Treatment of infections due to susceptible micro-organisms: 

Urinary tract infections.

Acute sinusitis, and malignant otitis externa.

Lower respiratory tract infections.

Exacerbations of cystic fibrosis.

Bone and joint infections.

Skin and soft tissue infections.

Gastrointestinal tract infections including biliary tract infections, infectious diarrhoea, typhoid and paratyphoid fevers.

Genital tract infections: prostatitis, gonorrhea and chancroid.

Septicemia and peritonitis.

Surgical infection prophylaxis.

Meningococcal meningitis prophylaxis.

Infections in immunocompromised patients (neutropenia).

Inhalation anthrax.

Oral Route. CIPROCIN can be taken without regard to meals.

CIPROCIN Tablets should be given every 12 hours.

The Usual Adult Dose: 

Depends upon the severity of infection.

Generally, CIPROCIN should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (postexposure).

Doses in Renal Function Impairment: 

Dosage In Hepatic Function Impairment: 

No dosage adjustment except in severe impairment.

IV Route: 

CIPROCIN Vials should be diluted prior to administration and given by intravenous (IV) infusion over 60 minutes.

Preparation of IV Dose: 

Prepare the IV dose by aseptically withdrawing the appropriate volume of concentrate from the vial. Dilute before use with a suitable IV infusion to a final concentration of 1-2 mg/mL.

Admixture Compatibility/Stability: 

Stable up to 14 days under refrigeration or at room temperature (5^ºC-25^ºC) when diluted with 0.9% sodium chloride injection or 5% dextrose injection, sterile water for injection, 10% dextrose for injection, 5% dextrose and 0.225% sodium chloride for injection, 5% dextrose and 0.45% sodium chloride for injection. 

If a Y – type IV infusion set or a piggyback method is used, temporarily discontinue the administration of any other solution during the CIPROCIN infusion.

CIPROCIN is incompatible with amoxicillin, mezlocillin, flucloxacillin, pefloxacin, heparin sodium, frusemide, aminophylline and lecicoplanin.

As with other quinolones, CIPROCIN is contraindicated in hypersensitivity to quinolones, tendinitis or tendon rupture associated with quinolone use, pregnant women or breast-feeding mothers, children and adolescents less than 18 years of age.

CIPROCIN should be cautiously used in patients with known or suspected central nervous system disorders, or other factors predisposing to seizures; impaired renal or hepatic function; G6PD deficiency; myasthenia gravis; elderly.

Exposure to strong sunlight or sunlamps should be avoided.

An adequate fluid intake should be maintained during treatment with CIPROCIN and excessive alkalinity of the urine avoided because of risk of crystalluria.

Tendon damage may occur rarely with fluoroquinones and treatment should be discontinued if patients experience tendon pain, inflammation, or rupture; subsequent use of fluoroquinolones is contraindicated.

The ability to drive or operate machinery may be impaired by CIPROCIN, especially when alcohol is also taken.

Hyper- or hypoglycemia, usually in diabetic patients receiving concomitant oral hypoglycemic agents or insulin, may occur with quinolones.

As with other fluoroquinolones, concurrent use of aluminium, magnesium hydroxide antacids, iron and zinc salts or sucralfate is better avoided.

(Aluminium, magnesium, or iron preparations are not given within 4 hours).

(Sucralfate can be given 6 hours before CIPROCIN).

Concurrent administration of ciprofloxacin with caffeine, theophylline, dairy products or enteral feedings is better avoided.

CIPROCIN may increase cyclosporine toxicity.

Opioid premedication should not be used if CIPROCIN is given for surgical infection prophylaxis.

CIPROCIN is generally well-tolerated.

Most reactions are mild to moderate. As with other quinolones, gastrointestinal disturbances e.g. nausea, vomiting, diarrhea, abdominal pain, dyspepsia, pseudomembraneous colitis (rarely) ; central nervous system disturbances e.g. headache, dizziness, restlessness, tremor, drowsiness, insomnia, visual disturbances; skin reactions e.g. photosensitivity, rash, pruritus; vaginitis; transient increases in serum creatinine, blood urea nitrogen, crystalluria; elevated liver enzymes; eosinophilia, leucopenia, thrombocytopenia; myalgia, tendinitis or tendon rupture; tachycardia, edema may occasionally occur. Pain and irritation may occur at the site of injection accompanied rarely by phlebitis or thrombophlebitis.

CIPROCIN is one of the most potent of the fluoroquinolone antibacterial group. It is bactericidal acting by inhibition of the A subunit of DNA gyrase enzyme essential for bacterial DNA reproduction.

CIPROCIN has a broad spectrum of activity against most Gram-negative bacteria and many Gram-positive bacteria including:

Enterobacteriaceae, including E. coli, Proteus, Klebsiella, Salmonella, Shigella, Serratia, Citrobacter, Enterobacter, Providentia, Yersinia; Pseudomonas aeruginosa; Moraxella catarrhalis and Haemophilus influenzae (including beta-lactamase producing strains), Haemophilus parainfluenzae and ducreyi, Neisseria gonorrhoeae (including beta-lactamase producing strains), Neisseria meningitidis, Campylobacter spp., and Vibrio spp.; Staphylococci (including penicillinase-producing and penicillinase-nonproducing strains and some methicillin-resistant strains), Streptococci (including pyogenes, faecalis and pneumoniae).

CIPROCIN has some activity against mycobacteria, and mycoplasmas.

Pharmacokinetics: 

Ciprofloxacin is rapidly and well absorbed from the gastrointestinal tract. Oral bioavailability is about 70% and a peak plasma concentration is achieved 1-2 hours after a dose of 500 mg by mouth. Absorption may be delayed by the presence of food but is not substantially affected overall.

Plasma half-life is about 3.5-4.5 hours. Protein binding ranges from 20-40%. It is widely distributed in the body and tissue penetration is generally good. High concentrations are achieved in bile. Ciprofloxacin is eliminated primarily by urinary excretion, but non-renal clearance may account for about a third of elimination and includes hepatic metabolism, biliary excretion , and possible transluminal secretion across the intestinal mucosa. About 40-50% of the oral dose is excreted unchanged in urine and about 15% as metabolites which have antimicrobial activity, but are less active than unchanged ciprofloxacin. Up to 70% of the parenteral dose may be excreted unchanged and within 24 hours and 10% as metabolites. Fecal excretion over 5 days has accounted for 20-30% of an oral dose and 15% of an intravenous dose.

CIPROCIN Tablets: Stored at a temperature not exceeding 30^ºC.

CIPROCIN Vials: Stored at a temperature 15^ºC - 30^ºC.

CIPROCIN 250 mg Film coated Tablets: Box containing 1 blister of 10 film coated tablets.

CIPROCIN 500 mg Film coated Tablets: Box containing 1 blister of 10 film coated tablets.

CIPROCIN 750 mg Film coated Tablets: Box containing 2 blisters of 5 film coated tablets each.

CIPROCIN 200 mg Vials: Box containing 1 vial of 20 ml.