Cefixime 100mg/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 used to treat various bacterial infections, such as ear infections, throat infections, lung infections, urinary tract infections, and gonorrhea. It works by stopping the growth of bacteria.
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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 use it even if your symptoms improve. Before each use, shake the medication well. When measuring a liquid 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.

Missing 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 a missed one.
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Lifestyle & Tips

  • Take the medication exactly as prescribed, even if symptoms improve, to prevent the infection from returning and to reduce the risk of antibiotic resistance.
  • Shake the oral suspension well before each use.
  • Measure the dose accurately using the provided measuring device (spoon or cup), not a household spoon.
  • This medication can be taken with or without food.
  • Store the reconstituted suspension in the refrigerator and discard any unused portion after 14 days.

Dosing & Administration

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Adult Dosing

Standard Dose: 400 mg (20 mL of 100mg/5ml suspension) orally once daily or 200 mg (10 mL of 100mg/5ml suspension) orally every 12 hours
Dose Range: 200 - 400 mg

Condition-Specific Dosing:

Uncomplicated Gonorrhea: 400 mg (20 mL of 100mg/5ml suspension) orally as a single dose
Streptococcal Pharyngitis: 400 mg (20 mL of 100mg/5ml suspension) orally once daily for 10 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 orally once daily or 4 mg/kg orally every 12 hours. Max 400 mg/day.
Child: 6 months to 12 years: 8 mg/kg/day orally once daily or 4 mg/kg orally every 12 hours. Max 400 mg/day.
Adolescent: 12 years and older or >45 kg: 400 mg (20 mL of 100mg/5ml suspension) orally once daily or 200 mg (10 mL of 100mg/5ml suspension) orally every 12 hours.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed for CrCl > 60 mL/min
Moderate: CrCl 21-60 mL/min: 300 mg (15 mL of 100mg/5ml suspension) orally once daily
Severe: CrCl < 20 mL/min: 200 mg (10 mL of 100mg/5ml suspension) orally once daily
Dialysis: Hemodialysis or CAPD: 200 mg (10 mL of 100mg/5ml suspension) orally once daily (not removed significantly by dialysis)

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed

Pharmacology

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Mechanism of Action

Cefixime is a third-generation cephalosporin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs) located inside the bacterial cell wall. This binding prevents the cross-linking of peptidoglycan chains, leading to the disruption of cell wall integrity and ultimately bacterial cell lysis and death.
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Pharmacokinetics

Absorption:

Bioavailability: 40-50% (oral suspension bioavailability is slightly higher than tablet)
Tmax: 2-6 hours
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 (achieves therapeutic concentrations in CSF only when meninges are inflamed)

Elimination:

HalfLife: 3-4 hours (average)
Clearance: Approximately 2 L/hour
ExcretionRoute: Primarily renal (glomerular filtration and tubular secretion); some biliary excretion.
Unchanged: Approximately 50% of an absorbed dose is excreted unchanged in the urine within 24 hours.
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Pharmacodynamics

OnsetOfAction: Rapid (within hours for antibacterial effect)
PeakEffect: Correlates with Tmax (2-6 hours)
DurationOfAction: 24 hours (due to once-daily dosing regimen, despite relatively short half-life, based on time above MIC)

Safety & Warnings

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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 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
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 a life-threatening bowel problem. If you experience any of the following symptoms, contact your doctor right away:

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 may cause side effects. Many people experience no side effects or only 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, consult with your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe or persistent diarrhea (may indicate C. difficile infection)
  • Bloody or watery stools
  • New or worsening rash, hives, or itching
  • Swelling of the face, lips, tongue, or throat
  • Difficulty breathing or swallowing
  • Yellowing of the skin or eyes (jaundice)
  • Unusual bruising or bleeding
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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.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.

To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any existing health problems or conditions

Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
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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 it 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 tests to use, as this medication may affect the accuracy of certain tests. Additionally, be sure to notify all your healthcare providers and laboratory personnel that you are taking this medication, 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 ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Seizures (rare, especially in renally impaired patients)

What to Do:

In case of overdose, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Treatment is primarily supportive; hemodialysis or peritoneal dialysis are not effective in removing cefixime from the body.

