SPECTRAXIME (Cefuroxime for Injection IP)

SPECTRAXIME (Cefuroxime sodium) is a semi synthetic broad spectrum bactericidal cephalosporin for parenteral administration. It is the sodium salt of 16 R, 7R -3- Carbamoyloxy methyl-7 (Z-2-methoxy-imino-2(fur-2-yl) ceph-3-em-4-carboxylate.

SPECTRAXIME acts on the bacterial cell wall and prevents the synthesis of polypeptide cross linkages by binding to the PBPs.

Cefuroxime is usually active against the following organisms invitro.

Gram-positive aerobes:
Staphylococcus aureus (including penicillinase and non-penicillinase producing strins), Staphylococcus epidermis, Streptococcus pneumoniae, Streptococcus pyogenes (and other streptococci)

Gram-negative aerobes:
Haemophilus influenzae (including ampicillin-resistant strains), Haemophilus parainfluenzae, Neisseria gonorrhoeae(including penicillinase and non-penicillinase producing strains), Niesseria meningitides, Escherichia coli, Klebsiella spp. (including klebsiella pneumoniae), Citrobacter spp., Enterobacter spp., Salmonella spp., Shigella spp., Proteus mirabilis, Providencia rettgeri, Morganella morganii,
Moraxella (Branhamella ) Catarrhalis.

Anaerobes:
Gram positive and Gram negative cocci (including peptococcus and peptostreptococcus spp.)
Gram positive bacilli (including clostridium spp.)
Gram negative bacilli (including bacteroides and fusobacterium)

Following organisms are not susceptible to cefuroxime
Enterobacter cloacae, cirobacter spp., Enterococcus, Strains of bacteroides fragillis, Pseudomonas, campylobacter spp,
Acinetobacter calcoacerticus, serratia spp, Proteus vulgaris, Methicillin resistant staphylococci, clostridium difficile and Listeria monocytogenes.

Composition:

Each vial contains:

Cefuroxime sodium IP sterile

Cefuroxime 250 mg / 750 mg / 1500 mg

Contra-Indications, Precautions and Waring:
Cefuroxime sodium is contraindicated in patients known to be hypersensitive to cephalosporin antibiotics.
Cephalosporin antibiotics may in general be given safely to patients, who are hypersensitive to penicillin, although cross-reactions have been reported. Special care needs to be taken in patients who have history of allergic reaction or an anaphylactic reactions to penicillin.

Interaction:
Spectraxime does not interfere in enzyme-based tests for glycosuria. Slight interference with copper reduction methods (Benedict's, Fehling's, Clinitest) may be observed. However, this should not lead to false-positive results, as may be experienced with some other cephalosporins.

Pregnancy and Lactation: There is no experimental evidence of embryopathic or teratogenic effects attributable to cefuroxime, but, as with all drugs, it should be administered with caution during the early months of pregnancy. Cefuroxime is excreted in human milk, and consequently caution should be exercised when Spectraxime is administered to a nursing mother.

Side Effects:
Adverse reactions to SPECTRAXIME have occurred relatively infrequently and have been generally mild and trasient in nature. There have been rare reports of hypersensitivity reactions including skin rashes, urticaria, pruritis, interstitial nephritis, drug fever and very rarely anaphylaxis.

Reports of erythema multiforme, Steven-Johnson syndrome and toxic epidermal necrolysis are rare. The principal changes in haematological parameters seen in some patients have been decreased haemoglobin concentration and of eosinophilia, leukopenia and neutropenia.

A positive Coombs test has been found in some patients treated with cefuroxime - this phenomenon can interfere with the cross-matching of blood. Although there are sometimes transient rises in serum liver enzymes or serum bilirubin, particularly in patients with pre-existing liver disease, there is no evidence of adverse effect to the liver.

Elevations in serum creatinine and/or blood urea nitrogen and decreased creatinine clearance have been observed. Transient mild pain may be experienced at the site of intramuscular injection. This is more likely to occur with higher doses.
Occasionally, thrombophlebitis may follow intravenous injection.

Dosage:

Administered at 2 different sites with 1 g oral probenecid.

Usual Adult dosage:
750 mg to 1500 mg IM or IV every 8 hours usually 5 to 10 days. It is advisable to continue Spectraxime therapy for at least 48 hours after the complete remission of symptoms.

Renal function impairment:
Reduce dosage

Parenteral cefuroxime dosage in Renal impairment (Adults)
Creatinine Clearance (ml/min)	Dose and Frequency
>20	750 mg to 1500 mg every 8 hours
10 to 20	750 mg every 12 hours
<10	750 mg every 24 hours

Since Cefuroxime is dialyzable, give patients on haemo-dialysis is a further dose at the end of dialysis.

Prophylaxis:
The usual dose is 1500 mg I V with induction of anaesthesia for abdominal, pelvic and orthopaedic operations. This may be supplemented with two 750 mg I.M. doses eight and sixteen hours later. In cardiac, pulmonary, oesophageal and vascular operations, the usual dose is 1500 mg I V with induction of anaesthesia,continuing with 750 mg I M t.d.s. for a further 24 to 48 hours.

Infants and Children:
Doses of 30 to 100 mg/kg/day given as three or four divided doses. A dose of 60 mg/kg/day is appropriate for most infections.

Neonates:
Doses of 30 to 100 mg/kg/day given as two or here divided doses. In the first weeks of life the serum half-life of cefuroxime can be three to five times that in the adult. Gonorrhoea: 1500 mg as a single dose (as 2X 750 mg injections intr-muscularly) with different sites, e.g,. each buttock).

Meningitis:
Spectraxime is suitable for mono therapy of bacterial meningitis due to sensitive strains.

Adults:
3 g IV every eight hours.

Infants & children:
150 - 250 mg/kg/day IV in 3 or 4 divided doses.

Neonates:
The dosage should be 100 mg/kg/day IV

Administration:

Strength	Route	Minimum diluent to add(ml)y
250 mg	IM	1 ml Sterile water for injection
750 mg	IM	3 ml Sterile water for injection
1500 mg	IM	5 ml Sterile water for injection
250 mg	IV	2 ml Sterile water for injection
750 mg	IV	6 ml Sterile water for injection
1500 mg	IV	15 ml Sterile water for injection

Intravenous infusion: For short intravenous infusion (e.g. upto 30 minutes), 1500 mg may be dissolved in 50-100 ml Sterile Water for injections. These solutions may be given directly into the vein or introduced into the tubing of the giving set if the patient is receiving parenteral fluids.

Storage:
Protect from light. Store in a dry place at a temperature not exceeding 25° C.

Incompatibilities:

1. Spectraxime should not be mixed in the syringe with amioglycoside antibiotics.
2. Sodium Bicarbonate injection BP is not recommended for the dilution of SPECTRAXIME.
3. Recommended storage condition for Reconstituted Suspension / Solution Suspension / Solution should be used within 5 hrs of preparation if stored at a temperature below 25 °C within 48 hrs if stored between 2°C and 10°C.
4. More dilute solutions, such as 750 mg or 1500 mg reconstituted with 50 to 100 ml sterile water for injections, 5% dextrose injection or 0.9% sodium chloride injection maintain satisfactory potency for 24 hours at room temperature and for 72 hours under refrigeration at 5°C.
5. Some change in the colour of prepared solutions and suspensions of Spectraxime may occur on storage, which does not indicate any loss of potency.