Ceftibuten

Common side effects of ceftibuten include:

• nausea
• headache
• diarrhea
• upset stomach
• dizziness
• stomach pain
• vomiting

This is not a complete list of ceftibuten side effects. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with ceftibuten. See the “Drug Precautions” section.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Take ceftibuten exactly as prescribed.

This medication is available in a capsule and oral (by mouth) solution form taken once daily. The oral solution form should be taken 2 hours before a meal or at least 1 hour after a meal.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of ceftibuten at the same time.

If you take too much ceftibuten, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If ceftibuten is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Do not take this medication if you are allergic to ceftibuten, or to similar antibiotics, such as Ceftin, Cefzil, Keflex, Omnicef, and others.

Before taking this medication, tell your doctor if you are allergic to any drugs (especially penicillin). Also tell your doctor if you have kidney disease or a history of intestinal problems.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Ceftibuten will not treat a viral infection such as the common cold or flu.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Do not take this medication if you are allergic to ceftibuten or to other cephalosporin antibiotics, such as:

• cefaclor (Raniclor);

• cefadroxil (Duricef);

• cefazolin (Ancef);

• cefdinir (Omnicef);

• cefditoren (Spectracef);

• cefpodoxime (Vantin);

• cefprozil (Cefzil);

• cefuroxime (Ceftin);

• cephalexin (Keflex); or

• cephradine (Velosef).

Before taking ceftibuten, tell your doctor if you are allergic to any drugs (especially penicillins) or if you have.

• kidney disease (or if you are on dialysis); or

• a history of intestinal problems, such as colitis.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether ceftibuten passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

The ceftibuten suspension (liquid) contains sucrose. Talk to your doctor before using this form of ceftibuten if you have diabetes.

Antibacterial; β-lactam antibiotic; aminothiazolyl third generation cephalosporin.1 3

Absorption

Bioavailability

Rapidly and almost completely absorbed following oral administration.1 5 28 29 31 Oral bioavailability is 75–90%.5

In adults, a 400-mg ceftibuten dose given as the oral suspension is bioequivalent to a 400-mg dose given as 400-mg capsules.40

Food

Food decreases rate and extent of absorption of ceftibuten; this effect is more pronounced with the oral suspension than with capsules.1 31

Distribution

Extent

Distributed into blister fluid,31 bronchial secretions,1 31 33 nasal secretions,31 sputum,1 middle ear fluid,1 31 32 tracheal secretions,31 and tonsillar tissue.41

Not known whether the drug crosses the placenta or is distributed into milk.1 66

Plasma Protein Binding

Approximately 65%.1

Elimination

Metabolism

Ceftibuten is present in plasma and urine principally as cis-ceftibuten; about 10% of a dose is converted in vivo to trans-ceftibuten.1 29 The trans-isomer has only about 12% of the antibacterial activity of the cis-isomer.1 30

Elimination Route

The cis- and trans-isomers of ceftibuten eliminated principally in urine.1 29 30 Approximately 56% of a dose eliminated in urine and 39% excreted in feces within 24 hours.1

Half-life

Adults with normal renal function: 2–2.6 hours.1 29 30 31

Children 6 months to 16 years of age: 1.9–2.5 hours.31 35

Special Populations

In renal impairment, plasma half-life averages 7.1–22.3 hours depending on creatinine clearance.1

Take ceftibuten only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Take the oral liquid at least 2 hours before or 1 hour after a meal.

Shake the oral liquid well before each use. Measure the medicine with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Keep using ceftibuten for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Dosing

The dose of ceftibuten will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of ceftibuten. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules or suspension):
  • For infections:
    • Adults and teenagers—400 milligrams (mg) once a day for 10 days.
    • Infants and children 6 months up to 12 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 9 milligrams (mg) per kilogram (kg) of body weight per day taken for 10 days.
    • Infants up to 6 months of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of ceftibuten, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the capsules in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the oral liquid in the refrigerator. Throw away any unused medicine after 14 days.

Overdosage of cephalosporins can cause cerebral irritation leading to convulsions. Ceftibuten is readily dialyzable and significant quantities (65% of plasma concentrations) can be removed from the circulation by a single hemodialysis session. Information does not exist with regard to removal of Ceftibuten by peritoneal dialysis.

The recommended doses of Ceftibuten Oral Suspension are presented in the table below. Ceftibuten Oral Suspension must be administered at least 2 hours before or 1 hour after a meal.

