Therapeutic Indication

Treatment of severe infections of GI & urinary tracts including Campylobacter jejuni, Shigella or Salmonella; susceptible STD eg gonococcal (including penicillin-resistant) & nongonococcal (chlamydial) urethritis; osteomyelitis/septicemia caused by susceptible organisms including bacteria resistant to β-lactams; severe infections of the resp tract due to susceptible gm -ve infections including Pseudomonas aeruginosa; multidrug resistant TB in combination w/ other drugs; multidrug resistant typhoid fever; post-exposure prophylaxis for meningococcal disease & anthrax in adults.

Dosage Forms

Soln for inj (vial) 2 mg/mL x 100 mL.

Bioavailability and Pharmacokinetics

They are rapidly and almost completely absorbed from the gastrointestinal tract. Peak serum concentrations obtained after oral administration are very near those achieved with intravenous administration. Consequently, oral route is generally preferred. Distribution of the quinolones into respiratory tract tissues and fluids is of particular interest because of the activity of these agents against common respiratory pathogens. The long half-lives of the newer fluoroquinolones allow once- or twice-daily dosing. The quinolones vary with respect to the relative contribution of renal and nonrenal pathways for their elimination. Ciprofloxacin is taken 250 to 750 mg twice daily orally and 400 mg every 12 hours intravenously.

Dose Range

IV Adult 100-400 mg 12 hrly. Mild to moderate UTI 200 mg 12 hrly. Severe or complicated UTI, lower resp tract infections, skin & skin structure infections & mild to moderate bone & joint infections 400 mg 12 hrly. Duration of treatment: 7-14 days. For bone & joint infections treatment of ≥4-6 wk.

Known Adverse Effects and Toxicities

Local IV site reactions. Occasionally elevated BUN & serum creatinine; abnormal hepatic function values; leukopenia, thrombocytopenia, eosinophilia; anorexia, diarrhea, abdominal discomfort, nausea, vomiting, abdominal pain & distension; headache, dizziness; insomnia; agitation, alienation; joint pain; candidiasis, anergia; dysgeusia; phlebitis.

Special Precautions

Discontinue use if tendon pain, inflammation or rupture occurs. Epilepsy or CNS disorders. Consider diagnosis of pseudomembranous colitis if severe or persistent diarrhea occurs. Avoid direct exposure to sunlight. Patients requiring Na supplement eg those w/ renal & cardiac failure, nephrotic syndrome. Severe renal disorder; history of convulsions; suspected or severe cerebral arteriosclerosis; venous system damage; severe myasthenia; G6PD deficiency. Concomitant use w/ theophylline, phenyl acetates or propionate NSAID eg fenbufen & flurbiprofen. May affect ability to drive or operate machinery. Elderly.

Indications

Ciprofloxacin is indicated for the treatment of infections.

1. Treatment of infections cause by microorganisms; Esch. Coli, Shigella, Salmonella, Citrobacter, Klebsiella, Enterobacter, Serratia, Hafnia proteus, Pseudomonas, Acinetobacter, Streptococcus, Clamydia, Streptococcus,Corynebacterium, Clostridium, Bacteriodes.
2. Infections; Respiratory infections, auris, nasus and sphagitis, mouth, teeth, genital inflammation, renal or urinary tract infections, genital infections including gonorrhoea, GI infections, biliation canal infections, bone and joint
   infections, soft tissue infections, gynaecological and OB infections, septicaemia, meningitis, peritonitis, ophthalmic infections.

Dosage And Administration

The usual adult IV dose is 100-400mg twice daily, given over 30-60 minutes as a solution containing the equivalent of 1-2mg/ml.

For acute exacerbation of cystic fibrosis associated with Pseudomonas aeruginosa infection, a dose of 10mg/kg may be given by IV infusion over 60 minutes three times daily, to a maximum of 400mg three times daily. For inhalation anthrax, a dose 10mg/kg twice daily may be given by IV infusion, up to a maximum of 400mg twice daily.

Ciprofloxacin is not generally recommended for other uses in children and adolescents but, if considered essential, doses of 4-8mg/kg twice daily IV have been suggested. Or as prescribed by the physician.

Precautions

1. Warning
   It has been reported that tendon ruptures of Achilles tendon, shoulders, hands which cause disability or require surgery. If a patient feels a pain, inflammation, tendon rupture, the administration should be discontinued. And the patient should take a rest, avoid exercising until it is certain that the symptom is proven not to be a tendonitis or tendon rupture.
2. The drug is contraindicated in the following patients.
   
