Cefevex

Each vial contains Cefepime Hydrochloride equivalent to cefepime 1 gram.

Pharmacology: Pharmacokinetics: Cefepime is given by injections as hydrochloride. It is rapidly and almost completely absorbed following intramuscular injection and mean peak plasma concentrations of about 14 and 30 micrograms/mL have been reported about 1.5 hours after doses of 500 mg and 1 gram respectively. Within 30 minutes of intravenous administration of similar doses, peak plasma concentrations of about 40 and 80 micrograms/mL are achieved. The plasma half-life of cefepime is approximately 2 hours and is prolonged in patients with renal impairment. About 20% of cefepime is bound to plasma proteins.
Cefepime is widely distributed in body tissues and fluids. High concentrations are achieved in bile. Low concentrations have been detected in breast milk.
Cefepime is eliminated principally by the kidneys and about 85% of a dose is recovered unchanged in the urine. Cefepime is substantially removed by haemodialysis.

Cefepime (CEFEVEX) is a fourth-generation cephalosporin antibacterial used in the treatment of infections due to susceptible organisms that include infections of the urinary tract, respiratory tract infections and skin and skin structure infections.

Cefepime is given as hydrochloride by deep intramuscular injection, or intravenously by infusion over at least 30 minutes. Doses are expressed in terms of the equivalent amount of cefepime. 1.19 g of Cefepime hydrochloride is approximately equivalent to 1 gram of Cefepime. The usual adult dose is 1 to 2 grams daily in 2 divided doses for mild to moderate injections, increased to 4 g daily in 2 divided doses in severe infections, although up to 6 g daily in 3 divided doses has been given for febrile neutropenia. Children aged over 2 months and weighing up to 40 kg may be given 50 mg/kg twice daily; this dose may be given 3 times daily for febrile neutropenia.
Administration in Renal Impairment: Dosage of cefepime should be modified in renal impairment; after a normal initial loading dose the maintenance dosage should be adjusted according to the patient's creatinine clearance (CC) and the severity of the infection: CC 30 to 60 mL/minute: 0.5 to 2 g every 24 hours.
CC 11 to 29 mL/minute: 0.5 to 1 g every 24 hours.
CC 10 mL/minute or less: 250 to 500 mg every 24 hours.
Patients undergoing haemodialysis should be given a repeat dose (equivalent to the initial dose) after each dialysis session, while those undergoing continuous ambulatory peritoneal dialysis should receive normal recommended doses at intervals of 48 hours.

Cefepime (CEFEVEX) is contraindicated in patients with known allergy to Cephalosporin group of antibiotics.

The adverse effects associated with cefepime and other cephalosporins are broadly similar to those described for penicillins (see Benzylpenicillin). The most common are hypersensitivity reactions, including skin rashes, urticaria, eosinophilia, fever, reactions resembling serum sickness, and anaphylaxis.
There may be a positive response to the Coombs' test although haemolytic anaemia rarely occurs. Neutropenia and thrombocytopenia have occasionally been reported. Agranulocytosis has been associated rarely with some cephalosporins. Bleeding complications related to hypoprothrombinaemia and/or platelet dysfunction have occurred especially with cephalosporins and cephamycins having an N-methylthiotetrazole side-chain, including cefamandole, cefbuperazone, cefmenoxime, cefmetazole, cefonicid, cefoperazone, ceforanide, cefotetan, cefpiramide, and latamoxef. The presence of a methylthiadiazolethiol side-chain, as in cefazolin, or an N-methylthiotriazine ring, as in ceftriaxone, might also be associated with such bleeding disorders.
Nephrotoxicity has been reported with cefepime although it is less toxic than cefaloridine. Acute renal tubular necrosis has followed excessive dosage and has also been associated with its use in older patients or those with pre-existing renal impairment, or when used with nephrotoxic drugs such as aminoglycosides. Acute interstitial nephritis is also a possibility as a manifestation of hypersensitivity.
Transient increases in liver enzyme values have been reported. Hepatitis and cholestatic jaundice have occurred rarely with some cephalosporins.
Convulsions and other signs of CNS toxicity have been associated with high doses, especially in patients with severe renal impairment.
Gastrointestinal adverse effects such as nausea, vomiting, and diarrhoea have been reported rarely. Prolonged use may result in overgrowth of non-susceptible organisms and, as with other broad-spectrum antibiotics, pseudomembranous colitis may develop.
There may be pain at the injection site following intramuscular use, and thrombophlebitis has occurred following intravenous infusion of cephalosporins.

Direction for Reconstitution: For I.V. Administration: Add 10 mL of sterile water for injection.

Store at temperatures not exceeding 30°C.

Cephalosporins

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

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