Duricef 500mg/5ml Susp 100ml

Manufacturer WARNER Active Ingredient Cefadroxil Suspension(sef a DROKS il) Pronunciation sef a DROKS il
It is used to treat bacterial infections.
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Drug Class
Antibiotic
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Pharmacologic Class
First-generation Cephalosporin
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Pregnancy Category
Category B
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FDA Approved
Dec 1977
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Cefadroxil is an antibiotic used to treat various bacterial infections, such as those of the throat, tonsils, urinary tract, and skin. It works by killing the bacteria that cause these infections.
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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. If you experience stomach upset, taking it with food may help. Before using the liquid form, shake the bottle well and measure your dose carefully using the provided measuring device. If one is not included, ask your pharmacist for a suitable measuring device.

It's essential to continue taking your medication as prescribed by your doctor or healthcare provider, even if you're feeling well. This will help ensure you receive the full benefits of the treatment.

Storing and Disposing of Your Medication

Store your medication in the refrigerator at all times. If you don't use the entire contents within 2 weeks, discard any remaining medication. Do not freeze your medication. Keep all medications in a safe and secure location, out of the reach of children and pets.

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 a missed one.
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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 resistant bacteria.
  • Shake the suspension well before each use.
  • Measure the liquid medicine carefully using the provided measuring spoon or cup, not a household spoon.
  • Cefadroxil can be taken with or without food. If it causes stomach upset, take it with food or milk.
  • Store the suspension in the refrigerator after mixing and discard any unused portion after 14 days.
  • Drink plenty of fluids to help prevent kidney problems.
  • Avoid alcohol while taking this medication, as it may worsen stomach upset.

Dosing & Administration

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Adult Dosing

Standard Dose: 1 to 2 grams daily, given as a single dose or in two divided doses
Dose Range: 1000 - 2000 mg

Condition-Specific Dosing:

Pharyngitis/Tonsillitis (Streptococcal): 1 gram once daily or 500 mg twice daily for 10 days
Urinary Tract Infections (uncomplicated): 1 to 2 grams daily as a single dose or in two divided doses
Skin and Skin Structure Infections: 1 gram daily as a single dose or in two divided doses
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Pediatric Dosing

Neonatal: Not established
Infant: 30 mg/kg/day in two divided doses
Child: 30 mg/kg/day in two divided doses (max 100 mg/kg/day or 4 grams/day)
Adolescent: 30 mg/kg/day in two divided doses (max 100 mg/kg/day or 4 grams/day), or adult dose if weight allows
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Dose Adjustments

Renal Impairment:

Mild: CrCl 50-75 mL/min: No adjustment needed
Moderate: CrCl 25-49 mL/min: 500 mg every 12 hours or 1 gram every 24 hours
Severe: CrCl 10-24 mL/min: 500 mg every 24-36 hours
Dialysis: CrCl <10 mL/min: 500 mg every 36 hours or after dialysis session. Cefadroxil is dialyzable.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

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

Absorption:

Bioavailability: Approximately 90%
Tmax: 1.5 to 2 hours
FoodEffect: Food does not affect the extent of absorption, but may delay the peak concentration (Tmax) and decrease peak concentration (Cmax). Can be taken with or without food; taking with food may reduce gastrointestinal upset.

Distribution:

Vd: 0.21 L/kg
ProteinBinding: Approximately 20%
CnssPenetration: Limited (does not achieve therapeutic concentrations in CSF)

Elimination:

HalfLife: Approximately 1.5 hours (normal renal function)
Clearance: Primarily renal clearance
ExcretionRoute: Renal (glomerular filtration and tubular secretion)
Unchanged: Approximately 90% within 24 hours
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Pharmacodynamics

OnsetOfAction: Rapid
PeakEffect: 1.5 to 2 hours (peak plasma concentration)
DurationOfAction: 12 to 24 hours (due to sustained therapeutic concentrations)

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 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
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Seizures
Difficulty urinating or changes in urine output
Vaginal itching or discharge
Diarrhea, especially if it is severe, bloody, or accompanied by stomach pain or cramps (a rare but potentially life-threatening condition called C. diff-associated diarrhea, or CDAD, may occur during or after antibiotic treatment)

Other Possible Side Effects

Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

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.
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Seek Immediate Medical Attention If You Experience:

  • Signs of a severe allergic reaction: rash, hives, itching, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing. Seek immediate medical attention.
  • Severe, watery, or bloody diarrhea (with or without fever and abdominal cramps) that occurs during or after treatment. This could be a sign of a serious intestinal infection (Clostridioides difficile-associated diarrhea). Do not take anti-diarrhea medicine without consulting your doctor.
  • New or worsening signs of infection (e.g., fever, sore throat, vaginal itching or discharge, white patches in the mouth) which could indicate a superinfection.
  • 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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist identify potential interactions.
* Any existing health problems, as this medication may interact with other medical 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 change the dose of any medication without first consulting your doctor.
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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. Do not exceed the prescribed duration of treatment, as this may increase the risk of a second infection.

If you are taking this drug for an extended period, your doctor may recommend regular blood tests to monitor your condition. Be aware that this medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug.

