PETSOW CIPROFLOXACIN -500 P.O.M
(Ciprofloxacin Tablets B.P 500mg).
Petsow Ciprofloxacin is presented as a white film coated Caplet inscribed with PETSOW on one face and CIPRO -500 on the other side of the tablet.
PHARMACOLOGICAL ACTIONS: Ciprofloxacin has an activity against a wide range of gram-negative and gram-positive organisms. The action of bactericidal ciprofloxacin results from interference with the enzyme DNA gyrase which is needed for the synthesis of bacterial DNA.
INDICATIONS, Haem: Ciprofloxacin is active against a wide variety of organisms including Gram-negative bacteria: Acinetobacter sp. Aeromonas sp, Brucella melitensis, campylobacter sp, Citrobacter sp, Edwardsiella tarda, Enterobacter sp. Escherichia coli, Haemophilus ducreyi ophilus influenza, Haemophilus parainfluenza , Klebsiella sp, Legionella sp, Listeria monocytogenes, Moraxella (Branhamella) catarrhalis, Morganella morganii, Neisseria gonorrhoea, Neisseria meningitis, Pasteurella multocida, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas aeruginosa, Salmonella sp. Serratia sp, Shigella sp, Vibro sp, Yersinia enterocolitica.
Gram-positive bacteria, Staphylococcus sp, Streptococcus faecalis, Streptococcus pneumoniae, Streptococcus pyogenes.
Other organism: Chlamydia trachomatis and Mycobacterium tuberculosis (moderately susceptible).
CONTRA-INDICATIONS: Hypersensitivity to fluoroquinolones or the quinolone group of antibacterial agents. Ciprofloxacin should be used with caution in patients with epilepsy or a history of CNS Disorders. Since Ciprofloxacin and related fluoroquinolones have been shown to cause degenerative changes in weight – bearing joints of young animals. It has been suggested that these compounds should not be used in children, adolescents, pregnant women, or breast feeding mothers. Care is necessary in patients with impaired hepatic or renal function, Gluco-6-phosphate dehydrogenase deficiency, or myasthenia gravis. An 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. The ability to operate machinery may be impaired by Ciprofloxacin, especially when alcohol is also taken.
ADVERSE REACTIONS :Ciprofloxacin may interact with various compounds including antacids, iron preparations, theophylline, and warfarin. It is therefore recommended that Ciprofloxacin should not be taken by mouth within 4 hours of taking preparations containing magnesium, aluminium, or iron salts. Ciprofloxacin is known to inhibit hepatic drug metabolism and may interfere with the clearance of the drugs metabolised by the liver such as theophylline. Concurrent administration of fenbufen with quinolone antibiotics may increase the incidence of quinolone CNS adverse effects. The absorption of Ciprofloxacin is reduced by antacids containing aluminium or magnesium and also by calcium, iron and zinc salts. Ciprofloxacin enhance the effect of oral coagulants such as warfarin. The urinary excretion of Ciprofloxacin and some other fluoroquinolones is reduced by the concomitant administration of probenecid; plasma concentrations are not necessarily increased.
ROUTE AND CONDITION OF ADMINISTRATION:
1. Route of administration: Oral (tablets should be swallowed unchewed with fluid, and can be taken independent of meal times.
2. Condition of Administration: The usual adult oral dose of ciprofloxacin ranges from 250 to 750 mg twice daily depending on the severity and nature of the infection. A dose of 100 mg twice daily by mouth for 3 days is suitable in women with acute uncomplicated cystitis. A 28-day course of treatment with a dose of 500 mg twice daily should be given for chronic bacterial prostatitis.
For acute exacerbations of cystic fibrosis associated with Pseudomonas aeruginosa infection, ciprofloxacin may be given to adolescents and children aged 5 years or more in a dose of 20 mg/kg by mouth twice daily, up to a maximum of 750 mg twice daily. Single oral doses of 250 or 500 mg are used for the treatment of gonorrhoea, depending upon patterns of resistance.
A single oral dose of 750 mg is suggested for surgical infection prophylaxis, given 60 to 90 minutes before the procedure.
PRECAUTION: Ciprofloxacin tablets should not be taken with dairy products( e.g milk,yoghurt,fortified fruit juice).
ANTIDOTE IN THE EVENT OF OVERDOSAGE:
There is no specific antidote for Ciprofloxacin. Treatment of over dosage should be symptomatic and supportive and may include:
– Induction of emesis or gastric lavage if taken orally.
– Maintainance of adequate hydration
– Careful observation of patient
– Haemodialysis or peritoneal dialysis may aid in the removal of Ciprofloxacin from the body.
STORAGE/WARNING: Ciprofloxacin should be stored in a cool dry place away at a temperature below 30˚C. Keep all medicines out of the reach of Children.