Cefadroxil 500mg Capsules

Manufacturer LUPIN PHARMACEUTICALS Active Ingredient Cefadroxil Capsules and Tablets(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 affecting the skin, throat, or urinary tract. It works by killing the bacteria that cause these infections. It belongs to a class of antibiotics called cephalosporins.
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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. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you're feeling well.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of 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're unsure about the best way to dispose 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's close to the time for your next dose, skip the missed dose and resume your regular 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, even if you start feeling better. Do not skip doses or stop taking it early, as this can lead to the infection returning or bacteria becoming resistant.
  • Cefadroxil can be taken with or without food. If it causes stomach upset, taking it with food or milk may help.
  • Drink plenty of fluids while taking this medication.
  • Avoid alcohol consumption, as it may worsen stomach upset or other side effects.

Dosing & Administration

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Adult Dosing

Standard Dose: 1 to 2 grams per day, administered as a single dose or in two divided doses (e.g., 500 mg to 1 g every 12 or 24 hours)
Dose Range: 500 - 2000 mg

Condition-Specific Dosing:

pharyngitis_tonsillitis: 1 g once daily or 500 mg twice daily for 10 days
skin_skin_structure_infections: 1 g once daily or 500 mg twice daily
urinary_tract_infections_uncomplicated: 1 to 2 g per day, as a single dose or in two divided doses (e.g., 1 g once daily or 500 mg twice daily)
urinary_tract_infections_complicated: 1 g twice daily
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Pediatric Dosing

Neonatal: Not established (use with caution, consider alternative)
Infant: 30 mg/kg/day in two divided doses (every 12 hours)
Child: 30 mg/kg/day in two divided doses (every 12 hours) for most infections; for pharyngitis/tonsillitis, 30 mg/kg/day as a single dose or in two divided doses for 10 days.
Adolescent: Adult dosing applies for adolescents weighing >40 kg or with adult body surface area.
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Dose Adjustments

Renal Impairment:

Mild: CrCl 50 mL/min: Initial 1 g, then 500 mg every 12 hours
Moderate: CrCl 25-49 mL/min: Initial 1 g, then 500 mg every 24 hours
Severe: CrCl 10-24 mL/min: Initial 1 g, then 500 mg every 36 hours; CrCl <10 mL/min: Initial 1 g, then 500 mg every 48 hours
Dialysis: Administer 500 mg after each hemodialysis session on dialysis days. On non-dialysis days, follow severe impairment dosing.

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 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.
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Pharmacokinetics

Absorption:

Bioavailability: >90%
Tmax: 1.5 to 2 hours
FoodEffect: Food does not significantly affect the extent of absorption, but may delay the peak plasma concentration (Tmax).

Distribution:

Vd: 0.21 L/kg
ProteinBinding: Approximately 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: >90% excreted unchanged in urine within 24 hours
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Pharmacodynamics

OnsetOfAction: Rapid (within hours of first dose)
PeakEffect: Achieves peak plasma concentrations within 1.5-2 hours, with bactericidal activity sustained as long as concentrations remain above MIC.
DurationOfAction: Dependent on dosing frequency (e.g., 12 or 24 hours for once or twice daily dosing)

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
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)

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor 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 is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 watery diarrhea, especially if it contains blood or mucus (may occur up to several weeks after stopping the medication)
  • Signs of an allergic reaction: rash, itching, hives, swelling of the face/lips/tongue, difficulty breathing
  • Unusual bruising or bleeding
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine or pale stools
  • Severe stomach pain or cramping
  • New signs of infection (e.g., fever, sore throat, chills) that develop during or after treatment (may indicate a new infection or superinfection)
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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 health problems you have, as they may affect the safety and efficacy of this medication.

To ensure your safety, it is crucial to:

Discuss all your medications and health problems with your doctor and pharmacist to verify that it is safe to take this medication in combination with your other treatments.
* Avoid starting, stopping, or changing the dose of any medication without first consulting your doctor. This precaution will help prevent potential interactions and adverse effects.
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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 prolonged use 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. Older adults, 65 years and older, should exercise caution when using this medication, as they may be more susceptible to side effects. If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal discomfort
  • Hematuria (blood in urine)
  • Kidney dysfunction (rare)
  • Neuromuscular hypersensitivity (e.g., seizures, especially in patients with renal impairment)

What to Do:

In case of overdose, seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Treatment is primarily supportive and symptomatic. Hemodialysis may be useful in removing the drug from the blood, especially in patients with impaired renal function.

