Pime-4®

Cefepime
Pime-4®

Prescribing Details



Description

Pime-4 ® is a preparation of Cefepime Hydrochloride. It is a semi-synthetic, fourth generation broad spectrum cephalosporin with a wide range of activity against gram-positive andgram-negative bacteria. Cefepime is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. It is highly resistant to hydrolysis by most beta-lactamases and exhibits rapid penetration into gram negative bacterial cells.


Uses

No Data


Indications

Pime-4 ® is indicated in the treatment of the following infections:

  1. Moderate to Severe Pneumonia due to S. pneumoniae, P. aeruginosa, K. pneumoniae, or Enterobacter species
  2. Empiric therapy for Febrile Neutropenic patients
  3. Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli, K. pneumoniae, or P. mirabilis
  4. Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli or K. pneumoniae
  5. Moderate to Severe Uncomplicated Skin and Skin Structure Infections due to S. aureus or S. pyogenes
  6. Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by E. coli, viridans group streptococci, P. aeruginosa, K. pneumoniae, Enterobacter species, or B. fragilis.

Dosage and administration

Pime-4 ® can be administered either IV or IM. The dose and route of administration should be determined according to the susceptibility of the causative organism, the severity of the infection and the condition and renal function of the patient; higher doses or more frequent administration may be required in pseudomonal infections. Pime-4 ® should be administered intravenously over approximately 30 minutes.

Recommended adult dosage and routes of administration schedule for Pime-4 ®

Site & type of infection Dose Frequency Duration
Moderate to severe Pneumonia 1-2 gm IV 12 hourly 10 days
Empiric therapy for Febrile neutropenic patients 2 gm IV 8 hourly 7 days
Mild to moderate uncomplicated or complicated urinary tract infections (including pyelonephritis) 500 mg-1 gm IV/IM* 12 hourly 7-10 days
Severe uncomplicated or complicated UTI, including Pyelonephritis 2 gm IV 12 hourly 10 days
Moderate to severe uncomplicated skin and skin structure infections 2 gm IV 12 hourly 10 days
Complicated Intra-abdominal infections (Used in combination with metronidazole) 2 gm IV 12 hourly 7-10 days
* IM route of administration is indicated only for mild to moderate, uncomplicated or complicated UTIs due to E. coli when the IM route is considered to be a more appropriate route of drug administration.


Impaired hepatic function: No dosage adjustment is necessary for patients with impaired hepatic function.

Impaired renal function: In patients with impaired renal function (creatinine clearance 60 mL/min), the dose of Cefepime (cefepime Hydrochloride) should be adjusted. The recommended initial dose of Cefepime should be the same as in patients with normal renal function.
In patients undergoing continuous ambulatory peritoneal dialysis: Cefepime may be administered at normally recommended doses at a dosage interval of every 48 hours.
In patients undergoing hemodialysis: Approximately 68% of the total amount of cefepime present in the body at the start of dialysis will be removed during a 3-hour dialysis period. The dosage of Cefepime for hemodialysis patients is 1 g on Day 1 followed by 500 mg every 24 hours for the treatment of all infections except febrile neutropenia, which is 1 g every 24 hours. Cefepime should be administered at the same time each day following the completion of hemodialysis on hemodialysis days.

Paediatric Patients (2 months up to 12 years): The maximum dose for Paediatric patients should not exceed the recommended adult dose.

The recommended dosages schedule for Paediatric patients:

Paediatric patients upto 40 kg in weight Dose Frequency Duration
Uncomplicated and complicated urinary tract infections, including pyelonephritis 50 mg/kg 12 hourly 7-10 days
Uncomplicated skin and skin structure infections 50 mg/kg 12 hourly 10 days
Pneumonia 50 mg/kg 12 hourly 10 days
Febrile Neutropenic patients 50 mg/kg 8 hourly 7 days



Preparation of solutions of Pime-4 ® (IV/IM) injections
Single-dose vial administration amount of diluents to be added: 500 mg IV with 5 ml water for injection, 500 mg IM with 1.3 ml water for injection, 1 gm IV with 10 ml water for injection, 1 gm IM with 2.4 ml water for injection, 2gm IV with 10 ml water for injection. These solutions may be stored up to 24 hours at room temperature or 7 days in a refrigerator.

Preparation of Pime-4 ® Intravenous Infusion: Pime-4 ® injection is compatible at concentrations between 1 and 40 mg/ml with the following IV infusion fluids: 0.9% Sodium chloride, 5% & 10% Dextrose.


Use in pregnancy & lactation

There are no adequate and well-controlled studies of cefepime use in pregnant women. Reproduction studies performed in mice, rabbits and rats showed no evidence of fetal damage (at a maximum human daily dose). Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus. Cefepime is excreted in human breast milk in very low concentrations (0.5µg/mL). Caution should be exercised when cefepime is administered to a nursing woman.


Geriatric use
No Data

Precautions

As with other antibiotics, prolonged use of cefepime may result in overgrowth of non-susceptible organisms. Should superinfection occur during therapy, appropriate measures should be taken. The dose of Cefepime should be adjusted in patients with impaired renal function (Creatinine clearance 60 ml/min). Cefepime should be prescribed with caution in individuals with a history of gastrointestinal diseases, particularly colitis.


Side effects

Cefepime is generally well tolerated. However, few side-effects urticaria, fever, headache, nausea, vomiting, diarrhoea, dizziness, oral moniliasis may occur.


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.


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.


Overdose

No Data


Preparation

No Data


Pharmaceutical precautions

Store in a cool and dry place. Protect from light.


Presentation
Pime-4 ® 1 gm Injection: A white to pale yellow, sterile dry powder for reconstitution. Each vial contains Cefepime 1gm as Hydrochloride USP mixed with L-Arginine USP.
Pime-4 ® 2 gm Injection: A white to pale yellow, sterile dry powder for reconstitution. Each vial contains Cefepime 2gm as Hydrochloride USP mixed with L-Arginine USP.
Pime-4 ® 500 gm Injection: A white to pale yellow, sterile dry powder for reconstitution. Each vial contains Cefepime 500 mg as Hydrochloride USP mixed with L-Arginine USP.

Package quantities
Pime-4 ® 1 gm Injection: Box containing 1 vial of dry powder equivalent to 1g Cefepime as Hydrochloride USP mixed with L-Arginine USP, 1 ampoule of 10 ml of Water for Injection BP and a 10 ml disposable syringe.
Pime-4 ® 2 gm Injection: Box containing 1 vial of dry powder equivalent to 2g Cefepime as Hydrochloride USP mixed with L-Arginine USP, 1 ampoule of 10 ml of Water for Injection BP and a 10 ml disposable syringe.
Pime-4 ® 500 gm Injection: Box containing 1 vial of dry powder equivalent to 500 mg Cefepime as Hydrochloride USP mixed with L-Arginine USP, 1 ampoule of 5 ml of Water for Injection BP and a 5 ml disposable syringe.