If you have a sulfite allergy, consult your doctor before taking this medication, as some products may contain sulfites. Additionally, if you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

Before taking this medication, inform your doctor if you are pregnant, planning to become pregnant, or are breastfeeding. Your doctor will discuss the potential benefits and risks of this medication to both you and your baby, allowing you to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal discomfort
  • Hematuria (blood in urine)
  • Hyperreflexia
  • Seizures (rare)

What to Do:

Call 1-800-222-1222 (Poison Control Center) immediately or seek emergency medical attention. Treatment is generally supportive; hemodialysis may be useful in severe cases.

Drug Interactions

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Major Interactions

  • Live bacterial vaccines (e.g., BCG, typhoid oral): May decrease therapeutic effect of vaccine.
  • Aminoglycosides (e.g., gentamicin, tobramycin): Increased risk of nephrotoxicity (monitor renal function).
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Moderate Interactions

  • Probenecid: May increase cefadroxil plasma concentrations and prolong its half-life by decreasing renal tubular secretion.
  • Oral anticoagulants (e.g., warfarin): May enhance anticoagulant effect (monitor INR/PT).
  • Loop diuretics (e.g., furosemide): May increase risk of nephrotoxicity with high doses of cephalosporins.
  • Metformin: Cefadroxil may increase metformin plasma concentrations by inhibiting renal tubular secretion (monitor for metformin toxicity).

Monitoring

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Baseline Monitoring

Culture and Sensitivity

Rationale: To identify the causative pathogen and determine its susceptibility to cefadroxil.

Timing: Prior to initiation of therapy

Renal Function (BUN, Creatinine)

Rationale: To establish baseline renal function, especially in elderly patients or those with pre-existing renal impairment, as cefadroxil is primarily renally eliminated.

Timing: Prior to initiation of therapy

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Routine Monitoring

Signs and Symptoms of Infection Resolution

Frequency: Daily

Target: Improvement in fever, pain, inflammation

Action Threshold: Lack of improvement or worsening symptoms after 2-3 days may indicate treatment failure or resistant organism.

Renal Function (BUN, Creatinine)

Frequency: Periodically, especially with prolonged therapy or in patients with renal impairment or concomitant nephrotoxic drugs

Target: Within patient's baseline or acceptable limits

Action Threshold: Significant increase in BUN/creatinine may require dose adjustment or discontinuation.

Signs of Superinfection (e.g., oral thrush, vaginal candidiasis, severe diarrhea)

Frequency: Daily

Target: Absence of new infections

Action Threshold: Development of new infections, especially C. difficile-associated diarrhea, requires evaluation and appropriate management.

Complete Blood Count (CBC) with differential

Frequency: Periodically with prolonged therapy

Target: Within normal limits

Action Threshold: Significant changes (e.g., eosinophilia, leukopenia, thrombocytopenia) may indicate drug-induced hematologic effects.

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Symptom Monitoring

  • Rash
  • Hives
  • Itching
  • Swelling (face, lips, tongue, throat)
  • Difficulty breathing or swallowing
  • Severe diarrhea (especially if bloody or watery)
  • Abdominal pain/cramping
  • Nausea
  • Vomiting
  • Headache
  • Dizziness
  • Vaginal itching or discharge
  • Oral thrush (white patches in mouth)

Special Patient Groups

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Pregnancy

Cefadroxil is classified as Pregnancy Category B. Animal reproduction studies have not demonstrated a risk to the fetus, but there are no adequate and well-controlled studies in pregnant women. Generally considered safe for use during pregnancy when clearly needed.

Trimester-Specific Risks:

First Trimester: Low risk, no evidence of teratogenicity.
Second Trimester: Low risk.
Third Trimester: Low risk.
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Lactation

Cefadroxil is excreted in small amounts into breast milk. The American Academy of Pediatrics considers cephalosporins compatible with breastfeeding. Monitor breastfed infants for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions.

Infant Risk: L2 (Likely Compatible)
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Pediatric Use

Dosing is weight-based. Safety and efficacy in neonates (infants <1 month) have not been established. Use with caution in infants due to immature renal function.

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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 may be necessary based on renal function, which commonly declines with age.

Clinical Information

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Clinical Pearls

  • Cefadroxil is a first-generation cephalosporin, effective against many Gram-positive bacteria (e.g., Streptococcus pyogenes, Staphylococcus aureus) and some Gram-negative bacteria (e.g., E. coli, Klebsiella pneumoniae, Proteus mirabilis).
  • It is often used for uncomplicated urinary tract infections, skin and skin structure infections, and pharyngitis/tonsillitis.
  • Due to its long half-life, it can often be dosed once or twice daily, which may improve patient adherence.
  • Advise patients to complete the entire course of therapy to prevent the development of antibiotic resistance.
  • Refrigerate the reconstituted suspension and discard after 14 days.
  • Patients with a history of penicillin allergy should be monitored closely for cross-reactivity, although it is less common with first-generation cephalosporins (approximately 5-10%).
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Alternative Therapies

  • Other first-generation cephalosporins (e.g., cephalexin, cefazolin)
  • Penicillins (e.g., amoxicillin, penicillin V)
  • Macrolides (e.g., azithromycin, erythromycin) for penicillin-allergic patients
  • Sulfonamides (e.g., trimethoprim/sulfamethoxazole) for UTIs
  • Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) for specific indications
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Cost & Coverage

Average Cost: Varies, typically $20-$50 per 100ml 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 your 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 medication taken, the amount, and the time it happened.