Ciprofloxacin (Prolaxa) 2mg/ml (200mg/100ml) Solution For IV Infusion 100ml

Description:
Medical Description. Antibiotic, belongs to the Fluoroquinolone group used in the treatment of pneumonia, prostatitis, salmonella infection, shigella infection, urinary tract infection, surgical site infection, bacterial meningitis and diabetic foot infection.

Product Description:

Ciprofloxacin (Prolaxa) 2mg/ml (200mg/100ml) Solution For IV Infusion is a broad-spectrum antibiotic used to treat a variety of bacterial infections. It contains Ciprofloxacin as the active ingredient, which belongs to the class of fluoroquinolone antibiotics. Ciprofloxacin works by inhibiting the enzymes DNA gyrase and topoisomerase IV, which are essential for bacterial DNA replication, leading to the death of the bacteria.

This intravenous (IV) formulation is typically used for patients who cannot take oral antibiotics or need rapid treatment for serious bacterial infections. The product comes in a 100ml vial containing a 200mg dose of Ciprofloxacin.

Key Features:

• Active Ingredient: Ciprofloxacin 200mg/100ml.

• Formulation: IV solution for infusion, ideal for hospital or clinical use.

• Broad-Spectrum Antibiotic: Effective against a wide range of gram-negative and gram-positive bacteria.

• Indications: Used for treating various infections, including urinary tract infections, respiratory infections, abdominal infections, and skin infections.

• Treatment for Serious Infections: Reserved for infections where oral administration may not be possible or rapid action is required.

Indications:

Ciprofloxacin (Prolaxa) IV infusion is used in the treatment of infections caused by susceptible bacteria, including but not limited to:

1. Urinary Tract Infections (UTIs): Infections in the kidneys, bladder, or other parts of the urinary tract.

2. Lower Respiratory Tract Infections: Such as pneumonia, bronchitis, and other lung infections.

3. Skin and Soft Tissue Infections: Infections of the skin or underlying soft tissues, including cellulitis and abscesses.

4. Abdominal Infections: Such as peritonitis or infections following abdominal surgery.

5. Bone and Joint Infections: Osteomyelitis and other bone infections.

6. Bacterial Endocarditis: Infections of the heart valves caused by bacteria.

7. Sepsis: Severe systemic infections that can lead to organ failure.

8. Prophylaxis in Immunocompromised Patients: To prevent infections in patients with weakened immune systems, such as those undergoing chemotherapy.

Dosage:

The dosage of Ciprofloxacin (Prolaxa) IV infusion depends on the severity and type of infection being treated, as well as the patient's renal function. Below are general guidelines for adult dosing:

• Standard Dose:

  • 200mg every 12 hours as an intravenous infusion over 60 minutes for most serious infections. The typical duration of treatment ranges from 7 to 14 days, depending on the infection.

• Severe Infections:

  • 400mg every 12 hours may be recommended for more severe infections, administered as an IV infusion over 60 minutes.

• Urinary Tract Infections:

  • For uncomplicated UTIs, the dose may be 200mg every 12 hours. For complicated UTIs or pyelonephritis, the dose may increase to 400mg every 12 hours.

• Renal Impairment:

  • In patients with renal impairment, dosage adjustments may be required. For those with creatinine clearance (CrCl) less than 30 mL/min, the dose may need to be reduced.

Administration:

• Ciprofloxacin IV should be administered via a slow intravenous infusion (typically over 60 minutes).

• It must be diluted before administration, and the solution should be infused in a vein that is large enough to avoid irritation or phlebitis (inflammation of the vein).

• The solution should not be infused together with other drugs or electrolytes unless specifically recommended.

Side Effects:

Common side effects of Ciprofloxacin (Prolaxa) IV infusion include:

• Gastrointestinal disturbances: Nausea, vomiting, diarrhea, abdominal pain.

• Headache: Mild headaches may occur, especially with higher doses.

• Dizziness or light-headedness.

• Skin reactions: Rash or itching may occur in some patients.

• Elevated liver enzymes: This may indicate liver strain or mild liver dysfunction.

Serious side effects are rare but may include:

• Tendinitis or tendon rupture: Ciprofloxacin has been associated with tendonitis, particularly in older adults, and can increase the risk of tendon rupture.

