Ciproshin
Ciprofloxacin 250/ 500
Indication
It is used in the treatment of documented or suspected infections of the lower respiratory tract, sinuses, skin and skin structure, bone/joint and urinary tract due to susceptible bacterial strains; especially indicated for pseudomonal infection and those due to multi-drug resistant gram-negative or...
Dosage and Administration
Usual adult dose is 250 – 750 mg twice daily, depending on the severity and nature of infection. Dose adjustment is required in patients with renal impairment.
Lower Respiratory Tract Infections: 500 - 750 mg, twice daily for 7 to 14 days Acute Sinusitis: 500 mg, twice daily for 10 days
Skin and Skin Structure Infections: 500 - 750 mg, twice daily for 7 to 14 days
Bone and Joint Infections: 500 - 750 mg, twice daily for 4 to 8 weeks
Urinary Tract Infections: 250 - 500 mg, twice daily for 7 to 14 days
Chronic Bacterial Prostatitis: 500 mg, twice daily for 28 days Infectious Diarrhoea: 500 mg, twice daily for 5 to 7 days Complicated Intra-Abdominal Infections: 500 mg, twice daily for 7 to 14 days
Typhoid Fever: 500 mg, twice daily for 10 days
Acute Uncomplicated Cystitis: 250 mg. twice daily for 3 days Uncomplicated Cervical and Urethral Gonorrhea: 250 mg as single dose
In clinical trial, Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age): 10mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing more than 51 kg), every 12 hours for 10 to 21 days.
Conversion of IV to Oral Dosing in Adults Patients whose therapy is started with Ciprofloxacin IV may be switched to Ciprofloxacin Tablets or Oral Suspension when clinically indicated at the discretion of the physician.
Table: Equivalent AUC Dosing Regimens
Ciprofloxacin Oral Dosage -Equivalent Ciprofloxacin IV Dosage
250 mg Tablet every 12 hours - 200 mg Intravenous every 12 hours
500 mg Tablet every 12 hours - 400 mg Intravenous every 12 hours
750 mg Tablet every 12 hours - 400 mg Intravenous every 8 hours
Composition
Each film-coated caplet contains:
Ciprofloxacin Hydrochloride B.P equivalent to
Ciprofloxacin ... 250 mg / 500 mg.
Description
Ciprofloxacin is the most potent first generation bactericidal fluoroquinolone, active against a wide range of bacteria. Chemically, ciprofloxacin is 1-Cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic acid hydrochloride. Its molecular formula is C17H19ClFN3O3 and molec...
Clinical Pharmacology
It inhibits DNA gyrase in susceptible organism; inhibits relaxation of supercoiled DNA and promotes breakage of double-stranded DNA. Ciprofloxacin is a broad-spectrum of the fluoroquinolone class. It is active against both Gram-positive and Gram-negative bacteria. It functions by inhibiting DNA gyr...
Ciprofloxacin has been shown to be active against most strains of the following organisms both in vitro and in clinical infections: Gram-positive: Staphylococcus aureus, Sta-phylococcus epidermidis, Streptococcus pneumoniae, Streptococcus (Viridans group); Gram-negative: Haemophilus influenzae, Pse...
Pharmacokinetics
Ciprofloxacin is rapidly absorbed after oral administration. Cmax ranges between 1.5 – 2 mg/L with Tmax of about 60 – 75 minutes. It is widely distributed into body fluids and tissues except CSF. Plasma protein binding is 20 to 40% which is not likely to be high enough to cause significant protein...
Contraindication
Hypersensitivity to ciprofloxacin, any component of the formulation or other quinolones; pregnant and lactating mothers.
Precaution
Ciprofloxacin should be used with caution in patients with epilepsy or a history of epilepsy, in hepatic or renal impairment, in pregnancy, during breastfeeding and in children or adolescents. Crystalluria may occur in a neutral or alkaline pH. Avoid excessive alkalinity of urine and ensure adequate...
Adverse Effects
Ciprofloxacin may cause nausea, vomiting, abdominal pain, diarrhoea, headache, dizziness, sleep disorders, rash, pruritus, anaphylaxis, photosensitivity, increase in blood urea and creatinine, transient disturbances in liver enzymes and bilirubin, arthralgia and myalgia and blood disorder.
Drug Interaction
Antacid and other cations: Early investigational trials with quinolones revealed decreased ciprofloxacin absorption when co-administered with magnesium aluminium antacids. Administer ciprofloxacin tablets at least 2 hours before or 6 hours after administration of these agents. Theophylline: Theophyl...
Others: Rifampicin may induce the metabolism of ciprofloxacin, leading to lower serum concentrations and failure of therapy. The combination of ciprofloxacin and chloramphenicol may be antagonistic.
Storage
Store below 30°C in cool, dry place. Protect from light and moisture. Keep out of reach and sight of children.
Presentation
10 x 10’s Blisters.