Cefixime 400mg Capsules
It is used to treat bacterial infections.
Drug Class
Antibiotic
Pharmacologic Class
Third-generation cephalosporin
Pregnancy Category
Category B
FDA Approved
Dec 1989
DEA Schedule
Not Controlled
Overview
What is this medicine?
Cefixime is an antibiotic medication used to treat various bacterial infections, such as ear infections, throat infections, lung infections (bronchitis), and urinary tract infections. It works by killing the bacteria that cause these infections. It is important to take the full course of medication as prescribed, even if you start feeling better, to ensure the infection is completely cleared and to prevent antibiotic resistance.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food, and continue to take it even if your symptoms improve. It's essential to follow your treatment plan as prescribed by your doctor.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method or inquire about potential drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's 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 the missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food, and continue to take it even if your symptoms improve. It's essential to follow your treatment plan as prescribed by your doctor.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method or inquire about potential drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's 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 the missed one.
Lifestyle & Tips
- Take the medication exactly as prescribed by your doctor. Do not skip doses or stop taking it early, even if you feel better.
- Cefixime can be taken with or without food. If it causes stomach upset, try taking it with food.
- Shake the oral suspension well before each use.
- Store the medication at room temperature, away from moisture and heat. The oral suspension should be refrigerated after reconstitution and discarded after 14 days.
- Do not share your medication with others.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
400 mg orally once daily or 200 mg orally every 12 hours
Dose Range:
200 - 400 mg
Condition-Specific Dosing:
uncomplicatedGonorrhea:
400 mg orally as a single dose
pharyngitisTonsillitis:
400 mg orally once daily or 200 mg orally every 12 hours for 5-10 days
acuteBronchitis:
400 mg orally once daily or 200 mg orally every 12 hours for 10-14 days
uncomplicatedUTI:
400 mg orally once daily or 200 mg orally every 12 hours for 7-14 days
otitisMedia:
400 mg orally once daily or 200 mg orally every 12 hours for 10 days
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for infants under 6 months. For 6 months to 12 years: 8 mg/kg/day orally once daily or 4 mg/kg every 12 hours.
Child:
6 months to 12 years: 8 mg/kg/day orally once daily or 4 mg/kg every 12 hours. Max 400 mg/day.
Adolescent:
12 years and older or >45 kg: 400 mg orally once daily or 200 mg orally every 12 hours.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed for CrCl > 60 mL/min.
Moderate:
CrCl 21-60 mL/min: 300 mg orally once daily.
Severe:
CrCl < 20 mL/min: 200 mg orally once daily.
Dialysis:
Hemodialysis or Peritoneal Dialysis: 200 mg orally once daily. Cefixime is not significantly removed by dialysis.
Hepatic Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
No adjustment needed.
Pharmacology
Mechanism of Action
Cefixime is a bactericidal antibiotic that acts by inhibiting bacterial cell wall synthesis. It binds to penicillin-binding proteins (PBPs) located inside the bacterial cell wall, which interferes with the transpeptidation reaction of peptidoglycan synthesis, a crucial step in bacterial cell wall formation. This leads to the disruption of the cell wall, resulting in bacterial cell lysis and death.
Pharmacokinetics
Absorption:
Bioavailability:
40-50%
Tmax:
2-6 hours (capsules), 2-8 hours (oral suspension)
FoodEffect:
Food may delay Tmax but does not significantly alter the extent of absorption (AUC).
Distribution:
Vd:
0.11 L/kg
ProteinBinding:
Approximately 65%
CnssPenetration:
Limited (does not achieve therapeutic concentrations in CSF)
Elimination:
HalfLife:
3-4 hours (normal renal function)
Clearance:
Not available
ExcretionRoute:
Renal (approximately 50% unchanged in urine), some biliary/fecal excretion.
Unchanged:
Approximately 50% (renal)
Pharmacodynamics
OnsetOfAction:
Rapid (within hours of first dose, clinical effect seen within 24-48 hours)
PeakEffect:
Not directly applicable in the same way as other drug classes; efficacy is related to maintaining concentrations above the minimum inhibitory concentration (MIC) for the pathogen.
DurationOfAction:
24 hours (due to once-daily dosing, maintaining therapeutic concentrations)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
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
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of kidney problems, such as:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Seizures
Diarrhea and Antibiotic Use
Diarrhea is a common side effect of antibiotics. In rare cases, a severe form of diarrhea called Clostridioides difficile-associated diarrhea (CDAD) may occur. This condition can lead to life-threatening bowel problems. If you experience stomach pain, cramps, or loose, watery, or bloody stools, contact your doctor right away. Before treating diarrhea, consult with your doctor.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Upset stomach or vomiting
* Stomach pain or diarrhea
Reporting Side Effects
This is not an exhaustive 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.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
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
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of kidney problems, such as:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Seizures
Diarrhea and Antibiotic Use
Diarrhea is a common side effect of antibiotics. In rare cases, a severe form of diarrhea called Clostridioides difficile-associated diarrhea (CDAD) may occur. This condition can lead to life-threatening bowel problems. If you experience stomach pain, cramps, or loose, watery, or bloody stools, contact your doctor right away. Before treating diarrhea, consult with your doctor.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Upset stomach or vomiting
* Stomach pain or diarrhea
Reporting Side Effects
This is not an exhaustive 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.
Seek Immediate Medical Attention If You Experience:
- Severe watery diarrhea or bloody diarrhea (may occur up to several months after treatment)
- Severe skin rash, peeling skin, or blistering (signs of severe allergic reaction)
- Hives, itching, swelling of the face, lips, tongue, or throat (signs of allergic reaction)
- Difficulty breathing or swallowing
- Unusual bleeding or bruising
- Yellowing of the skin or eyes (jaundice)
- Dark urine, pale stools
- Fever, sore throat, swollen glands
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:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances you are taking.
