a cheap [30:<12 years of age; 1 use in this age group not recommended. 1 3 Geriatric Use Safety and efficacy in those> 65 years of age similar to that in younger adults. 1 Substantially eliminated by kidneys; risk of toxicity may be greater in those with impaired renal function. 1 Select dosage with caution and consider monitoring renal function because of age-related decreases in renal function. 1 (See Renal Impairment under Dosage and Administration.) Hepatic Impairment AUC increased slightly in adults with mild or moderate hepatic impairment (Child-Pugh class A or B); 1 no dosage adjustments required in these patients. 1 Not studied in patients with severe hepatic impairment (Child-Pugh class C). 1 Renal Impairment Decreased clearance. 1 Reduce dosage in those with Cl cr <50 mL/minute. 1 (See Renal Impairment under Dosage and Administration.) Common Adverse Effects Diarrhea, 1 3 nausea, 1 3 headache, 1 3 abdominal pain, 1 3 vaginal moniliasis, 1 3 dyspepsia, 1 vomiting. 1 3 Interactions for Cefditoren Pivoxil Specific Drugs and Laboratory Tests Drug or Test Interaction Comments Antacids (aluminum- or magnesium-containing) Decreased absorption of cefditoren 1 Do not administer antacids containing aluminum or magnesium concomitantly with cefditoren 1 Histamine H 2 -receptor antagonists (famotidine) Possible decreased absorption of cefditoren. 1 3 Do not administer H 2 -receptor antagonists concomitantly with cefditoren 1 Hormonal contraceptives No effect on the pharmacokinetics of ethinyl estradiol. 1 3 May be used concomitantly with oral contraceptives 1 Probenecid Increased cefditoren plasma concentrations and half-life 1 Tests for glucose Possible false-positive reactions in urine glucose tests using Clinitest , Benedict s solution, or Fehling s solution 1 Use glucose tests based on enzymatic glucose oxidase reactions (e.g., Clinistix , Tes-Tape ) 1 Cefditoren Pivoxil Pharmacokinetics Absorption Bioavailability Cefditoren pivoxil is a prodrug that is absorbed from the GI tract and hydrolyzed by esterases to the active metabolite, cefditoren. 1 Absolute bioavailability only 14% when given without food; 1 peak plasma concentrations of cefditoren attained within 1.5 3 hours. 1 Food Administration with a moderate- or high-fat meal increases the rate and extent of absorption. 1 Distribution Extent Distributed into tonsils and skin blister fluid. 1 Distributed into milk in rats. 1 Plasma Protein Binding 88%; 1 binding is independent of concentration. 1 Binds principally to albumin; 3.3 8.1% bound to α-1-acid glycoprotein. 1 Elimination Metabolism Cefditoren pivoxil is a prodrug and has little, if any, antibacterial activity until hydrolyzed in vivo by esterases to cefditoren. 1 Hydrolysis of the drug also results in the formation of pivalate, which is absorbed and excreted as pivaloylcarnitine in urine. 1 Cefditoren is not appreciably metabolized. 1 Elimination Route Principally eliminated in urine by renal tubular excretion and glomerular filtration. 1 Half-life Terminal elimination half-life is 1.6 hours in adults with normal renal function. 1 Special Populations AUC only slightly increased in adults with mild or moderate hepatic impairment (Child-Pugh class A or B). 1 Pharmacokinetics have not been studied in patients with severe hepatic impairment (Child-Pugh class C). 1 Clearance of the drug reduced in those with renal impairment. 1 Stability Storage Oral Tablets 25 C (may be exposed to 15 30 C). 1 Protect from light and moisture; dispense in a tight, light-resistant container. 1 Actions and Spectrum Third-generation cephalosporin with an expanded spectrum of activity against gram-negative bacteria compared with first and second generation cephalosporins. 1 3 4 In addition, the methylthiazolyl group in cefditoren enhances activity against gram-positive bacteria. 3 Cefditoren pivoxil is a prodrug and has little, if any, antibacterial activity until hydrolyzed in vivo to cefditoren. 1 3 Usually bactericidal. 1 Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis. 1 a In vitro spectrum of activity includes many gram-positive aerobic bacteria and some gram-negative aerobic bacteria; inactive against fungi and viruses. 1 a Gram-positive aerobes: active in vitro and in clinical infections against Staphylococcus aureus (methicillin-susceptible [oxacillin-susceptible] strains, including β-lactamase-producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Streptococcus pyogenes (group A β-hemolytic streptococci). 1 Also active in vitro against Streptococcus agalactiae (group B streptococci), groups C and G streptococci, and viridans streptococci (penicillin-susceptible and -intermediate strains). 1 Methicillin-resistant (oxacillin-resistant) staphylococci are resistant. 1 Gram-negative aerobes: active in vitro and in clinical infections against Haemophilus influenzae (including β-lactamase-producing strains), H. parainfluenzae (including β-lactamase-producing strains), and Moraxella catarrhalis (including β-lactamase-producing strains). 