Ciprofloxacin is indicated for the treatment of single or mixed infections caused by two or more susceptible organisms. It may also be used in infections caused by organisms resistant to other antibiotics, including aminoglycosides, penicillins, and cephalosporins.

Following oral administration, ciprofloxacin achieves effective antibacterial concentrations in the serum, body tissues, and urine. Due to its wide tissue distribution and broad antibacterial activity, including antipseudomonal activity, ciprofloxacin may be used alone, pending sensitivity results, or in combination with an aminoglycoside, beta-lactam antibiotic, or an antibiotic active against anaerobes when appropriate.

Ciprofloxacin is indicated for the treatment of the following infections caused by susceptible bacteria:

• Severe systemic infections: such as septicaemia, bacteraemia, peritonitis, infections in immunosuppressed patients with haematological or solid tumors, and infections in intensive care patients, including infected burns.
• Respiratory tract infections: including lobar pneumonia, bronchopneumonia, acute and chronic bronchitis, acute exacerbation of cystic fibrosis, bronchiectasis, and empyema.
• Urinary tract infections: including uncomplicated and complicated urethritis, cystitis, pyelonephritis, prostatitis, and epididymitis.
• Skin and soft tissue infections: such as infected ulcers, wound infections, abscesses, cellulitis, otitis externa, erysipelas, and infected burns.
• Gastrointestinal infections: including enteric fever and infective diarrhea.
• Biliary tract infections: such as cholangitis, cholecystitis, and empyema of the gall bladder.
• Intra-abdominal infections: including peritonitis and intra-abdominal abscesses.
• Bone and joint infections: including osteomyelitis and septic arthritis.
• Pelvic infections: including salpingitis, endometritis, and pelvic inflammatory disease.
• Eye, ear, nose, and throat infections: including otitis media, sinusitis, mastoiditis, and tonsillitis.
• Gonorrhoea: including urethral, rectal, and pharyngeal gonorrhoea caused by beta-lactamase-producing organisms or organisms moderately sensitive to penicillin.

Ciprofloxacin is a synthetic quinolone anti-infective agent with a broad spectrum of antibacterial activity. It is effective against most aerobic gram-negative bacteria, including members of the Enterobacteriaceae family and Pseudomonas aeruginosa. Ciprofloxacin is also active against certain aerobic gram-positive bacteria, including penicillinase-producing, non-penicillinase-producing, and methicillin-resistant staphylococci. However, many strains of streptococci are relatively less susceptible to ciprofloxacin. Its bactericidal effect results from inhibition of the bacterial enzyme DNA gyrase, which is essential for DNA replication, transcription, repair, and recombination. Following oral administration, ciprofloxacin is rapidly and well absorbed from the gastrointestinal tract. It is widely distributed throughout body tissues and fluids. The elimination half-life is approximately 3.5 hours. Within 24 hours, about 30% to 50% of an oral dose is excreted in the urine as unchanged drug and biologically active metabolites.

General dosage recommendations: The dosage of ciprofloxacin depends on the severity and type of infection, the susceptibility of the causative organism(s), and the patient’s age, body weight, and renal function.

Adults: The usual adult dosage ranges from 100 mg to 750 mg twice daily.

Lower and upper urinary tract infections: 250–500 mg twice daily, depending on severity.

Respiratory tract infections: 250–500 mg twice daily for upper or lower respiratory tract infections, depending on severity. For confirmed Streptococcus pneumoniae infection, the recommended dose is 750 mg twice daily.

Gonorrhoea: A single dose of 250 mg or 500 mg.

Most other infections: 500–750 mg twice daily.

Cystic fibrosis: In adults with pseudomonal infections of the lower respiratory tract, the usual dose is 750 mg twice daily. Since the pharmacokinetics of ciprofloxacin remain unchanged in patients with cystic fibrosis, the low body weight often seen in these patients should be taken into account when determining the dose.

Impaired renal function: Dose adjustment is usually not required except in patients with severe renal impairment (serum creatinine >265 micromol/L or creatinine clearance <20 mL/minute). If adjustment is necessary, the total daily dose may be reduced by half. Monitoring serum drug levels provides the most reliable basis for dose adjustment.

Elderly: Although higher serum levels of ciprofloxacin may occur in elderly patients, dosage adjustment is generally not necessary.

Adolescents and children: As with other drugs in this class, ciprofloxacin has been shown to cause arthropathy in weight-bearing joints of immature animals. Although the relevance of this finding in humans is unknown, its use in children, growing children, and adolescents is generally not recommended. However, if the expected benefit outweighs the potential risk, the recommended dosage is 7.5–15 mg/kg/day in two divided doses, depending on the severity of infection.

Duration of treatment: The duration of therapy depends on the severity of infection, clinical response, and bacteriological findings.