Drug Interactions

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Major Interactions

  • Live bacterial vaccines (e.g., Typhoid vaccine, oral): Cefadroxil may reduce the therapeutic effect of these vaccines. Avoid concurrent use or administer vaccine at least 24 hours after last antibiotic dose.
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Moderate Interactions

  • Probenecid: May decrease the renal tubular secretion of cefadroxil, resulting in increased and prolonged plasma concentrations of cefadroxil.
  • Oral anticoagulants (e.g., Warfarin): May enhance the anticoagulant effect by altering gut flora and reducing vitamin K synthesis. Monitor INR/PT.
  • Aminoglycosides: Although less common with cephalosporins than penicillins, concurrent use with other nephrotoxic drugs (e.g., aminoglycosides, loop diuretics) may increase the risk of nephrotoxicity. Monitor renal function.

Monitoring

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Baseline Monitoring

Renal function (Serum creatinine, BUN, CrCl)

Rationale: Cefadroxil is primarily renally eliminated; dose adjustment is necessary 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 (e.g., resolution of symptoms, fever)

Frequency: Daily during acute treatment

Target: Improvement in signs and symptoms of infection

Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure, resistant organism, or superinfection; consider culture and sensitivity testing.

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

Frequency: Daily during treatment and for several weeks post-treatment

Target: Absence of new infections

Action Threshold: Development of new symptoms, especially severe or persistent diarrhea (consider C. difficile infection); discontinue cefadroxil and initiate appropriate therapy.

Renal function (Serum creatinine, BUN)

Frequency: Periodically during prolonged therapy or in patients with pre-existing renal impairment or concurrent nephrotoxic drugs.

Target: Stable renal function within patient's baseline

Action Threshold: Significant increase in creatinine/BUN; consider dose adjustment or discontinuation.

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Symptom Monitoring

  • Diarrhea (especially severe or persistent, may indicate C. difficile-associated diarrhea)
  • Rash, itching, hives (signs of allergic reaction)
  • Nausea, vomiting, abdominal pain
  • Signs of superinfection (e.g., white patches in mouth, vaginal itching/discharge)
  • Unusual bleeding or bruising (if on anticoagulants)

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. It is generally considered safe for use during pregnancy when clearly needed.

Trimester-Specific Risks:

First Trimester: No increased risk of congenital anomalies observed in animal studies.
Second Trimester: Generally considered safe.
Third Trimester: Generally considered safe.
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Lactation

Cefadroxil is excreted in low concentrations in human breast milk. The amount ingested by a breastfed infant is generally considered to be low and unlikely to cause significant adverse effects. However, monitor infants for potential changes in bowel flora (e.g., diarrhea, candidiasis) or allergic reactions.

Infant Risk: Low risk (L2 - likely compatible)
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Pediatric Use

Cefadroxil is generally safe and effective for use in pediatric patients. Dosing is weight-based. Safety and efficacy in neonates (infants <1 month of age) have not been established, and use should be approached with caution.

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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 is often necessary.

Clinical Information

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Clinical Pearls

  • Cefadroxil is a first-generation cephalosporin, often used for skin and soft tissue infections, urinary tract infections, and pharyngitis/tonsillitis caused by susceptible organisms.
  • It has excellent oral absorption and can be given once or twice daily, which may improve patient adherence compared to drugs requiring more frequent dosing.
  • Unlike some other cephalosporins, cefadroxil is not significantly metabolized by the liver, making it a good option for patients with hepatic impairment.
  • Always confirm susceptibility of the causative organism before initiating therapy, if possible.
  • Patients should be advised to complete the full course of therapy to prevent the development of antibiotic resistance.
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Alternative Therapies

  • Other first-generation cephalosporins (e.g., Cephalexin, Cefazolin [IV])
  • Penicillins (e.g., Amoxicillin, Penicillin V, Dicloxacillin) depending on the specific infection and susceptibility
  • Macrolides (e.g., Azithromycin, Clarithromycin) for certain respiratory or skin infections, especially in penicillin-allergic patients
  • Fluoroquinolones (e.g., Ciprofloxacin, Levofloxacin) for specific UTIs or more resistant infections, but generally not first-line for common indications of cefadroxil due to broader spectrum and resistance concerns.
  • Sulfonamides (e.g., Trimethoprim/Sulfamethoxazole) for UTIs.
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Cost & Coverage

Average Cost: $15 - $50 per 30 capsules (500mg)
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 is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.