CIPLADOC - Infection Update - Antibacterial Therapeutic Index

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Antibacterial Therapeutic Index
Ciplox

Ciplox-100 Tablets Ciplox-250 Tablets Ciplox-500 Tablets Ciplox-750 Tablets Ciplox-OD 1000 Tablets Ciplox-OD 500 Tablets
Composition Ciplox-100 Tablets Each film coated tablet contains .... Ciprofloxacin Hydrochloride IP equivalent to Ciprofloxacin IP 100 mg. Ciplox-250 Tablets Each film coated tablet contains .... Ciprofloxacin Hydrochloride IP equivalent to Ciprofloxacin IP 250 mg. Ciplox-500 Tablets Each film coated tablet contains .... Ciprofloxacin Hydrochloride IP equivalent to Ciprofloxacin IP 500 mg. Ciplox-750 Tablets Each film coated tablet contains .... Ciprofloxacin Hydrochloride IP equivalent to Ciprofloxacin IP 750 mg. Ciplox-OD 1000 Tablets Each extended release film coated tablet contains Ciprofloxacin USP 1000 mg Ciplox-OD 500 Tablets Each extended release film coated tablet contains Ciprofloxacin USP 500 mg Description Ciprofloxacin, a fluoroquinolone is a synthetic broadspectrum antibacterial agent for oral and intravenous administration. The bactericidal action of ciprofloxacin results from interference with the enzyme DNA gyrase which is needed for the replication of bacterial DNA. Indications Ciplox is indicated for the treatment of the following infections caused by susceptible bacteria: Respiratory Tract Infections Acute and chronic bronchitis, obstructive airways disease (COPD), empyema, lung abscess, bronchiectasis, lobar and bronchopneumonia, acute exacerbation of cystic fibrosis, otitis media, sinusitis and mastoiditis especially due to gram-negative 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 ulcers, wound infections, abscesses, cellulitis, erysipelas, infected burns. Surgical Infections Peritonitis, intra-abdominal abscess, cholangitis, cholecystitis, empyema of gall bladder. Bone And Joint Infections Acute and chronic osteomyelitis, septic arthritis. Pelvic Infections Salpingitis, endometritis, pelvic inflammatory disease. Sexually Transmitted Diseases Gonorrhoea 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 Ciplox Tablets Ciplox tablets should be swallowed whole with adequate amount of liquid. Ciplox tablets can be taken without regard to meals. Fluids should be taken liberally. Antacids should not be taken concomitantly or within two hours of dosing. Adults Respiratory tract, bone and joint infections Mild/moderate 500 mg twice daily/or 1000 mg once daily Severe/complicated 750 mg twice daily Urinary tract infections Acute uncomplicated 500 mg od for 3 days Mild/moderate 250 mg twice daily / 500 mg once daily Severe/complicated 500 mg twice daily/or 1000 mg once daily Infectious diarrhoea Mild/moderate/severe 500 mg twice daily/or 1000 mg once daily Gonorrhoea 250 mg single dose Non-gonococcal urethritis 750 mg twice daily Chancroid 500 mg twice daily/1000 mg once daily Other infections 500-750 mg twice daily Chronic Bacterial prostatitis: 1000 mg o.d. for 28 days Ciplox Infusion Ciplox Infusion may be used directly and should be administered over periods of 30-60 minutes. Lower and upper urinary tract infections 100 mg twice daily Lower and upper respiratory tract infections 200 mg twice daily Cystic fibrosis 200 mg twice daily Gonorrhoea 100 mg single dose Other infections 200 mg twice daily Ciplox Infusion is compatible with physiological saline solution, Ringer's lactate solution, 5 per cent and 10 per cent dextrose solution, dextrose/saline and 10 per cent fructose solution. Any aqueous dilutions should be used within 24 hours of preparation. Caution Do not use Ciplox Infusion, if the solution is not clear, contains any particle or if the bottle is damaged or leaking. Children Ciprofloxacin is not recommended for use in children. However, in serious infections, if benefits of ciprofloxacin outweigh the potential risk, then 5-10 mg/kg/day intravenous or 7.5-15 mg/kg/day (oral) in two divided doses may be administered depending on the severity of infection. Duration Of Therapy For most infections, therapy should be continued for at least 48 hours after the patient becomes asymptomatic. The usual duration is 5-7 days with infusion and 5-10 days with tablets, but severe or complicated infections may require more prolonged therapy. Contraindications Hypersensitivity to fluoroquinolones or the quinolone group of antibacterial agents.
Warnings and Precautions DRUG INTERACTIONS Theophylline: Serum concentrations and elimination halflife 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. PREGNANCY Should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. NURSING MOTHERS The drug should be used only after taking into account the benefits offered and the potential risks involved. PAEDIATRIC USE As with other drugs of this class, ciprofloxacin has been shown to cause arthropathy in weight-bearing joints of immature animals. Hence ciprofloxacin is usually not recommended for use in children. IN IMPAIRED RENAL FUNCTION If creatinine clearance is less than 20 ml/min, half the recommended dosage may be administered. OTHERS CNS stimulation: Ciprofloxacin 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. 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. 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, tendonitis/rupture, exacerbation of myasthenia gravis and increases in serum transaminase levels. Storage Since Ciplox Infusion is light sensitive, the bottles should always be stored in the cardboard outer Container. Presentation
Ciplox-100 Ciplox-250 Ciplox-500 Ciplox-750 Ciplox- OD 1000 Ciplox- OD 500	Blister pack of 10 Blister pack of 10 Blister pack of 10 Blister pack of 10 Blister pack of 5 Blister pack of 5	tablets tablets tablets tablets tablets tablets

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