Cedax

Name: Cedax

Warnings

Contraindications

Documented hypersensitivity

Cautions

Diabetics: oral suspension contains 1 g sucrose/tsp

Modify dosage in severe renal impairment; prolonged use may result in superinfection; caution in seizure disorder; may cause antibiotic associated colitis

What special precautions should I follow?

Before taking ceftibuten,

  • tell your doctor and pharmacist if you are allergic to ceftibuten; other cephalosporin antibiotic such as cefaclor (Ceclor), cefadroxil cefazolin (Ancef, Kefzol), cefdinir, cefditoren (Spectracef), cefepime (Maxipime), cefixime (Suprax), cefotaxime (Claforan), cefotetan, cefoxitin (Mefoxin), cefpodoxime, cefprozil, ceftaroline (Teflaro), ceftazidime (Fortaz, Tazicef, in Avycaz), ceftriaxone (Rocephin), cefuroxime (Zinacef),and cephalexin (Keflex); penicillin antibiotics; or any other medications. Also tell your doctor if you are allergic to any of the ingredients in ceftibuten capsules or suspension.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking, or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have or have ever had gastrointestinal disease (GI; affecting the stomach or intestines), especially colitis (condition that causes swelling in the lining of the colon [large intestine]), or kidney disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking ceftibuten, call your doctor.
  • If you have diabetes, you should know that ceftibuten suspension solution contains sucrose (sugar).

US Brand Name

  1. Cedax

Ceftibuten Interactions

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.

Before taking ceftibuten, tell your doctor if you are taking any medication that reduces stomach acid, such as:

  • cimetidine (Tagamet);
  • famotidine (Pepcid);
  • omeprazole (Prilosec); or
  • ranitidine (Zantac), and others.

This list is not complete and there may be other drugs that can interact with ceftibuten. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start taking a new medication without telling your doctor.

Drug interactions

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: live bacterial vaccines, probenecid.Although most antibiotics probably do not affect hormonal birth control such as pills, patch, or ring, some antibiotics may decrease their effectiveness. This could cause pregnancy. Examples include rifamycins such as rifampin or rifabutin. Be sure to ask your doctor or pharmacist if you should use additional reliable birth control methods while using this antibiotic.This medication may interfere with certain laboratory tests (including Coombs' test, certain urine glucose tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Uses

This medication is used to treat a wide variety of bacterial infections. This medication is known as a cephalosporin antibiotic. It works by stopping the growth of bacteria.This antibiotic treats only bacterial infections. It will not work for viral infections (e.g., common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

Description

CEDAX (ceftibuten capsules) and (ceftibuten for oral suspension) contain the active ingredient ceftibuten as ceftibuten dihydrate. Ceftibuten dihydrate is a semisynthetic cephalosporin antibiotic for oral administration. Chemically, it is (+)-(6R,7R)-7-[(Z)-2-(2Amino-4-thiazolyl)-4-carboxycrotonamido]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2carboxylic acid, dihydrate. Its molecular formula is C15H14N4O6S2•2H2O. Its molecular weight is 446.43 as the dihydrate.

Ceftibuten dihydrate has the following structural formula:

CEDAX Capsules contain ceftibuten dihydrate equivalent to 400 mg of ceftibuten. Inactive ingredients contained in the capsule formulation include: magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The capsule shell and/or band contains gelatin, sodium lauryl sulfate, titanium dioxide, and polysorbate 80. The capsule shell may also contain benzyl alcohol, sodium propionate, edetate calcium disodium, butylparaben, propylparaben, and methylparaben.

CEDAX Oral Suspension after reconstitution contains ceftibuten dihydrate equivalent to 90 mg of ceftibuten per 5 mL or 180 mg of ceftibuten per 5 mL. CEDAX (ceftibuten) Oral Suspension is cherry flavored and contains the inactive ingredients: cherry flavoring, polysorbate 80, silicon dioxide, simethicone, sodium benzoate, sucrose (approximately 1 g/5 mL), titanium dioxide, and xanthan gum.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Colitis (inflammation in gut), history of or
  • Diarrhea, severe, history of—Use with caution. May make these conditions worse.
  • Diabetes—The oral liquid form of this medicine contains sucrose (table sugar), which can make this condition worse.
  • Kidney disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

How should I take Cedax (ceftibuten)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take this medicine with a full glass of water.

Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Ceftibuten oral liquid should be taken at least 2 hours before or 1 hour after eating a meal.