Drug Interactions

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Major Interactions

  • Oral anticoagulants (e.g., Warfarin): Increased prothrombin time (PT) and INR, leading to increased bleeding risk. Mechanism: Possible inhibition of vitamin K synthesis by gut flora or displacement from protein binding sites.
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Moderate Interactions

  • Carbamazepine: Increased carbamazepine levels. Mechanism: Cefixime may decrease carbamazepine clearance.
  • Nifedipine: Increased cefixime levels. Mechanism: Nifedipine may increase cefixime absorption.
  • Probenecid: Increased cefixime levels and prolonged half-life. Mechanism: Probenecid inhibits renal tubular secretion of cefixime.

Monitoring

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Baseline Monitoring

Renal function (CrCl)

Rationale: To determine appropriate dosing, especially in elderly or renally impaired patients.

Timing: Prior to initiation of therapy, particularly if renal impairment is suspected or known.

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Routine Monitoring

INR/PT

Frequency: Regularly, especially at initiation and discontinuation of cefixime, and during dose changes

Target: Therapeutic range for the specific indication

Action Threshold: If INR/PT significantly increases, consider dose adjustment of anticoagulant or alternative antibiotic.

Signs of superinfection (e.g., C. difficile-associated diarrhea)

Frequency: Throughout therapy and for several weeks post-therapy

Target: Absence of severe diarrhea, abdominal pain, fever

Action Threshold: If severe, persistent diarrhea occurs, discontinue cefixime and initiate appropriate treatment for C. difficile.

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Symptom Monitoring

  • Diarrhea (especially severe or bloody)
  • Abdominal pain
  • Nausea
  • Vomiting
  • Skin rash or hives
  • Itching
  • Difficulty breathing or swallowing (signs of allergic reaction)
  • Signs of superinfection (e.g., oral thrush, vaginal yeast infection)

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. Human data are limited but generally reassuring. It is generally considered safe for use during pregnancy when clearly needed.

Trimester-Specific Risks:

First Trimester: Low risk; no evidence of increased risk of congenital anomalies.
Second Trimester: Low risk; generally considered safe.
Third Trimester: Low risk; generally considered safe.
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Lactation

Cefixime is excreted in human milk in small amounts (Lactation Risk Category L3 - Moderately Safe). The amount ingested by the infant is typically low. Monitor breastfed infants for potential adverse effects such as diarrhea, candidiasis (thrush), or allergic reactions.

Infant Risk: Low risk of adverse effects; monitor for gastrointestinal disturbances (diarrhea, candidiasis) or allergic reactions.
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Pediatric Use

Cefixime is widely used in pediatric patients 6 months of age and older. Dosing is weight-based (8 mg/kg/day). Safety and efficacy have not been established in infants younger than 6 months.

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Geriatric Use

No specific dose adjustment is required based on age alone. However, elderly patients are more likely to have decreased renal function, which necessitates dose adjustment based on creatinine clearance. Monitor renal function closely.

Clinical Information

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Clinical Pearls

  • Cefixime is a convenient once-daily or twice-daily oral option for various bacterial infections, including otitis media, pharyngitis, bronchitis, and uncomplicated UTIs.
  • It is a common choice for uncomplicated gonococcal infections (single dose).
  • Not active against Pseudomonas aeruginosa or enterococci.
  • Patients should be advised to complete the full course of therapy, even if symptoms improve, to prevent resistance and relapse.
  • Oral suspension must be refrigerated after reconstitution and discarded after 14 days.
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Alternative Therapies

  • Other oral cephalosporins (e.g., Cefdinir, Cefpodoxime, Cefuroxime)
  • Penicillins (e.g., Amoxicillin, Amoxicillin/clavulanate)
  • Macrolides (e.g., Azithromycin, Clarithromycin) for specific indications
  • Fluoroquinolones (e.g., Ciprofloxacin, Levofloxacin) for specific indications (consider resistance patterns and side effects)
  • Sulfonamides (e.g., Trimethoprim/sulfamethoxazole) for specific indications
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Cost & Coverage

Average Cost: Not available (varies widely by pharmacy, location, and insurance) per 50ml bottle
Generic Available: Yes
Insurance Coverage: Generally Tier 1 or 2 for generic formulations, Tier 3 or higher for brand name, depending on insurance plan formulary.
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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 seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.