high priced [5:<12 years: Oral: 9 mg/kg/dose once daily (maximum dose: 400 mg/day) for 10 days Children 12 years and Adolescents: Oral: Refer to adult dosing. Pharyngitis/tonsillitis: Infants and Children 6 months to> <12 years: Oral: 9 mg/kg/dose once daily (maximum dose: 400 mg/day) for 10 days Children 12 years and Adolescents: Oral: Refer to adult dosing. Dosing: Renal Impairment CrCl 50 mL//minute: No dosage adjustment necessary. CrCl 30 to 49 mL//minute: 4.5 mg/kg or 200 mg every 24 hours. CrCl 5 to 29 mL/minute: 2.25 mg/kg or 100 mg every 24 hours. End-stage renal disease (ESRD) on intermittent hemodialysis (IHD) (2 or 3 times weekly): 65% removed by a 2- to 4-hour hemodialysis session; administer 400 mg or 9 mg/kg/dose (maximum: 400 mg/dose) after each hemodialysis session Dosing: Hepatic Impairment There are no dosage adjustments provided in the manufacturer s labeling. Reconstitution Refer to manufacturer s product labeling for reconstitution instructions. Shake well. Administration Capsule: Administer without regard to food. Suspension: Administer at least 2 hours before or 1 hour after meals. Shake well before use. Dietary Considerations Capsule: Take without regard to food. Suspension: Take 2 hours before or 1 hour after meals. Storage Store at 2 C to 25 C (36 F to 77 F). Reconstituted suspension is stable for 14 days when refrigerated at 2 C to 8 C (36 F to 46 F). Drug Interactions Aminoglycosides: Cephalosporins (3rd Generation) may enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Avoid combination Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease the serum concentration of Ceftibuten. Specifically, the zinc contained in many multivitamins may decrease ceftibuten absorption. Management: Consider administering oral zinc-containing multivitamins at least 3 hours after ceftibuten. Consider therapy modification Multivitamins/Minerals (with AE, No Iron): May decrease the serum concentration of Ceftibuten. Specifically, the zinc contained in many multivitamins may decrease ceftibuten absorption. Management: Consider administering oral zinc-containing multivitamins at least 3 hours after ceftibuten. Consider therapy modification Probenecid: May increase the serum concentration of Cephalosporins. Monitor therapy Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification Vitamin K Antagonists (eg, warfarin): Cephalosporins may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy Zinc Salts: May decrease the serum concentration of Ceftibuten. Management: Consider administering oral zinc salts at least 3 hours after ceftibuten. Exceptions: Zinc Chloride. Consider therapy modification Test Interactions Positive direct Coombs', false-positive urinary glucose test using cupric sulfate (Benedict's solution, Clinitest , Fehling's solution), false-positive serum or urine creatinine with Jaffé reaction Adverse Reactions 1% to 10%: Central nervous system: Headache ( 3%), dizziness ( 1%) Gastrointestinal: Nausea ( 4%), diarrhea (3% to 4%), dyspepsia ( 2%), loose stools ( 2%), abdominal pain (1% to 2%), vomiting (1% to 2%) Hematologic & oncologic: Eosinophilia (3%), decreased hemoglobin (1% to 2%), change in platelet count (increase: 1%) Hepatic: Increased serum ALT ( 1%), increased serum bilirubin ( 1%) Renal: Increased blood urea nitrogen (2% to 4%)> <1% (Limited to important or life-threatening): Agitation, anorexia, aphasia, candidiasis, constipation, dehydration, diaper rash, drowsiness, dysgeusia, dyspnea, dysuria, eructation, fatigue, fever, flatulence, hematuria, hyperkinesia, increased serum alkaline phosphatase, increased serum AST, increased serum creatinine, insomnia, irritability, jaundice, leukopenia, melena, nasal congestion, paresthesia, pruritus, pseudomembranous colitis, psychosis, rigors, serum sickness, skin rash, Stevens-Johnson syndrome, stridor, thrombocytopenia, toxic epidermal necrolysis, urticaria, vaginitis, xerostomia Warnings/Precautions Concerns related to adverse effects: Penicillin allergy: Use with caution in patients with a history of penicillin allergy; if a hypersensitivity reaction occurs, discontinue therapy and institute supportive emergency measures. Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile -associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed> 2 months postantibiotic treatment. Disease-related concerns: Colitis: Use with caution in patients with a history of colitis and other gastrointestinal diseases. Renal impairment: Use with caution in patients with renal impairment; modify dosage in moderate to severe impairment and in hemodialysis patients. Concurrent drug therapy issues: Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Dosage form specific issues: Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol ( 99 mg/kg/day) have been associated with a potentially fatal toxicity ( gasping syndrome ) in neonates; the gasping syndrome consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer s labeling. Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer s labeling. Sucrose: Some formulations may contain sucrose. Monitoring Parameters Monitor renal, hepatic, and hematologic function periodically with prolonged therapy. Observe for signs and symptoms of anaphylaxis during first dose. Pregnancy Risk Factor B Pregnancy Considerations Adverse events have not been observed in animal reproduction studies. An increase in most types of birth defects was not found following first trimester exposure to cephalosporins (Crider 2009). Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience nausea or diarrhea. Have patient report immediately to prescriber bruising, bleeding, urinary retention, change in amount of urine passed, chills, pharyngitis, seizures, severe loss of strength and energy, vaginitis, or signs of Clostridium difficile ( C. diff )-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools) (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients. Next Interactions Print this page Add to My Med List More about ceftibuten Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 3 Reviews Add your own review/rating Drug class: third generation cephalosporins Consumer resources Ceftibuten ... +3 more Professional resources Ceftibuten (AHFS Monograph) Ceftibuten (FDA) Other brands: Cedax Related treatment guides Bladder Infection Bronchitis Otitis Media Pneumonia ... +3 more 1%> 12> 12>]} 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 Ceftibuten Rating 3 User Reviews 9.4 /10 3 User Reviews 9.4 Rate it! Drug Class Third generation cephalosporins Related Drugs third generation cephalosporins cefdinir , ceftriaxone , Rocephin , Omnicef , cefpodoxime , cefixime Bladder Infection ciprofloxacin , amoxicillin , cephalexin , Levaquin , Keflex , More... Sinusitis prednisone , ciprofloxacin , amoxicillin , azithromycin , Augmentin , More... Strep Throat Augmentin , cefdinir , cefuroxime , erythromycin , Ceftin , clarithromycin , More... 4 more conditions...} } prompted
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