L-Keflex is a newly manufactured cephalexin product in order to maintain effective blood level of the drug for a long period of time. The results of the fundamental and clinical studies are as follows: 1. Mean blood levels of the drug after its single oral dose of 1 g in fasting in 22 cases before operations were: 7.19 mcg/ml at 2 hours (peak), 4.35 mcg/ml at 4 hours, 4.21 mcg/ml at 6 hours, 2.47 mcg/ml at 8 hours and 1.81 mcg/ml at 12 hours, respectively. Existence of the drug in blood was observed for a long period of time. 2. The distribution into the tissues of L-Keflex was generally good. The tissue levels in 19 of 22 samples ranged from 1.30 to 18.0 mcg/g, but 3 samples did not detect the drug in the tissues. Tissue level/blood level ratios were 0.19 approximately 2.67. 3. Half of 30 cases with mild dental infections was treated with a daily dose of 1 g with clinical response of 60.0%, and the other half with 2 g was 78.6% in clinical response. The overall efficacy rate was 69.0%. 4. As a side effect of the drug, only one of 52 cases (fundamental 22 cases, clinical 30 cases) complained of edema on both eyelids. No. abnormality was observed in blood finding, hepatic and/or renal function. From the above results, it is considered that L-Keflex is an effective antibiotic product in infections in the field of oral surgery. Also, L-Keflex has an advantage in that its administration frequence (b.i.d) is less than that of regular cephalexin (q.i.d.).
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The cases of two patients who took a cephalosporin antibiotic, cephalexin (Keflex, Eli Lilly), and then developed TTP are reported. One patient subsequently received a third-generation cephalosporin, ceftriaxone (Rocephin, Roche), without adverse reaction. Of interest, one patient had taken cefaclor (Ceclor, Eli Lilly) 8 years before and had also developed TTP at that time. The other patient also took cefaclor for approximately 3 weeks before taking cephalexin. In addition, she had had a dose of clarithromycin (Biaxin, Abbott Laboratories) the day before the onset of the TTP symptoms.
The resistance of two biomaterials, one synthetic and one biologic in origin, to deliberate bacterial infection was compared in a dog model of orthopedic soft tissue reconstruction. Twenty-four adult female dogs were randomly divided into two equal groups and a 2.0-cm-round full-thickness defect was created on the lateral surface of the stifle joint, leaving only the synovium and skin intact. The defect was surgically repaired with either Dacron trade mark mesh or a porcine derived extracellular matrix (ECM) scaffold material. The repair site was inoculated with 1 x 10(8) Staphylococcus aureus at the time of surgery and the dogs were survived for 28 days. Results showed a chronic pyogranulomatous inflammatory response at the Dacron trade mark implant sites versus a constructive tissue-remodeling response without residual inflammation at the ECM implant site. Three dogs in the group receiving the Dacron trade mark mesh were treated with Keflex trade mark (500 mg bid x 7 days) for signs of septicemia. A quantitative bacterial count of the implant sites at the time of sacrifice showed 6.52 x 10(5) +/- 1.2 x 10(6) and 6.5 x 10(2) +/- 1.8 x 10(3) bacteria per gram of tissue for the Dacron trade mark and ECM scaffold sites, respectively (P <.03). The ECM implant material was more resistant than the synthetic implant material to persistent infection following deliberate bacterial contamination and the ECM scaffold supported constructive tissue remodeling.
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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.
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There is increasing concern regarding antimicrobial resistance in Pakistan. Data are limited on the prevalence, pattern of resistance and risk factors associated with resistant organisms. This Study was done to address these issues as they relate to common infection of male/female.
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In order to evaluate efficacy and safety of L-Keflex (granule form of sustained release cephalexin), a double blind study comparing it with Keflex (capsule of regular cephalexin) was conducted in dental infections. Evaluable cases in adults for efficacy of the drugs were 196 consisting of 97 for L-Keflex and 99 for Keflex. Those in children were 19 (8 for L-Keflex and 11 for Keflex). There were no significant differences in background of the patients and severity of the diseases between both groups (L-Keflex and Keflex groups). The daily doses used in both groups were 1,000 mg in adults and 500 mg in children, respectively. The dose was given in two divided doses for L-Keflex group and in four divided doses for Keflex group. Following are evaluation by the committee members for the study: Adults 1. Clinical response rate at final therapy day was 93.8% in L-Keflex group and 92.9% in Keflex group, showing no significant difference between both groups. 2. No significant difference in severity of subjective and objective symptoms between both groups was observed at each therapy day. 3. Side effects were found in 6.7% of 105 patients receiving L-Keflex and in 5.6% of 107 patients with Keflex, and there was no significant difference between both groups. As the side effects, gastrointestinal symptoms, rash and itching were observed, but no any other side effects were found in both groups. Children 1. As shown in the above, number of the cases enough to evaluate statistically was not obtained, but all of both groups clinically responded to the drugs. 2. As for side effects diarrhea was observed in only one patient of Keflex group consisting of 12 patients. In the patient, however, discontinuation of the drug was not required and the side effect disappeared during the therapy. From the above results, L-Keflex (granule) is judged to have more convenience than Keflex (capsule) in that (1) it can be administered with b.i.d. regimen and (2) it can be easily taken in dental patients such as patients having difficulty in opening mouth of swallowing pain.
A prospective, randomized, double-blind evaluation of Loridine-Keflex prophylaxis in a homogeneous group of 32 patients undergoing sequential cervical conization and vaginal hysterectomy is reported. There was no infectious or febrile morbidity in the 18 oatuebts receuvubg abtubuitucs, Morbidity occurred in six of 14 patients receiving placebos (P is less than 0.05). Antibiotic prophylaxis and conization-hysterectomy morbidity are discussed.
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Spinal epidural abscesses (SEA) are uncommon in children. This paper reported a two-year-old boy who was noted to have neck stiffness, with local tenderness posteriorly. Bacterial meningitis was suspected initially in terms of the finding of the cerebral spinal fluid; antibiotics were prescribed. Three days later another spinal tap was performed because of persistent high fever and irritability. A pus-like material drained out as the needle punctured into the spinal region. A magnetic resonance image (MRI) scan of the spine revealed a SEA, with extensive involvement from the second cervical spine to the lumbosacral spine region. Culture of the pus, as well as the blood and CSF, were positive for Staphylococcus aureus. Because of extensive involvement of the spinal epidural space, the patient was again given antibiotics: Prostaphllin and Amikin intravenously for six weeks instead of laminectomy. Then the oral antibiotic (Keflex) was given to the patient for another three months after the boy was discharged from the hospital. A review of the literature shows the incidence of SEA to be increasing and the bacterial spectra to be broadening because of increasing use of immunosuppressing drugs or antibiotics, and the increase in numbers of immunecompromised patient. The clinical symptoms and signs of the SEA were non-specific, but SEA can be early diagnosed by computurized tomography (CT) scan or MRI scan with caution. The literature suggests that, if the patient's condition fits the criteria for non-surgical treatment, antibiotic therapy is the first choice for preventing the complication of spinal deformity, especially in children.