Novapime

Cefepime HCl.

Novapime is a 4th generation injectable cephalosporin antibiotic intended for IM or IV administration.
Microbiology: Cefepime is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. It has a spectrum of activity against a range of gram-positive and gram-negative bacteria. Cefepime is highly resistant to hydrolysis by a number of β-lactamases, has a low affinity for chromosomally encoded β-lactamases and exhibits rapid penetration into gram-negative bacterial cells.
Cefepime has been shown to be active against most strains tested of the following organisms both in vitro and in clinical infections.
Gram-Negative Aerobes: Acinetobacter calcoaceticus (subsp anitratus, lwoffi); Enterobacter spp (including E. aerogenes, E. agglomerans, E. cloacae, E. sakazakii), Escherichia coli; Haemophilus influenzae (including strains of β-lactamase-producing H. influenzae); Haemophilus parainfluenzae; Klebsiella spp (including K. oxytoca, K. ozaenae, K. pneumoniae); Moraxella catarrhalis (formerly Branhamella catarrhalis); Morganella morganii; Proteus mirabilis; Pseudomonas aeruginosa; Serratia marcescens.
Cefepime exhibits in vitro minimum inhibitory concentrations (MICs) of ≤8 mcg/mL against ≥90% of the strains of the following microorganisms; however, in vitro activity does not necessarily imply clinical efficacy.
Gram-Positive Aerobes: Staphylococcus aureus (including β-lactamase-producing strains but excluding methicillin-resistant staphylococci), Staphylococcus epidermidis (including β-lactamase-producing strains), Staphylococcus hominis, Staphylococcus saprophyticus, Group D streptococci (Streptococcus bovis), Viridans streptococci.
Anaerobes: Clostridium perfringens, Mobiluncus sp.
Pharmacokinetics: The average plasma concentration of cefepime observed in healthy adult male volunteers at various times following single 30-min infusion (IV) of cefepime 500 mg, 1 g and 2 g are summarized in Table 1. Elimination of cefepime is principally via renal excretion with an average (±SD) t_½ of 2±0.3 hrs.
There is no evidence of accumulation. The protein-binding of cefepime in blood is approximately 20% and is independent of its concentration in serum. Cefepime is excreted unchanged in urine which accounts for approximately 85% of the administered dose. (See Tables 1 and 2.)

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Lower respiratory tract infection, empiric therapy for febrile neutropenia, uncomplicated and complicated urinary tract infection, uncomplicated skin and skin structure infections and complicated intra-abdominal infections.

Novapime can be administered either IV or IM.
The dosage and route vary according to the susceptibility of the causative organisms, the severity of the infection and the overall condition and renal function of the patient. (See Table 3.)

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Children 2 months to 16 years: The maximum dose should not exceed that for the adults. Usual Recommended Dose: 50 mg/kg/dose every 12 hrs (every 8 hrs for febrile neutropenic patients).
Administration: For direct IV administration, constitute the 500 mg, 1 g or 2 g vial, and add an appropriate quantity of the resulting solution to an IV container with one of the compatible IV fluids. The resulting solution should be administered over approximately 30 min.
For IM administration, Novapime should be constituted with one of the following diluents: Sterile water for injection, 0.9% sodium chloride, 5% dextrose injection, 0.5% or 1% lidocaine hydrochloride or sterile bacteriostatic water for injection. (See Table 4.)

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Patients who have had previous hypersensitivity reactions to any component of Novapime, the cephalosporin class of antibiotics, penicillins or other β-lactam antibiotics.
Use in pregnancy & lactation: Safety of use in pregnancy and lactation has not been established.

Concomitant administration of antibiotic should be done with caution to avoid any hypersensitivity reaction.

Use is contraindicated during pregnancy. Safety of use in pregnancy and lactation has not been established.

Hypersensitivity: Anaphylaxis, rash, pruritus, urticaria, fever.
Gastrointestinal: Diarrhoea, nausea, vomiting, oral moniliasis, colitis (including pseudomembranous colitis), taste perversion, constipation, abdominal pain, dyspepsia.
Cardiovascular: Vasodilation.
Respiratory: Dyspnea.
Central Nervous System: Headache, dizziness, paraesthesia, seizures have been reported.
Hepatitis and cholestatic jaundice have occurred less frequently.
Local reactions eg, phlebitis and inflammation at the site of IV injection and inflammation or pain at the site of IM injection occurred with some patients.

Concomitant administration of aminoglycosides or diuretics may lead to nephrotoxicity.

In the dry state, store between 2-25°C (36-77°F). Protect from light.

Cephalosporins

J01DE01 - cefepime ; Belongs to the class of fourth generation cephalosporins. Used in the systemic treatment of infections.

POM

Inj (vial) 1 g x 1's. 2 g x 1's.