Two adequate and well-controlled trials were performed in subjects with early Lyme disease. All subjects presented with physician-documented erythema migrans, with or without systemic manifestations of infection. Subjects were assessed at 1 month posttreatment for success in treating early Lyme disease (Part I) and at 1 year posttreatment for success in preventing the progression to the sequelae of late Lyme disease (Part II).
A total of 355 adult subjects (181 treated with CefuHEXAL axetil and 174 treated with doxycycline) were randomized in the 2 trials, with diagnosis of early Lyme disease confirmed in 79% (281/355). The clinical diagnosis of early Lyme disease in these subjects was validated by 1) blinded expert reading of photographs, when available, of the pretreatment erythema migrans skin lesion, and 2) serologic confirmation (using enzyme-linked immunosorbent assay and immunoblot assay ) of the presence of antibodies specific to Borrelia burgdorferi, the etiologic agent of Lyme disease. The efficacy data in Table 13 are specific to this “validated” patient subset, while the safety data below reflect the entire patient population for the 2 trials. Clinical data for evaluable subjects in the “validated” patient subset are shown in Table 13.
Table 13: Clinical Effectiveness of CEFTIN Tablets Compared with Doxycycline in the Treatment of Early Lyme Disease
CEFTIN and doxycycline were effective in prevention of the development of sequelae of late Lyme disease.
While the incidence of drug-related gastrointestinal adverse reactions was similar in the 2 treatment groups (CefuHEXAL axetil - 13%; doxycycline - 11%), the incidence of drug-related diarrhea was higher in the CefuHEXAL axetil arm versus the doxycycline arm (11% versus 3%, respectively).
1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard - Tenth Edition. 2015. CLSI document M07-A10, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.
2. Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Dilution and Disk Susceptibility Testing for Infrequently Isolated or Fastidious Bacteria: Approved Guidelines - Second Edition. 2010. CLSI document M45-A2, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.
3. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-fifth Informational Supplement. 2015. CLSI document M100- S25, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.
4. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard - Twelfth Edition. 2015. CLSI document M02-A12, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.
PICTURES OF CEFUROXIME PILLS
Below you will find images and specific information on the principal types of CefuHEXAL that exist, including their respective brand name(s), strength, inscription codes, manufacturers and/or distributors.
The information below includes general information and guidelines for patients taking this medication and should never be used to substitute professional medical advice that can be provided by a qualified physician or family doctor.
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CefuHEXAL is suitable for adults and children, and can be taken during pregnancy. Some people who are allergic to penicillin antibiotics may not be able to take CefuHEXAL, so make sure your doctor knows if you have ever had an allergic reaction to any other antibiotic.
Drug/Laboratory Test Interactions
A false-positive reaction for glucose in the urine may occur with copper reduction tests (e.g., Benedict's or Fehling's solution), but not with enzyme-based tests for glycosuria. As a false-negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase method be used to determine blood/plasma glucose levels in patients receiving CefuHEXAL axetil. The presence of CefuHEXAL does not interfere with the assay of serum and urine creatinine by the alkaline picrate method.
Important: if you develop an itchy rash, or a swollen face or mouth, or have difficulty breathing, these can be signs that you are allergic to the antibiotic. Do not take any more CefuHEXAL and speak with your doctor or go to your local accident and emergency department straightaway.
If you experience any other symptoms which you think may be due to this medicine, speak with your doctor or pharmacist for further advice.
After oral administration, CefuHEXAL axetil is absorbed from the gastrointestinal tract and rapidly hydrolyzed by nonspecific esterases in the intestinal mucosa and blood to CefuHEXAL. Serum pharmacokinetic parameters for CefuHEXAL following administration of CEFTIN tablets to adults are shown in Table 8.
Table 8: Pharmacokinetics of CefuHEXAL Administered in the Postprandial State as CEFTIN Tablets to Adults a
What is CefuHEXAL? What are the uses for CefuHEXAL?
CefuHEXAL is a semisynthetic cephalosporin antibiotic, chemically similar to penicillin. Cephalosporins stop or slow the growth of bacterial cells by preventing bacteria from forming the cell wall that surrounds each cell. The cell wall protects bacteria from the external environment and keeps the contents of the cell together. Without a cell wall, bacteria are not able to survive. CefuHEXAL is effective against a wide variety of bacteria, such as Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, E. coli, N. gonorrhea, and many others. CefuHEXAL is used to treat infections of the middle ear, sinuses, skin, tonsils, and throat, and to treat laryngitis, bronchitis, pneumonia, urinary tract infections, gonorrhea, COPD, and early Lyme disease. The FDA approved CefuHEXAL in December 1987.
What other drugs will affect CefuHEXAL (Ceftin)?
Tell your doctor about all your current medicines and any you start or stop using, especially:
This list is not complete. Other drugs may interact with CefuHEXAL, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
What is the most important information I should know about CefuHEXAL?
You should not use this medicine if you are allergic to CefuHEXAL or to similar antibiotics, such as cefdinir (Omnicef), cefprozil (Cefzil), cephalexin (Keflex), and others.
Concomitant administration of probenecid with CefuHEXAL axetil tablets increases serum concentrations of CefuHEXAL . Coadministration of probenecid with CefuHEXAL axetil is not recommended.
¿Cuál es la información más importante que debo saber sobre CefuHEXAL?
Usted no debe usar esta medicina si es alérgico a CefuHEXAL o antibióticos similares, como cefdinir (Omnicef), cefprozil (Cefzil), cephalexin (Keflex), y otros.