This medication can cause you to have false results with certain medical tests, including urine glucose (sugar) tests. Tell any doctor who treats you that you are using ceftibuten.

Take ceftibuten 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.

Store the tablets and capsules at room temperature away from moisture, heat, and light.

Store ceftibuten oral liquid in the refrigerator. Do not allow it to freeze. Throw away any unused medication that is older than 14 days.

What happens if I miss a dose?

Take the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

Cedax Dosage and Administration

Administration

Oral Administration

Administer capsules orally without regard to meals.1 15

Administer oral suspension at least 2 hours before or 1 hour after meals.1 (See Food under Pharmacokinetics.)

Reconstitution

Reconstitute oral suspension at time of dispensing by adding the amount of water specified on the container in 2 portions; invert bottle and shake after each addition.1

Dosage

Available as ceftibuten dihydrate; dosage expressed in terms of anhydrous ceftibuten.1

Pediatric Patients

Acute Otitis Media (AOM) Oral

Children 6 months through 11 years of age: 9 mg/kg (up to 400 mg) once daily for 10 days.1

Children ≥12 years of age: 400 mg once daily for 10 days.1 3

Pediatric Dosage of Ceftibuten Oral Suspension for AOM1

Weight (kg)

Daily Dosage

10

90 mg once daily1

20

180 mg once daily1

40

360 mg once daily1

>45

400 mg once daily1

Pharyngitis and Tonsillitis Oral

Children 6 months through 11 years of age: 9 mg/kg (up to 400 mg) once daily for 10 days.1

Children ≥12 years of age: 400 mg once daily for 10 days.1

Pediatric Dosage of Ceftibuten Oral Suspension for Pharyngitis and Tonsillitis1

Weight (kg)

Daily Dosage

10

90 mg once daily1

20

180 mg once daily1

40

360 mg once daily1

>45

400 mg once daily1

Respiratory Tract Infections Acute Exacerbations of Chronic Bronchitis Oral

Children ≥12 years of age: 400 mg once daily for 10 days.1 3

Adults

Acute Otitis Media (AOM) Oral

400 mg once daily for 10 days.1 3

Pharyngitis and Tonsillitis Oral

400 mg once daily for 10 days.1 3

Respiratory Tract Infections Acute Exacerbations of Chronic Bronchitis Oral

400 mg once daily for 10 days.1 3

Uncomplicated UTIs† Oral

400 mg once daily for 7 days.64

Prescribing Limits

Pediatric Patients

Oral

Maximum 400 mg once daily for children 6 months through 11 years of age.1

Adults

Oral

Maximum 400 mg once daily.1

Special Populations

Hepatic Impairment

Dosage adjustments not required.1

Renal Impairment

Dosage for Renal Impairment1

Clcr (mL/min)

Daily Dosage

>50

9 mg/kg or 400 mg once every 24 hours1

30–49

4.5 mg/kg or 200 mg once every 24 hours1 4

5–29

2.25 mg/kg or 100 mg once every 24 hours1 4

For patients undergoing hemodialysis 2 or 3 times weekly, a single 400-mg dose (given as a capsule) or 9 mg/kg (up to 400 mg; given as the oral suspension) may be given at the end of each dialysis period.1 5

Geriatric Patients

No dosage adjustments except those related to renal impairment.1 (See Renal Impairment under Dosage and Administration.)

Actions and Spectrum

  • Third generation cephalosporin with an expanded spectrum of activity against aerobic gram-negative bacteria compared with first and second generation cephalosporins.3 5

  • Usually bactericidal.a

  • Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.a

  • In vitro spectrum of activity includes some gram-positive aerobic bacteria and some gram-negative aerobic bacteria; inactive against most anaerobes; inactive against fungi and viruses.3 19 a

  • Gram-positive aerobes: active in vitro and in clinical infections against Streptococcus pneumoniae (penicillin-susceptible strains only) and S. pyogenes (group A β-hemolytic streptococci).1 Inactive against other streptococci, staphylococci, and enterococci (e.g., Enterococcus faecalis).3 19 a

  • Gram-negative aerobes: active in vitro and in clinical infections against Haemophilus influenzae (including β-lactamase-producing strains) and Moraxella catarrhalis (including β-lactamase-producing strains).1 Inactive against Pseudomonas aeruginosa.1 3 5 19 22 23

