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Axim

Cefuroxime

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

Product Details

Presentation

Axim 125 mg Tablet: Each film coated tablet contains Cefuroxime Axetil USP equivalent to Cefuroxime 125 mg.
Axim 250 mg Tablet: Each film coated tablet contains Cefuroxime Axetil USP equivalent to Cefuroxime 250 mg.
Axim 500 mg Tablet: 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 750 mg IM/IV Injection: Each vial contains Cefuroxime Sodium USP sterile powder equivalent to Cefuroxime 750 mg.
Axim IV Injection 1.5 g : Each vial contains Cefuroxime Sodium USP sterile powder equivalent to Cefuroxime 1.5 g.

Pharmacology

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

Indication

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 and early lyme disease.
7. Prophylaxis against infections in abdominal, pelvic, orthopedic, cardiac, pulmonary, oesophageal, & vascular surgery.

Dosage & Administration

Oral:
Adolescents and adults:




















































Infections Dosage Duration (days)
Pharyngitis/tonsillitis 250 mg b.i.d. 10
Acute bacterial maxillary sinusitis 250 mg b.i.d. 10
Acute bacterial exacerbation of chronic bronchitis 250-500 mg b.i.d. 10
Secondary bacterial infections of acute bronchitis 250-500 mg b.i.d. 5-10
Uncomplicated skin and skin structure infections 250-500 mg b.i.d. 10
Uncomplicated urinary tract infections 125-250 mg b.i.d. 7-10
Gonorrhoea 1000 mg once daily Single dose
Early Lyme disease 500 mg b.i.d. 20
MDR Enteric Fever 500 mg b.i.d. 14 days


Children:(over 3 months) Pharyngitis/tonsillitis; 20 mg/day in two divided doses for 10 days. Acute otitis meida, acute bacterial maxillary sinusitis & impetigo: 30 mg / kg /day in two divided doses for 10 days.

Parenteral:

Adults: 750 mg every 6-8 hours; 1.5 g every 6-8 hours. In severe infections: single doses over 750 mg intravenous route only.

Children: usual dose 60 mg / kg daily (range 30-100 mg/kg daily) in 3-4 divided doses (2-3 divided doses in neonates) 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.

Gonorrhoea : 1.5 g as a single dose by intramuscular injection (divided between 2 sites).

Surgical prophylaxix: 1.5 g IV at induction may be supplemented with 750 mg IM every 8 hours for further 24-48 hours (cardiac, pulmonary, oesopheal & vascular operations).

Meningitis: 3g intravenously every 8 hours.
Chlid:200-240 mg/kg daily (in 3-4 divided doses) reduced to 100 mg/kg daily after 3 days or on clinical improvement.
Neonate: 100 mg/kg daily reduced to 50 mg/kg daily.

Preparation of Solutions for Oral Suspension & Intramuscular/Intravenous Injections :

Suspension : Shake the bottle before adding water. Then add 35 ml boiled and cooled water to the bottle to produce 70 ml suspension. Then continue shaking the bottle unit the powder dissolves properly. For 750 mg intramuscular injection: Add 3 ml water for injection BP to vial and then shake gently to dissolve. For 750 mg intravenous injection: Add 6 ml water for injection BP to vial and then shake gently to dissolve.

For 1.5 g intravenous injection: Add 16 ml Water for injection BP to vial and then shake gently to dissolve. Reconstituted injections retain their potency for 24 hours at room temperature or for 48 hours if refrigerated at 5°C.

Contraindications

Patients with known allergy to cephalosporins.

Side effects

Diarrhoea and rarely antibiotic-associated colitis (CSM has warned both more likely with higher doses), nausea and vomiting, abdominal discomfort, headache.

Drug interaction

No potentially hazardous interaction has been reported.

Use in special groups

Use in pregnancy: 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.

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

Packing

Axim 125 mg Tablet: Box containing 10's tablets in Alu-Alu blister pack.
Axim 250 mg Tablet: Box containing 20's tablets in Alu-Alu blister pack.
Axim 500 mg Tablet: Box containing 10's tablets in Alu-Alu blister pack.
Axim powder for suspension: Bottle containing dry powder for the
reconstitution of 70 ml suspension.
Axim IV/Im Injection 750 mg: Combipack of 1 vial of 750 mg Cefuroxime (as sterile Cefuroxime Sodium USP) & 1 ampoule of 10 ml Water for Injection BP.
Axim IV Injection 1.5 g : Combipack of 1 vial of 1.5 g Cefuroxime (as sterile Cefuroxime sodium USP) & 2 ampoules of 10 ml Water for Injection BP.

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