1 Advice to Patients Advise patients that antibacterials (including cefditoren) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold). 1 Importance of completing full course of therapy, even if feeling better after a few days. 1 Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with cefditoren or other antibacterials in the future. 1 Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued. a Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose. a Importance of avoiding use of cefditoren tablets in patients with milk protein hypersensitivity (not lactose intolerance). 1 3 Importance of taking cefditoren with meals for optimum absorption. 1 3 Advise patients that cefditoren may be used concomitantly with oral estrogen-progestin contraceptives. 1 3 Importance of discontinuing cefditoren and informing clinician if an allergic reaction occurs. 1 3 Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. 1 3 Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs. 1 3 Importance of advising patients of other important precautionary information. 1 (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Cefditoren Pivoxil Routes Dosage Forms Strengths Brand Names Manufacturer Oral Tablets, film-coated 200 mg (of cefditoren) Spectracef Vansen 400 mg (of cefditoren) Spectracef Vansen AHFS DI Essentials. Copyright 2017, Selected Revisions October 10, 2013. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. References 1. Vansen Pharma Inc. Spectracef (cefditoren pivoxil) tablets prescribing information. Westmount, QC; 2011. 2. Johnson DM, Biedenbach DJ, Beach ML et al. Antimicrobial activity and in vitro susceptibility test development for cefditoren against Haemophilus influenzae, Moraxella catarrhalis , and Streptococcus species. Diagn Microbiol Infect Dis . 2000; 37:99-105. [PubMed 10863104] 3. Kuti JL. Cefditoren pivoxil: a novel broad-spectrum oral cephalosporin. Formulary . 2001; 36:265-75. 4. Yamaguchi K, Domon H, Miyazaki S et al. In vitro and in vivo antibacterial activities of CS-834, a new oral carbapenem. Antimicrob Agents Chemother . 1998; 42:555-63. [PubMed 9517932] 9. Mandell LA, Wunderink RG, Anzueto A et al. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis . 2007; 44 Suppl 2:S27-72. [PubMed 17278083] 10. American Academy of Pediatrics. Red Book: 2012 Report of the Committee on Infectious Diseases. 29th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2012. 11. Anon. Drugs for bacterial infections. Med Lett Treat Guid . 2010; 8:43-52. 16. Shulman ST, Bisno AL, Clegg HW et al. Clinical practice guideline for the diagnosis and management of group A streptococcal pharyngitis: 2012 update by the Infectious Diseases Society of America. Clin Infect Dis . 2012; 55:1279-82. [PubMed 23091044] 17. Gerber MA, Baltimore RS, Eaton CB et al. Prevention of rheumatic fever and diagnosis and treatment of acute Streptococcal pharyngitis: a scientific statement from the American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee of the Council on Cardiovascular Disease in the Young, the Interdisciplinary Council on Functional Genomics and Translational Biology, and the Interdisciplinary Council on Quality of Care and Outcomes Research: endorsed by the American Academy of Pediatrics. Circulation . 2009; 119:1541-51. [PubMed 19246689] 42. Cohen SH, Gerding DN, Johnson S et al. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA). Infect Control Hosp Epidemiol . 2010; 31:431-55. [PubMed 20307191] a. AHFS Drug Information 2009. McEvoy GK, ed. Cephalosporins General Statement. American Society of Health-System Pharmacists; 2009. Next Interactions Print this page Add to My Med List More about cefditoren Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 4 Reviews Add your own review/rating Drug class: third generation cephalosporins Consumer resources Cefditoren Cefditoren pivoxil (Advanced Reading) Professional resources Cefditoren Pivoxil (FDA) Cefditoren (Wolters Kluwer) Other brands: Spectracef Related treatment guides Skin and Structure Infection Bronchitis Pneumonia Skin or Soft Tissue Infection Tonsillitis/Pharyngitis> 50> 12>]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Third generation cephalosporins Related Drugs Skin or Soft Tissue Infection ciprofloxacin , amoxicillin , azithromycin , doxycycline , cephalexin , More... Pneumonia ciprofloxacin , amoxicillin , azithromycin , doxycycline , metronidazole , More... Skin and Structure Infection ciprofloxacin , azithromycin , Augmentin , Zithromax , cefdinir , More... Tonsillitis / Pharyngitis amoxicillin , azithromycin , Zithromax , cefdinir , cefuroxime , Ceftin , More... 1 more conditions... Cefditoren Rating 4 User Reviews 3.5 /10 4 User Reviews 3.5 Rate it!} } a sensible
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