1, African Church close, off Coker Road, Ilupeju, Lagos, Nigeria
Tel: 01-773-1473, 01-8179648, 08033160649
Micro Labs Ltd, 92, Sipcot Hosur 635 126 (TM) India.
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Tablet (NRN: 04-3002): Each film coated tablet contains: Ciprofloxacin Hydrochloride USP equivalent to Ciprofloxacin 500 mg.
Pack size: 1 x 10's; 14's.
Infusion (NRN: 04-6280): Each 100 mL contains: Ciprofloxacin Lactate equivalent to Ciprofloxacin USP 200 mg; Sodium Chloride USP 0.9% w/v, Water for Injection USP q.s.
Pack size: 1 x 100 mL.
Ciprofloxacin is bactericidal and acts by inhibiting the A subunit of DNA gyrase, (topoisomerase) which is essential in the reproduction of bacterial DNA.
Ciprofloxacin is highly active in vitro against most Gram-negative aerobic bacteria, including Enterobacteriaceae, Haemophilus, Neisseria and Pseudomonas aeruginosa. Ciprofloxacin is also active in vitro against many Gram-positive aerobic bacteria including penicillinase-producing and nonpenicillinase-producing and methicillin-resistant Staphylococci. Many strains of Streptococci are relatively resistant to the drug.
Rapid absorption. Wide distribution into body fluids and tissues except CSF. Metabolized in the body and eliminated mainly by kidneys.
Half-life is about 4 hours.
Crosses into foetal blood and is excreted into breast milk.
Ciprofloxacin has been shown to be effective in the treatment of infections caused by ciprofloxacin sensitive pathogens:
- Urinary Tract infections (UTI).
- Skin & Skin Structure infections
- Enteric Infections
- Bone & Joint Infections
- Sexual Transmitted diseases (STD)
- Respiratory Tract Infections (RTI)
- Prophylaxis against infections in granulocytopenic patients.
Hypersensitivity to quinolones, pregnancy, lactation and in children below 18 years.
Ciprofloxacin should be used with caution in patients with epilepsy or a history of CNS disorders. Patients receiving Ciprofloxacin should be well hydrated and alkalinity should be avoided.
Caution should be exercised during concurrent administration of Antacids, Theophylline and Probenecid and in patients with renal impairment.
The safety and effectiveness of Ciprofloxacin in children, adolescents (less than 18 years of age), pregnant women, and lactating women have not been established.
Concurrent administration of Ciprofloxacin with Theophylline may lead to elevated serum concentrations of Theophylline and prolongation of its eliminations half-life.
Concurrent administration of Ciprofloxacin with Antacids, Sucralfate or divalent and trivalent cations such as iron may substantially interfere with the absorption of Ciprofloxacin, resulting in serum and urine levels considerably lower than desired. Probenecid interferes with renal tubular secretion of Ciprofloxacinand produces increase in the level of Ciprofloxacin in the serum.
Use in Pregnancy and Lactation:
Since Ciprofloxacin causes arthropathy in immature animals, it should not be used in pregnant women, lactating women (Ciprofloxacin in secreted in milk) and children below 18 years.
Ciprofloxacin is generally well tolerated. Adverse effects are generally mild which include gastrointestinal disturbance, CNS effects and skin reactions.
Dosage & Administration
By mouth, Adults: 250 to 750 mg twice daily depending on severity and nature of infection.
Children and adolescents: Not recommended usually.
Dose adjustment required in renal impairment: A single Oral dose of 500 mg is suggested for treatment of Gonorrhoea.
In the event of acute overdosage, the stomach should be emptied by inducing vomiting or by gastric lavage. Adequate hydration should be maintained. Only a small amount of Ciprofloxacin is removed from the body after hemodialysis or peritoneal dialysis.
Keep out of the reach of children. Store in a cool, dry and dark place.