Ciprobiotic
CIPROBIOTIC TM-FORTE
Each film coated tablets contains:
Ciprofloxacin hydrochloride USP
Equivalent to ciprofloxacin 500 mg

Chemistry:
Chemistry it is monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline carboxylic acid. Its molecular weight is 385.8 with empirical formula C17H18FN3O3HCIH2O.
Mechanism of action:
Bactericidal action of ciprofloxacin results from interference with the enzyme DNA gyrase which is needed for the synthesis of bacterial DNA.

Microbiology:
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:

Pharmacokinetics:
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 strains:
• Lower Respiratory Tract infections
• Skin and Skin structure infections
• Bone and joint infections
• Urinary tract infection
• Typhoid fever
• Sexually transmitted Disease
• Infectious diarrhea

Side effects:
Nausea , Diarrhea, vomiting, abdominal pain, discomfort, headache, Restlessness.

Precaution:
Patients should be well hydrated to prevent formation of highly concentrated urine. Stop drug if pain in tendons occurs.

Drug Interaction:
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 made.
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.

Warning:
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.

Contraindications:
Hypersensitivity to ciprofloxaxin or any member of quinolone class of anti microbial agants.

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 functions.
Storage: store in a dry place, below 250C. Protect from light.

Presentation:
A blister strip of 10 tablets

Strength available:
250 mg tablets, 500 mg tablets.