0.2% CIPROFLOXACIN in 0.9% W/V SODIUM CHLORIDE INJECTION USP Infusion/Solution for

What is 0.2% CIPROFLOXACIN in 0.9% W/V SODIUM CHLORIDE INJECTION USP

0.2% Ciprofloxacin in 0.9% w/v Sodium Chloride Injection USP is a sterile, ready-to-use intravenous infusion that contains the broad-spectrum antibiotic ciprofloxacin, combined with isotonic sodium chloride to maintain osmotic balance during parenteral administration. It is primarily used for treating a wide variety of bacterial infections in hospitalized patients where oral treatment is not feasible.

• Formulation: Each 100 ml plastic bag contains 200 mg of ciprofloxacin and 0.9% sodium chloride in aqueous solution.
• Classification: Ciprofloxacin is a second-generation fluoroquinolone antibiotic.
• Indications: Effective against respiratory tract infections, urinary tract infections (UTIs), intra-abdominal infections, skin and soft tissue infections, and certain gynecological infections.
• Patient Group: Intended for adult and pediatric patients over 1 year of age, under medical supervision.
• Hospital Use: Commonly administered in inpatient settings such as ICU, emergency departments, and surgical wards.

This formulation ensures precise dosing, stability, and convenience for intravenous administration without the need for dilution, making it an essential treatment option for moderate to severe bacterial infections.

How to use 0.2% CIPROFLOXACIN in 0.9% W/V SODIUM CHLORIDE INJECTION USP

The use of 0.2% Ciprofloxacin in 0.9% w/v Sodium Chloride Injection USP must always be carried out under the supervision of a qualified healthcare provider in a hospital or clinical setting. It is administered via slow intravenous infusion to ensure therapeutic efficacy and to reduce the risk of adverse reactions.

• Route: Intravenous infusion (IV drip) only; not intended for intramuscular or subcutaneous use.
• Duration: Each dose is typically infused over a period of 60 minutes to minimize risks of vascular irritation.
• Dosage Frequency: Generally administered every 12 hours depending on the infection type, severity, and patient’s renal function.
• Pre-Use Checks: Visually inspect the bag for particulate matter or discoloration. Do not use if the solution is cloudy or the container is leaking.
• Device Compatibility: Compatible with standard IV infusion sets. Do not mix with other drugs in the same IV line without compatibility data.

Patients should remain under observation during and after administration, especially those with a history of hypersensitivity to quinolones. Fluid balance and renal function should be regularly monitored to adjust dose or frequency as necessary.

Mode of Action 0.2% CIPROFLOXACIN in 0.9% W/V SODIUM CHLORIDE INJECTION USP

Ciprofloxacin, the active component in this solution, is a fluoroquinolone antibiotic that works by disrupting essential bacterial functions, ultimately leading to cell death. The mechanism of action is bactericidal and targets DNA replication and transcription.

• DNA Gyrase Inhibition: Ciprofloxacin inhibits bacterial DNA gyrase and topoisomerase IV—enzymes required for DNA replication, transcription, and repair.
• Broad-Spectrum Activity: Effective against Gram-negative bacteria (e.g., Escherichia coli, Klebsiella, Pseudomonas) and select Gram-positive organisms (e.g., Staphylococcus aureus).
• Intracellular Penetration: Has good tissue penetration, including lungs, kidneys, and prostate, allowing it to treat both systemic and localized infections.
• Bactericidal Effect: Leads to rapid bacterial cell death by halting cell division and DNA maintenance processes.

When delivered in a sodium chloride base, the isotonic environment supports patient hemodynamics while enabling precise drug delivery. The onset of action is rapid, and it maintains therapeutic plasma concentrations for a duration that supports twice-daily dosing.

0.2% CIPROFLOXACIN in 0.9% W/V SODIUM CHLORIDE INJECTION USP Interactions 0.2% CIPROFLOXACIN in 0.9% W/V SODIUM CHLORIDE INJECTION USP

Ciprofloxacin interacts with several drugs, which can influence its therapeutic efficacy or increase the risk of adverse effects. It's essential to review a patient’s medication profile before administration.

• Antacids & Mineral Supplements: Products containing magnesium, aluminum, calcium, or iron may bind ciprofloxacin and reduce systemic absorption if taken orally—but not applicable to IV use directly.
• Antiarrhythmics: Concomitant use with drugs like amiodarone or quinidine may increase the risk of QT prolongation and serious arrhythmias.
• NSAIDs: Increased risk of CNS stimulation and seizures, especially in patients with epilepsy or neurological disorders.
• Theophylline: Ciprofloxacin may reduce clearance of theophylline, leading to toxicity (e.g., nausea, seizures).
• Anticoagulants (e.g., Warfarin): May enhance the anticoagulant effect, requiring close INR monitoring.
• Cyclosporine: Possible increased risk of nephrotoxicity with concurrent administration.

