Respiratory tract infections
Adult: 400 mg once daily for 10 days.
Child: >6 mth ≤45 kg: 9 mg/kg once daily for 10 days.
Child: >6 mth ≤45 kg: 9 mg/kg once daily for 10 days.
Indications and Dosage
Oral
Respiratory tract infections Adult: 400 mg once daily for 10 days.
Child: >6 mth ≤45 kg: 9 mg/kg once daily for 10 days. |
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Renal Impairment
Patient on haemodialysis: 400 mg after each session 2 or 3 times wkly.
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Administration
cap: May be taken with or without food.
susp: Should be taken on an empty stomach. Take 2 hr before or 1 hr after meals. |
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Reconstitution
Reconstitute powd for susp at the time of dispensing by adding the amount of water specified on the container to provide a susp containing 90 mg per 5 mL. Water should be added in 2 equal parts and shake the bottle after each addition.
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Contraindications
Hypersensitivity to ceftibuten and other cephalosporins.
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Special Precautions
Patient w/ history of penicillin allergy, history of colitis and other GI diseases. Renal impairment. Pregnancy and lactation.
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Adverse Reactions
Nausea, diarrhoea, melaena, dyspepsia, vomiting, abdominal pain; headache, dizziness; increased eosinophils, platelets, ALT, bilirubin or BUN, decreased Hb; Stevens-Johnson syndrome.
Potentially Fatal: Pseudomembranous colitis. |
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Monitoring Parameters
Periodically monitor renal, hepatic and haematologic function w/ prolonged therapy. Observe for signs and symptoms of anaphylaxis during 1st dose.
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Overdosage
Symptoms: Cerebral irritation leading to convulsions. Management: Haemodialysis may be useful in the removal from the circulation.
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Drug Interactions
Enhanced nephrotoxicity of aminoglycosides. Increased serum concentration w/ probenecid. Decreased serum concentration w/ zinc salts.
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Food Interaction
Food decreases rate and extent of absorption.
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Lab Interference
Positive Coombs' test; false-positive serum or urine creatinine w/ Jaffe reaction; false-positive urine glucose results may occur when using Clinitest®, Benedict's or Fehling's soln.
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Action
Description:
Mechanism of Action: Ceftibuten binds to 1 or more of the penicillin-binding proteins (PBPs) which inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell wall, thus inhibiting biosynthesis and arresting cell wall assembly resulting in bacterial cell death. Pharmacokinetics: Absorption: Rapidly absorbed from the GI tract. Rate and extent of absorption are decreased by food. Time to peak plasma concentration: Approx 2 hr. Distribution: Distributed into middle-ear fluid and bronchial secretions. Volume of distribution: 0.21 L/kg. Plasma protein binding: 65-77%. Excretion: Mainly via urine (approx 56%) and faeces (39%). Plasma half-life: Approx 2-2.3 hr. |
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Chemical Structure
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Storage
Store between 2-25°C. Reconstituted susp: Store between 2-8°C.
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MIMS Class
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ATC Classification
J01DD14 - ceftibuten ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
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References
Anon. Ceftibuten. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 06/11/2014. Buckingham R (ed). Ceftibuten. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/11/2014. Cedax Capsule, Suspension (Pernix Therapeutics, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 06/11/2014. Cedax Capsules 400 mg. U.S. FDA. https://www.fda.gov/. Accessed 06/11/2014. McEvoy GK, Snow EK, Miller J et al (eds). Ceftibuten. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 06/11/2014.
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