What do 4th generation cephalosporins cover? As I learned it - first generations are great for gram positive organisms and as you go "down the generations" you buy gram negative coverage but lose gram positive efficacy. Does this apply to forth generation cephalosporins? I wonder because I noticed that cefepime is indicated for skin and soft tissue infections. Thanks. Kim Burlingham, MD general peds. Texas -----Original Message----- From: Len Leshin <> To: <> Date: Tuesday, February 02, 1999 9:18 AM Subject: News: FDA approves Maxipime (cefepime) >FDA Approves Pediatric Use of Maxipime(R) (cefepime >hydrochloride) for Injection > >February 2, 1999 > > >SAN DIEGO, Feb. 1 /PRNewswire/ -- Dura >Pharmaceuticals, Inc. and Bristol-Myers Squibb >Company announced today approval by the U.S. Food >and Drug Administration (FDA) of Maxipime(R) (cefepime >hydrochloride) for Injection -- the only FDA-approved >fourth-generation cephalosporin antibiotic -- for the use in pediatric >patients age 2 months to 16 years. Safety and efficacy in pediatric >patients below the age of 2 months have not been established. > >Maxipime is the only antibiotic with an FDA-approved indication for >empiric monotherapy in febrile neutropenia (a fever associated with >an abnormally low number of white blood cells) and the only >antibiotic with this indication for pediatric patients. Persons with a >diagnosis of febrile neutropenia -- which affects nearly 1.5 million >patients in the U.S. -- include those who have received intense >chemotherapy or radiation, or those who suffer hematologic >disorders compromising their immune response. > >Maxipime is also now indicated for use in pediatric patients for >uncomplicated and complicated urinary tract infections (including >pyelonephritis), uncomplicated skin and skin structure infections, >and pneumonia due to unsusceptible strains of designated bacteria. > >There are insufficient clinical data to support use of Maxipime >where the suspected or proven pathogen is H. Influenzae type b. In >those patients in whom menngeal seeding from a distant infection >site or in whom meningitis is suspected or documented, an >alternate agent with demonstrated clinical efficacy in this setting >should be used. > >The usual recommended daily dosage of Maxipime in pediatric >patients weighing up to 40 kg is 50 mg/kg administered twice daily >(q8h for febrile neutropenic patients) for seven to 10 days >depending on the infection treated and the severity of the >infection. The maximum dose should not exceed the recommended >adult dose. Dosage adjustments are required in patients with >impaired renal function. > >In clinical trials, the safety of Maxipime in pediatric patients was >similar to that seen in adults. Maxipime is contraindicated for >patients who have shown hypersensitivity reactions to cefepime or >the cephalosporin class of antibiotics, penicillins or other >beta-lactam antibiotics. The most common adverse events are local >reactions (3%), including phlebitis (1.3%), pain and/or inflammation >(0.6%), and rash (1.1%). At the higher dose of 50mg/kg every >eight hours, the most common adverse events are rash (4%), >diarrhea (3%), nausea (2%), vomiting (1%), pruritus (1%), fever >(1%), and headache (1%). > >For complete prescribing information, please call 800-859-8585. > > >