Cedax 180/5ml Suspension 60ml
It is used to treat bacterial infections.
Drug Class
Antibiotic
Pharmacologic Class
Third-generation cephalosporin antibiotic
Pregnancy Category
Category B
FDA Approved
Dec 1992
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ceftibuten is an antibiotic medication used to treat various bacterial infections, such as ear infections, strep throat, bronchitis, and pneumonia. It works by killing the bacteria that cause these infections. It is a liquid suspension that you take by mouth, usually once a day.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication on an empty stomach, either at least 2 hours before or 1 hour after meals.
Before using the liquid form of this medication, shake the bottle well to mix the contents evenly.
Measure liquid doses precisely using the measuring device provided with the medication. If no device is included, ask your pharmacist for a suitable measuring tool.
Continue taking your medication as instructed, even if your symptoms improve.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it in the refrigerator.
Discard any unused portion after 2 weeks.
Do not freeze your medication.
Keep all medications in a secure location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you forget to take a dose of your medication:
Take the missed dose as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for a missed dose.
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication on an empty stomach, either at least 2 hours before or 1 hour after meals.
Before using the liquid form of this medication, shake the bottle well to mix the contents evenly.
Measure liquid doses precisely using the measuring device provided with the medication. If no device is included, ask your pharmacist for a suitable measuring tool.
Continue taking your medication as instructed, even if your symptoms improve.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it in the refrigerator.
Discard any unused portion after 2 weeks.
Do not freeze your medication.
Keep all medications in a secure location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you forget to take a dose of your medication:
Take the missed dose as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Take the medication exactly as prescribed by your doctor, even if you start feeling better. Do not skip doses or stop taking it early, as this can lead to antibiotic resistance.
- Shake the oral suspension well before each use.
- Use an accurate measuring spoon or cup, not a household spoon, to measure the dose.
- Store the reconstituted suspension in the refrigerator and discard any unused portion after 14 days.
- Drink plenty of fluids to stay hydrated, especially if experiencing diarrhea.
- Avoid antacids or iron supplements within 2 hours of taking ceftibuten, as they can reduce its absorption.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
400 mg once daily
Dose Range:
400 - 400 mg
Condition-Specific Dosing:
acuteBacterialExacerbationOfChronicBronchitis:
400 mg once daily for 10 days
acuteSinusitis:
400 mg once daily for 10 days
pharyngitisTonsillitis:
400 mg once daily for 10 days
communityAcquiredPneumonia:
400 mg once daily for 14 days
uncomplicatedUrinaryTractInfections:
400 mg once daily for 7 days
Pediatric Dosing
Neonatal:
Not established
Infant:
9 mg/kg/day (maximum 400 mg/day) once daily for 10 days (for otitis media, pharyngitis/tonsillitis)
Child:
9 mg/kg/day (maximum 400 mg/day) once daily for 10 days (for otitis media, pharyngitis/tonsillitis); 9 mg/kg/day (maximum 400 mg/day) once daily for 14 days (for community-acquired pneumonia)
Adolescent:
Same as adult dosing (400 mg once daily)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl > 50 mL/min)
Moderate:
200 mg once daily (CrCl 30-49 mL/min)
Severe:
100 mg once daily (CrCl < 29 mL/min)
Dialysis:
100 mg once daily after each dialysis session (hemodialysis or peritoneal dialysis)
Hepatic Impairment:
Mild:
No adjustment
Moderate:
No adjustment
Severe:
No adjustment
Pharmacology
Mechanism of Action
Ceftibuten is a third-generation cephalosporin antibiotic. It exerts its bactericidal action by inhibiting bacterial cell wall synthesis. It binds to penicillin-binding proteins (PBPs) located inside the bacterial cell wall, thereby inhibiting the transpeptidation step of peptidoglycan synthesis, which is crucial for maintaining the integrity and rigidity of the bacterial cell wall. This leads to the disruption of the cell wall, resulting in bacterial lysis and death.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 75-90% (oral suspension is higher than capsules)
Tmax:
2-3 hours
FoodEffect:
Food delays absorption and decreases Cmax, but the extent of absorption (AUC) is generally not significantly affected. The oral suspension is less affected by food than the capsule formulation.