Healthcare professionals should always consult updated interaction checkers and closely monitor patients receiving multiple medications to avoid harmful drug interactions.

Dosage of 0.2% CIPROFLOXACIN in 0.9% W/V SODIUM CHLORIDE INJECTION USP

The dosage of this intravenous ciprofloxacin formulation varies depending on the type and severity of infection, as well as the patient’s age, weight, renal function, and clinical response. Dosages should always be prescribed by a licensed healthcare professional.

• Standard Adult Dose: 200–400 mg every 12 hours infused over 60 minutes.
• Severe Infections: 400 mg IV every 8–12 hours may be required for serious systemic infections.
• Pediatric Use: Typically 10–20 mg/kg every 12 hours, not exceeding 400 mg per dose; reserved for complicated UTIs and pyelonephritis.
• Renal Impairment: Dose adjustment required based on creatinine clearance (CrCl); e.g., reduce frequency in patients with CrCl <30 mL/min.
• Duration of Therapy: Typically 7–14 days, but longer durations may be required for bone, joint, or abdominal infections.

Therapy should continue for at least 3 days after the resolution of fever and clinical signs of infection. Always monitor renal and hepatic function during prolonged therapy.

Possible side effects of 0.2% CIPROFLOXACIN in 0.9% W/V SODIUM CHLORIDE INJECTION USP

While generally well tolerated, ciprofloxacin can cause a range of side effects, particularly when administered intravenously. Patients should be closely observed during and after infusion for any adverse reactions.

• Common Side Effects: Nausea, diarrhea, headache, dizziness, infusion site reactions (e.g., erythema, phlebitis).
• Gastrointestinal: Abdominal discomfort, vomiting, and dyspepsia.
• Central Nervous System: Insomnia, restlessness, or confusion in elderly patients; rare seizures may occur.
• Musculoskeletal: Risk of tendonitis and tendon rupture, especially in older adults or those on corticosteroids.
• Allergic Reactions: Rash, pruritus, urticaria; rarely, anaphylaxis or Stevens-Johnson syndrome.
• Cardiac Effects: QT prolongation in susceptible individuals, especially when combined with other QT-prolonging agents.

Any signs of hypersensitivity, such as difficulty breathing, facial swelling, or severe rash, warrant immediate discontinuation and emergency medical attention.

0.2% CIPROFLOXACIN in 0.9% W/V SODIUM CHLORIDE INJECTION USP Contraindications 0.2% CIPROFLOXACIN in 0.9% W/V SODIUM CHLORIDE INJECTION USP

Ciprofloxacin injection is contraindicated in certain clinical scenarios due to the potential for serious adverse effects or reduced efficacy.

• Hypersensitivity: Known allergy to ciprofloxacin, other fluoroquinolones, or any component of the formulation.
• History of Tendon Disorders: Prior fluoroquinolone-associated tendon rupture or tendonitis.
• Children: Use is generally avoided in children unless absolutely necessary due to risk of joint and cartilage damage.
• Pregnancy: Contraindicated unless benefits outweigh risks; animal studies suggest potential harm to developing cartilage.
• QT Prolongation: Patients with a history of QT prolongation or taking medications that prolong QT interval.
• Seizure Disorders: Should be used with extreme caution in patients with a history of epilepsy or other CNS disorders.

Always evaluate patient history comprehensively to assess the risk-benefit ratio prior to initiating treatment with IV ciprofloxacin.

Storage of 0.2% CIPROFLOXACIN in 0.9% W/V SODIUM CHLORIDE INJECTION USP

Proper storage conditions are crucial to maintain the efficacy, sterility, and safety of ciprofloxacin intravenous solutions. Healthcare facilities must follow recommended storage guidelines to ensure stability.

• Temperature: Store between 15°C and 30°C (59°F–86°F). Avoid freezing as it may compromise solution integrity.
• Light Protection: Keep in the original packaging to protect from excessive light. Avoid direct sunlight exposure.
• Shelf Life: Refer to the manufacturer’s labeling. Typically stable until the expiration date if unopened and stored properly.
• Do Not Use If: The solution appears cloudy, discolored, or contains particulate matter. Also discard if the bag is damaged or leaking.
• Post-Opening: Once opened, use immediately. Discard any unused portion to avoid microbial contamination.
• Handling: Only trained personnel should handle and administer the product under aseptic conditions.

Always follow hospital protocols and manufacturer instructions when storing and handling ciprofloxacin infusions to preserve potency and patient safety.