Ceftibuten

What is Ceftibuten?

• Ceftibuten (Cedax) is a semisynthetic cephalosporin antibiotic for oral administration used to treat certain infections caused by bacteria such as bronchitis (infection of the airway tubes leading to the lungs); and infections of the ears, throat, and tonsils.

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Ceftibuten-Formulae

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Ceftibuten V1

What are the uses of this medicine?

Ceftibuten (Cedax) used for the treatment of:

• Acute Bacterial Exacerbations of Chronic Bronchitis due to Haemophilus influenzae (including β-lactamase-producing strains), Moraxella catarrhalis (including β-lactamase-producing strains), or Streptococcus pneumoniae.
• Acute Bacterial Otitis Media due to Haemophilus influenzae (including β-lactamase-producing strains), Moraxella catarrhalis (including β-lactamase-producing strains), or Streptococcus pyogenes.
• Pharyngitis and Tonsillitis due to Streptococcus pyogenes.

How does this medicine work?

• Ceftibuten - a semisynthetic, beta lactamase stable, third generation cephalosporin with antibacterial activity.
• Ceftibuten binds to and inactivates penicillin binding proteins (pbps) located on the inner membrane of the bacterial cell wall.
• Pbps are enzymes involved in the terminal stages of assembling the bacterial cell wall and in reshaping the cell wall during growth and division. Inactivation of pbps interferes with the cross linkage of peptidoglycan chains necessary for bacterial cell wall strength and rigidity.
• This results in the weakening of the bacterial cell wall and causes cell lysis.

Ceftibuten has been shown to be active against most strains of the following organisms: Gram-positive aerobes:

• Streptococcus pneumoniae (penicillin-susceptible strains only)
• Streptococcus pyogenes

Gram-negative aerobes:

• Haemophilus influenzae (including β-lactamase-producing strains)
• Moraxella catarrhalis (including β-lactamase-producing strains)

Who Should Not Use this medicine ?

This medicine cannot be used:

• with known allergy to the cephalosporin group of antibiotics.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• There have been no chemical or laboratory test interactions with ceftibuten noted to date.
• False-positive direct Coombs' tests have been reported during treatment with other cephalosporins.

Is this medicine FDA approved?

• Yes, it was FDA approved.

How should this medicine be used?

Recommended dosage:

• Cedax Oral Suspension must be administered at least 2 hours before or 1 hour after a meal.

In Acute Bacterial Exacerbations of Chronic Bronchitis and Pharyngitis and tonsillitis: ADULTS (12 years of age and older):

• 400 mg for 10 days.

PEDIATRIC PATIENTS:

• 400 mg for 10 days.
• Pediatric patients weighing more than 45 kg should receive the maximum daily dose of 400 mg.

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.

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.

Administration:

• Ceftibuten comes as a capsule and suspension (liquid) to take by mouth.
• It is usually taken once a day for 10 days. Take the suspension on an empty stomach, at least 2 hours before or 1 hour after eating; the capsules can be taken with or without food.
• Take ceftibuten at around the same time every day.
• Shake the suspension well before each use to mix the medication evenly.
• You should begin to feel better during the first few days of treatment with ceftibuten.
• Continue to take ceftibuten even if you feel better. If you stop taking ceftibuten too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.
• 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Cedax Capsules contain ceftibuten dihydrate equivalent to 400 mg of ceftibuten
• Cedax Oral Suspension after reconstitution contains ceftibuten dihydrate equivalent to 90 mg of ceftibuten per 5 mL.

This medicine is available in fallowing brand namesː

• Catapres; Jenloga

What side effects can this medication cause?

The most common side effects of this medicine include:

Cedax CAPSULES:

• Nausea
• Headache
• Diarrhea
• Dyspepsia
• Dizziness
• Abdominal pain
• Vomiting

Cedax ORAL SUSPENSION:

• Diarrhea
• Vomiting
• Abdominal pain
• Loose stools

Less frequent side effects may include:

Cedax CAPSULES:

• Anorexia
• Constipation
• Dry mouth
• Dyspnea
• Dysuria
• Eructation
• Fatigue
• Flatulence
• Loose stools
• Moniliasis
• Nasal congestion
• Paresthesia
• Pruritus
• Rash
• Somnolence
• Taste perversion
• Urticaria
• Vaginitis

Cedax ORAL SUSPENSION:

• Agitation
• Anorexia
• Dehydration
• Diaper dermatitis
• Dizziness
• Dyspepsia
• Fever
• Headache
• Hematuria
• Hyperkinesia
• Insomnia
• Irritability
• Nausea
• Pruritus
• Rash
• Rigors
• Urticaria

What special precautions should I follow?

• Pseudomembranous colitis has been reported with nearly all antibacterial agents, including ceftibuten, and may range in severity from mild to life threatening. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile.
• Treatment with antibacterial agents alters normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of "antibiotic-associated colitis".
• As with other broad-spectrum antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.
• Ceftibuten should be prescribed with caution to individuals with a history of gastrointestinal disease, particularly colitis.
• Patients should be informed that:

If the patient is diabetic, he/she should be informed that Cedax Oral Suspension contains 1 gram sucrose per teaspoon of suspension. Cedax Oral Suspension should be taken at least 2 hours before a meal or at least 1 hour after a meal.

• It is not known whether ceftibuten (at recommended dosages) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ceftibuten is administered to a nursing woman.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• cerebral irritation leading to convulsions

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• 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.

Can this medicine be used in pregnancy?

• Pregnancy Category B.
• There are no adequate and well-controlled studies in pregnant women.
• Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Can this medicine be used in children?

• The safety and efficacy of ceftibuten in infants less than 6 months of age has not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• Ceftibuten dihydrate

Inactive ingredients:

• gelatin
• sodium lauryl sulfate
• titanium dioxide
• polysorbate 80
• benzyl alcohol
• sodium propionate
• edetate calcium disodium
• butylparaben
• propylparaben
• methylparaben

Who manufactures and distributes this medicine?

Manufactured by:

• Schering Corporation

Distributed by:

• Sciele Pharma, Inc.

What should I know about storage and disposal of this medication?

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

• Dailymed label info on Ceftibuten
• FDA Ceftibuten

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