Metro Drug
Full Prescribing Info
Ciprofloxacin Hydrochloride.
Each tablet contains: Ciprofloxacin Hydrochloride 500 mg.
Pharmacology: Pharmacokinetics: Ciprofloxacin is rapidly well absorbed from the gastrointestinal tract. Oral bioavailability is approximately 70% and a peak plasma concentration of about 2.5 μg per mL is achieved 1 to 2 hours after a dose of 500 mg by mouth. Absorption may be delayed by the presence of food, but is not substantially affected over all. The plasma half-life is about 3.5 to 4.5 hours and there is evidence of modest accumulation. Half-life may be prolonged in severe renal failure a value of 8 hours has been reported in end stage renal disease and to some extent in the elderly. There is limited information on the effect of liver dysfunction; in one study the half-life of Ciprofloxacin was slightly prolonged in patients with severe cirrhosis of the liver. With one or two exceptions, most studies have shown the pharmacokinetics of Ciprofloxacin to be not markedly affected by cystic fibrosis.
Plasma protein binding ranges from 20 to 40%. Ciprofloxacin is widely distributed in the body and tissue penetration is generally good. It appears in the cerebrospinal fluid, but concentrations are only about 10% of those in plasma when the meninges are not inflamed. Ciprofloxacin crosses placenta and is excreted in the breast milk. High concentrations are achieved in bile. Ciprofloxacin is eliminated principally by urinary excretion, but non-renal clearance may account for about a third of elimination and includes hepatic metabolism, biliary excretion, and possibly transluminal secretion across the intestinal mucosa. At least 4 active metabolites have been identified. Oxociprofloxacin appears to be major urinary metabolite and sulphociprofloxacin the primary faecal metabolite. Urinary excretion is by active tubular secretion as well as glomerular filtration and is reduced by probenecid. Excretion is virtually complete within 24 hours; about 40 to 50% of an oral dose may be excreted unchanged within 24 hours and 10% as metabolites. Faecal excretion over 5 days has accounted for 20 to 35% of an oral dose and 15% of an intravenous dose.
Only small amounts of Ciprofloxacin are removed by heamodialysis or peritoneal dialysis.
Ciprofloxacin is used in the treatment of infections of the respiratory tract, middle ear, sinuses, eyes, kidneys and urinary tract, genital organ, abdomen, skin and soft tissues, bones and joints, further septicemia, infections in patients with reduced host defense and for selective gut decontamination.
It has been used in the treatment of wide range of infections including animal bites, biliary-tract infections, brucellosis, cat scratch disease, chancroid, gastro-enteritis (including traveler's diarrhea and cholera, salmonella enteritis and shigellosis), gonorrhea, immunocompromised patients (neutropenia), legionnaires disease, meningitis (meningococcal meningitis) prophylaxis, otitis externa, peritonitis, Q fever, lower respiratory tract infections (including pseudomonal infections in cystic fibrosis, including due to Streptococcus pneumoniae such as pneumococcal pneumonia), septicemia, skin disorders (skin and soft tissue infections), spotted fevers, typhoid and paratyphoid fever, typhus and urinary tract infections.
Dosage/Direction for Use
The adult oral dose of Ciprofloxacin ranges from 250 to 750 mg twice daily depending on the severity and nature of the infection. A single oral dose of 500 mg is suggested for the treatment of gonorrhea and also for meningococcal meningitis prophylaxis. Or as prescribed by the physician.
Generally, treatment should be continued for at least 3 days after the signs and symptoms of the infection have disappeared. For acute infections, the usual treatment period is 5-10 days. For severe and complicated infections, more prolonged therapy may be required.
Ciprofloxacin is not generally recommended in children and adolescents but if considered essential, dose of 5 to 15 mg per kg of body weight twice daily by mouth. Or as prescribed by the physician.
Ciprofloxacin should not be used in cases of hypersensitivity to Ciprofloxacin or other quinolone chemotherapeutics. Ciprofloxacin should not be used in children, adolescents, pregnant women or breast-feeding mothers.
Special Precautions
In epileptics and in patients who have suffered from previous CNS disorders (e.g lowered convulsion threshold, previous history of convulsion, reduced cerebral blood flow, altered brain structure or stroke). Ciprofloxacin should only be used where the benefits of the treatment exceed the risk, since these patients are endangered because of possible central nervous side effects.
Use In Pregnancy & Lactation
Ciprofloxacin should not be used in pregnant women or breast-feeding mothers.
Adverse Reactions
Ciprofloxacin is generally well tolerated. The range of adverse effects associated with Ciprofloxacin and the other fluoroquinolone antibacterial agents is broadly similar to quinolones such as nalidixic acid. They most often involve the gastrointestinal tract, central nervous system or skin.
Gastrointestinal disturbances include nausea, vomiting, diarrhea, abdominal pain and dyspepsia and are the most frequent adverse effects. Pseudomembranous colitis has been reported rarely. Headache, dizziness and restlessness are the most common effects on the CNS. Others include tremor, drowsiness, insomnia, bad dreams and visual disturbances and more rarely, hallucinations, psychotic reactions, depression and convulsion. Peripheral neuropathy has occurred occasionally.
In addition to rash and pruritus, hypersensitivity-type reactions affecting the skin have included photosensitivity and rarely vasculitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. Anaphylaxis has been reported. As with other quinolone antibacterial agents reversible arthralgia has sometimes occurred, but joint erosions have only been documented in immature animals. Other adverse effects reported with Ciprofloxacin include transient increase in serum creatinine or blood urea nitrogen and occasionally, acute renal failure secondary to intestinal nephritis, crystalluria, elevated liver enzyme values and hepatitis, eosinophilia, leucopenia and thrombocytopenia; myalgia and gynaecomastia.
Like other antibacterial agents superinfection with organism not very susceptible to Ciprofloxacin is possible. Such organism include Candida, Clostridium difficile and Streptococcus pneumoniae.
Drug Interactions
Ciprofloxacin may interact with various compounds including antacids, iron preparations, theophylline and warfarin. It is recommended that Ciprofloxacin should not be administered by mouth within 4 hours of taking preparations containing magnesium, aluminum or iron salts.
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.
Xipro tab 500 mg
100's (P3,604/pack)
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