Cefixime 200mg/5ml Susp 75ml

Manufacturer AUROBINDO PHARMA Active Ingredient Cefixime Oral Suspension(sef IKS eem) Pronunciation sef IKS eem
It is used to treat bacterial infections.
đŸˇī¸
Drug Class
Antibiotic
đŸ§Ŧ
Pharmacologic Class
Third-generation Cephalosporin
🤰
Pregnancy Category
Category B
✅
FDA Approved
Dec 1987
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Cefixime is an antibiotic used to treat various bacterial infections, such as ear infections, throat infections, lung infections, and urinary tract infections. It works by stopping the growth of bacteria.
📋

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, even if your symptoms improve. You can take this medication with or without food.

Before using the liquid form of this medication, shake the bottle well. To ensure accurate dosing, measure the liquid carefully using the measuring device that comes with the medication. If a measuring device is not provided, ask your pharmacist for one.

Storing and Disposing of Your Medication

Store the liquid suspension at room temperature or in the refrigerator. Do not freeze the medication. Discard any unused portion after 2 weeks. Keep all medications in a safe place, 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 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 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.
💡

Lifestyle & Tips

  • Take the medication exactly as prescribed by your doctor, even if you feel better. Do not skip doses or stop taking it early.
  • Shake the oral suspension well before each use.
  • You can take cefixime with or without food.
  • Store the reconstituted suspension in the refrigerator and discard any unused portion after 14 days.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

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

Condition-Specific Dosing:

uncomplicated_gonorrhea: 400 mg (10 mL) orally as a single dose
streptococcal_pharyngitis: 400 mg (10 mL) orally once daily for 10 days
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established (safety and efficacy not established in neonates or infants less than 6 months of age)
Infant: Not established (safety and efficacy not established in infants less than 6 months of age)
Child: 8 mg/kg/day orally once daily or 4 mg/kg every 12 hours. Max 400 mg/day. For 200mg/5ml suspension, this translates to 0.2 mL/kg/day once daily or 0.1 mL/kg every 12 hours.
Adolescent: Same as adult dosing (400 mg once daily or 200 mg every 12 hours)
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No adjustment needed for CrCl > 60 mL/min
Moderate: CrCl 21-60 mL/min: 300 mg (7.5 mL) orally once daily
Severe: CrCl < 20 mL/min: 200 mg (5 mL) orally once daily
Dialysis: Hemodialysis or CAPD: 200 mg (5 mL) orally once daily. Cefixime is not significantly removed by hemodialysis or peritoneal dialysis.

Hepatic Impairment:

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

Pharmacology

đŸ”Ŧ

Mechanism of Action

Cefixime is a bactericidal antibiotic that inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs). This inhibits the final transpeptidation step of peptidoglycan synthesis in the bacterial cell wall, leading to cell lysis and death.
📊

Pharmacokinetics

Absorption:

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

Distribution:

Vd: Not readily available, but widely distributed in body fluids and tissues.
ProteinBinding: Approximately 65%
CnssPenetration: Limited

Elimination:

HalfLife: 3-4 hours
Clearance: Approximately 2 L/hour (renal clearance)
ExcretionRoute: Renal (glomerular filtration and tubular secretion)
Unchanged: Approximately 50% of absorbed dose is excreted unchanged in urine within 24 hours.
âąī¸

Pharmacodynamics

OnsetOfAction: Rapid (within hours of first dose)
PeakEffect: Within 2-6 hours (Tmax)
DurationOfAction: 24 hours (due to once-daily dosing for most indications)

Safety & Warnings

âš ī¸

Side Effects

Serious Side Effects: Seek Medical Help Immediately

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 medical attention right away:

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
Note: In rare cases, allergic reactions can be fatal.
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, especially if it is severe, bloody, or accompanied by stomach pain or cramps (see below for more information on diarrhea)

Important Information About Diarrhea

Diarrhea is a common side effect of antibiotics. However, in rare cases, a severe form of diarrhea called Clostridioides difficile-associated diarrhea (CDAD) may occur. CDAD can happen during or several months after taking antibiotics and may lead to a life-threatening bowel problem. If you experience stomach pain, cramps, or very loose, watery, or bloody stools, contact your doctor immediately. Before treating diarrhea, consult with your doctor.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical attention:

Upset stomach or vomiting
* Stomach pain or diarrhea

Reporting Side Effects

This list is not exhaustive, and you may experience other 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 diarrhea (watery or bloody stools), even if it occurs several weeks after stopping the medication.
  • 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.
  • Fever, sore throat, or other signs of new infection.
📋

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. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
âš ī¸

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.
🆘

Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal discomfort
  • Seizures (rare, especially in patients with renal impairment)

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 is not effective in removing cefixime from the body.

