinitis/rupture, exacerbation of myasthenia gravis and increase in serum trasaminase levels.

Potential life-threatening effects: A series of 15 cases of anaphylactoid reactions has been reported associated with ciprofloxacin. Stevens-Johson syndrome, toxic epidermal necrolysis, fulminant hepatic failure have been reported rarely.

Severe irreversible effects: As with all quinolones, seizures may occur and this effect may be potentiated by concurrent use of on-steroidal anti-inflammatory drugs. Pseudomembranous colitis has occurred with ciprofloxacin therapy.

Transient disturbance of hearing has been reported, particularly during high-dose therapy.

Symptomatic adverse effects: Probable or possible drug-related reactions were reported in 93% of 9473 patients treated with ciprofloxacin worldwide. The incidence of severe reactions was 0.6%. The most frequent reactions were from the gastrointestinal system (nausea, diarrhea, vomiting, dyspepsia), central nervous system (dizziness, headache, nervousness, tremors, seizures, confusion) and skin (rash, pruritus, urticaria, photosensitivity).

Pregnancy

The data that are available on administration of ciprofloxacin to pregnant women indicates no malformatives or feto/neonatal toxicity of ciprofloxacin. Animal studies do not indicate direct or indirect harmful effects with respect to animals exposed to quinolones, effects on immature cartilage have been observed thus, it damage to articular cartilage in the human immature organism/ foetus.

As precautionary measures, it is preferable to avoid the use of ciprofloxacin during pregnancy.

Breast feeding

Ciprofloxacin is excreted in breast milk. Due to the potential risk of articular damage, ciprofloxacin should not be used during breast feeding.

Effects on ability to drive and use machines

Due to its neurological effects, ciprofloxacin may affect reaction time. Thus the ability to drive or to operate machinery may be impaired

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