Read this leaflet carefully before you start taking CIPROFLOXACIN TABLETS as it contains important information. If you have any questions or would like to know more about this medicine, ask your pharmacist or doctor.
Keep the leaflet, as you may want to read it again.
DESCRIPTION
Ciprofloxacin is a potent, broad spectrum, synthetic antibacterial agent belonging to the new class of drugs called fluoroquinolones. It is
1-cyclopropyl-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline-carboxy lix acid.
WHAT IS IN CIPROFLOXACIN TABLETS?
Each uncoated CIPROFLOXACIN tablet contains Ciprofloxacin Hydrochloride USP equivalent to Ciprofloxacin 500mg.
Other inactive ingredients are Maize Starch, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate, Colloidal Silicon Dioxide, Magnesium Stearate.
MECHANISM OF ACTIONS
CIPROFLOXACIN exerts a potent bacterial effect by inhibition of the A subunit of DNA gyrase, an essential enzyme involved in DNA:
INDICATIONS
Ciprofloxacin tablets are indicated for the treatment of a variety of infections caused by susceptible gram-positive & gram-negative organisms including mixed infections caused by two or more organisms. It may also be used for infections caused by multi-drug-resistant bacteria. Ciprofloxacin is indicated for the treatment of the following infections caused by susceptible bacteria.
Respiratory Tract Infection:
Acute bronchitis, exacerbation of chronic obstructive airway disease, empyema, lung abscess, infected bronchiectasis, cystic fibrosis and pneumonia.
Urinary Tract Infection:
Acute and chronic pyelonephritis, prostatitis, cystitis, epididymitis and chronic completed or recurrent UTI caused by multi-resistant organisms and/or Pseudomonas aeruginosa.
Skin & Soft Tissue Infections:
In surgical and post operative wound infections due to gram-negative organisms such as Enterobacteria case and Pseudomonas aeruginosa. Also useful in infections caused by resistant Staphylococci.
Surgical Infections:
Peritonitis, intra-abdominal abscess, cholangitis, cholecystitis, empyema of gall bladder.
Bone & Joint Infections:
Since Ciprofloxacin achieves adequate tissue concentrations in the bone, it is useful in the management of acute and chronic osteomyelitis.
Gynecological Infection:
Severe pelvic infections caused by susceptible bacteria.
Sexually Transmitted Infections:
Gonorrhea including that caused by beta-lactamase producing strains. Chancroid caused by H. ducreyi.
Gastrointestinal Infection:
Effective in the treatment of typhoid and may also eradicate carrier stage. Useful resistant Salmonella typhi infections.
Severe Systemic Infection:
Septicemia, bacteremia, infections in immunocompromised patients.
CONTRA INDICATIONS
Ciprofloxacin tablet is contra-indicated in individuals with a history of hypersensitivity to the active or any of the inactive ingredients, and in children below the age of 12 years.
PRECAUTIONS
As Ciprofloxacin may cause CNS stimulation, it should be used with caution in patients with CNS disorders such as severe cerebral arteriosclerosis or epilepsy.
Patients receiving this drug should be well hydrated to prevent crystalluria. Excessive alkalinization of urine should be avoided. The dosage should be reduced in patients with renal impairment.
USE IN PREGNANCY AND BREASTFEEDING
Reproduction studies in animal at doses up to 6 times the usual daily human dose have not revealed any evidence of impaired fertility or teratogenicity due to Ciprofloxacin.
Information from well controlled studies in pregnant women is not available. Since Ciprofloxacin caused arthropathy in immature animals, it should not be used in pregnant or nursing women.
DRUG INTERACTIONS
Serum concentrations and elimination half-life of theophylline may be increased when it is used concurrently with Ciprofloxacin. It is recommended that patients be monitored for the signs of theophylline toxicity during concurrent use and dosage adjustments made as appropriate.
Probenecid delays excretion of Ciprofloxacin.
Antacids containing magnesium hydroxide and/or aluminum hydroxide may interfere with the absorption of Ciprofloxacin resulting in lower serum and urine levels; hence concurrent administration of antacids with Ciprofloxacin should be avoided.
ADVERSE REACTIONS
Ciprofloxacin is generally well tolerated. During clinical trials in a large number of patients, adverse effects related to the drug occurred infrequently and were commonly reported as diarrhea, vomiting, abdominal pain, headache, restlessness and rash.
OTHER side effects which have been reported very rarely include arthralgia and increase in serum transaminases levels.
DOSAGE AND ADMINISTRATION
Ciprofloxacin tablet can be administered without regards to meals. Patients should be advised to drink fluids liberally.
Dosage Table
| Infection Site | Severity of Infection | Dosage |
|---|---|---|
| Respiratory tract, Bone and Joint, Skin / Soft tissue | Mild / Moderate | 500 mg twice daily |
| Severe / Complicated | 750 mg twice daily | |
| Urinary Tract | Mild / Moderate | 250 mg twice daily |
| Severe / Complicated | 500 mg twice daily | |
| Infected Diarrhoea | Mild / Moderate | 500 mg twice daily |
| Gonorrhoea | Uncomplicated | 250 mg single dose |
| Non-gonococcal urethritis | 750 mg twice daily | |
| Chancroid | 500 mg twice daily | |
| Other infections | 500–750 mg twice daily |
DURATION OF THERAPY
The duration of Ciprofloxacin therapy depends on the type and severity of the infection and should be determined by the clinical and bacteriological response of the patients.
For most infections, therapy should be continued for at least 48 hours after the patient become asymptomatic.
The usual duration is 1–2 weeks, but severe or complicated infections may require more prolonged therapy.
RENAL IMPAIRMENT
Dosage adjustment will be required in patients with moderate to severe impairment of renal function. Available information on oral administration of Ciprofloxacin states that if creatinine clearance is less than 20 ml/minute, half the recommended dosage may be administered.
IN CASE OF OVERDOSAGE
Symptoms of overdose include dizziness, tremor, headache, tiredness, hallucinations and seizures.
Contact your nearest casualty department immediately in case of overdose.
PRESENTATIONS
Blister of 10 tablets
STORAGE CONDITIONS
Store below 30°C, in a dry place.
Keep Out of Reach of Children
Revised: July, 2021
Manufactured by:
GR Industries Limited
15/5 Valco Road,
Heavy Industrial Area, Tema
Tel: 0244633661 / 0244702599