Duricef 250mg/5ml Susp 100ml

Manufacturer WARNER CHILCOTT 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 medication used to treat various bacterial infections, such as those of the throat, skin, and urinary tract. It works by stopping the growth of bacteria. It is important to take the full course of medication as prescribed, even if you start feeling better, to prevent the infection from returning.
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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 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 the missed one.
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Lifestyle & Tips

  • Take with food or milk if stomach upset occurs.
  • Shake the suspension well before each use.
  • Use an accurate measuring spoon or cup for the liquid form.
  • Complete the entire course of therapy as prescribed, even if symptoms improve.
  • Do not save medication for future infections.
  • Store the suspension in the refrigerator after reconstitution and discard any unused portion after 14 days.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication
Dose Range: 500 - 2000 mg

Condition-Specific Dosing:

Pharyngitis/Tonsillitis (Group A Streptococcal): 1 g once daily or 500 mg twice daily for 10 days
Skin and Skin Structure Infections: 1 g once daily or 500 mg twice daily
Urinary Tract Infections (uncomplicated): 1 to 2 g per day in 1 or 2 divided doses
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Pediatric Dosing

Neonatal: Not established (use with caution, consult specialist)
Infant: 30 mg/kg/day in 1 or 2 divided doses (max 1 g/day)
Child: 30 mg/kg/day in 1 or 2 divided doses (max 1 g/day); for Group A Strep pharyngitis/tonsillitis, 30 mg/kg/day once daily or in 2 divided doses for 10 days
Adolescent: Refer to adult dosing (typically >40 kg or >12 years old)
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Dose Adjustments

Renal Impairment:

Mild: CrCl 50 mL/min: 500 mg every 12 hours
Moderate: CrCl 25-50 mL/min: 500 mg every 24 hours
Severe: CrCl 10-25 mL/min: 500 mg every 36 hours; CrCl <10 mL/min: 500 mg every 48 hours
Dialysis: Administer dose after hemodialysis on dialysis days

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Cefadroxil is a bactericidal antibiotic that acts by inhibiting bacterial cell wall synthesis. It binds to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in the bacterial cell wall, thus inhibiting cell wall biosynthesis. This leads to bacterial cell lysis and death.
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Pharmacokinetics

Absorption:

Bioavailability: >90%
Tmax: 1.5 to 2 hours
FoodEffect: Absorption is not significantly affected by food, but peak concentrations may be delayed. Can be taken with food to minimize gastrointestinal upset.

Distribution:

Vd: 0.2-0.3 L/kg
ProteinBinding: 20%
CnssPenetration: Limited (does not achieve therapeutic concentrations in CSF)

Elimination:

HalfLife: 1.5 to 2 hours (normal renal function); significantly prolonged in renal impairment
Clearance: Primarily renal clearance
ExcretionRoute: Renal (glomerular filtration and tubular secretion)
Unchanged: 85-90% excreted unchanged in urine within 24 hours
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Pharmacodynamics

OnsetOfAction: Rapid
PeakEffect: 1.5 to 2 hours (corresponds to Tmax)
DurationOfAction: 12 to 24 hours (depending on dosing frequency and renal function)

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
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling very 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 (this could be a sign of a rare but potentially life-threatening condition called C. diff-associated diarrhea, or CDAD)

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only have mild ones, it's 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, 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 allergic reaction: rash, hives, itching, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing.
  • Severe or watery diarrhea, especially if it contains blood or mucus (may indicate Clostridioides difficile-associated diarrhea).
  • Unusual bruising or bleeding.
  • Signs of new infection (e.g., fever, sore throat, vaginal itching or discharge, white patches in the mouth).
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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 any allergies you have, including:
- An allergy to this medication or any of its components
- An allergy to other medications, foods, or substances
When discussing your allergy, be sure to describe the symptoms you experienced.

This medication may interact with other medications or health conditions. To ensure safe use, it is crucial to:
- Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
- Share information about any health problems you have
You must verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dosage 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.

If you are pregnant, planning to become pregnant, or are breast-feeding, discuss the potential benefits and risks of this medication with your doctor to determine the best course of treatment for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal discomfort
  • Hematuria (blood in urine)
  • Hyperactivity
  • Convulsions (rare)

What to Do:

In case of suspected overdose, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is primarily supportive and may include gastric lavage or activated charcoal if ingestion was recent. Hemodialysis may be useful in severe cases of renal impairment.

Drug Interactions

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Moderate Interactions

  • Probenecid
  • Oral anticoagulants (e.g., Warfarin)
  • Aminoglycosides
  • Loop diuretics (e.g., Furosemide)
  • Live bacterial vaccines (e.g., Typhoid vaccine)

Monitoring

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Baseline Monitoring

Renal function (Serum creatinine, BUN, CrCl)

Rationale: Cefadroxil is primarily renally eliminated; baseline assessment is crucial for dose adjustment in patients with impaired renal function.

Timing: Prior to initiation of therapy, especially in elderly patients or those with known or suspected renal impairment.

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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 need for alternative therapy.

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

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

Target: Absence of new infections

Action Threshold: Development of new symptoms requires investigation and appropriate management (e.g., C. difficile infection).

Renal function (Serum creatinine, BUN)

Frequency: Periodically during prolonged therapy or in patients with pre-existing renal impairment

Target: Stable within patient's baseline or expected range

Action Threshold: Significant increase may require dose adjustment or discontinuation.

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Symptom Monitoring

  • Rash
  • Hives
  • Itching
  • Swelling (face, lips, tongue, throat)
  • Difficulty breathing or swallowing (signs of allergic reaction)
  • Severe diarrhea (especially watery or bloody)
  • Abdominal pain or cramps
  • 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, and there are no adequate and well-controlled studies in pregnant women. It is 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, commonly used for infections.
Third Trimester: Low risk, no known adverse effects on the fetus or newborn.
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Lactation

Cefadroxil is excreted in human milk in low concentrations. It is generally considered compatible with breastfeeding (Lactation Risk L2). Monitor breastfed infants for potential gastrointestinal disturbances (e.g., diarrhea, candidiasis) or allergic reactions.

Infant Risk: Low risk; potential for mild gastrointestinal upset or sensitization in the infant.
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Pediatric Use

Cefadroxil is widely used in pediatric patients for appropriate indications. Dosing is weight-based. Renal function should be monitored, especially in neonates and infants, as renal elimination is the primary route.

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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. Due to the higher likelihood of decreased renal function in elderly patients, dose adjustment based on creatinine clearance may be necessary.

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 - MSSA) and some Gram-negative bacteria (e.g., E. coli, Klebsiella pneumoniae, Proteus mirabilis).
  • It is often preferred for once-daily or twice-daily dosing due to its relatively long half-life compared to other first-generation cephalosporins like cephalexin.
  • Instruct patients to complete the full course of therapy to prevent the development of antibiotic resistance.
  • Advise patients to take with food if gastrointestinal upset occurs, as this does not significantly impair absorption.
  • Not effective against MRSA (Methicillin-resistant Staphylococcus aureus) or Pseudomonas aeruginosa.
  • May cause a false-positive direct Coombs' test.
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Alternative Therapies

  • Penicillin V (for Group A Strep pharyngitis)
  • Amoxicillin
  • Cephalexin (another first-generation cephalosporin)
  • Cefaclor (second-generation cephalosporin)
  • Azithromycin (for penicillin-allergic patients with certain infections)
  • Clindamycin (for skin/soft tissue infections, especially in penicillin-allergic patients)
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Cost & Coverage

Average Cost: Check current market prices per 100ml suspension
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (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 seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.