Cefotaxime (Cefolan) 1g Powder for Injection (I.M/I.V) Antibacterial Vial 1's

Cefotaxime (Cefolan) 1g Powder for Injection (I.M/I.V) Antibacterial Vial 1's

Product Description:

Cefolan 1g is a sterile powder for injection containing Cefotaxime, a third-generation cephalosporin antibiotic. It is designed to be reconstituted and administered either intravenously (IV) or intramuscularly (IM). Cefotaxime is effective against a wide range of bacterial infections by inhibiting bacterial cell wall synthesis, thus preventing bacteria from growing and reproducing.

Each vial of Cefolan contains 1g of Cefotaxime, and the reconstitution of the powder results in a solution for injection. The medication is used in hospitals and healthcare settings for the treatment of moderate to severe infections.

Indications:

Cefolan (Cefotaxime) is used for the treatment of various bacterial infections caused by susceptible organisms, including:

1. Respiratory Tract Infections:

   • Pneumonia (community-acquired and hospital-acquired).

   • Bronchitis (acute exacerbation).

   • Sinusitis.

   • Pharyngitis and tonsillitis.

2. Urinary Tract Infections:

   • Cystitis (bladder infection).

   • Pyelonephritis (kidney infection).

3. Intra-abdominal Infections:

   • Peritonitis.

   • Intra-abdominal abscesses.

4. Gynecological Infections:

   • Pelvic inflammatory disease (PID).

   • Endometritis.

5. Meningitis:

   • Cefotaxime is often used in the treatment of bacterial meningitis, particularly for infections caused by Neisseria meningitidis, Haemophilus influenzae, and Streptococcus pneumoniae.

6. Sepsis:

   • Used for the management of septicemia or bacteremia, often in combination with other antibiotics.

7. Soft Tissue Infections:

   • Cellulitis, wound infections, and abscesses.

8. Bone and Joint Infections:

   • Osteomyelitis and septic arthritis.

9. Surgical Prophylaxis:

   • Preventative use in surgeries where there is a high risk of infection.

Dosage and Administration:

The dosage of Cefolan 1g is individualized based on the type and severity of the infection, the patient's age, weight, renal function, and the specific pathogen involved. The usual recommended dosages are as follows:

• Adults:

  • Moderate to severe infections: 1-2g every 12 hours, administered via IV or IM.

  • Severe infections or life-threatening infections: 2g every 8 hours.

  • Meningitis: 2g every 6-8 hours.

• Children:

  • Infants and children (2 months - 12 years): 50-100mg/kg/day, divided into two or three doses, depending on the severity of the infection.

  • Neonates (up to 2 months): 50mg/kg/day divided into two doses (every 12 hours).

• Renal Impairment:

  • For patients with impaired renal function, the dose should be adjusted based on creatinine clearance. In severe renal impairment (creatinine clearance <10 mL/min), the dosing interval should be extended.

Administration:

• Intravenous (IV) Injection: Administer slowly over 3-5 minutes.

• Intramuscular (IM) Injection: Administer deep into the muscle, typically in the gluteus or thigh.

Side Effects:

While Cefolan (Cefotaxime) is generally well-tolerated, like any medication, it can cause side effects. Common side effects include:

1. Gastrointestinal Issues:

   • Diarrhea.

   • Nausea.

   • Vomiting.

   • Abdominal pain.

2. Hematologic Effects:

   • Leukopenia (low white blood cell count).

   • Eosinophilia (high eosinophil count).

   • Thrombocytopenia (low platelet count).

   • Hemolytic anemia.

3. Skin Reactions:

   • Rash.

   • Urticaria (hives).

   • Pruritus (itching).

4. Hepatic Effects:

   • Elevated liver enzymes (AST, ALT).

   • Jaundice (yellowing of the skin or eyes) in severe cases.

5. Renal Effects:

   • Nephrotoxicity (rare but possible in high doses or in patients with pre-existing kidney conditions).

6. Allergic Reactions:

   • Anaphylaxis (a severe allergic reaction, though rare).

   • Angioedema (swelling of deeper skin layers, particularly around the eyes and lips).

7. Injection Site Reactions:

   • Pain, redness, or swelling at the site of the injection.

8. Superinfections:

   • Long-term use may lead to the overgrowth of non-susceptible organisms, such as Clostridium difficile, leading to pseudomembranous colitis.

Contraindications:

Cefolan (Cefotaxime) is contraindicated in the following conditions:

1. Hypersensitivity to Cephalosporins:

   • Contraindicated in patients with a known allergy to Cefotaxime, other cephalosporins, or any component of the formulation. Cross-reactivity may occur in individuals allergic to penicillins.

2. Severe Renal Impairment (if unadjusted):

   • In patients with severe renal impairment, caution is required, and dosage adjustments must be made to avoid toxicity.

3. Neonates with Hyperbilirubinemia:

   • Cefotaxime should be avoided in neonates with hyperbilirubinemia (high levels of bilirubin) as it may increase the risk of bilirubin encephalopathy.

4. History of Severe Allergic Reactions:

   • Caution is advised in individuals with a history of severe allergic reactions (e.g., anaphylaxis) to any class of beta-lactam antibiotics, including cephalosporins.

Precautions and Warnings:

• Renal Impairment: Adjust the dose in patients with renal dysfunction to prevent accumulation and toxicity.

• Superinfection: Prolonged use of antibiotics may result in the development of superinfections, particularly with resistant organisms. Monitor for signs of new infections during treatment.

• Gastrointestinal Effects: Patients should be monitored for gastrointestinal disturbances, particularly Clostridium difficile-associated diarrhea. If diarrhea becomes severe, the medication should be discontinued.

• Pregnancy and Lactation:

  • Pregnancy Category B: Cefotaxime should be used during pregnancy only if clearly needed. It is not known whether Cefotaxime is excreted in breast milk, but it is generally considered safe for breastfeeding mothers when used appropriately.

• Use in Elderly: Elderly patients, especially those with reduced renal function, should receive a modified dose to avoid the risk of toxicity.

Conclusion:

Cefolan 1g (Cefotaxime) is a broad-spectrum antibiotic used to treat serious bacterial infections. It is commonly used in hospital settings to manage severe infections such as pneumonia, sepsis, and meningitis. Though it is effective for a wide range of bacterial pathogens, it must be used cautiously in patients with renal impairment and those with a history of allergic reactions to beta-lactam antibiotics. Proper dosing, monitoring, and management of side effects are essential to ensure safe and effective treatment. Always consult a healthcare provider for the appropriate usage and dosage tailored to the patient's specific condition.