268, Ikorodu Road, Obanikoro P.O. Box 7210, Shomolu, Lagos. Km 38, Lagos-Abeokuta Exp, Sango Otta.
Emcure Pharma. Ltd, C-10 (12), MIDC, Bhosari, Pune-411 026, India.
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Tablet 250 mg (NRN: 04-2308): Each film coated tablet contains: Ciprofloxacin HCl USP eq. to Ciprofloxacin 250 mg.
Pack size: 10's.
Tablet 500 mg (NRN: 04-2307): Each film coated tablet contains: Ciprofloxacin HCl USP eq. to Ciprofloxacin 500 mg.
Pack size: 10's.
Bactericidal action of ciprofloxacin results from interference with the enzyme DNA gyrase which is needed for the synthesis of bacterial DNA.
Ciprofloxacin is effective against a wide range of both gram positive and gram negative bacteria. the MIC's for gram negative aerobic organisms range from 0.004 to 2 mcg/mL and for gram positive organisms 0.12 to 4 mcg/mL.
Spectrum of action: Gram positive bacteria: Enterococcus faecalis, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes.
Gram negative bacteria: Campylobacter jejuni, Proteus mirabilis, Citrobacter diversus, Proteus vulgaris, Citrobacter fruendii, Providencia rettgeri, Enterobacter cloacae, Providencia stuartii, Escherichia coli, Pseudomonas aeruginosa, Haemophilus influenzae, Salmonella typhi, Haemophilus parainfluenzae, Serratia marcensens, Klebsiella pneumoniae, Shigella flexineri, Shigella sonnei, Morganella morganii, Neisseria gonorrhoeae.
Ciprobiotic tablets are rapidly and well absorbed from gastro intestinal tract after oral administration. The absolute bioavailability is approximately 70% with no substantial loss by first pass metabolism. Maximum serum concentration of 1.2 mcg/ml and 2.4 mcg/ml are achieved for 250 and 500 mg tablets with 1 to 2 hours Tmax. Serum elimination half life in subjects with normal renal function is approximately 4 hours.
In patients with reduced renal function, half life ciprofloxacin is slightly prolonged. 40 to 50% of an orally administered dose is excreted in urine as unchanged drug. Four metabolites accounting for 15% of oral dose are found to be excreted through urine These metabolites have antimicrobial action less than the parent compound.
Urinary excretion of ciprofloxacin is virtually complete within 24 hours after oral dosing. Bile concentration of ciprofloxacin though reaches several folds higher than serum concentrations after oral dosing, only a small amount of the dose administered to recorded from bile as unchanged drug. Approximately 20 to 35% oral dose is recovered from faeces within 5 days after dosing.
Tissue concentration often exceeds serum concentrations. Ciprofloxacin is seen in an active form in saliva, nasal and bronchial secretion, sputum, skin blisters fluids, lymph and peritoneal fluid, bile, lung, skin, fat, muscle and cartilage.
For treatment of the following infections caused by susceptible strains: Lower respiratory tract infections; Skin and skin structure infections; Bone and joint infections; Urinary tract infections; Typhoid fever; Sexually Transmitted Diseases; Infectious Diarrhoea.
Hypersensitivity to Ciprofloxacin or any member of quinolone class of antimicrobial agents.
Patients should be well hydrated to prevent formation of highly concentrated urine. Stop drug if pain in tendons occurs.
Safety and effectiveness in children, less than 18 years of age, pregnant women and lactating women not established.
Ciprofloxacin is found to cause arthropathy in juvenile animals, though not established in human infants.
Concurrent administration of sucralfate or divalent and trivalent ions like iron, antacids should be avoided since they are found to interfere with oral absorption of ciprofloxacin.
Theophylline is found to elevate ciprofloxacin serum levels.
If concomitant use cannot be avoided, dosage adjustments be made.
Nausea, Diarrhoea, Vomiting, Abdominal pain, Discomfort, Headache, Restlessness.
Dosage & Administration
250 mg or 500 mg every 12 hours depending on the severity of infection.
Usual duration of treatment is 7 to 14 days.
In severe and complicated infections prolonged therapy may be required, 500 to 750 mg twice a day.
Oral maintenance dose should be halved in patients with creatinine clearance of less than 20 mL per minute. This will ensure to maintain plasma concentrations in the same range as in with normal renal functions.
No case of this kind appears to have been reported.
In the event of acute overdosage, stomach should be emptied by inducing vomiting or by gastric lavage followed symptomatic and supportive treatment.
Adequate hydration must be maintained.
Store in a dry place, below 25oC. Protect from light.