Auro-Cefepime Injection

Adults: AURO CEFEPIME INJECTION is indicated in the treatment of the infections listed below when caused by susceptible bacteria. Culture and susceptibility studies should be performed to determine susceptibility of the causative organism(s) to cefepime.

LOWER RESPIRATORY TRACT INFECTIONS: Nosocomial and Community-Acquired Pneumonia caused by Staphylococcus aureus (methicillin-susceptible strains), Pseudomonas aeruginosa, Klebsiella species (including Klebsiella pneumoniae), Enterobacter species, Escherichia coli, Proteus mirabilis, Streptococcus pneumoniae (including intermediate penicillin resistant strains), Haemophilus influenzae (including beta-lactamase producing strains), Haemophilus parainfluenzae and Moraxella (Branhamella) catarrhalis (including beta-lactamase producing strains), including cases associated with bacteraemia. When P. aeruginosa is isolated or suspected, combination therapy with an aminoglycoside should be used.

Acute Bacterial Exacerbation of Chronic Bronchitis and Acute Bronchitis due to Streptococcus pneumoniae (including intermediate penicillin resistant strains), Haemophilus influenzae (including beta-lactamase producing strains), Moraxella (Branhamella) catarrhalis (including beta-lactamase producing strains).

URINARY TRACT INFECTIONS: Complicated Urinary Tract Infections caused by Escherichia coli, Pseudomonas aeruginosa, Klebsiella pneumoniae, Proteus mirabilis and Enterobacter species, including cases associated with bacteraemia. When P. aeruginosa is isolated or suspected, combination therapy with an aminoglycoside should be used. Uncomplicated Urinary Tract Infections due to Escherichia coli, Proteus mirabilis, Klebsiella species and Enterobacter species.

SKIN AND SKIN STRUCTURE INFECTIONS: Skin and Skin Structure Infections caused by Staphylococcus aureus (methicillin-susceptible strains), Streptococcus pyogenes (Group A streptococci), Streptococcus agalactiae (Group B streptococci), other beta-haemolytic Streptococcus species, Enterobacter species, Klebsiella species, Proteus mirabilis, Morganella morganii, Escherichia coli, Serratia marcescens and Acinetobacter calcoaceticus.

INTRA-ABDOMINAL INFECTIONS: Complicated Intra-abdominal Infections Including Peritonitis and Biliary Tract Infections caused by Escherichia coli, sensitive Pseudomonas aeruginosa. Peritonitis is often polymicrobial and may include anaerobic micro-organisms such as bacteroides species which are resistant to cefepime. When resistant anaerobes are suspected, cefepime should be combined with an antibiotic effective against these micro-organisms, including cases associated with bacteraemia. In patients who are at risk of mixed aerobic-anaerobic infection, including infections in which Bacteroides fragilis may be present, concurrent therapy with an anti-anaerobic agent is recommended.

EMPIRIC TREATMENT IN FEBRILE NEUTROPENIA: AURO CEFEPIME INJECTION is indicated for empiric monotherapy of febrile neutropenia. Combination of AURO CEFEPIME INJECTION with other appropriate antimicrobial agents should be considered in patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, hypotension at presentation, an underlying haematologic malignancy, or severe or prolonged neutropenia) or when called for by host; or local epidemiological factors.

Children: AURO CEFEPIME INJECTION is indicated in children (2 months and older) for the treatment of the infections listed below when caused by susceptible bacteria, (when P. aeruginosa is isolated or suspected, combination therapy with an aminoglycoside should be used):

LOWER RESPIRATORY TRACT INFECTION: Pneumonia caused by S. aureus, S. pneumoniae, H. influenzae.

URINARY TRACT INFECTIONS: caused by E. coli.

SKIN AND SKIN STRUCTURE: Infections caused by Staphylococcus epidermidis, streptococcus, S. aureus, S. pyogenes.

EMPIRIC TREATMENT IN FEBRILE NEUTROPENIA: AURO CEFEPIME INJECTION is indicated for empiric monotherapy of febrile neutropenia. Combination of AURO CEFEPIME INJECTION with other appropriate antimicrobial agents should be considered in patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, hypotension at presentation, an underlying haematologic malignancy, or severe or prolonged neutropenia) or when called for by host or local epidemiological factors.

AURO CEFEPIME INJECTION is contraindicated in patients who have had previous hypersensitivity reactions to any component of the formulation, the cephalosporin class of antibiotics, penicillins or other beta-lactam antibiotics.