Renal Impairment

Ceftibuten Capsules and Ceftibuten Oral Suspension may be administered at normal doses in the presence of impaired renal function with creatinine clearance of 50 mL/min or greater. The recommendations for dosing in patients with varying degrees of renal insufficiency are presented in the following table.

Hemodialysis Patients

In patients undergoing hemodialysis two or three times weekly, a single 400-mg dose of Ceftibuten capsules or a single dose of 9 mg/kg (maximum of 400 mg of Ceftibuten) oral suspension may be administered at the end of each hemodialysis session.

Directions for Mixing Ceftibuten Oral Suspension

Ceftibuten Capsules, containing 400 mg of Ceftibuten (as Ceftibuten dihydrate) are white, opaque capsules imprinted with the strength, are available as follows:

 20 Capsules/Bottle (NDC 44183-400-22)

Store the capsules between 2° and 25°C (36° and 77°F). Replace cap securely after each opening.

Ceftibuten Oral Suspension is an off-white to cream-colored powder that, when reconstituted as directed, contains Ceftibuten equivalent to 180 mg/5 mL, supplied as follows:

180 mg/5 mL

 36 mg/mL 30-mL Bottle (NDC 44183-180-30) 

 36 mg/mL 60-mL Bottle (NDC 44183-180-02)

Prior to reconstitution, the powder must be stored between 2° and 25°C (36° and 77°F). Once it is reconstituted, the oral suspension is stable for 14 days when stored in the refrigerator between 2° and 8°C (36° and 46°F).

• Cedax

Hypersensitivity to ceftibuten, other cephalosporins, or any component of the formulation.

Refer to adult dosing.

Applies to ceftibuten: oral capsule, oral powder for reconstitution

General

Ceftibuten is generally well tolerated. In clinical trials, 2% of patients discontinued medication due to adverse events, primarily diarrhea, nausea, or vomiting, and 0.3% discontinued due to rash or pruritus.[Ref]

Gastrointestinal

If diarrhea occurs and is unresponsive to discontinuation of the drug and/or standard therapy, pseudomembranous colitis should be considered.[Ref]

Gastrointestinal side effects have included nausea (4%), diarrhea (3%), dyspepsia (2%), abdominal pain (1%) and vomiting (1%). Anorexia, constipation, dry mouth, eructation, flatulence, loose stools and moniliasis have been reported in less than 1% of patients. Melena has been reported during postmarketing experience. Pseudomembranous colitis has been reported in patients treated with cephalosporins.[Ref]

Nervous system

Nervous system side effects have included headache in 3% of patients and dizziness in 1%. Somnolence, fatigue, agitation, hyperkinesia, irritability, insomnia, and paresthesia have been reported in less than 1% of patients. Some cephalosporins have been associated with seizures in renally impaired patients.[Ref]

Hypersensitivity

Hypersensitivity side effects have included rash and pruritus in less than 1% of patients. Serum sickness-like reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported during postmarketing experience. Cephalosporin class antibiotics have been associated with anaphylaxis, drug fever, Stevens-Johnson syndrome, and erythema multiforme.[Ref]

Hematologic

Hematologic side effects have included increased eosinophils (3%), decreased hemoglobin (2%), increased or decreased platelets (less than 1%) and decreased leukocytes (less than 1%). Cephalosporins as a class have been associated with aplastic anemia, hemolytic anemia, prolonged prothrombin time, hemorrhage, neutropenia, pancytopenia, and agranulocytosis.[Ref]

Hepatic

Hepatic side effects have included increased ALT (1%), increased bilirubin (1%), increased alkaline phosphatase (less than 1%), and increased AST (less than 1%). Jaundice and transient increases in LDH have been reported during postmarketing experience. Cephalosporins as a class have been associated with hepatic dysfunction including cholestasis.[Ref]

Renal

Renal side effects have included increased BUN (1%), increased creatinine (less than 1%), and dysuria (less than 1%). Cephalosporins as a class have been associated with renal dysfunction and toxic nephropathy.[Ref]

Genitourinary

Genitourinary side effects have included dysuria, hematuria, and vaginitis in less than less than 1% of patients.[Ref]

Other

Other side effects have included taste perversion in less than 1% of patients.[Ref]

Dermatologic

Dermatologic side effects have included pruritus, rash, diaper rash, and urticaria in less than 1% of patients.[Ref]

Respiratory

Respiratory side effects have included dyspnea and nasal congestion in less than 1% of patients.[Ref]

Psychiatric

Psychiatric side effects have included reports of psychosis during postmarketing experience.[Ref]

Some side effects of ceftibuten may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

400 mg orally every 24 hours for 10 days

200 mg orally every 12 hours for 7 to 14 days