Each film coated tablets contains:
Ciprofloxacin hydrochloride USP
Equivalent to ciprofloxacin 500 mg
Chemistry it is monohydrochloride monohydrate salt of
carboxylic acid. Its molecular weight is 385.8 with empirical formula
Mechanism of action:
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 MICs 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:
Cipobiotic 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
of 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
antimicrobial action less than the parent compound . Urinary excretion of
ciprofloxacin is virtually complete within 24 hours after oral dosing.
Bile concentrations of ciprofloxacin through reaches several folds higher
than serum concentration after oral dosing, only a small amount of the dose
administered is recorded from bile as unchanged drug. Approximately 20 to
35% of oral dose is recovered from faces 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.
Indications: For treatment of the following infections caused by susceptible
Lower Respiratory Tract infections
Skin and Skin structure infections
Bone and joint infections
Urinary tract infection
Sexually transmitted Disease
Nausea , Diarrhea, vomiting, abdominal pain, discomfort, headache,
Patients should be well hydrated to prevent formation of highly concentrated
urine. Stop drug if pain in tendons occurs.
Concurrent administration of sucraifate or divalent and trivalent ions like
iron, antacids should be avoided since they are found to interfere with oral
absorption of ciprofloxacin. Theophyline is found to elevate Ciprofloxacin
serum levels. It concomitant use cannot be avoided, dosage adjustment are
Over dosage and treatment:
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.
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.
KEEP AWAY FROM THE REACH OF CHILDREN.
Hypersensitivity to ciprofloxaxin or any member of quinolone class of anti
Dosage & Administration:
Adult: 250 mg or 500 mg every 12 hours depending on he severity of
infection. Usual duration of treatment is 7 to 14 days.
In severe and complicated infections prolonged therapy may be required. 500
twice daily. Oral maintenance dose should be halved in patients with
creatinine clearance of less than 20ml per minute. This will ensure to
maintain plasma concentrations in the same range as in with normal renal
Storage: store in a dry place, below 250C. Protect from light.
A blister strip of 10 tablets
250 mg tablets, 500 mg tablets.