* Any health problems you have, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances you are taking.
* Any health problems you have, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. To minimize the risk of a second infection, do not use this drug for a longer duration than prescribed. If you have diabetes and regularly test your urine glucose levels, consult with your doctor to determine the most suitable tests to use, as this medication may affect the accuracy of certain tests. Additionally, be sure to notify all of your healthcare providers and laboratory personnel that you are taking this drug, as it may impact the results of certain lab tests. If you are pregnant, planning to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to make an informed decision about its use.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Headache
- Dizziness
- Convulsions (rare)
What to Do:
In case of overdose, seek immediate medical attention or call a Poison Control Center (e.g., 1-800-222-1222). Treatment is primarily supportive and symptomatic. Hemodialysis or peritoneal dialysis are not effective in removing cefixime from the body.
Drug Interactions
Major Interactions
- Oral anticoagulants (e.g., Warfarin): May increase prothrombin time (PT) and INR, leading to increased bleeding risk. Mechanism: Possible interference with vitamin K metabolism or displacement from protein binding sites.
- Carbamazepine: Increased carbamazepine levels. Mechanism: Cefixime may inhibit carbamazepine metabolism.
Moderate Interactions
- Probenecid: Increases cefixime plasma concentrations and AUC by decreasing renal tubular secretion. Mechanism: Inhibition of renal tubular secretion.
- Nifedipine: May increase cefixime peak plasma concentrations and AUC. Mechanism: Not fully elucidated, possibly affecting absorption or distribution.
- Live bacterial vaccines (e.g., Typhoid vaccine, BCG): May reduce the therapeutic effect of the vaccine. Mechanism: Antibiotic activity may inhibit bacterial growth required for vaccine efficacy.
Monitoring
Baseline Monitoring
Renal function (Serum Creatinine, eGFR/CrCl)
Rationale: Cefixime is primarily renally eliminated; dose adjustment is required in renal impairment.
Timing: Prior to initiation, especially in elderly patients or those with known renal issues.
Routine Monitoring
Clinical response to infection
Frequency: Daily during treatment
Target: Resolution of signs and symptoms of infection
Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure, resistance, or incorrect diagnosis.
Adverse effects (e.g., diarrhea, rash, nausea)
Frequency: Daily during treatment
Target: Absence or mild, tolerable side effects
Action Threshold: Severe diarrhea (especially bloody), severe rash, signs of allergic reaction (e.g., angioedema, dyspnea) require immediate medical attention and discontinuation.
INR/PT (if co-administered with Warfarin)
Frequency: More frequently (e.g., daily to every few days) during co-administration and for several days after discontinuation of cefixime.
Target: Within therapeutic range for the patient's indication
Action Threshold: INR/PT outside target range requires dose adjustment of anticoagulant.
Symptom Monitoring
- Severe or persistent diarrhea (may indicate Clostridioides difficile-associated diarrhea)
- Skin rash, itching, hives (signs of allergic reaction)
- Swelling of face, lips, tongue, or throat (angioedema)
- Difficulty breathing or swallowing (severe allergic reaction)
- Unusual bleeding or bruising (if on anticoagulants)
- Nausea, vomiting, abdominal pain
Special Patient Groups
Pregnancy
Cefixime is classified as Pregnancy Category B. Animal reproduction studies have shown no evidence of harm to the fetus. Limited human data suggest no increased risk of major birth defects or miscarriage. Generally considered acceptable for use when clearly needed.
Trimester-Specific Risks:
First Trimester:
Low risk; no evidence of increased risk of major birth defects.
Second Trimester:
Low risk; no evidence of adverse effects.
Third Trimester:
Low risk; no evidence of adverse effects.
Lactation
Cefixime is excreted in human milk in very low concentrations. The amount ingested by the infant is typically very small and unlikely to cause adverse effects. Considered compatible with breastfeeding by most experts, but monitor infant for diarrhea, candidiasis (thrush, diaper rash), or allergic reaction.
Infant Risk:
Low risk
Pediatric Use
Safety and efficacy established for children 6 months of age and older. Dosing is weight-based for children. Not recommended for infants younger than 6 months due to insufficient data.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dose adjustment is necessary in elderly patients with significant renal impairment.
Clinical Information
Clinical Pearls
- Cefixime is a convenient once-daily or twice-daily oral cephalosporin, making it useful for outpatient treatment of various infections.
- It is often a good option for treating uncomplicated gonorrhea, especially in cases where injectable ceftriaxone is not feasible or as part of dual therapy.
- Counsel patients on the importance of completing the full course of therapy to prevent resistance and ensure eradication of the infection.
- Warn patients about the potential for Clostridioides difficile-associated diarrhea (CDAD), which can occur during or even several months after antibiotic treatment.
- Patients with a history of severe penicillin allergy (e.g., anaphylaxis) should generally avoid cefixime due to potential cross-reactivity, although the risk is lower with third-generation cephalosporins compared to first-generation.
Alternative Therapies
- Other oral third-generation cephalosporins (e.g., Cefdinir, Cefpodoxime)
- Other classes of antibiotics depending on the specific infection and pathogen susceptibility (e.g., Macrolides, Fluoroquinolones, Penicillins, Tetracyclines, Sulfonamides)
Cost & Coverage
Average Cost:
$30 - $150 per 30 capsules (400mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (preferred generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.