Ciproshin Infusion
Ciprofloxacin B.P 2mg/mL
(Sterile, Pyrogen Free, Single Dose)
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 multidrug resistant gram-negative or...
Dosage and Administration
Bone and Joint Infections:
Mild to moderate: 400 mg every 12 hours for 4 - 6 weeks Severe or complicated: 400 mg every 8 hours for 4 - 6 weeks
Lower Respiratory Tract, 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
Nosocomial pneumonia: Mild, moderate to severe: 400 mg every 8 hours for 10 - 14 days
Prostatitis (chronic, bacterial): 400 mg every 12 hours for 28 days
Sinusitis (acute): 400 mg every 12 hours for IO days
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.
Febrile neutropenia (with piperacillin): 400 mg every 8 hours for 7 - 14 days
Intra-abdominal Infection (with metronidazole): 400 mg every 12 hours for 7 - 14 days
Anthrax: Inhalational (post-exposure prophylaxis): 400 mg every 12 hours for 60 days Inhalational/ gastrointestinal oropharygeal (treatment): 400 mg every 12 hours. Initial treatment should include two or more agents predicted to be effective (per CDC recommendations). Agents suggested for use in co...
Composition
Each 100 mL contains:
Ciprofloxacin B.P ... 200 mg
Water for Injection B.P ... q.s.
Description
Ciprofloxacin is the most potent first generation bactericidal fluoroquinolone, active against a wide range of bacteria. Chemically, ciprofloxacin is 1-Cyclo-propy1-6-fl uoro-4-oxo- 7-(pi pe raz i n-1-y1 )-1,4-dihydroquinoline-3-carboxylic acid. Its molecular formula is C17H18FN3o3 and molecular wei...
Clinical Pharmacology
Mechanism of Action
It inhibits DNA gyrase in susceptible organism; inhibits relaxation of supercoiled DNA and promotes breakage of double-stranded DNA.
Pharmacological Action
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 gyrase and a type II topoisomerase, topoisomerase IV, necessary to separate bacterial DNA, thereby inhibiting cell division.
Antimicrobial Spectrum
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, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus (Viridans group)
Gram-negative: Haemophilus injluenzae, Pseudomonas aeruginosa, Serratia marcescens.
The minimal bactericidal concentration (MBC) generally does not exceed the minimal inhibitory concentration (MIC) by more than a factor of 2. Resistance to ciprofloxacin in vitro usually develops slowly (multiple-step mutation). Ciprofloxacin does not cross-react with other antimicrobial agents such...
Pharmacokinetics
The pharmacokinetics of ciprofloxacin are linear over the dose range of 200 to 400 mg administered intravenously. Absolute bioavailability has been shown to be 70 - 80% in various studies by a direct comparison between the oral and intravenous forms of ciprofloxacin Distribution: After intravenous a...
Metabolism: After IV administration, three metabolites of ciprofloxacin have been identified in human urine which together account for approximately 10% of the IV dose. The binding of ciprofloxacin to serum protein is 20 to 40%.
Excretion: The serum elimination half-life is approximately 5 - 6 hours and the total clearance is around 35 L/hr. After intravenous administration, approximately 50% to 70% of the dose is excreted in the urine as unchanged drug. Following a 200 mg IV dose, concentrations in the urine usually exceed...
Contraindication
Hypersensitivity to ciprofloxacin, any component of the formulation or other quinolones.
Warning and 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. Avoid excessive alkalinity of urine and ensure adequate fluid intake.
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.
Overdose
Overdose of ciprofloxacin may result in reversible renal toxicity. Treatment of overdose includes emptying of the stomach by induced vomiting or gastric lavage, as well as administration of antacids containing magnesium, aluminium or calcium to reduce drug absorption. Renal function and urinary pH s...
Drug Interaction
Antacid and other cations: Early investigational trials with quinolones revealed decreased ciprofloxacin absorption when co-administered with magnesium aluminium antacids.
Theophylline: Theophylline serum concentrations have been found to be markedly elevated when co-administered with ciprofloxacin.
Others: Rifampicin may induce the metabolism of ciprofloxacin, leading to lower serum concentrations and failure of therapy. The combination of ciprofloxacin and chlorphenicol may be antagonistic.
Storage
Should be stored in cool and dark place. Avoid freezing.
Do not remove inner container from carton box until ready for use.