CIPROSAN
CIPROSAN
TRADE NAME
Ciprosan
INTERNATIONAL NONPROPRIETARY NAME
Ciprofloxacin
DOSAGE FORM
Film-coated tablets.
Description:
Ciprosan 250 mg: white, round, biconvex, film-coated tablets. Ciprosan 500 mg: white, biconvex, film-coated tablets with a break- line on one side.
Ciprosan 750 mg: white, oblong, film-coated tablets.
COMPOSITION
Film-coated tablet contains
Active ingredient: ciprofloxacin(as ciprofloxacinhydrochloridemono- hydrate) 250 mg, 500 mg or 750 mg.
Excipients: microcrystalline cellulose, maize starch, crospovidone, croscarmellose sodium, silica colloidal anhydrous, magnesium stea- rate.
Opadry white (Y-1-7000) film composition: hydroxypropylmethylcel- lulose 29105 ср, titanium dioxide, polyethylene glycol 400.
ATC CODE J01MA02
PHARMACOTHERAPEUTIC GROUP
Antibacterials for systemic use. Fluroquinolones.
PHARMACOLOGICAL PROPERTIES PHARMACODYNAMICS
Ciprosan is a broad spectrum antimicrobial agent, the group of fluro- quinolones. It inhibits enzymes - DNA-gyrase and topoisomerase-4 bacteria - which leads to the damage of DNA replication and bacterial cell protein synthesis. It acts as a bactericide agent both in relation to the growing microorganisms and microorganisms in resting phase.
It is active against:
Most staphylococci resistant to methicillin are also resistant to сip- rofloxacin.
Streptococcus pneumoniae, Enterococcus faecalis are moderately sensitive to the drug.
Corynebacterium spp., Bacteroides fragilis, Pseudomonas cepacia, Pseudomonas maltophila, Ureaplasma urealyticum, Clostridium dif- ficile, Nocardia asteroids are also resistant.
The action of the drug in relation to Treponema pallidum is under- studied.
No development of parallel resistance to other antibiotics (not belon- ging to the group of gyrase inhibitors) occurs during Ciprosan admi- nistration, which makes the drug highly efficient in relation to bacteria resistant to aminoglycosides, penicillins, cephalosporins and tetra- cyclines.
PHARMACOKINETICS
After oral administration, сiprofloxacin is rapidly absorbed from the gastrointestinal tract. Drug bioavailability is 50-85%. Plasma protein binding is 30%.
It crosses the placental barrier.
It is excreted via urine. Elimination half-life makes 3-5 hours.
THERAPEUTIC INDICATIONS
Ciprofloxacin is indicated for the treatment of infectious inflammatory diseases caused by microorganisms susceptible to the drug, inclu- ding:
DOSAGE AND ADMINISTRATION
Ciprosan is administered orally on an empty stomach washing down with sufficient amount of liquid.
Dosage regimen should be determined individually for each patient taking into consideration the location and severity of the infection, body state, age, body weight and renal function of patients.
In case of uncomplicated kidney disease and urinary tract disease: 250 mg twice daily, in case of complicated diseases - 500 mg twice daily.
In case of urinary tract infections caused by Chlamydia: the daily do- se of Ciprosan should be increased up to 750 mg twice daily, if neces- sary.
In case of lower respiratory tract diseases: 250 mg twice daily, in se- vere cases: 500 mg twice daily.
In case of gonorrhea: 250-500 mg once a day.
In case of enteritis, severe colitis, gynecological infections, prosta- titis, osteomyelitis: 500 mg twice daily.
For diarrhea treatment: 250 mg twice daily.
In case of extremely severe, life-threatening infections (streptococ- cal pneumonia, recurrent infections at cystic fibrosis, bone and joint
Infections, septicaemia, peritonitis): 750 mg twice daily. Duration of treatment depends on the disease severity.
For patients with renal impairment, a single oral dose of the drug sho- uld be half the average daily dose.
In case of chronic renal insufficiency, the drug is administered de- pending on creatinine clearance.
Creatinine Clearance (ml/min) |
Dose |
>50 |
Usual Dosage |
30-50 |
250-500 mg once every 12 h |
5-29 |
250-500 mg once every 18 h |
Topatients receiving hemodialysis or peritoneal dialysis, 250-500 mg once every 24 h should be administered after dialysis.
CONTRAINDICATIONS
SIDE EFFECTS
From gastrointestinal tract: nausea, vomiting, diarrhea, abdominal pain, anorexia, pseudomembranous colitis.
From central nervous system: vertigo, headache, fatigue feeling, som- nipathy, faintness, visual disturbances.
