Cefixime 200mg/5ml Susp 50ml

Manufacturer AUROBINDO PHARMA Active Ingredient Cefixime Oral Suspension(sef IKS eem) Pronunciation sef IKS eem
It is used to treat bacterial infections.
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Drug Class
Antibiotic
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Pharmacologic Class
Third-generation Cephalosporin
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Pregnancy Category
Category B
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FDA Approved
Dec 1989
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Cefixime is an antibiotic medication used to treat various bacterial infections, such as ear infections, strep throat, 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 all bacteria are killed and prevent resistance.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication effectively, follow your doctor's instructions and read all the information provided. Take your medication as directed, even if your symptoms improve. You can take this medication with or without food. Before using the liquid form, shake the bottle well to ensure the ingredients are mixed properly. To measure the correct dose, use the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device.

Storing and Disposing of Your Medication

Store the liquid suspension at room temperature or in the refrigerator, but do not freeze it. Discard any unused portion after 2 weeks. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, 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 the missed one.
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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 oral suspension can be taken with or without food. Shake the suspension well before each use.
  • Use an accurate measuring spoon or oral syringe to measure the dose, not a household spoon.
  • Store the suspension in the refrigerator after mixing and discard any unused portion after 14 days.
  • Avoid alcohol consumption as it may worsen gastrointestinal side effects.
  • Stay hydrated, especially if experiencing diarrhea.

Dosing & Administration

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Adult Dosing

Standard Dose: 400 mg once daily or 200 mg every 12 hours
Dose Range: 200 - 400 mg

Condition-Specific Dosing:

uncomplicated_gonorrhea: 400 mg as a single oral dose
pharyngitis_tonsillitis: 400 mg once daily or 200 mg every 12 hours for 5-10 days
acute_bronchitis: 400 mg once daily or 200 mg every 12 hours for 10-14 days
otitis_media: 400 mg once daily or 200 mg every 12 hours for 10 days
uncomplicated_uti: 400 mg once daily or 200 mg every 12 hours for 7 days
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Pediatric Dosing

Neonatal: Not established (safety and efficacy not established in infants less than 6 months of age)
Infant: 6 months to 12 years: 8 mg/kg/day once daily or 4 mg/kg every 12 hours (max 400 mg/day)
Child: 6 months to 12 years: 8 mg/kg/day once daily or 4 mg/kg every 12 hours (max 400 mg/day)
Adolescent: 12 years and older or >50 kg: 400 mg once daily or 200 mg every 12 hours
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Dose Adjustments

Renal Impairment:

Mild: CrCl 31-60 mL/min: No adjustment needed for standard doses. Consider 300 mg once daily if 400 mg/day is used.
Moderate: CrCl 21-30 mL/min: 200 mg once daily
Severe: CrCl < 20 mL/min: 200 mg every other day
Dialysis: Hemodialysis or Peritoneal Dialysis: 200 mg every other day. Cefixime is not substantially removed by dialysis.
Confidence: High

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Confidence: High

Pharmacology

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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 cell wall formation. This leads to the disruption of the cell wall, resulting in cell lysis and bacterial death.
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Pharmacokinetics

Absorption:

Bioavailability: Oral suspension: 40-50% (slightly higher than tablet)
Tmax: 2-6 hours
FoodEffect: Food may delay Tmax but does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: Approximately 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: Approximately 2 L/hour
ExcretionRoute: Renal (glomerular filtration and tubular secretion)
Unchanged: Approximately 50% excreted unchanged in urine within 24 hours
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Pharmacodynamics

OnsetOfAction: Rapid (within hours of first dose, clinical effect seen within 24-48 hours)
PeakEffect: Within 2-6 hours (Tmax)
DurationOfAction: Sustained antibacterial activity due to prolonged time above MIC (T>MIC) allowing for once or twice daily dosing.
Confidence: Medium

Safety & Warnings

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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 or seek immediate 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 any of the following symptoms, contact your doctor immediately:

Stomach pain
Cramps
Very loose, watery, or bloody stools

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 may only have mild 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

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor.

