AXIM

Cefuroxime

Description:

Axim is a preparation of Cefuroxime. Cefuroxime is a semi-synthetic, broad-spectrum 2^nd generation cephalosporin antibiotic for oral & parenteral administration.

Composition:

Axim Tablet 125 mg: Each film coated tablet contains Cefuroxime Axetil USP equivalent to Cefuroxime 125 mg.

Axim Tablet 250 mg: Each film coated tablet contains Cefuroxime Axetil USP equivalent to Cefuroxime 250 mg.

Axim Tablet 500 mg: Each film coated tablet contains Cefuroxime Axetil USP equivalent to Cefuroxime 500 mg.

Axim powder for suspension: After reconstitution each 5 ml contains Cefuroxime Axetil USP equivalent to Cefuroxime 125 mg.

Axim Injection 750 mg: Each vial contains Cefuroxime Sodium USP sterile powder equivalent to Cefuroxime 750 mg.

Clinical Pharmacology:

Axim is active against a wide range of gram-positive & gram-negative bacteria including Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae, Neisseria spp, Haemophilus influenzae and many common gram- negative hospital pathogenes such as Escherichia coli, Klebsiella spp., Proteus mirabilis. Axim has noteworthy activity against beta-lactamase producing strains of Haemophilus influenzae and Neisseria gonorrhoeae, which are resistant to ampicillin and penicillin.

Indications:

1. Upper and lower respiratory tract infections, such as acute and chronic bronchitis, pneumonia, sinusitis, otitis media, tonsillitis & pharyngitis. 2. Skin & soft tissue structure infections such as peritonitis, wound infections and impetigo, 3. Urinary tract infections such as pyelonephritis and cystitis. 4. Gonorrhoea. 5. Septicaemia. 6. Meningitis. 7. Prophylaxis against infections in abdominal, pelvic, orthopedic, cardiac, pulmonary, oesophageal, & vascular surgery.  8. Early Lyme disease.

Dosage & Administration:

Oral:

Adolescents and adults:

Children over 3 months: 125 mg twice daily, if necessary doubled in children over 2 years with acute otitis media.

 Parenteral:

Adults: Usual dose is 750 mg every three to four daily intravenously or intramuscularly. In severe infections: 1.5 g IV 3-4 times daily. Pneumonia: Sequential therapy: 1.5 g twice daily IV/IM for 48/72 hours followed by 500 mg Cefuroxime oral therapy for 7 days. Acute exacerbation of chronic bronchitis: Sequential therapy: 750 mg twice daily IV/IM for 48/72 hours followed by 500 mg Cefuroxime oral therapy for 5-10 days. Children above 3 months: 30-100 mg/kg body weight daily in equally divided doses every 6 to 8 hours. Prophylaxis: 1.5 g IV/IM with induction of anesthesia followed by 750 mg IM at 8 hours & 16 hours or three times daily for a further 24-48 hours.

Contraindications:

Patients with known allergy to cephalosporins.

Adverse Reactions:

Diarrhoea and rarely antibiotic-associated colitis (CSM has warned both more likely with higher doses), nausea and vomiting, abdominal discomfort, headache; allergic reactions including rashes, pruritus, urticaria, serum sickness-like reactions with rashes, fever and arthralgia, and anaphylaxis; erythema multiforme, toxic epidermal necrolysis reported; disturbances in liver enzymes, transient hepatitis and cholestatic jaundice; other side-effects reported include eosinophilia and blood disorders (including thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia and haemolytic anaemia); reversible interstitial nephritis, hyperactivity, nervousness, sleep disturbances, confusion, hypertonia, and dizziness.

High Risk Group:

Children: Cefuroxime Axetil cannot be used in children under 3 months of age.

Pregnant women: While all antibiotics should be avoided in the first trimester if possible cefuroxime has been safely used in later pregnancy to treat urinary and other infections.

Drug Interaction:

No potentially hazardous interaction has been reported.

Packing:

Axim Tablet 125 mg: Box containing 1x10's/2x10's tablets in alu/alu blister pack.

Axim Tablet 250 mg: Box containing 1x10's tablets in alu/alu blister pack.

Axim Tablet 500 mg: Box containing 1×10's tablets in alu-alu blister pack.

Axim powder for suspension: Bottle containing dry powder for the reconstitution of 70 ml suspension.

Axim IM Injection 750 mg: Combipack of 1 vial of 750 mg Cefuroxime (as sterile Cefuroxime Sodium USP) & 1 ampoule of 5 ml Water for Injection BP.