Cipocil Infusion
CIPOCIL INFUSION
Ciprofloxacin Injection B.P 200mg/100ml
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FORMULATION:
Each 100ml contains:
Ciprofloxacin (as lactate): 200 mg
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DESCRIPTION AND PHARMACOKINETICS
Ciprofloxacin is a synthetic broad-spectrum antibacterial agent classified as a fluoroquinolone. Ciprofloxacin is an effective antibacterial agent for most of the Gram-negative and some of the Gram-positive aerobes but is generally less effective against anaerobic bacteria. Ciprofloxacin has a rapid bactericidal action brought about by the inhibition of DNA gyrase and topoisomerase IV during the proliferation phase of bacterial chromosomal division.
For many Gram-negative bacteria, DNA gyrase is the primary target while in Gram-positive bacteria topolsomerase IV is the primary target of the quinolone class of antibacterial agent. Development of plasmid mediated resistance as observed with &Beta-Iactam antibiotics, aminoglycosides and tetracycline has not been observed with ciprofloxacin.
Ciprofloxacin given as an oral tablet is rapidly and well absorbed from the gastrointestinal tract. The bioavailability of ciprofloxacin is about 70% with no substantial loss by first pass metabolism. Maximum serum concentration is attained 1 to 2 hours after oral dosing. The serum half-life of ciprofloxacin among patients with normal renal function is approximately 4 hours. After oral administration of ciprofloxacin, 40 to 50% is excreted as unchanged drug while 15 is excreted as metabolites in the urine. Although ciprofloxacin attains bile concentrations several fold higher compared to that in the serum, only a small amount of the drug is recovered unchanged from the bile, About 20 to 35% of the drug is recovered from the faeces within 5 days after a single oral dose either from bile excretion or through the trans-intestinal route.
A 250 or 500 mg oral tablet given every 12 hours produce an area under the curve (AUC) equivalent to that produced by an intravenous infusion over 60 minutes of 200 or 400 mg every 12 hours respectively. Serum protein binding of ciprofloxacin is 20 to 40% and is unlikely to cause significant protein binding interaction with other drugs.
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INDICATIONS
For the treatment of wide range of infections including biliary-tract infections, infected bites and stings, bone and joint infections, brucellosis, cat scratch disease, chancroid, exacerbations of cystic fibrosis, gastro-enteritis, gonorrhoea infections in immunocomprised patients, legionnaires disease, meningitis, otitis externa, otitis media, peritonitis, Q fever. Lower respiratory tract infections, spotted fevers, surgical infection prophylaxis, typhoid and para-typhoid, typhus and urinary tract infections. -
DOSAGE AND ADMINISTRATION
Respiratory Tract Infections - 500 mg every 12 hours but maybe increased to 750 mg every 12 hours in more severe or complicated infections.
Acute sinusitis and otitis media - 500mg every 12 hours.
Urinary Tract Infections - 250 mg every 12 hours for mild to moderate Infections but maybe increased to 500 mg every 12 hour for severe or complicated infections.
Chronic prositis - 500 mg every 12 hours
Cervical and urethral infections - a single 250mg dose is recommended for uncomplicated gonococcal infections.
Skin and skin structure infection - 500mg every 12 hours but maybe increased to 750mg every 12 hours in more severe or complicated infections.
Bone and joint infections - 500mg every 12 hours but maybe increased to 750mg every 12 hours in more severe or complicated infections.
Infectious diarrhoea - 500 mg every 12 hours.
Intra-abdominal Infections - 500mg every 12 hours as sequential therapy of complicated Intra-abdominal infections. Should be given concomitantly with metronidazole to provide anaerobic coverage.
Typhoid fever - 500 mg every 12 hours.
The duration of treatment will depend on the severity of the infection but should generally be continued for at least 2 days after and disappearance of the signs and symptoms of infection. The usual duration of treatment for most mild to moderate infections unless otherwise specified is 7 to 14 days but may be given for a longer duration for severe complicated infections.
The recommended duration of treatment with ciprofloxacin is 28 days for chronic prostitis, 4 to 6 weeks for bone and joint infections, 5 to 7 days for infectious diarrhoea and 10 days for typhoid fever.
Ciprofloxacin tablets should be swallowed whole without chewing to be taken with sufficient amounts of liquid. Concomitant administration of sucralfate, iron supplements or antacids may substantially interfere with the absorption of ciprofloxacin and it should therefore be administered at least 2 hours before and 4 hours after giving aforementioned preparations.