In patients with impaired renal function, such as reduction of urinary output because of renal insufficiency (creatinine clearance u2264 50 mI/min) or other conditions that may compromise renal function, the dosage of AURO CEFEPIME INJECTION should be adjusted to compensate for the slower rate of renal elimination. Because high and prolonged serum antibiotic concentrations can occur from usual dosages in patients with renal insufficiency or other conditions that may compromise renal function, the maintenance dosage should be reduced when AURO CEFEPIME INJECTION is administered to such patients. Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organisms (see u201cDOSAGE AND DIRECTIONS FOR USEu201d and u201cPharmacokineticsu201d).

Special Precautions: Antibiotics should be administered with caution to any patient who has demonstrated some form of allergy, particularly to medicines. If an allergic reaction to AURO CEFEPIME INJECTION occurs, discontinue the medicine and treat the patient appropriately. Serious immediate hypersensitivity reactions may require epinephrine and other supportive therapy. Pseudomembranous colitis has been reported with virtually all broad-spectrum antibiotics including AURO CEFEPIME INJECTION; therefore, it is important to consider this diagnosis in patients who develop diarrhoea in association with the use of antibiotics. Mild cases of colitis may respond to drug discontinuation alone; moderate to severe cases may require more elaborate management. Use of AURO CEFEPIME INJECTION may result in overgrowth of non-susceptible organisms. Should super-infection occur during therapy, appropriate measures should be taken.

Renal Impairment: Renal function should be monitored carefully if medicines with nephrotoxic potential, such as aminoglycosides and potent diuretics, are administered with AURO CEFEPIME INJECTION.

Geriatric Use: AURO CEFEPIME INJECTION is known to be substantially excreted by the kidney and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and renal function should be monitored (see u201cSIDE-EFFECTSu201d and u201cPHARMACOLOGICAL ACTIONu201d). Serious adverse events, including reversible encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma) myoclonus, seizures (including non-convulsive status epilepticus), and/or renal failure have occurred in geriatric patients with renal insufficiency given the usual dose of AURO CEFEPIME INJECTION.

AURO CEFEPIME INJECTION exhibits physical or chemical incompatibility when admixed with vancomycin hydrochloride, gentamycin sulphate and aminophylline. In patients treated with AURO CEFEPIME INJECTION, false positive urinary tests for glucose may result when reducing agents are employed. False positives are not seen with glucose-oxidase methods.

The safe use of AURO CEFEPIME INJECTION in pregnancy and lactation has not been established.

Not provided in the document.

Haematological disorders: Less frequent: Haemolytic anaemia, transient leukopenia, neutropenia, and thrombocytopenia. The following side-effects have been reported and frequencies are unknown: Agranulocytosis, aplastic anaemia, haemorrhage.

Immune system disorders: Frequent: Eosinophilia. Less frequent: Anaphylaxis. The following side-effects have been reported and frequencies are unknown: Fever.

Nervous system disorders: Frequent: Headache. Less frequent: Dizziness, seizures. The following side-effects have been reported and frequencies are unknown: Paraesthesia.

Vascular disorders: The following side-effects have been reported and frequencies are unknown: Vasodilation.

Respiratory, thoracic and mediastinal disorders: The following side-effects have been reported and frequencies are unknown: Dyspnoea, fever, chills.

Gastrointestinal disorders: Frequent: Diarrhoea, nausea, vomiting, oral moniliasis. Less frequent: Pseudomembranous colitis, dyspepsia. The following side-effects have been reported and frequencies are unknown: Colitis, taste perversion, constipation, abdominal pain.

Hepato-biliary disorders: The following side-effects have been reported and frequencies are unknown: Hepatitis and cholestatic jaundice.

Skin and subcutaneous tissue disorders: Less frequent: Rash, pruritus, urticaria, erythema, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome. The following side-effects have been reported and frequencies are unknown: Unspecified moniliasis.

Reproductive system and breast disorders: Less frequent: Vaginitis. The following side-effects have been reported and frequencies are unknown: Genital pruritus.

General disorders and administration site conditions: Less frequent: Local reactions such as phlebitis and inflammation at the site of IV injection and inflammation or pain at the site of intramuscular injection.

(See u201cSIDE - EFFECTSu201d.) Treatment should be symptomatic and supportive. In case of severe overdosage, especially in patients with compromised renal function, haemodialysis will aid in the removal of AURO CEFEPIME INJECTION from the body; peritoneal dialysis is of no value. Accidental overdosing has occurred when large doses were given to patients with impaired renal function (see u201cDOSAGE AND DIRECTIONS FOR USEu201d, u201cSIDE-EFFECTSu201d).