MIHICI

INDICATIONS

Treatment of UTIs, acute uncomplicated cystitis in females, chronic bacterial prostatitis, lower respiratory tract infections, acute exacerbations of chronic bronchitis, acute sinusitis, skin and skin structure infections, bone and joint infections, complicated intra-abdominal infections (in combination with metronidazole), infectious diarrhea, typhoid fever (enteric fever) and uncomplicated cervical and urethral gonorrhea caused by susceptible strains of microorganisms) in adults. Treatment of complicated UTIs and pyelonephritis caused by susceptible strains of microorganisms in pediatric patients 1-17 years of age. To reduce the incidence or progression of postexposure inhalational anthrax in both adult and pediatric patients from birth to 17 years of age. Treatment of plague, including pneumonic and septicemic plague and prophylaxis for plague in adults and pediatric patients from birth to 17 years of age.

DOSAGE AND ADMINSTRATION

The dosage is determined by the indication, the severity and the site of the infection, the susceptibility to Ciprofloxacin of the causative organism(s). the renal function of the patient and in children and adolescents the body weight.

The duration of treatment depends on the severity of the illness and on the clinical and bacteriological course.

Treatment of infections due to certain bacteria (e.g. Pseudomonas aeruginosa, Acinetobacter or Staphylococci) may require higher ciprofloxacin doses and co-administration with other appropriate antibacterial agents.

Treatment of some infections (e.g. pelvic inflammatory disease, Intra-abdominal infections, infections in neutropenic patients and infections of bones and joints) may require co-administration with other appropriate antibacterial agents depending on the pathogens involved.

Adults:

- Urinary tract infections: 250mg twice daily to 500mg twice daily. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin) 7-14days.

- Uncomplicated Cystitis-Acute: 250mg twice daily. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin) 3 days.

- Chronic bacterial prostatitis: 500mg twice daily. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin) 28 days.

- Lower respiratory tract infections: 500mg twice daily to 750mg twice daily. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin) 7-14 days.

- Acute bacterial sinusitis: 500mg twice daily. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin) 10 days

- Skin and skin structure infections: 500mg twice daily to 750mg twice daily. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin) 7-14 days.

- Bone/joint infections: 500mg twice daily to 750mg twice daily. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin) 4-8 weeks.

- Intra-abdominal infections-complicated: 500mg twice daily. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin) 7-14 days.

- Diarrhoea-Infectious: 500mg twice daily. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin) 5-7 days.

- Typhoid fever: 500mg twice daily. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin) 10 days.

- Gonococcal infections-uncomplicated Urethral and Cervical: 250mg single dose.

- Plague: 500mg twice daily to 750mg twice daily. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin) 14 days.

Pediatric dosage:

- Urinary Tract infections complicated UTIs or pyelonephritis 1-17 years: 10-20mg/kg twice daily Max: 750mg/dose, not to be exceed even if ≥ 51kg. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin) 10-21 days.

- Plague: 15mg/kg twice daily Max: 500mg/dose. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin) 10-21 days.

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

Side effect

Diarrhea, Abdominal pain, neurological events, abnormal LFTs, rash.

Over dose:

An overdose of 12g has been reported to lead to mild symptoms of toxicity. An acute overdose of 16g has been reported to cause acute renal failure.

Symptoms in overdose consist of dizziness, tremor, headache, tiredness, seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria and haematuria.

Avoid concomitant administration with dairy products (eg. Milk yogurt) or Ca2+ -fortified juices alone, absorption may be reduced. May increase levels of CYP1A2 substrates (eg, theophylline, methylxanthines, olanzapine), duloxetine, or sildenafil. Use with caution and monitor for sildenafil toxicity. Avoid use with duloxetine, if unavoidable, monitor for duloxetine toxicity. Increased theophylline levels may increase the risk of developing CNS or other adverse reactions, if coadministration cannot be avoided, monitor theophylline levels and adjust dose. May inhibit the formation of paraxanthine after caffeine administration (or pentoxifylline containing products) monitor for xanthine toxicity and adjust dose as necessary. Monitor for clozapine or ropinirole related adverse reactions and adjust dose of clozapine or ropinirole during and shortly after coadministration. Avoid with class IA (eg. Quinidine, procainamide) and class III (eg. Amiodarone, sotalol) antiarrhythmics, TCAs macrolides and antipsychotics, may further prolong QT interval. Hypoglycemia reported with oral antidiabetic agents, mainly sulfonylureas (eg. Glyburide, glimepiride), monitor blood glucose. May alter serum levels of phenytoin, monitor phenytoin therapy, including phenytoin levels during and shortly after coadministration. Transient SrCr elevations with cyclosporine, monitor renal function. May increase effects of oral anticoagulants, monitor PT and INR frequently during and shortly after coadministration. May increase levels and toxic reactions of methotrexate, carefully monitor with concomitant use.

High-dose quinolones in combination with NSAIDs (not acetyl salicylic acid) may provoke convulsions. Antacids, sucralfate, multivitamins, and other multivitamin cation-containing products (eg. MG2+/aluminum antacids, polymeric phosphate binders, videx (didanosine) chewable/buffered tab or pediatric powder) may decrease, absorption, resulting in lower serum and urine levels than desired, administer ≥ 2 hours before or 6 hours after these drugs. Probenecid may increase levels, use with caution. Caution with drugs that may lower seizure threshold.

Pregnancy: Category C

Lactation: Not for use in nursing.

Not a drug of 1st choice in the treatment of presumed or confirmed pneumonia secondary to streptococcus pneumonia. Caution with history of tendon disorders, discontinue if patient experiences pain, swelling, inflammation or rupture of tendon. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions reported, d/c immediately at the 1st appearance of skin rash, jaundice or any sign of hypersensitivity. Severe hepatoxicity, including hepatic necrosis, life-threatening hepato-failure and fatal events, reported, d/c immediately if symptoms of hepatitis occur. Caution with epilepsy and CNS disorders (severe cerebral arteriosclerosis, history of convulsion, reduced cerebral blood flow), d/c if seizures occur, may need to d/c if Clostridium-difficile-associated diarrhea (CDAD) reported confirmed, d/c if cases of peripheral neuropathy occur. May prolong QT interval, avoid with known QT interval prolongation and risk factors for QT prolongation (eg. Congenital long QT syndrome, uncorrected electrolyte imbalance, cardiac disease) adverse reactions related to joints or surrounding tissues observed in pediatric patients. If crystalluria reported maintain hydration and avoid alkalinity of urine. Caution in elderly.