COMPOSITION :
Each film coated tablet contains : Ciprofloxacin Hydrochloride USP equivalent to Ciprofloxacin 250 , 500 or 750 mg.
DESCRIPTION :
Ciprosan (Ciprofloxacin) is a synthetic fluoroquinolone with broad spectrum antibacterial activity for oral administration . It is bactericidal and acts by inhibiting the A subunit of DNA gyrase (topoisomerase) which is essential to reproduction of bacterial DNA . Ciprofloxacin is active in vitro against Gram negative anaerobic bacteria including Enterobactericeae (Escherichia coli and Citrobacter), Enterobacter, Klebsiella , Proteus , Providencia , Salmonella, Serratia, Yersinia spp. , Pseudomonas aeruginosa but less so against other Pseudomonas spp. Haemophilus ducreyi , H.influenzae , Moraxella (Branhamella) catarrhalis , Neisseria gonorrhoeae, and N.meningitidis are all very sensitive , including beta-lactamase producing strains of H.influenzae , M. catarrhalis and N.gonorrhoeae . Other gram negative anaerobic bacteria reported to be sensitive to Ciprofloxacin included Acinetobacter spp. , Compylobacter spp. , Gardenella vaginalis , Helicobacter pylori , Legionella spp. and Vibrio spp. Ciprofloxacin is also active against Staphylococci including penicillinase-producing and nonproducing strains and against some methicillin resistant strains . Ciprofloxacin is rapidly and widely absorbed from the gastrointestinal tract . Oral bioavailability is approximately 70 % and a peak plasma concentration of about 2.5 µg / ml is achieved 1 - 2 hours after a dose of 500 mg by mouth. The plasma half life is about 3.5 - 4.5 hours . Plasma protein binding ranges from 20 to 40% . Ciprofloxacin is widely distributed in all body tissues . It appears in the CSF, crosses the placenta and appears in breast milk. High concentrations are achieved in bile . Ciprofloxacin is eliminated principally by urinary excretion and to a lesser extent by non renal clearance.
INDICATIONS :
Ciprosan is indicated in the treatment of a wide range of infections including enteric fever and shigellosis , urinary tract infections e.g. acute and chronic pyelonephritis , upper and lower respiratory tract infections , otitis media , sinusitis and mastoiditis , skin and soft tissue infections , surgical infections , bone and joint infections , pelvic infections , sexually transmitted infections e.g. gonorrhea , severe systemic infections such as septicemia , bacteremia and infections in immunocompromised patients .
DOSAGE & ADMINISTRATION :
- The usual oral daily dose of Ciprofloxacin ranges from 250 to 750 mg twice daily depending on the nature and severity of the infection.
- Gonorrhea : single oral dose of 250 - 500 mg .
- Meningococcal meningitis prophylaxis : single oral dose of 750 mg .
RESTRICTIONS ON USE : Contraindications Hypersensitivity to the active ingredient. Precautions
- Doses should be reduced in patients with severe renal impairment . Halving the dose is suggested when the creatinine clearance is less than 20 ml / min.
- Concurrent administration of antacids should be avoided because it results in lower serum and urinary levels of Ciprofloxacin.
- Prolongation of bleeding time has been reported during concomitant administration of Ciprofloxacin and anticoagulants. Use in Pregnancy and lactation
Ciprofloxacin should not be recommended for use in pregnant and lactating women.
ADVERSE EFFECTS :
Ciprofloxacin is usually well tolerated . Nausea , vomiting , diarrhea , abdominal pain, and skin rash have been reported. Rarely transient increase in transaminases and arthralgia have been reported.
STORAGE INSTRUCTIONS : Store below 30ºC in a dry place.
PRESENTATIONS :
Ciprosan 250 , 500 , 750 Tablets : Pack of 10 tablets and hospital packs of different sizes.
INSTRUCTIONS TO THE PATIENT
- Medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for you.
- Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are experts in medicine, its benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed for you.
- Do not repeat the same prescription without consulting your doctor.
012-06-014 11/12
Council of Arab Health Ministers