Preparation:
Xemimax 500 mg IM/IV injection: Each vial contains Cefepime 500 mg as Cefepime Hydrochloride USP with L-Arginine sterile powder and each ampoule contains 5 ml water for injection BP for reconstitution.
Xemimax 1 gm IM/IV injection: Each vial contains Cefepime 1 gm as Cefepime Hydrochloride USP with L-Arginine sterile powder and each ampoule contains 10 ml water for injection BP for reconstitution.
Description:
Cefepime is a semi-synthetic, broad spectrum, cephalosporin antibiotic for parenteral administration. It 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 beta-lactamases, has a low affinity for chromosomally encoded beta-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-positive Microorganisms: Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Staphylococcus epidermidis, Staphylococcus hominis, Staphylococcus saprophyticus, Streptococcus bovis, Viridans streptococci.
Gram-negative Microorganisms: Acinetobacter calcoaceticus, Enterobacter spp., Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella spp., Moraxella catarrhalis, Morganella morganii, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens. Pseudomonas putida, P. stutzeri, Proteus vulgaris, Aeromonas hydrophila, Capnocytophaga spp., Citrobacter spp., Campylobacter jejuni, Gardnerella vaginalis, Haemophilus ducreyi, Hafnia alvei, Neisseria gonorrhoeae, Neisseria meningitidis, Providencia spp., Salmonella spp., Serratia liquefaciens, Shigella spp., Yersinia enterocolitica.
Anaerobes: Clostridium perfringens, Mobiluncus spp.
Indications:
Xemimax (Cefepime) is indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms:
i. Moderate to Severe Pneumonia due to Streptococcus pneumoniae, Pseudomonas aeruginosa, Klebsiella pneumoniae or Enterobacter species.
ii. Empiric therapy for febrile neutropenic patients.
iii. Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections including pyelonephritis, due to E. coli, K. pneumoniae, or Proteus mirabilis.
iv. Uncomplicated Skin and Skin Structure Infections due to Staphylococcus aureus or Streptococcus pyogenes.
v. Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by Escherichia coli, viridans group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis.
Dosage & Administrations:
The recommended adult and pediatric dosages and routes of administration are outlined in the following table. Xemimax (Cefepime) should be administered over approximately 30 minutes when administered intravenously.
1.Moderate to Severe Pneumonia due to S. pneumoniae*, P.aeruginosa, K. pneumoniae or Enterobacter species. Dose: 1 to 2 gm IV. Frequency : Every 12 hours for 10 days.
2. Empiric therapy for febrile neutropenic patients. Dose: 2 gm IV. Frequency : Every 8 hours for 7** days.
3. Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections including pyelonephritis, due to E. coli, K. pneumoniae, or P. mirabilis.* Dose: 500 mg to 1 gm IV/IM*** Frequency : Every 12 hours for 7-10 days.
4. Severe Uncomplicated or Complicated Urinary Tract Infections including pyelonephritis, due to E. coli or K. pneumonia.* Dose: 2 gm IV. Frequency : Every 12 hours for 10 days.
5. Moderate to Severe Uncomplicated Skin and Skin Structure Infections due to S.aureus or S. pyogenes. Dose: 2 gm IV. Frequency : Every 12 hours for 10 days.
6. Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by E. coli, viridans group streptococci, P. aeruginosa, K. pneumoniae, Enterobacter species, or Bfragilis.Dose: 2 gm IV. Frequency : Every 12 hours for 7-10 days.
*Including cases associated with concurrent bacteremia.
**Or until resolution of neutropenia. In patients whose fever resolves but who remain neutropenic for more than 7 days, the need for continued antimicrobial therapy should be re-evaluated frequently.
***Intramuscular route of administration is indicated only for mild to moderate, uncomplicated or complicated UTIs due to E. coli when the intramuscular route is considered to be a more appropriate route of drug administration.
Warning & Precautions:
Before therapy with Cefepime for injection is instituted, careful inquiry should be made to determine whether the patient has had previous immediate hypersensitivity reactions to Cefepime, Cephalosporins, Penicillins or other drugs. If this product is to be given to penicillin-sensitive patients, caution should be exercised because cross-hypersensitivity among beta-lactam antibiotics has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to Cefepime occurs, discontinue the drug. Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures including oxygen, corticosteroids, intravenous fluids, intravenous antihistamines, pressor amines, and airway management, as clinically indicated.
Side Effects:
Generally Cefepime is well tolerated. The most common side effects are gastrointestinal symptoms and sensitivity reactions. Adverse events that may occurred in body system are: 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. Others- fever, vaginitis, erythema, genital pruritus, chills and unspecified moniliasis. Hepatitis and cholestatic jaundice have occurred less frequently.
Drug Interactions:
Renal function should be monitored carefully if high doses of aminoglycosides are to be administered with Cefepime because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibiotics. Nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide.
Use in Special Groups:
Pregnancy: Pregnancy Category B. However, there are no adequate and well-controlled studies of Cefepime use in pregnant women. Cefepime should be used during pregnancy only if clearly needed.
Nursing Mothers: Cefepime is excreted in human breast milk in very low concentrations (0.5 mcg/ml). Caution should be exercised when Cefepime is administered to a nursing woman.
Contraindications:
Cefepime is contraindicated in patients who have shown immediate hypersensitivity reactions to Cefepime or the cephalosporin class of antibiotics, penicillins or other beta-lactam antibiotics.
Storage Conditions:
Store below 25 ° C. Protected from light and moisture. Use reconstituted solution immediately. Reconstituted solutions are stable for 6 hours at room temperature and for 24 hours at 20° C- 80°C. Keep out of reach of children.
Commercial Pack:
Xemimax 500 mg IM/IV Injection: Each box contains 1 vial of 500 mg Cefepime as Cefepime Hydrochloride USP accompanied by one ampoule of 5 ml water for injection BP, a 5 ml disposable syringe & a baby needle.
Xemimax 1 gm IM/IV Injection: Each box contains 1 vial of 1 gm Cefepime as Cefepime Hydrochloride USP accompanied by one ampoule of 10 ml water for Injection BP, a 10 ml disposable syringe, a butterfly needle & an alcohol pad.
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