Auro Cefuroxime Injection

AURO CEFOTAXIME is indicated for the treatment of infections caused by susceptible strains of organisms in the following infections:-

Upper Respiratory Tract Infections:

• Pneumococcal infections u2013 Pneumonia, bronchitis, cellulites, otitis media
• Haemophilus influenzae infections u2013 Otitis media, laryngotracheobronchitis, meningitis (in children)

Urinary tract infections:

• E.coli infections u2013 Pneumonia, urinary tract infections, meningitis (in children)

Gastrointestinal Infections:

• Shigella infections u2013 Bacillary dysentery
• Salmonella infections u2013 Enteritis

Other:

• Neisseria meningitides u2013 Meningitis (in children)
• Acute uncomplicated cystitis caused by E. coli and Klebsiella pneumoniae.

Note: Bacteriological tests to determine causative organisms and sensitivities are recommended.

AURO CEFOTAXIME is indicated perioperatively to reduce the incidence of post-operative infections in patients undergoing surgical procedures classified as potentially contaminated.

Dosage, route of administration and frequency of injections depends on the nature and severity of the infection, the condition of the patient and the sensitivity of the pathogens to AURO CEFOTAXIME.

Adults: 2 g daily administered as two injections of 1 g. In severe injections, the dose may be increased to 3 g or 4 g daily given in 2 to 4 administrations. Very severe infections may require a dose of up to 12 g IV.

Children:

• Neonates (0 to 1 week of age): 50 mg/kg body weight IV 12-hourly
• Neonates (1 to 4 weeks of age): 50 mg/kg body weight IV 8-hourly

Note: It is not necessary to differentiate between premature and normal gestational age infants.

Infants and children: 50 mg/kg to 100 mg/kg weight administered in 2 to 4 injections. In exceptional cases, the dose may be increased to 200 mg/kg body weight per day.

Renal function impairment: Reduce the dose by 50% in patients with a creatinine clearance of less than 20 ml/minute. Do not alter the dosing intervals.

Directions for preparation of injections:

IV and IM injections: Dissolve AURO CEFOTAXIME in Water For Injection (WFI) BP (0.5 g vial in 2 ml WFI: 1g vial in 4 ml WFI). Shake vial until dissolved. Withdraw the entire contents of the vial into the syringe and use immediately.

Intravenous infusions: Dissolve AURO CEFOTAXIME 1 g or 2 g vials in 40 to 100 ml of: - Water For Injection, 0.9% sodium chloride, 5% dextrose or Ringeru2019s solution. The prepared infusion solutions should be administered over 20 to 60 minutes.

Note: Use freshly prepared solution. AURO CEFOTAXIME IV infusion solution in a concentration of 1 g per 250 ml is stable for 24 hours in a refrigerator or for 12 hours at a temperature not exceeding 23 u00b0C.

Hypersensitivity to cefotaxime, cephalosporin antibiotics or to any of the ingredients.

Hypersensitivity to penicillin and other beta-lactam antibiotics.

The sodium content of cefotaxime sodium (48.2 mg/g) should be taken into consideration in patients on sodium restriction. The white cell count should be monitored for treatment courses of more than 10 days. Treatment should be discontinued in the event of neutropenia. Pseudomembranous colitis has been reported with the use of AURO CEFOTAXIME. Patients who develop abdominal or stomach cramps, abdominal tenderness, severe and watery diarrhoea (which may be blood) and fever should be investigated for this diagnosis. If the diagnosis of pseudomembranous colitis is suspected AURO CEFOTAXIME should be stopped immediately and the appropriate therapy initiated.

AURO CEFOTAXIME should be used with caution in patients with:

• A history of gastrointestinal disease, especially ulcerative colitis, regional enteritis or antibiotic-associated colitis.
• Renal function impairment u2013 A reduced dose may be required (see DOSAGE AND DIRECTIONS FOR USE).
• Porphyria: Safety has not been established.

Concurrent administration of potentially nephrotoxic medicines or diuretics may increase the risk of possible nephrotoxicity. Do not mix AURO CEFOTAXIME with another antibiotic in the same syringe or infusion solution.

Interaction with Laboratory tests: A positive Coombs reaction appears in patients who receive large doses of AURO CEFOTAXIME. Haemolysis is not usually associated with the phenomenon but it may interfere with cross-matching of blood. AURO CEFOTAXIME may give false-negative test results with ferricyanide blood glucose test. A false-positive reaction can occur on testing for glucose in the urine with reducing substances. This can be avoided with the use of methods specific to gluco-oxidase.

Safety and efficacy in pregnancy and lactation has not been established.

Not provided in the text.

Side Effects

Blood and lymphatic system disorders

• Frequent: eosinophilia
• Less frequent: haemolytic anaemia, neutropenia, thrombocytopenia (reversible)

The following side effects have been reported and frequencies are unknown:

• Agranulocytosis

Cardiovascular disorders

The following side effects have been reported and frequencies are unknown:

• Arrhythmias following rapid bolus infusion through a central venous catheter

Nervous system disorders

• Frequent: headache
• The following side effects have been reported and frequencies are unknown: confusion, encephalopathy

Gastrointestinal disorders

• Frequent: diarrhoea, nausea, vomiting, abdominal pain

Renal and urinary disorders

• Less frequent: decrease in renal function (especially when co-prescribed with aminoglycosides)
• The following side effects have been reported and frequencies are unknown: interstitial nephritis

Hepato-biliary disorders

The following side effects have been reported and frequencies are unknown:

• Transient increases in hepatic enzyme levels and / or bilirubin (Values may exceed twice the upper limit of normal and lead to asymptomatic cholestatic liver injury.)

Skin and subcutaneous tissue disorders

• Less frequent: rash, pruritus, urticaria, erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis

General disorders and administration site conditions

• Less frequent: local inflammatory reactions at the injection site

Immune system disorders

• Less frequent: Hypersensitivity reactions including skin rashes, urticaria, pruritus, bronchospasm, drug fever, serum sickness, shock, anaphylaxis

Symptoms of overdose: Encephalopathy (impairment of consciousness, abnormal movements and seizures) has been reported.

Treatment of overdose: Treatment is symptomatic and supportive.