ABSTRACT
In two prospective, randomized multicenter double-blind studies with a dosage of either 250 mg given four times a day (study A) or 500 mg given two times a day (study B), the comparative efficacy and safety of cephalexin hydrochloride (LY061188; Keftab) and cephalexin monohydrate (Keflex) for treatment of skin and soft tissue infections were determined. In study A, 97 patients received cephalexin hydrochloride and 101 patients received cephalexin monohydrate. In study B, 75 patients received cephalexin hydrochloride and 70 patients received cephalexin monohydrate. Diagnoses included abscesses, cellulitis, wound infections, and infected dermatitis, and were comparable in the different treatment groups. Pathogens were isolated from 82% of patients enrolled; the majority of isolates were of Staphylococcus aureus, Streptococcus pyogenes, other staphylococcal species, and a few gram-negative bacteria. In study A, 68 of 71 (95.7%) evaluable patients who received cephalexin hydrochloride responded satisfactorily; 73 of 81 (90%) patients who received cephalexin monohydrate also responded satisfactorily. In study B, 56 of 58 (96.5%) evaluable patients who received cephalexin hydrochloride responded satisfactorily; 47 of 50 (94%) patients who received cephalexin monohydrate also responded satisfactorily. An adverse clinical event leading to discontinuation of the treatment drug developed in 17 of 343 (4.95%) patients in both studies. No differences were noted between the two drugs. Skin eruptions, pruritus, and mild gastrointestinal symptoms were the common adverse effects. These data suggest that cephalexin hydrochloride, a new formulation of cephalexin, is a safe and effective antimicrobial agent for treatment of a variety of skin and subcutaneous infections in a dosage of either 250 mg four times a day or 500 mg twice a day.
Subject(s)
Bacterial Infections/drug therapy , Cephalexin/therapeutic use , Skin Diseases, Infectious/drug therapy , Adult , Bacterial Infections/microbiology , Cephalexin/adverse effects , Clinical Trials as Topic , Double-Blind Method , Female , Humans , Male , Random Allocation , Skin Diseases, Infectious/microbiologySubject(s)
Cefaclor/therapeutic use , Cephalexin/analogs & derivatives , Skin Diseases, Infectious/drug therapy , Staphylococcal Infections/drug therapy , Streptococcal Infections/drug therapy , Adolescent , Adult , Aged , Cefaclor/adverse effects , Child , Child, Preschool , Female , Humans , Infant , Male , Middle Aged , Staphylococcus aureusSubject(s)
Anti-Bacterial Agents/pharmacology , Skin Diseases, Infectious/physiopathology , Staphylococcal Infections/physiopathology , Staphylococcus aureus/drug effects , Streptococcal Infections/physiopathology , Streptococcus/drug effects , Ampicillin/pharmacology , Humans , Impetigo/physiopathology , Microbial Sensitivity Tests , Penicillin G/pharmacology , Penicillin Resistance , Pyoderma/physiopathology , Skin Diseases, Infectious/microbiology , Staphylococcus aureus/physiology , Streptococcus/physiologyABSTRACT
This case illustrates the danger of Hydrea taken for more than three years, even though results of monthly blood studies and platelet counts were within normal limits. In this patient, thrombocytopenia suddenly developed only five weeks after normal laboratory results. Fortunately, the sodium level reverted to normal and the pancytopenia disappeared within a week with no residual effects.