  • Stable in the presence of a variety of plasmid-mediated β-lactamases produced by gram-positive and gram-negative bacteria;1 3 5 7 8 19 20 21 22 23 more active in vitro than other currently available oral third generation cephalosporins against Enterobacteriaceae that produce plasmid-mediated β-lactamases.3 5 7 19 20 21 22 23 Unstable in the presence of chromosomally-mediated cephalosporinases.1

  • Strains of staphylococci resistant to penicillinase-resistant penicillins (methicillin-resistant [oxacillin-resistant] staphylococci) should be considered resistant to ceftibuten, although results of in vitro susceptibility tests may indicate that the organisms are susceptible to the drug.24

Advice to Patients

  • Importance of administering oral suspension at least 2 hours before or 1 hour after meals.1 Capsules may be administered without regard to meals.1 15

  • Importance of completing full course of therapy.1

  • Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued. 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.

  • Importance of discontinuing ceftibuten and informing clinician if an allergic reaction occurs.1

  • For patients with diabetes, importance of being informed of sucrose content of oral suspension.1

  • Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • 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.

Ceftibuten Dihydrate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

400 mg (of anhydrous ceftibuten)

Cedax

Pernix

For suspension

90 mg (of anhydrous ceftibuten) per 5 mL

Cedax

Pernix

Adverse events

Clinical Trials

Cedax CAPSULES (adult patients)

In clinical trials, 1728 adult patients (1092 US and 636 international) were treated with the recommended dose of ceftibuten capsules (400 mg per day). There were no deaths or permanent disabilities thought due to drug toxicity in any of the patients in these studies. Thirty-six of 1728 (2%) patients discontinued medication due to adverse events thought by the investigators to be possibly, probably, or almost certainly related to drug toxicity. The discontinuations were primarily for gastrointestinal disturbances, usually diarrhea, vomiting, or nausea. Six of 1728 (0.3%) patients were discontinued due to rash or pruritus thought related to ceftibuten administration.

In the US trials, the following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to ceftibuten capsules in multipledose clinical trials (n = 1092 ceftibuten-treated patients).

ADVERSE REACTIONS
CEFTIBUTEN CAPSULES
US CLINICAL TRIALS IN ADULT PATIENTS
(n = 1092)
Incidence equal to or greater than 1% Nausea 4%
Headache 3%
Diarrhea 3%
Dyspepsia 2%
Dizziness 1%
Abdominal pain 1%
Vomiting 1%
Incidence less than 1% but greater than 0.1% Anorexia, Constipation, Dry mouth, Dyspnea, Dysuria, Eructation, Fatigue, Flatulence, Loose stools, Moniliasis, Nasal congestion, Paresthesia, Pruritus, Rash, Somnolence, Taste perversion, Urticaria, Vaginitis
LABORATORY VALUE CHANGES*
CEFTIBUTEN CAPSULES
US CLINICAL TRIALS IN ADULT PATIENTS
* Changes in laboratory values with possible clinical significance regardless of whether or not the investigator thought that the change was due to drug toxicity.
Incidence equal to or greater than 1% ↑ BUN 4%
↑ Eosinophils 3%
↓ Hemoglobin 2%
↑ ALT (SGPT) 1%
↑ Bilirubin 1%
Incidence less than 1% but greater than 0.1% ↑ Alk phosphatase
↑ Creatinine
↑ Platelets
↓ Platelets
↓ Leukocytes
↑ AST (SGOT)
Cedax ORAL SUSPENSION (pediatric patients)

In clinical trials, 1152 pediatric patients (772 US and 380 international), 97% of whom were younger than 12 years of age, were treated with the recommended dose of ceftibuten (9 mg/kg once daily up to a maximum dose of 400 mg per day) for 10 days. There were no deaths, life-threatening adverse events, or permanent disabilities in any of the patients in these studies. Eight of 1152 (<1%) patients discontinued medication due to adverse events thought by the investigators to be possibly, probably, or almost certainly related to drug toxicity. The discontinuations were primarily (7 out of 8) for gastrointestinal disturbances, usually diarrhea or vomiting. One patient was discontinued due to a cutaneous rash thought possibly related to ceftibuten administration.

In the US trials, the following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to ceftibuten oral suspension in multipledose clinical trials (n = 772 ceftibuten-treated patients).