Reporting Side Effects

To report side effects, you can:

Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
* Visit the FDA's MedWatch website at https://www.fda.gov/medwatch
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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)
  • Signs of an allergic reaction: rash, hives, itching, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing
  • Severe stomach pain or cramping
  • Unusual bleeding or bruising
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine or pale stools
  • Fever, chills, body aches (may indicate a new infection or worsening condition)
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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, 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.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication, including this one.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere to the prescribed duration of treatment, as using this drug for an extended period may increase the risk of a second infection. If you have diabetes and regularly test your urine glucose levels, consult with your doctor to determine the most suitable testing methods to use while taking this medication. Be aware that this drug may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this medication. Additionally, 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.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • 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

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Major Interactions

  • Warfarin and other oral anticoagulants (increased prothrombin time/INR, increased bleeding risk)
  • Carbamazepine (increased carbamazepine levels)
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Moderate Interactions

  • Nifedipine (increased cefixime levels)
  • Probenecid (increased cefixime levels and half-life)
  • Aminoglycosides (potential for increased nephrotoxicity, though less common with cephalosporins than with penicillins)
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Minor Interactions

  • Oral contraceptives (theoretical reduction in efficacy, but not clinically significant for most antibiotics)

Monitoring

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Baseline Monitoring

Renal function (BUN, creatinine)

Rationale: Cefixime is primarily renally eliminated; dose adjustment is required in renal impairment.

Timing: Prior to initiation, especially in elderly or patients with known renal dysfunction.

Culture and Sensitivity

Rationale: To confirm susceptibility of the causative pathogen to cefixime.

Timing: Prior to initiation of therapy, if clinically indicated.

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Routine Monitoring

Clinical response to therapy

Frequency: Daily

Target: Resolution of signs and symptoms of infection

Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure, resistance, or alternative diagnosis.

Signs of superinfection (e.g., oral thrush, vaginal candidiasis, C. difficile-associated diarrhea)

Frequency: Daily throughout therapy and for several weeks post-therapy

Target: Absence of new infections

Action Threshold: Development of new or worsening diarrhea, white patches in mouth, or vaginal itching/discharge requires evaluation and potential discontinuation.

INR/PT (if on oral anticoagulants)

Frequency: More frequently (e.g., 2-3 times per week initially)

Target: Therapeutic INR range for the patient's indication

Action Threshold: Significant increase in INR requires dose adjustment of anticoagulant and close monitoring for bleeding.

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Symptom Monitoring

  • Diarrhea (especially severe or persistent, may indicate C. difficile infection)
  • Nausea, vomiting, abdominal pain
  • Skin rash, itching, hives (signs of allergic reaction)
  • Swelling of face, lips, tongue, or throat (signs of angioedema/anaphylaxis)
  • Unusual bleeding or bruising
  • Yellowing of skin or eyes (jaundice)
  • Dark urine, pale stools
  • Fever, sore throat (may indicate blood dyscrasias, though rare)

Special Patient Groups

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Pregnancy

Cefixime 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, but human data are limited.
Second Trimester: Low risk, generally considered safe if clinically indicated.
Third Trimester: Low risk, generally considered safe if clinically indicated.
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Lactation

Cefixime is excreted in very low concentrations into breast milk. It is generally considered compatible with breastfeeding (Lactation Risk Category L2). Monitor breastfed infants for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions.

Infant Risk: Low risk
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Pediatric Use

Cefixime is widely used and generally well-tolerated in pediatric patients aged 6 months and older. Dosing is weight-based. Safety and efficacy have not been established in infants younger than 6 months.

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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. Dosage adjustment is necessary in elderly patients with significant renal impairment.

Clinical Information

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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 pediatric patients due to its palatable suspension formulation and once-daily dosing for many indications.
  • Always complete the full course of therapy to prevent bacterial resistance and ensure eradication of the infection.
  • Counsel patients on the importance of proper measurement of the oral suspension dose.
  • Be vigilant for C. difficile-associated diarrhea, which can occur during or even several weeks after antibiotic therapy.
  • Monitor INR closely if co-administered with warfarin due to potential for increased bleeding risk.
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Alternative Therapies

  • Amoxicillin/clavulanate (Augmentin)
  • Azithromycin (Zithromax)
  • Clarithromycin (Biaxin)
  • Other oral cephalosporins (e.g., Cefdinir, Cefpodoxime)
  • Doxycycline (for certain indications like bronchitis)
  • Levofloxacin (for certain indications like bronchitis, UTI, but with broader spectrum and more side effects)
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Cost & Coverage

Average Cost: Varies widely, typically $20-$100 per 50ml 200mg/5ml suspension
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic)
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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 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 medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.