• Severe allergic reactions (anaphylaxis): Symptoms include swelling of the throat, difficulty breathing, or severe rash.

• CNS effects: Seizures, confusion, or hallucinations (especially in older adults or those with renal impairment).

• QT prolongation: Ciprofloxacin may cause changes in heart rhythm, which can lead to dangerous arrhythmias.

• Clostridium difficile-associated diarrhea: A serious, potentially life-threatening condition caused by an overgrowth of the bacteria Clostridium difficile in the colon.

• Peripheral neuropathy: Tingling or numbness in the limbs, often related to nerve damage.

If any of these serious side effects occur, the treatment should be discontinued, and medical attention should be sought immediately.

Contraindications:

Ciprofloxacin (Prolaxa) IV infusion should be avoided or used with caution in the following situations:

1. Hypersensitivity: If the patient has a known allergy or hypersensitivity to Ciprofloxacin or other fluoroquinolones, this product should not be used.

2. Tendon Disorders: Ciprofloxacin may increase the risk of tendonitis and tendon rupture, particularly in elderly patients and those on concurrent corticosteroid therapy.

3. Severe Renal Impairment: Use with caution in patients with severe kidney impairment (especially if the renal function is significantly compromised).

4. Pregnancy: Ciprofloxacin is generally not recommended during pregnancy due to potential harm to the developing fetus. It should only be used if the potential benefit outweighs the potential risk.

5. Breastfeeding: Ciprofloxacin is excreted in breast milk and should be avoided during breastfeeding unless absolutely necessary and prescribed by a doctor.

6. Myasthenia Gravis: Ciprofloxacin may worsen symptoms in patients with myasthenia gravis, a condition that causes muscle weakness.

7. Children and Adolescents: The use of Ciprofloxacin in children should be avoided unless absolutely necessary, as it can cause joint and cartilage toxicity in developing bones.

Warnings and Precautions:

• Cardiovascular: Ciprofloxacin has been associated with QT interval prolongation, which may increase the risk of serious arrhythmias. Use with caution in patients with a history of heart disease or those taking other medications that prolong the QT interval.

• Gastrointestinal: Monitor for signs of Clostridium difficile-associated diarrhea, which can be life-threatening.

• Nervous System: Ciprofloxacin may cause central nervous system side effects, including dizziness, confusion, and hallucinations, particularly in elderly patients or those with renal dysfunction.

• Hepatic Function: Regular monitoring of liver function is recommended during prolonged treatment, as Ciprofloxacin can affect liver enzymes.

Drug Interactions:

• Antacids and Sucralfate: These can decrease the absorption of Ciprofloxacin. Ciprofloxacin should be taken at least 2 hours before or 6 hours after these medications.

• Theophylline: Ciprofloxacin may increase the concentration of theophylline, a medication used for asthma, potentially increasing the risk of side effects such as seizures.

• Warfarin: Ciprofloxacin can increase the anticoagulant effect of warfarin, increasing the risk of bleeding. Close monitoring of INR (International Normalized Ratio) is advised.

• Corticosteroids: Concurrent use with corticosteroids increases the risk of tendonitis and tendon rupture.

• NSAIDs: Combining Ciprofloxacin with nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of CNS side effects, such as seizures.

Storage:

• Store Ciprofloxacin (Prolaxa) 2mg/ml Solution For IV Infusion in a cool, dry place away from light and moisture.

• Keep the solution at room temperature and avoid freezing it.

• Do not use past the expiration date printed on the packaging.

• Once the vial is opened, the solution should be used immediately or within the timeframe specified by the manufacturer.

Conclusion:

Ciprofloxacin (Prolaxa) 2mg/ml (200mg/100ml) Solution for IV Infusion is a highly effective broad-spectrum antibiotic used to treat a variety of serious bacterial infections. It is typically administered in a hospital setting when oral antibiotics are not appropriate or when rapid intervention is necessary. Ciprofloxacin should be used carefully, particularly in patients with existing heart conditions, liver or kidney issues, or those at higher risk for tendonitis. Like any antibiotic, it is important to follow the prescribed dosage and complete the full course of treatment to avoid the development of resistance. Always consult a healthcare provider for any concerns or side effects during treatment.