Distribution:
Vd:
0.21 L/kg
ProteinBinding:
62-64%
CnssPenetration:
Limited (does not achieve therapeutically relevant concentrations in CSF)
Elimination:
HalfLife:
2-4 hours
Clearance:
Not readily available, but primarily renal
ExcretionRoute:
Renal (glomerular filtration)
Unchanged:
Approximately 95% (in urine)
Pharmacodynamics
OnsetOfAction:
Rapid (within hours of first dose)
PeakEffect:
Within 2-3 hours (Tmax)
DurationOfAction:
24 hours (due to once-daily dosing regimen and sustained concentrations above MIC)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following signs or symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Difficulty urinating or changes in urine output
Seizures
Vaginal itching or discharge
Diarrhea, especially if it is severe, bloody, or accompanied by stomach pain or cramps (this could be a sign of a rare but potentially life-threatening condition called C. diff-associated diarrhea, or CDAD)
Common Side Effects
Like all medications, this drug can cause side effects. Most people experience no side effects or only mild ones. However, if you notice any of the following side effects or if they bother you or do not go away, contact your doctor:
Upset stomach
Diarrhea
Reporting Side Effects
This is not a complete list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice about side effects and help you determine the best course of action.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following signs or symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Difficulty urinating or changes in urine output
Seizures
Vaginal itching or discharge
Diarrhea, especially if it is severe, bloody, or accompanied by stomach pain or cramps (this could be a sign of a rare but potentially life-threatening condition called C. diff-associated diarrhea, or CDAD)
Common Side Effects
Like all medications, this drug can cause side effects. Most people experience no side effects or only mild ones. However, if you notice any of the following side effects or if they bother you or do not go away, contact your doctor:
Upset stomach
Diarrhea
Reporting Side Effects
This is not a complete list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice about side effects and help you determine the best course of action.
Seek Immediate Medical Attention If You Experience:
- Severe or watery diarrhea, especially if it contains blood or mucus (may be a sign of C. difficile infection)
- New or worsening fever, chills, or body aches (may indicate a new infection)
- Rash, hives, itching, or swelling of the face, lips, tongue, or throat (signs of allergic reaction)
- Difficulty breathing or swallowing
- Unusual bruising or bleeding
- Yellowing of the skin or eyes (jaundice)
- Severe stomach pain
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
If you have a known allergy to ceftibuten or any component of this medication. Be sure to discuss the specifics of your allergy, including any symptoms you experienced.
If you are allergic to this medication, any of its ingredients, or other substances, such as foods, drugs, or other products. Share the details of your allergy and the symptoms that occurred.
Additionally, this medication may interact with other medications or health conditions. To ensure safe use, it is crucial to:
Inform your doctor and pharmacist about all medications you are currently taking, including prescription and over-the-counter (OTC) medications, natural products, and vitamins.
Share information about any existing health problems.
Verify that it is safe to take this medication with your other medications and health conditions.
Do not initiate, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
If you have a known allergy to ceftibuten or any component of this medication. Be sure to discuss the specifics of your allergy, including any symptoms you experienced.
If you are allergic to this medication, any of its ingredients, or other substances, such as foods, drugs, or other products. Share the details of your allergy and the symptoms that occurred.
Additionally, this medication may interact with other medications or health conditions. To ensure safe use, it is crucial to:
Inform your doctor and pharmacist about all medications you are currently taking, including prescription and over-the-counter (OTC) medications, natural products, and vitamins.
Share information about any existing health problems.
Verify that it is safe to take this medication with your other medications and health conditions.
Do not initiate, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are taking this drug for an extended period, your doctor may recommend regular blood tests to monitor your condition.
If you have diabetes and regularly test your urine for glucose, consult with your doctor to determine the most suitable testing method for you while taking this medication. Additionally, be aware that this drug may interfere with certain laboratory tests, so it is crucial to inform all your healthcare providers and laboratory personnel that you are taking this medication.
Do not take this medication for longer than prescribed, as this may increase the risk of a secondary infection. Older adults (65 years and older) should exercise caution when taking this drug, as they may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor to make an informed decision. If you have diabetes, it is vital to closely monitor your blood sugar levels while taking this medication.
If you have diabetes and regularly test your urine for glucose, consult with your doctor to determine the most suitable testing method for you while taking this medication. Additionally, be aware that this drug may interfere with certain laboratory tests, so it is crucial to inform all your healthcare providers and laboratory personnel that you are taking this medication.