Acute infections: The usual treatment duration is 5 to 10 days. In general, treatment should be continued for 3 days after the signs and symptoms of infection have resolved.

Extended-release tablet: Uncomplicated urinary tract infection (acute cystitis): 1000 mg once daily for 3 days.

For IV infusion:

• Urinary tract infection:  Mild to moderate: 200 mg every 12 hours for 7–14 days
• Severe or complicated: 400 mg every 12 hours for 7–14 days
• Lower respiratory tract infection:  Mild to moderate: 400 mg every 12 hours for 7–14 days Severe or complicated: 400 mg every 8 hours for 7–14 days
• Nosocomial pneumonia: Mild, moderate, or severe: 400 mg every 8 hours for 10–14 days
• Skin and skin structure infections: Mild to moderate: 400 mg every 12 hours for 7–14 days Severe or complicated: 400 mg every 8 hours for 7–14 days.
• Bone and joint infections: Mild to moderate: 400 mg every 12 hours for more than 4–6 weeks . Severe or complicated: 400 mg every 8 hours for more than 4–6 weeks.
• Intra-abdominal infection (acute abdomen): Complicated: 400 mg every 12 hours for 7–14 days
• Acute sinusitis: Mild to moderate: 400 mg every 12 hours for 10 days
• Chronic bacterial prostatitis: Mild to moderate: 400 mg every 12 hours for 28 days

Instructions for use of Ciprofloxacin IV infusion:

• Check the bag for small leaks by squeezing the inner bag firmly. If leaks are found or the seal is broken, discard the solution.
• Do not use the solution if it is cloudy or contains precipitates.
• Do not use flexible bags in series connections.
• Close the flow-control clamp of the administration set.
• Remove the cover from the port at the bottom of the bag.
• Insert the piercing pin of the administration set into the port with a twisting motion until it is firmly seated.
• Hang the bag on a suitable support.
• Squeeze and release the drip chamber to establish the proper fluid level during infusion.
• Open the flow-control clamp to expel air from the set, then close the clamp.
• Regulate the rate of administration using the flow-control clamp.

Concurrent administration of ciprofloxacin with magnesium- or aluminum-containing antacids, sucralfate, or other products containing calcium, iron, or zinc should be avoided, as these may reduce the absorption of ciprofloxacin. Such products should be taken either 2 hours after or 6 hours before ciprofloxacin. Ciprofloxacin should also not be taken at the same time as milk or other dairy products, as they may significantly reduce its absorption. However, calcium present as part of a regular meal does not significantly affect the absorption of ciprofloxacin.

Ciprofloxacin is contraindicated in patients with known hypersensitivity to ciprofloxacin or any other quinolone antibiotics.

Ciprofloxacin may cause gastrointestinal disturbances such as nausea, diarrhea, vomiting, dyspepsia, and abdominal pain. Central nervous system effects may also occur, including headache, dizziness, fatigue, confusion, and convulsions, with a possible risk of retinal detachment. Hypersensitivity reactions such as skin rash, pruritus, and, very rarely, severe reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis may occur. Other less commonly reported adverse effects include joint pain, mild photosensitivity, and transient increases in liver enzymes, serum bilirubin, urea, or creatinine levels, particularly in patients with pre-existing liver impairment. There is also a risk of hypoglycemia and mental health-related adverse effects.

Reproduction studies in mice, rats, and rabbits using both oral and parenteral administration have shown no evidence of teratogenicity, impaired fertility, or adverse effects on peri- or postnatal development. However, as with other quinolones, ciprofloxacin has been shown to cause arthropathy in immature animals; therefore, its use during pregnancy is not recommended. Studies in rats have also shown that ciprofloxacin is excreted in milk. Accordingly, its use in nursing mothers is not recommended.

Ciprofloxacin should be used with caution in patients with suspected or known central nervous system disorders, such as arteriosclerosis or epilepsy, or in those with other risk factors that may predispose them to seizures or convulsions.

• Ciprofloxacin may be taken with or without food, and patients are advised to maintain adequate fluid intake during treatment.
• Concurrent use of ciprofloxacin with magnesium- or aluminum-containing antacids, sucralfate, or other products containing calcium, iron, or zinc should be avoided, as these may reduce its absorption. These products should be taken either 2 hours after or 6 hours before ciprofloxacin.
• Ciprofloxacin should not be taken at the same time as milk or yogurt alone, since this may significantly reduce its absorption. However, calcium taken as part of a regular meal does not significantly affect ciprofloxacin absorption.

Although ciprofloxacin has demonstrated efficacy in clinical trials, it is not considered a first-line treatment option in the pediatric population.

Overdose of ciprofloxacin may result in seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment, crystalluria, haematuria, and reversible renal toxicity.

4-Quinolone preparations; anti-diarrhoeal antimicrobial agents.

Store below 30°C, protected from light and moisture. Keep out of reach of children.