ADVERSE REACTIONS
CEFTIBUTEN ORAL SUSPENSION
US CLINICAL TRIALS IN PEDIATRIC PATIENTS
(n = 772)
* NOTE: The incidence of diarrhea in pediatric patients ≤2 years old was 8% (23/301) compared with 2% (9/471) in pediatric patients >2 years old.
Incidence equal to or greater than 1% Diarrhea* 4%
Vomiting 2%
Abdominal pain 2%
Loose stools 2%
Incidence less than 1% but greater than 0.1% Agitation, Anorexia, Dehydration, Diaper dermatitis, Dizziness, Dyspepsia, Fever, Headache, Hematuria, Hyperkinesia, Insomnia, Irritability, Nausea, Pruritus, Rash, Rigors, Urticaria
LABORATORY VALUE CHANGES*
CEFTIBUTEN ORAL SUSPENSION
US CLINICAL TRIALS IN PEDIATRIC PATIENTS
* Changes in laboratory values with possible clinical significance regardless of whether or not the investigator thought that the change was due to drug toxicity.
Incidence equal to or greater than 1% ↑ Eosinophils 3%
↑ BUN 2%
↓ Hemoglobin 1%
↑ Platelets 1%
Incidence less than 1% but greater than 0.1% ↑ ALT (SGPT)
↑ AST (SGOT)
↑ Alk phosphatase
↑ Bilirubin
↑ Creatinine

In Post-marketing Experience

The following adverse experiences have been reported during worldwide post-marketing surveillance: aphasia, jaundice, melena, psychosis, serum sickness-like reactions, stridor, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

Cephalosporin-class Adverse Reactions

In addition to the adverse reactions listed above that have been observed in patients treated with ceftibuten capsules, the following adverse events and altered laboratory tests have been reported for cephalosporin-class antibiotics:

  allergic reactions, anaphylaxis, drug fever, Stevens-Johnson syndrome, renal dysfunction, toxic nephropathy, hepatic cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, false-positive test for urinary glucose, neutropenia, pancytopenia, and agranulocytosis. Pseudomembranous colitis; onset of symptoms may occur during or after antibiotic treatment (see WARNINGS).

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced (see DOSAGE AND ADMINISTRATION and OVERDOSAGE). If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

Cedax Dosage and Administration

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

Type of infection (as qualified in the INDICATIONS AND USAGE section of this labeling) Daily Maximum Dose Dose and Frequency Duration
ADULTS (12 years of age and older): 400 mg 400 mg QD 10 days
Acute Bacterial Exacerbations of Chronic Bronchitis due to H. influenzae (including β-lactamase-producing strains), M. catarrhalis (including β-lactamase-producing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only).
(See INDICATIONS AND USAGE - NOTE.)
Pharyngitis and tonsillitis due to S. pyogenes. Acute Bacterial Otitis Media due to H. influenzae (including β-lactamase-producing strains), M. catarrhalis (including β-lactamase-producing strains), or S. pyogenes.
(See INDICATIONS AND USAGE - NOTE.)
PEDIATRIC PATIENTS: 400 mg 9 mg/kg QD 10 days
Pharyngitis and tonsillitis due to S. pyogenes. Acute Bacterial Otitis Media due to H. influenzae (including β-lactamase-producing strains), and M. catarrhalis (including β-lactamase-producing strains), or S. pyogenes.
(See INDICATIONS AND USAGE - NOTE.)
CEFTIBUTEN ORAL SUSPENSION
PEDIATRIC DOSAGE CHART
CHILD'S WEIGHT 180 mg/5 mL
Pediatric patients weighing more than 45 kg should receive the maximum daily dose of 400 mg.
10 kg 22 lbs 1/2 tsp QD
20 kg 44 lbs 1 tsp QD
40 kg 88 lbs 2 tsp QD

Renal Impairment

Cedax Capsules and Cedax 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.

Creatinine Clearance Recommended Dosing Schedules
(mL/min)
>50 9 mg/kg or 400 mg Q24h
(normal dosing schedule)
30-49 4.5 mg/kg or 200 mg Q24h
5-29 2.25 mg/kg or 100 mg Q24h

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 Cedax Oral Suspension

DIRECTIONS FOR MIXING Cedax ORAL SUSPENSION
Final Concentration Bottle Size Amount of Water Directions
After mixing, the suspension may be kept for 14 days and must be stored in the refrigerator.
Keep tightly closed. Shake well before each use. Discard any unused portion after 14 days.
180 mg per 5 mL 30 mL Suspend in 28 mL of water First tap the bottle to loosen powder. Then add water in two portions, shaking well after each aliquot.
60 mL Suspend in 53 mL of water

Ceftibuten Identification

Substance Name

Ceftibuten

CAS Registry Number

97519-39-6

Drug Class

Antiinfective Agents

Antibacterial Agents

Cephalosporins

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