Union Korea Pharm


Full Prescribing Info
Ciprofloxacin HCl.
Pharmacokinetics: Ciprofloxacin is rapidly absorbed from the gastrointestinal tract. Oral bioavailability is approximately 70% and a peak plasma concentration of about 2.5 mcg/mL is achieved 1-2 hrs after a dose of 500 mg by mouth. Absorption may be delayed by the presence of food but is not substantially affected overall. The plasma t½ is about 3.5-4.5 hrs. Half-life may be prolonged in renal impairment and to some extent in the elderly.
Plasma protein-binding ranges from 20-40%. Ciprofloxacin is widely distributed in the body and tissue penetration is generally good. It appears in the cerebrospinal fluid (CSF), but concentrations are only about 10% of those in the plasma when the meninges are not inflamed. Ciprofloxacin crosses the placenta and is also distributed into the breast milk. High concentrations are achieved in the bile.
Ciprofloxacin is eliminated principally by urinary excretion. Only small amounts of ciprofloxacin are removed by hemodialysis or peritoneal dialysis.
Treatment of a wide range of infections including biliary tract, bone and joint, lower respiratory tract, skin (including soft tissue infections) and urinary tract infections, infected bites and stings, cat scratch disease, chancroid, exacerbations of cystic fibrosis, gastroenteritis (including traveller's diarrhea, campylobacter and salmonella enteritis, cholera, shigellosis), gonorrhea, infections in immunocompromised patients (neutropenia), legionnaire's disease, otitis externa and media, peritonitis, septicemia, typhoid and paratyphoid fever, and typhus.
Used for meningococcal meningitis and surgical infection prophylaxis.
Dosage/Direction for Use
Adults: Usual Dose: 250-750 mg twice daily depending on the severity and nature of the infection.
Acute Exacerbations of Cystic Fibrosis Associated with Pseudomonas aeruginosa Infection: Adolescents and Children ≥5 years: 20 mg/kg twice daily up to a maximum of 750 mg twice daily.
Gonorrhea: 250 or 500 mg as a single dose depending upon the patterns of resistance.
Meningococcal Meningitis Prophylaxis: 500 mg as a single dose.
Surgical Infection Prophylaxis: 750 mg as a single dose given 60-90 min before the procedure.
Special Precautions
Ciprofloxacin should be used with caution in patients with epilepsy or a history of central nervous system (CNS) disorders. Tendon damage may occur rarely and treatment should be discontinued if patients experience tendon pain, inflammation or rupture.
Care is necessary in patients with impaired hepatic or renal function, glucose-6-phosphate dehydrogenase (G6PD) deficiency or myasthenia gravis. Adequate fluid intake should be maintained during treatment with ciprofloxacin and excessive alkalinity of the urine avoided because of the risk of crystalluria. Exposure to strong sunlight or sunlamps should also be avoided.
Ciprofloxacin and other quinolones should be avoided in methicillin-resistant Staphylococcus aureus infections because of high level of resistance.
Effects on the Ability to Drive or Operate Machinery: The ability to drive or operate machinery may be impaired.
Adverse Reactions
Gastrointestinal disturbances including nausea, vomiting, diarrhea, abdominal pain and dyspepsia. Pseudomembranous colitis has been reported rarely. Headache, dizziness and restlessness are among the most common effect on the CNS. Others include tremor, drowsiness, insomnia, nightmares, and visual and other sensory disturbances and more rarely, hallucinations, psychotic reactions, depression and convulsions. Paresthesia and peripheral neuropathy have occurred occasionally.
In addition to rash and pruritus, hypersensitivity-type reactions affecting the skin have included, rarely, vasculitis, erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis. Photosensitivity has occurred.
Other adverse effects reported include transient increase in serum creatinine or blood urea nitrogen and, occasionally acute renal failure secondary to interstitial nephritis, crystalluria, elevated liver enzyme values, jaundice and hepatitis; hematological disturbances.
As with other antibacterials, superinfection with organisms not very susceptible to ciprofloxacin is possible.
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
J01MA02 - ciprofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Tab 500 mg x 100's.
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