Do not take this medication for longer than prescribed, as this may increase the risk of a secondary infection. Older adults (65 years and older) should exercise caution when taking this drug, as they may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor to make an informed decision. If you have diabetes, it is vital to closely monitor your blood sugar levels while taking this medication.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Abdominal discomfort
- Headache
- Dizziness
- Convulsions (rare)
What to Do:
Call 1-800-222-1222 (Poison Control Center) immediately or seek emergency medical attention. Treatment is primarily supportive and symptomatic. Hemodialysis may be useful in removing ceftibuten from the body.
Drug Interactions
Moderate Interactions
- Antacids (e.g., aluminum hydroxide, magnesium hydroxide): May reduce ceftibuten absorption.
- Iron supplements: May reduce ceftibuten absorption.
- Probenecid: May increase ceftibuten plasma concentrations by decreasing renal tubular secretion.
Monitoring
Baseline Monitoring
Renal function (BUN, creatinine)
Rationale: Ceftibuten is primarily renally eliminated; dosage adjustment is required in renal impairment.
Timing: Prior to initiation of therapy, especially in patients with known or suspected renal impairment.
Routine Monitoring
Signs and symptoms of superinfection (e.g., fungal infections, C. difficile-associated diarrhea)
Frequency: Daily during therapy and for several weeks post-therapy
Target: Absence of new infections
Action Threshold: Development of new or worsening symptoms; discontinue ceftibuten and initiate appropriate therapy.
Complete Blood Count (CBC) with differential
Frequency: Periodically during prolonged therapy (e.g., >10 days)
Target: Within normal limits
Action Threshold: Significant abnormalities (e.g., leukopenia, thrombocytopenia) may warrant discontinuation.
Liver function tests (ALT, AST, bilirubin)
Frequency: Periodically during prolonged therapy
Target: Within normal limits
Action Threshold: Significant elevations may warrant discontinuation.
Symptom Monitoring
- Diarrhea (especially severe or persistent)
- Abdominal pain
- Fever
- Rash or itching
- Difficulty breathing or swallowing (signs of allergic reaction)
- Unusual tiredness or weakness
- Yellowing of skin or eyes (jaundice)
Special Patient Groups
Pregnancy
Ceftibuten is classified as Pregnancy Category B. Animal reproduction studies have shown no evidence of harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed.
Trimester-Specific Risks:
First Trimester:
Low risk based on animal data; human data limited.
Second Trimester:
Low risk based on animal data; human data limited.
Third Trimester:
Low risk based on animal data; human data limited.
Lactation
Ceftibuten is excreted in human milk in very low concentrations. The American Academy of Pediatrics considers cephalosporins compatible with breastfeeding. However, caution should be exercised when ceftibuten is administered to a nursing woman.
Infant Risk:
L3 (Moderately Safe) - Potential for disruption of infant gut flora, leading to diarrhea or candidiasis. Allergic sensitization is also a theoretical concern, though unlikely with low exposure.
Pediatric Use
Ceftibuten oral suspension is commonly used in pediatric patients for various infections. Dosing is weight-based (9 mg/kg/day) up to a maximum of 400 mg/day. Safety and efficacy in infants less than 6 months of age have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dosage adjustment is primarily based on renal function, which may be impaired in elderly patients.
Clinical Information
Clinical Pearls
- Ceftibuten oral suspension has better bioavailability than the capsule formulation, especially when taken with food.
- It is a good option for pediatric patients due to its once-daily dosing and palatable suspension form.
- Always ensure proper measurement of the suspension dose using an oral syringe or measuring spoon.
- Counsel patients on the importance of completing the full course of therapy to prevent resistance and recurrence of infection.
- Be vigilant for signs of Clostridioides difficile-associated diarrhea (CDAD), which can occur with nearly all antibacterial agents, including ceftibuten.
Alternative Therapies
- Amoxicillin/clavulanate
- Cefdinir
- Cefixime
- Cefpodoxime
- Azithromycin
- Clarithromycin
- Levofloxacin (for adults, specific indications)
Cost & Coverage
Average Cost:
Varies widely by pharmacy and insurance plan per 60ml suspension
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic), Tier 3 or higher (for brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.