From urogenital system: crystalluria, interstitial glomerulonephritis, dysuria, polyuria, albuminuria, hematuria, transient increase in serum creatinine.
From hematologic system: eosinophilia, leukopenia, neutropenia, pla- telet count decrease.
From cardiovascular system: tachycardia, heart rhythm disorder, ar- terial hypotension.
Allergic reactions: skin itch, urticaria, Quincke's edema, Stevens- Johnson syndrome, arthralgias.
Adverse reactions caused by chemotherapeutic action: candidiasis. From laboratory indicators: increment in activity of hepatic transa- minase, alkaline phosphatase, bilirubin, lactic dehydrogenase, in- crease in concentration of urea, creatinine.
Other reactions: arthralgias; rarely - photosensitization.
PARTICULARINDICATIONS
The drug should be prescribed with caution to the patients with cere- bral atherosclerosis, cerebrovascular disease, mental illnesses, epi- lepsy, convulsive disorder, apparent renal or hepatic insufficiency, el- derly patients.
In case the tendon pain appears or the first signs of tendovaginitis occur, the treatment should be ceased.
In case heavy and long-lasting diarrhea occurs during or after the treatment with ciprofloxacin the diagnosis of pseudomembranous colitis should be excluded as it demands an immediate cessation of the drug and prescribes the relevant treatment.
Due to the possible photosensibilization during the treatment with
Ciprosan one should avoid the contact with direct sunlight.
INFLUENCE ON ABILITY TO DRIVE AND OPERATE MECHANISMS
When applying the drug one should exercise caution while driving and performing other potentially hazardous activities demanding in- creased attention and quick psychomotor reactions.
PREGNANCY AND LACTATION
Ciprosan is contraindicated during pregnancy and lactation.
PEDIATRIC USE
Ciprosan is contraindicated for the treatment of infants and adoles- cents under 18 years old.
DRUG INTERACTIONS
Drug activity increases in combination with betalactam antibiotics,
aminoglycosides, vancomycin, clindamycin, metronidazole. Ciprofloxacin administration raises plasma concentrations of theo- phylline, aminophylline and caffeine. It increases the cyclosporine nephrotoxicity, the risk of jerk responses against nonsteroidal anti- inflammatory drugs. It strengthens the effect of warfarin and other oral anticoagulants (it lengthens the bleeding time).
Urine alkalizing agents decrease the drug dissolution (the possibility of crystalluria increases).
Ciprofloxacin inhibits the liver oxidative enzymes and may streng- then the activity of drugs that metabolize involving cytochrome Р450 system.
Ciprofloxacin may also reduce the clearance and prolong the elimi- nation half-life of caffeine. Ciprofloxacin may cause transient increa- ses in serum creatinine levels in patients undergoing cyclosporine treatment.
Probenecid may increase the plasma level of ciprofloxacin by block- ing its tubular secretion.
In some patients who have been using phenytoin and ciprofloxacin concomitantly the changes (increase or decrease) in serum pheny- toin levels have been reported.
Co-administration of ciprofloxacin and glyburide, an antidiabetic agent of the sulphonylurea class, may result in severe hypoglycemia in rare cases.
Co-administration of ciprofloxacin and magnesium-, aluminium- and calcium-containing antacids, sucralfate, didanosine, or bivalent or tri-valent cations such as calcium, iron, or zinc cations may lower the absorption of ciprofloxacin, therefore, ciprofloxacin should be admi- nistered at least 2 hours before or 6 hours after the administration of these drugs.
Absorption of ciprofloxacin may be significantly reduced if it is admi- nistered with products such as milk and yogurt.
OVERDOSE
There are no specific symptoms of overdose.
Treatment: gastric lavage, introduction of large amounts of liquid, making of acidic urine reaction, additionally - hemodialysis or peri- toneal dialysis (may eliminate less than 10% of the received dose); all the procedures are carried out in association with basic life sup- port. There is no any specific antidote.
PACKAGING
Film-coated tablets. 14 tablets in a blister.
1 blister in a carton box with the enclosed leaflet.
STORAGE CONDITIONS
Store at temperature not exceeding 25°С. Keep out of reach of children.
SHELF LIFE
Ciprosan 250 mg: 5 years from the manufacturing date. Ciprosan 500 mg: 5 years from the manufacturing date. Ciprosan 750 mg: 5 years from the manufacturing date. Do not use after expiry date.
SALES TERMS
Sold under prescription.
MANUFACTURER
CIPROSAN is a product and a trade mark of "Sanolife", Great Britain.
Manufactured by
“WORLD MEDICINE İLAÇ SAN. VE TİC. А.Ş.”, TURKEY