Generic Medicine Info
Indications and Dosage
Respiratory tract infections
Adult: 400 mg once daily for 10 days.
Child: >6 mth ≤45 kg: 9 mg/kg once daily for 10 days.
Renal Impairment
Patient on haemodialysis: 400 mg after each session 2 or 3 times wkly.
CrCl (mL/min) Dosage
5-29 100 mg once daily.
30-49 200 mg once daily.
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.
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.
Hypersensitivity to ceftibuten and other cephalosporins.
Special Precautions
Patient w/ history of penicillin allergy, history of colitis and other GI diseases. Renal impairment. Pregnancy and lactation.
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.
Monitoring Parameters
Periodically monitor renal, hepatic and haematologic function w/ prolonged therapy. Observe for signs and symptoms of anaphylaxis during 1st dose.
Symptoms: Cerebral irritation leading to convulsions. Management: Haemodialysis may be useful in the removal from the circulation.
Drug Interactions
Enhanced nephrotoxicity of aminoglycosides. Increased serum concentration w/ probenecid. Decreased serum concentration w/ zinc salts.
Food Interaction
Food decreases rate and extent of absorption.
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.
Description: 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.
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.
Chemical Structure

Chemical Structure Image

Source: National Center for Biotechnology Information. PubChem Database. Ceftibuten, CID=5282242, https://pubchem.ncbi.nlm.nih.gov/compound/Ceftibuten (accessed on Jan. 21, 2020)

Store between 2-25°C. Reconstituted susp: Store between 2-8°C.
MIMS Class
ATC Classification
J01DD14 - ceftibuten ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
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.

Disclaimer: This information is independently developed by MIMS based on Ceftibuten from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in