   • Patients with a history of hypersensitivity to ciprofloxacin.
   • Pregnant women and nursing mothers.
   • Infants and children.
   • Patients with epilepsy.
   • Patients who have a history of rupture and inflammation of tendon, hypersensitivity related to quinolone antibacterial
3. The administration of the drug should be cautioned.
   
   • Patients with severe impairment of renal function.
   • In patients with history cerebral seizure, the use of ciprofloxacin should be instituted after appropriate anticonvulsant therapy.
   • The aged.
   • Patients with cerebral hemokinetic disorder.
   • Patients with impaired vein system.
4. Adverse Reactions
   
   • Shock: Rarely, shock may occur, it should therefore be observed sufficiently. If any symptoms occur, the administration should be discontinued and appropriate therapy instituted.
   • Skin: Rarely, muco-cutaneous- ocular syndrome (Stevens-Johnson syndrome), photosensitivity may occur, it should therefore observed sufficiently. If it occurs, the administration should be discontinued.
   • Hypersensitivity: Rare cases of pharyngeal edema, facial edema, pruritus, flush, may occur. If it occurs, the administration should be discontinued.
   • Renal: Rarely, acute kidney failure, and occasionally, increased serum creatinine and BUN concentration may occur.
   • Hepatic: Rarely, jaundice and occasionally, elevations in GOT, GPT, Al-P may occur, it should be therefore observed sufficiently. If any symptom occurs, the administration should discontinued and appropriate therapy instituted.
   • Hematologic: Occasionally, leukopenia, thrombocytopenia, eosinophilia, and rarely, decreased platelet count, oligochromemia, decreased hematocrit level may occur.
   • Digestive system: Rarely, severe colitis accompanied with hemafecia, including psedomembranous colitis, may occur. If abdominal pain, frequent diarrhoea occurs, an appropriate therapy, such as discontinuation of the therapy, should be instituted. Occasionally, anorexia, diarrhoea, gastric discomfort, vomiting, abdominal pain, abdominal distention, and rarely, stomatitis may also occur.
   • CNS: Occasionally, HA, dizziness, and rarely, lingual numbness, drowsiness, tremor, visual disorder may occur.
   • Muscle: Myalgia, a sense of exhaustion, increased CPK, myocytosis of striated muscle accompanied with sudden ingavescence of renal function, which increases myoglobin in blood and urine may occur, it should therefore be cautioned.
   • Respiratory: Interstitial pneumonia, accompanied with flush, eosinophilia, may occur. If this symptoms occur, the administration should be discontinued and appropriate therapy, including adenocortical hormone therapy instituted.
   • Others.
     K1. Rarely arthralgia may occur.
     K2. Rare case of hypoglycaemia by other new quinolone antibacterials has been reported, it should therefore be cautioned.
     K3. Seizure, somnipathy may occur.
5. General Precautions
   
   • Patients with disposition should receive counselling with respect of adverse effects, including seizure or other CNS effects.
   • If. Pain, inflammatory, tendon rupture occurs, the administration should be discontinued, and the patients consult with a physician, and take a rest until it is certain that the symptom is proven not to be a tendonitis or tendon rupture.
6. Drug Interactions
   
   • Concomitant administration of ciprofloxacin in patients receiving a theophylline may result in higher and prolonged serum theophylline concentrations. If plasma theophylline concentrations are increased, concomitant use of ciprofloxacin and a theophylline should be avoided if possible.
   • Concomitant use of ciprofloxacin with ketoprofen may cause convulsion rarely, it should therefore be avoided. Concomitant use of ciprofloxacin with other phenylacetic acid group or propionic group anti- inflammatory agents (NSAIA) may also cause convulsion, it should therefore cautioned.
   • Concurrent administration of Ciprofloxacin with antacids containing magnesium, aluminum, or calcium with sucralfate or divalent and trivalent cations such as iron may substantially interfere with the absorption of Ciprofloxacin, resulting in serum and urine levels considerably lower than desired.
   • Ciprofloxacin is associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.
7. Use to a pregnant woman and a nursing mother
   Safety use during pregnancy and lactations has not been established and it should not be therefor administered.
8. Use to children
   Safety use in children has not been established and therefore its use in children is not recommended.