Dosage adjustment is recommended among patients with impaired renal function as follows; no adjustments needed for creatinine clearance of > 50mL/min, maximum daily dose of 1000 mg for creatinine clearance of 30 - 50 mL/min, maximum daily dose of 500 mg/day of creatinine clearance of < 30 mL/min. For patients with renal failure on haemodialysis or peritoneal dialysis, the maximum daily dose is 500 mg/day. No dosage adjustment is required for patients with impaired hepatic function, or as prescribed by physician.
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ADVERSE EFFECTS
The most frequently reported adverse event are nausea and vomiting, diarrhoea, abdominal pain or discomfort, headache, restlessness and skin rash. Less frequent adverse events occurring in 1% of patients taking ciprofloxacin include:
Cardiovascular - palpitation, atrial flutter, ventricular ectopy, syncope, hypertension, angina pectoris, myocardial infarction, cerebral thrombosis, thrombophlebitis
Central Nervous System - dizziness, light-headedness, insomnia, nightmares, hallucinations, manic reaction, irritability, tremor, ataxia, convulsive seizures, lethargy, drowsiness, weakness, malaise, anorexia, phobia, depersonalization, depression, parathesia.
Gastrointestinal - painful oral mucosa, oral candidiasis, dysphagia, intestinal perforation, gastrointestinal bleeding, cholestatic jaundices ALT and AST elevation, bilirubinemia Musculoskeletal -Arthalgia or back pain, joint stiffness, flare up to gout
Renal - interstitial nephritis, renal failure, polyuria, urinary retention, urethral bleeding, vaginitis
Respiratory - Dyspnea, epistaxis, pulmonary and laryngeal edema, hiccups, hemoptysis, bronchospasm, pulmonary embolism.
Hematologic - Eosinophilia, leukopenia, anemia, thrombocytopenia, thrombocytosis, altered prothrombin time
Skin/ hypersensitivity ? Pruritus, urticaria, photosensitivity, flushing, fever, chills, angioedema, edema of the face, neck, lips. conjunctivae or hands, cutaneous candidiasis, hyperpigmentation, erythema nodosum, Steven-Johnson Syndrome
Sight/ hearing - blurring of vision, decreased visual acuity, diplopia, eye pain. tinnitus, deafness, taste perversion.
Most of the aforementioned adverse events reported were described as mild or moderate in severity and abated with discontinuation of the drug.
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SPECIAL WARNINGS AND PRECAUTIONS
The safety of ciprofloxacin in paediatric and adolescent patients less than 18 years of age, pregnant and lactating women has not been established and should therefore not be used in these patients.
Ciprofloxacin has been associated with erosions of the cartilage of weight bearing joints and other arthropathies in studies on animals of various species. As seen with other quinolone class of anitibacterial agents, concomitant administration of ciprofloxacin and theophyline which may result in an increased risk of theophyline-associated adverse events including cardiac arrest, seizures, status epilepticus and respiratory failure.
Although similar adverse events have been reported among patients solely on theophyline, the possibility that these adverse events might have been potentiated by ciprofloxacin cannot be excluded. Concurrent administration of high doses of quinolones and certain nonsteroidal anti-inflammatory drugs (NSAID) may provoke the development of seizures because of augmentation of the displacement of gamma-aminobutyric acid (GABA) from its receptors by the NSAID.
Concomitant administration of ciprofloxacin and cephalosporine has been associated with transient elevations of the serum creatinine and would therefore require monitoring of the serum creatinine in such a situation. Quinolones have been reported to enhance the effects of warfarin necessitating close monitoring of the prothrombin time when these 2 drugs are given concomitantly. Pseudomembranous enterocolitis ranging in severity from mild to life threatening has been reported with nearly all antibacterial drugs including ciprofloxacin.
In cases where severe and/ or persistent diarrhoea develops either during or after the administration of ciprofloxacin, it is important that pseudomembranous colitis be considered so that appropriate therapeutic measures can be instituted. Achilles and other tendon rupture has been reported with ciprofloxacin and other quinolones and should therefore be immediately discontinued if patient develops, any sign, of tendinitis.
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CONTRAINDICATIONS
Ciprofloxacin is contraindicated in patients who have exhibited a history of hypersensitivity reaction to ciprofloxacin or other antibacterial agents of the quinolone class. -
CAUTION
Food, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription. -
STORE AT TEMPERATURES NOT EXCEEDING 30°C
Protect from light. -
AVAILABILITY
PP Plastic bottle in 100ml. -
WARNING
Keep medicine out of reach of children.