Cedax

Cedax (ceftibuten) is a cephalosporin antibiotic used to treat many different types of infections caused by bacteria. Common side effects of Cedax include:

• nausea,
• vomiting,
• belching,
• constipation,
• diarrhea,
• stomach upset or pain,
• headache,
• dizziness,
• drowsiness,
• tired feeling,
• stiff or tight muscles,
• numbness or tingly feeling,
• feeling agitated,
• irritability,
• restlessness,
• hyperactivity,
• dry mouth,
• white patches or sores inside your mouth or on your lips,
• unusual or unpleasant taste in your mouth,
• stuffy nose,
• noisy breathing,
• sleep problems (insomnia),
• itching or skin rash, or
• vaginal itching or discharge.

Tell your doctor if you have unlikely but serious side effects of Cedax including:

• dark urine,
• persistent nausea or vomiting,
• yellowing eyes or skin (jaundice),
• black stools,
• changes in the amount of urine, or
• joint pain.

The dose of Cedax for adults and children 12 years and older is 400 mg once daily for 10 days. Pediatric dose is determined by the child's weight. Cedax may interact with medication that reduces stomach acid, such as cimetidine, famotidine, omeprazole, or ranitidine. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, Cedax should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Cedax (ceftibuten) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

SIDE EFFECTS: Nausea/vomiting, diarrhea, stomach upset, or headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: dark urine, persistent nausea/vomiting, yellowing eyes/skin, black stool, change in the amount of urine, joint pain.

Tell your doctor immediately if any of these rare but very serious side effects occur: new signs of infection (e.g., fever, persistent sore throat), easy bleeding/bruising, tiredness, fast/pounding heartbeat, seizures, mental/mood changes (such as confusion).

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Cedax (Ceftibuten)

 

Cedax Professional Information

SIDE EFFECTS

Clinical Trials

CEDAX (ceftibuten) 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
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 (SCOT)
* Changes in laboratory values with possible clinical significance regardless of whether or not the investigator thought that the change was due to drug toxicity.

CEDAX (ceftibuten) 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)
Incidence equal to or greater than1%	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
* 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.

LABORATORY VALUE CHANGES* CEFTIBUTEN ORAL SUSPENSION US CLINICAL TRIALS IN PEDIATRIC PATIENTS
Incidence equal to or greater than1%	↑ Eosinophils	3%
	↑ BUN	2%
	↓ Hemoglobin	1%
	↑ Platelets	1%
Incidence less than 1% but greater than 0.1%	↑ ALT (SGPT)
	↑ AST (SCOT)
	↑ Alk phosphatase
	↑ Bilirubin
	↑ Creatinine
* Changes in laboratory values with possible clinical significance regardless of whether or not the investigator thought that the change was due to drug toxicity.

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.

Read the entire FDA prescribing information for Cedax (Ceftibuten)