Drug Interactions

🔴

Major Interactions

  • Warfarin (and other oral anticoagulants): Increased prothrombin time (PT) with or without bleeding. Mechanism: Possible inhibition of vitamin K synthesis by gut flora or direct effect on coagulation factors. Monitor INR/PT closely.
  • Carbamazepine: Increased carbamazepine levels. Mechanism: Cefixime may inhibit carbamazepine metabolism. Monitor carbamazepine levels.
🟡

Moderate Interactions

  • Probenecid: Increases cefixime plasma concentrations and prolongs its half-life. Mechanism: Inhibits renal tubular secretion of cefixime.
  • Nifedipine: May increase cefixime peak plasma concentrations and AUC. Clinical significance is usually minor.

Monitoring

đŸ”Ŧ

Baseline Monitoring

Renal function (CrCl)

Rationale: To determine appropriate dosing, especially in elderly patients or those with known renal impairment.

Timing: Prior to initiation of therapy

INR/PT

Rationale: If patient is concurrently on oral anticoagulants (e.g., warfarin) due to increased bleeding risk.

Timing: Prior to initiation and regularly during co-administration

📊

Routine Monitoring

Signs and symptoms of superinfection (e.g., oral thrush, vaginal yeast infection)

Frequency: Daily during therapy

Target: Absence of new infections

Action Threshold: If new infection develops, consider antifungal/alternative antibiotic therapy.

Bowel movements (for C. difficile-associated diarrhea)

Frequency: Daily during therapy and up to several weeks post-therapy

Target: Normal bowel habits

Action Threshold: If severe, persistent diarrhea occurs, test for C. difficile and discontinue cefixime if positive.

INR/PT

Frequency: Regularly (e.g., 2-3 times per week initially, then as clinically indicated)

Target: Therapeutic range for anticoagulation

Action Threshold: If INR/PT is elevated, adjust anticoagulant dose or consider alternative antibiotic.

đŸ‘ī¸

Symptom Monitoring

  • Diarrhea (especially severe or bloody)
  • Nausea
  • Abdominal pain
  • Rash or hives
  • Itching
  • Difficulty breathing or swallowing (signs of allergic reaction)
  • Signs of superinfection (e.g., white patches in mouth, vaginal itching/discharge)

Special Patient Groups

🤰

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: No increased risk of congenital anomalies observed in animal studies.
Second Trimester: No specific risks identified.
Third Trimester: No specific risks identified.
🤱

Lactation

Cefixime is excreted in very low concentrations in human breast milk. The American Academy of Pediatrics considers cephalosporins compatible with breastfeeding. Monitor breastfed infants for potential adverse effects such as diarrhea, candidiasis (thrush), or allergic reactions.

Infant Risk: Low risk (L3 - Moderately safe)
đŸ‘ļ

Pediatric Use

Safety and efficacy have not been established in infants younger than 6 months of age. Dosing for children 6 months and older is weight-based. Close monitoring for adverse effects is recommended.

👴

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 impaired renal function.

Clinical Information

💎

Clinical Pearls

  • Cefixime is a convenient once-daily oral cephalosporin, making it useful for improving patient adherence.
  • It is a common choice for treating uncomplicated gonorrhea (single dose) and acute otitis media in children.
  • Always complete the full course of therapy, even if symptoms improve, to prevent antibiotic resistance and recurrence of infection.
  • Reconstituted suspension must be refrigerated and discarded after 14 days.
🔄

Alternative Therapies

  • Other oral third-generation cephalosporins (e.g., cefpodoxime, ceftibuten)
  • Other beta-lactam antibiotics (e.g., amoxicillin/clavulanate, ampicillin)
  • Macrolides (e.g., azithromycin, clarithromycin) for certain infections
  • Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) for specific indications, but generally avoided in children due to cartilage concerns.
💰

Cost & Coverage

Average Cost: Varies widely, typically $30-$100+ per 75 mL bottle of 200mg/5mL suspension
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for 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 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.